RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "80830-1188-7",
      "PackageDescription": "10 VIAL in 1 CARTON (80830-1188-7)  / 20 mL in 1 VIAL (80830-1188-1) ",
      "NDC11Code": "80830-1188-07",
      "ProductNDC": "80830-1188",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propofol",
      "NonProprietaryName": "Propofol",
      "DosageFormName": "INJECTION, EMULSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240816",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217525",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "PROPOFOL",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240816",
      "SamplePackage": "N",
      "IndicationAndUsage": "Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for.",
      "Description": "Propofol injectable emulsion USP, 10 mg per mL is an anesthetic available as a sterile, nonpyrogenic, white, homogeneous emulsion for intravenous administration. The structural formula of propofol, USP is. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.28 g/mol. Propofol, USP is a clear, colorless to slightly yellowish liquid. It is very soluble in methanol and in ethanol, slightly soluble in cyclohexane and in isopropyl alcohol and very slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6.0 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg propofol, USP; soybean oil, 100 mg; glycerol, 22.5 mg; egg phospholipids, 12 mg; disodium edetate anhydrous, 0.05 mg and sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion, USP is isotonic and has a pH of 7.00 to 8.50."
    },
    {
      "NDCCode": "80830-1691-7",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (80830-1691-7)  / 15 mL in 1 VIAL, SINGLE-DOSE (80830-1691-6) ",
      "NDC11Code": "80830-1691-07",
      "ProductNDC": "80830-1691",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Phosphates",
      "NonProprietaryName": "Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,",
      "DosageFormName": "SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250709",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216344",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC",
      "StrengthNumber": "224; 236",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-09-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250709",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium phosphates injection is indicated as a source of phosphorus: : 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. , 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. .",
      "Description": "Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile clear, colorless, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in water for injection. It is supplied as a 15 mL single-dose vial. Monobasic potassium phosphate, USP is chemically designated potassium dihydrogen phosphate. The molecular formula is KH2PO4, molecular weight is 136.084 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water and practically insoluble in alcohol. Dibasic potassium phosphate, USP is chemically designated dipotassium hydrogen phosphate. The molecular formula is K2HPO4, molecular weight is 174.18 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water. Each mL of Potassium Phosphates Injection, USP contains monobasic potassium phosphate USP, 224 mg; dibasic potassium phosphate USP, 236 mg and water for injection. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
    },
    {
      "NDCCode": "80830-2365-7",
      "PackageDescription": "10 VIAL in 1 CARTON (80830-2365-7)  / 100 mL in 1 VIAL (80830-2365-1) ",
      "NDC11Code": "80830-2365-07",
      "ProductNDC": "80830-2365",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propofol",
      "NonProprietaryName": "Propofol",
      "DosageFormName": "INJECTION, EMULSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240816",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217525",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "PROPOFOL",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240816",
      "SamplePackage": "N",
      "IndicationAndUsage": "Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for.",
      "Description": "Propofol injectable emulsion USP, 10 mg per mL is an anesthetic available as a sterile, nonpyrogenic, white, homogeneous emulsion for intravenous administration. The structural formula of propofol, USP is. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.28 g/mol. Propofol, USP is a clear, colorless to slightly yellowish liquid. It is very soluble in methanol and in ethanol, slightly soluble in cyclohexane and in isopropyl alcohol and very slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6.0 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg propofol, USP; soybean oil, 100 mg; glycerol, 22.5 mg; egg phospholipids, 12 mg; disodium edetate anhydrous, 0.05 mg and sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion, USP is isotonic and has a pH of 7.00 to 8.50."
    },
    {
      "NDCCode": "80830-1683-3",
      "PackageDescription": "5 TRAY in 1 CARTON (80830-1683-3)  / 5 VIAL, GLASS in 1 TRAY (80830-1683-2)  / 1 mL in 1 VIAL, GLASS",
      "NDC11Code": "80830-1683-03",
      "ProductNDC": "80830-1683",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phytonadione",
      "NonProprietaryName": "Phytonadione",
      "DosageFormName": "INJECTION, EMULSION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
      "StartMarketingDate": "20260601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217734",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "PHYTONADIONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phytonadione injectable emulsion is a vitamin K replacement indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 Anticoagulant-induced hypoprothrombinemia deficiency caused by coumarin or indanedione derivatives. (1.1), 2 Hypoprothrombinemia due to antibacterial therapy. (1.1), 3 Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis. (1.1), 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. (1.1).",
      "Description": "Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, very viscous liquid. It is soluble in dehydrated alcohol, in benzene, in chloroform, in ether and in vegetable oils; slightly soluble in alcohol and insoluble in water. It has a molecular weight of 450.70 g/mol. Phytonadione is 2-Methyl-3-(3,7,11,15-tetramethylhexadec-2-en-1-yl)naphthalene-1,4-dione. It’s molecular formula is C31H46O2 and its molecular structure is. Phytonadione injectable emulsion, USP is a clear, yellow color, sterile, nonpyrogenic aqueous dispersion available for injection by the intravenous, intramuscular and subcutaneous routes. Phytonadione injectable emulsion, USP is available in 10 mg (10 mg/mL) single-dose vial. Each milliliter contains phytonadione USP, 10 mg; polyoxyethylated fatty acid derivative 70 mg; citric acid monohydrate 1 mg; disodium hydrogen phosphate dihydrate 3 mg and dextrose, hydrous 37.5 mg in water for injection. May contain hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0). Phytonadione is oxygen sensitive."
    },
    {
      "NDCCode": "80830-1691-2",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (80830-1691-2)  / 15 mL in 1 VIAL, SINGLE-DOSE (80830-1691-1) ",
      "NDC11Code": "80830-1691-02",
      "ProductNDC": "80830-1691",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Phosphates",
      "NonProprietaryName": "Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,",
      "DosageFormName": "SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231023",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216344",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC",
      "StrengthNumber": "224; 236",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231023",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium phosphates injection is indicated as a source of phosphorus: : 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. , 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. .",
      "Description": "Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile clear, colorless, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic potassium phosphate, USP is chemically designated potassium dihydrogen phosphate. The molecular formula is KH2PO4, molecular weight is 136.084 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water and practically insoluble in alcohol. Dibasic potassium phosphate, USP is chemically designated dipotassium hydrogen phosphate. The molecular formula is K2HPO4, molecular weight is 174.18 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water. Each mL of Potassium Phosphates Injection, USP contains monobasic potassium phosphate USP, 224 mg; dibasic potassium phosphate USP, 236 mg and water for injection. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
    },
    {
      "NDCCode": "80830-1691-5",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (80830-1691-5)  / 15 mL in 1 VIAL, SINGLE-DOSE (80830-1691-1) ",
      "NDC11Code": "80830-1691-05",
      "ProductNDC": "80830-1691",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Phosphates",
      "NonProprietaryName": "Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,",
      "DosageFormName": "SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231023",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216344",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC",
      "StrengthNumber": "224; 236",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231023",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium phosphates injection is indicated as a source of phosphorus: : 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. , 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. .",
      "Description": "Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile clear, colorless, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic potassium phosphate, USP is chemically designated potassium dihydrogen phosphate. The molecular formula is KH2PO4, molecular weight is 136.084 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water and practically insoluble in alcohol. Dibasic potassium phosphate, USP is chemically designated dipotassium hydrogen phosphate. The molecular formula is K2HPO4, molecular weight is 174.18 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water. Each mL of Potassium Phosphates Injection, USP contains monobasic potassium phosphate USP, 224 mg; dibasic potassium phosphate USP, 236 mg and water for injection. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
    },
    {
      "NDCCode": "80830-1691-9",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (80830-1691-9)  / 15 mL in 1 VIAL, SINGLE-DOSE (80830-1691-3) ",
      "NDC11Code": "80830-1691-09",
      "ProductNDC": "80830-1691",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Phosphates",
      "NonProprietaryName": "Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,",
      "DosageFormName": "SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250709",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216344",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC",
      "StrengthNumber": "224; 236",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-09-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250709",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium phosphates injection is indicated as a source of phosphorus: : 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. , 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. .",
      "Description": "Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile clear, colorless, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in water for injection. It is supplied as a 15 mL single-dose vial. Monobasic potassium phosphate, USP is chemically designated potassium dihydrogen phosphate. The molecular formula is KH2PO4, molecular weight is 136.084 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water and practically insoluble in alcohol. Dibasic potassium phosphate, USP is chemically designated dipotassium hydrogen phosphate. The molecular formula is K2HPO4, molecular weight is 174.18 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water. Each mL of Potassium Phosphates Injection, USP contains monobasic potassium phosphate USP, 224 mg; dibasic potassium phosphate USP, 236 mg and water for injection. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
    },
    {
      "NDCCode": "80830-1692-2",
      "PackageDescription": "10 VIAL in 1 CARTON (80830-1692-2)  / 50 mL in 1 VIAL (80830-1692-1) ",
      "NDC11Code": "80830-1692-02",
      "ProductNDC": "80830-1692",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Phosphates",
      "NonProprietaryName": "Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,",
      "DosageFormName": "SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231023",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216344",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC",
      "StrengthNumber": "224; 236",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231023",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium phosphates injection is indicated as a source of phosphorus: : 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. , 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. .",
      "Description": "Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile clear, colorless, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic potassium phosphate, USP is chemically designated potassium dihydrogen phosphate. The molecular formula is KH2PO4, molecular weight is 136.084 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water and practically insoluble in alcohol. Dibasic potassium phosphate, USP is chemically designated dipotassium hydrogen phosphate. The molecular formula is K2HPO4, molecular weight is 174.18 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water. Each mL of Potassium Phosphates Injection, USP contains monobasic potassium phosphate USP, 224 mg; dibasic potassium phosphate USP, 236 mg and water for injection. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
    },
    {
      "NDCCode": "80830-1692-5",
      "PackageDescription": "25 VIAL in 1 CARTON (80830-1692-5)  / 50 mL in 1 VIAL (80830-1692-1) ",
      "NDC11Code": "80830-1692-05",
      "ProductNDC": "80830-1692",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Phosphates",
      "NonProprietaryName": "Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,",
      "DosageFormName": "SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231023",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216344",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC",
      "StrengthNumber": "224; 236",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231023",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium phosphates injection is indicated as a source of phosphorus: : 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. , 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. .",
      "Description": "Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile clear, colorless, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic potassium phosphate, USP is chemically designated potassium dihydrogen phosphate. The molecular formula is KH2PO4, molecular weight is 136.084 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water and practically insoluble in alcohol. Dibasic potassium phosphate, USP is chemically designated dipotassium hydrogen phosphate. The molecular formula is K2HPO4, molecular weight is 174.18 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water. Each mL of Potassium Phosphates Injection, USP contains monobasic potassium phosphate USP, 224 mg; dibasic potassium phosphate USP, 236 mg and water for injection. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
    },
    {
      "NDCCode": "80830-1693-3",
      "PackageDescription": "5 VIAL, SINGLE-DOSE in 1 CARTON (80830-1693-3)  / 5 mL in 1 VIAL, SINGLE-DOSE (80830-1693-1) ",
      "NDC11Code": "80830-1693-03",
      "ProductNDC": "80830-1693",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Phosphates",
      "NonProprietaryName": "Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,",
      "DosageFormName": "SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231023",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216344",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC",
      "StrengthNumber": "224; 236",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231023",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium phosphates injection is indicated as a source of phosphorus: : 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. , 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. .",
      "Description": "Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile clear, colorless, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic potassium phosphate, USP is chemically designated potassium dihydrogen phosphate. The molecular formula is KH2PO4, molecular weight is 136.084 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water and practically insoluble in alcohol. Dibasic potassium phosphate, USP is chemically designated dipotassium hydrogen phosphate. The molecular formula is K2HPO4, molecular weight is 174.18 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water. Each mL of Potassium Phosphates Injection, USP contains monobasic potassium phosphate USP, 224 mg; dibasic potassium phosphate USP, 236 mg and water for injection. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
    },
    {
      "NDCCode": "80830-1693-5",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (80830-1693-5)  / 5 mL in 1 VIAL, SINGLE-DOSE (80830-1693-1) ",
      "NDC11Code": "80830-1693-05",
      "ProductNDC": "80830-1693",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Phosphates",
      "NonProprietaryName": "Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,",
      "DosageFormName": "SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20231023",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216344",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC",
      "StrengthNumber": "224; 236",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231023",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium phosphates injection is indicated as a source of phosphorus: : 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. , 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. .",
      "Description": "Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile clear, colorless, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic potassium phosphate, USP is chemically designated potassium dihydrogen phosphate. The molecular formula is KH2PO4, molecular weight is 136.084 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water and practically insoluble in alcohol. Dibasic potassium phosphate, USP is chemically designated dipotassium hydrogen phosphate. The molecular formula is K2HPO4, molecular weight is 174.18 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water. Each mL of Potassium Phosphates Injection, USP contains monobasic potassium phosphate USP, 224 mg; dibasic potassium phosphate USP, 236 mg and water for injection. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
    },
    {
      "NDCCode": "80830-2305-2",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (80830-2305-2)  / 50 mL in 1 VIAL, SINGLE-DOSE (80830-2305-1) ",
      "NDC11Code": "80830-2305-02",
      "ProductNDC": "80830-2305",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Bicarbonate",
      "NonProprietaryName": "Sodium Bicarbonate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260113",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217523",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "SODIUM BICARBONATE",
      "StrengthNumber": "84",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Alkalinizing Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-03-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260113",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium bicarbonate injection is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis - e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial - e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.",
      "Description": "Sodium bicarbonate injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in concentration of 8.4%. See table in HOW SUPPLIED section for contents and characteristics. The solution contains no bacteriostat, antimicrobial agent or added buffer and are intended only for use as a single-dose injection, the approximate pH of the solution is between 7.0 to 8.5. When smaller doses are required, the unused portion should be discarded. Sodium bicarbonate USP, 84 mg is equal to one milliequivalent each of Na+ and HCO3-. Sodium bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water and insoluble in ethanol. Water for injection, USP is chemically designated H2O."
    },
    {
      "NDCCode": "80830-2364-8",
      "PackageDescription": "20 VIAL in 1 CARTON (80830-2364-8)  / 50 mL in 1 VIAL (80830-2364-1) ",
      "NDC11Code": "80830-2364-08",
      "ProductNDC": "80830-2364",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propofol",
      "NonProprietaryName": "Propofol",
      "DosageFormName": "INJECTION, EMULSION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240816",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217525",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "PROPOFOL",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240816",
      "SamplePackage": "N",
      "IndicationAndUsage": "Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for.",
      "Description": "Propofol injectable emulsion USP, 10 mg per mL is an anesthetic available as a sterile, nonpyrogenic, white, homogeneous emulsion for intravenous administration. The structural formula of propofol, USP is. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.28 g/mol. Propofol, USP is a clear, colorless to slightly yellowish liquid. It is very soluble in methanol and in ethanol, slightly soluble in cyclohexane and in isopropyl alcohol and very slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6.0 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg propofol, USP; soybean oil, 100 mg; glycerol, 22.5 mg; egg phospholipids, 12 mg; disodium edetate anhydrous, 0.05 mg and sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion, USP is isotonic and has a pH of 7.00 to 8.50."
    },
    {
      "NDCCode": "80830-2435-2",
      "PackageDescription": "25 BOTTLE, PLASTIC in 1 CARTON (80830-2435-2)  / 20 mL in 1 BOTTLE, PLASTIC (80830-2435-1) ",
      "NDC11Code": "80830-2435-02",
      "ProductNDC": "80830-2435",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Acetate",
      "NonProprietaryName": "Sodium Acetate",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260303",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218469",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "SODIUM ACETATE ANHYDROUS",
      "StrengthNumber": "164",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260303",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium acetate injection, 40 mEq is indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.",
      "Description": "Sodium acetate injection USP, 40 mEq (2 mEq/mL) is a sterile, clear, colorless, nonpyrogenic, concentrated solution of sodium acetate 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 20 mL contains 3.28 g of sodium acetate, USP (anhydrous) which provides 40 mEq each of sodium (Na+) and acetate (CH3COO−). The solution contains no bacteriostat, antimicrobial agent or added buffer. May contain acetic acid for pH adjustment; the pH is 6.0 to 7.0. The osmolar concentration is 4 mOsmol/mL (calc). The solution is intended as an alternative to sodium chloride to provide sodium ion (Na+) for addition to large volume infusion fluids for intravenous use. Sodium acetate, USP (anhydrous) is chemically designated CH3COONa, a hygroscopic powder freely soluble in water."
    },
    {
      "NDCCode": "80830-2436-2",
      "PackageDescription": "25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-2436-2)  / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-2436-1) ",
      "NDC11Code": "80830-2436-02",
      "ProductNDC": "80830-2436",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Acetate",
      "NonProprietaryName": "Sodium Acetate",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250812",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218469",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "SODIUM ACETATE ANHYDROUS",
      "StrengthNumber": "164",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250812",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium acetate injection, 2 mEq/mL is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.",
      "Description": "Sodium acetate injection, USP (2 mEq/mL) is a sterile, clear, colorless, nonpyrogenic, concentrated solution of sodium acetate 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 164 mg of sodium acetate, USP (anhydrous) which provides 2 mEq each of sodium (Na+) and acetate (CH3COO-). The solution contains no bacteriostat, antimicrobial agent or added buffer. May contain acetic acid for pH adjustment; the pH is 6.5 (6.0 to 7.0). The osmolar concentration is 4 mOsmol/mL (calc.); specific gravity 1.081. The solution is intended as an alternative to sodium chloride to provide sodium ion (Na+) for addition to large volume infusion fluids for intravenous use. Sodium acetate, USP, anhydrous is chemically designated CH3COONa, a hygroscopic powder freely soluble in water. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion."
    },
    {
      "NDCCode": "80830-2437-2",
      "PackageDescription": "10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-2437-2)  / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-2437-1) ",
      "NDC11Code": "80830-2437-02",
      "ProductNDC": "80830-2437",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Acetate",
      "NonProprietaryName": "Sodium Acetate",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250812",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218469",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "SODIUM ACETATE ANHYDROUS",
      "StrengthNumber": "164",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250812",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium acetate injection, 2 mEq/mL is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.",
      "Description": "Sodium acetate injection, USP (2 mEq/mL) is a sterile, clear, colorless, nonpyrogenic, concentrated solution of sodium acetate 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 164 mg of sodium acetate, USP (anhydrous) which provides 2 mEq each of sodium (Na+) and acetate (CH3COO-). The solution contains no bacteriostat, antimicrobial agent or added buffer. May contain acetic acid for pH adjustment; the pH is 6.5 (6.0 to 7.0). The osmolar concentration is 4 mOsmol/mL (calc.); specific gravity 1.081. The solution is intended as an alternative to sodium chloride to provide sodium ion (Na+) for addition to large volume infusion fluids for intravenous use. Sodium acetate, USP, anhydrous is chemically designated CH3COONa, a hygroscopic powder freely soluble in water. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion."
    },
    {
      "NDCCode": "80830-2465-9",
      "PackageDescription": "24 POUCH in 1 CARTON (80830-2465-9)  / 1 BAG in 1 POUCH (80830-2465-1)  / 100 mL in 1 BAG",
      "NDC11Code": "80830-2465-09",
      "ProductNDC": "80830-2465",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metronidazole",
      "NonProprietaryName": "Metronidazole",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230617",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217665",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "METRONIDAZOLE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
      "Status": "Active",
      "LastUpdate": "2025-09-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230617",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metronidazole injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole injection therapy. In a mixed aerobic and anaerobic infection, antibacterial drugs appropriate for the treatment of the aerobic infection should be used in addition to metronidazole injection. Metronidazole injection is effective in Bacteroides fragilis infections resistant to clindamycin, chloramphenicol and penicillin. : 1 Intra-Abdominal Infections, including peritonitis, intra-abdominal abscess and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species and Peptostreptococcus species in adults and pediatric patients less than 4 months of age. .",
      "Description": "Metronidazole injection, USP, is a parenteral formulation of the synthetic nitroimidazole antibacterial agent 2-methyl-5-nitro-1H-imidazole-1-ethanol. Metronidazole injection USP, 500 mg/100 mL (5 mg/mL) is a sterile, clear, colorless to pale yellow color, nonpyrogenic, iso-osmotic, buffered solution supplied in 100 mL single-dose non-PVC plastic container. Each 100 mL contains 500 mg metronidazole, USP; 790 mg sodium chloride, USP; 47.6 mg dibasic sodium phosphate dried, USP; and 22.9 mg citric acid anhydrous, USP. Metronidazole injection, USP has an osmolarity of 308.66 mOsmol/L (calc) and a pH of 5.5 (4.5 to 7.0). Each container contains 14 mEq of sodium."
    },
    {
      "NDCCode": "80830-2613-2",
      "PackageDescription": "6 POUCH in 1 CARTON (80830-2613-2)  / 1 BAG in 1 POUCH (80830-2613-1)  / 1000 mL in 1 BAG",
      "NDC11Code": "80830-2613-02",
      "ProductNDC": "80830-2613",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Bicarbonate",
      "NonProprietaryName": "Sodium Bicarbonate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260713",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA220790",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "SODIUM BICARBONATE",
      "StrengthNumber": "12.6",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Alkalinizing Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260713",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium bicarbonate injection is an alkalinizing agent indicated: 1 to raise plasma pH in adults and pediatric patients with clinically significant metabolic acidosis. (1.1) , 2 to alkalinize the urine in drug poisoning in adult and pediatric patients in cases in which urinary drug elimination is enhanced by urinary alkalinaztion. (1.2).",
      "Description": "Sodium bicarbonate injection, USP is an alkalinizing agent, supplied as a sterile, nonpyrogenic, clear, colorless, ready-to-use solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous infusion as an electrolyte replenisher and systemic alkalizer. Sodium bicarbonate, 12.6 mg is equal to 0.15 milliequivalent each of Na+ and HCO3-. Sodium bicarbonate, USP is chemically designated NaHCO3, molecular weight 84.01 g/mol, a white crystalline powder soluble in water and insoluble in ethanol. Solution is offered in concentration of 1.26% [see How Supplied Storage and Handling (16.1)]. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as an intravenous infusion. Carbon dioxide is added to adjust pH between 7 to 8.5. When smaller doses are required, the unused portion should be discarded."
    },
    {
      "NDCCode": "0019-1188-27",
      "PackageDescription": "20 BOX in 1 CARTON (0019-1188-27)  > 1 SYRINGE, PLASTIC in 1 BOX > 125 mL in 1 SYRINGE, PLASTIC",
      "NDC11Code": "00019-1188-27",
      "ProductNDC": "0019-1188",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVASCULAR",
      "StartMarketingDate": "20120901",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021569",
      "LabelerName": "Liebel-Flarsheim Company LLC",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": ".9",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-12-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120901",
      "SamplePackage": "N",
      "IndicationAndUsage": "125 mL Syringe:  Sodium Chloride Injection USP 0.9% is indicated for use in flushing compatible contrast agents through Liebel-Flarsheim intravenous administration sets into indwelling intravascular access devices only when delivered by the following Liebel-Flarsheim power injectors: Angiomat®, Illumena®, Illumena® Néo, CT9000®, CT9000® ADV, Optistat®, Optivantage® and Optistar Elite.",
      "Description": "Sodium Chloride Injection USP 0.9% is a formulation of sodium chloride in Water for Intravascular Injection. No preservative, antimicrobial agent or buffer is added. Sodium Chloride Injection USP 0.9% is provided as a sterile, nonpyrogenic, clear, colorless, odorless solution.    Molecular formula = NaCl                   MW = 58.44Each mL of Sodium Chloride Injection USP 0.9% contains 9 mg of sodium chloride. The pH is 4.5 to 7.0. The osmolarity is 308 mOsm/L (calc.).  Sodium Chloride Injection USP 0.9% is provided in a 125 mL syringe with a 125 mL fill.  The syringes are for single patient use and are disposable and not meant for reuse."
    },
    {
      "NDCCode": "0019-1188-81",
      "PackageDescription": "20 BOX in 1 CARTON (0019-1188-81)  > 1 SYRINGE, PLASTIC in 1 BOX > 125 mL in 1 SYRINGE, PLASTIC",
      "NDC11Code": "00019-1188-81",
      "ProductNDC": "0019-1188",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVASCULAR",
      "StartMarketingDate": "20120901",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021569",
      "LabelerName": "Liebel-Flarsheim Company LLC",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": ".9",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-12-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120901",
      "SamplePackage": "N",
      "IndicationAndUsage": "125 mL Syringe:  Sodium Chloride Injection USP 0.9% is indicated for use in flushing compatible contrast agents through Liebel-Flarsheim intravenous administration sets into indwelling intravascular access devices only when delivered by the following Liebel-Flarsheim power injectors: Angiomat®, Illumena®, Illumena® Néo, CT9000®, CT9000® ADV, Optistat®, Optivantage® and Optistar Elite.",
      "Description": "Sodium Chloride Injection USP 0.9% is a formulation of sodium chloride in Water for Intravascular Injection. No preservative, antimicrobial agent or buffer is added. Sodium Chloride Injection USP 0.9% is provided as a sterile, nonpyrogenic, clear, colorless, odorless solution.    Molecular formula = NaCl                   MW = 58.44Each mL of Sodium Chloride Injection USP 0.9% contains 9 mg of sodium chloride. The pH is 4.5 to 7.0. The osmolarity is 308 mOsm/L (calc.).  Sodium Chloride Injection USP 0.9% is provided in a 125 mL syringe with a 125 mL fill.  The syringes are for single patient use and are disposable and not meant for reuse."
    },
    {
      "NDCCode": "50090-1188-0",
      "PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (50090-1188-0) ",
      "NDC11Code": "50090-1188-00",
      "ProductNDC": "50090-1188",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cefprozil",
      "NonProprietaryName": "Cefprozil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20051223",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065208",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "CEFPROZIL",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20141128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
      "Description": "Cefprozil, USP is a semi-synthetic broad-spectrum cephalosporin antibiotic. Cefprozil, USP is a cis and trans isomeric mixture (≥ 90% cis). The chemical name for the monohydrate is (6R,7R)-7-[(R)-2-amino-2-(p-hydroxyphenyl)acetamido]-8-oxo-3-propenyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate, and the structural formula is. C18H19N3O5SH2O M.W. 407.45. Cefprozil, USP is a white to yellowish powder. Cefprozil Tablets USP are intended for oral administration. Cefprozil Tablets USP contain cefprozil, USP equivalent to 250 mg or 500 mg of anhydrous cefprozil. In addition, each tablet contains the following inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 250 mg tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, and FD&C Yellow No. 6 Aluminum Lake."
    },
    {
      "NDCCode": "53002-1188-1",
      "PackageDescription": "1 KIT in 1 BLISTER PACK (53002-1188-1) ",
      "NDC11Code": "53002-1188-01",
      "ProductNDC": "53002-1188",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cryselle",
      "NonProprietaryName": "Norgestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20020724",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075840",
      "LabelerName": "RPK Pharmaceuticals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20190101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cryselle is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.",
      "Description": "Cryselle® is a combination oral contraceptive containing the progestational compound norgestrel, USP and the estrogenic compound ethinyl estradiol, USP. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Cryselle tablet contains 0.3 mg norgestrel, USP and 0.03 mg ethinyl estradiol, USP. The inactive ingredients present are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and pregelatinized corn starch. The light-green inactive tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Norgestrel, USP. C21H28O2 MW: 312.45. Ethinyl Estradiol, USP. C20H24O2    MW: 296.40."
    },
    {
      "NDCCode": "53002-1188-3",
      "PackageDescription": "3 BLISTER PACK in 1 POUCH (53002-1188-3)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "53002-1188-03",
      "ProductNDC": "53002-1188",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cryselle",
      "NonProprietaryName": "Norgestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20020724",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075840",
      "LabelerName": "RPK Pharmaceuticals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20190101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cryselle is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.",
      "Description": "Cryselle® is a combination oral contraceptive containing the progestational compound norgestrel, USP and the estrogenic compound ethinyl estradiol, USP. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Cryselle tablet contains 0.3 mg norgestrel, USP and 0.03 mg ethinyl estradiol, USP. The inactive ingredients present are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and pregelatinized corn starch. The light-green inactive tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Norgestrel, USP. C21H28O2 MW: 312.45. Ethinyl Estradiol, USP. C20H24O2    MW: 296.40."
    },
    {
      "NDCCode": "58118-1188-8",
      "PackageDescription": "30 TABLET in 1 BLISTER PACK (58118-1188-8) ",
      "NDC11Code": "58118-1188-08",
      "ProductNDC": "58118-1188",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate",
      "NonProprietaryName": "Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate",
      "DosageFormName": "TABLET",
      "RouteName": "SUBLINGUAL",
      "StartMarketingDate": "20140627",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203326",
      "LabelerName": "Clinical Solutions Wholesale, LLC",
      "SubstanceName": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE",
      "StrengthNumber": "2; .5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
      "DEASchedule": "CIII",
      "Status": "Active",
      "LastUpdate": "2026-03-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260304",
      "SamplePackage": "N",
      "IndicationAndUsage": "Buprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.",
      "Description": "Buprenorphine and Naloxone Sublingual Tablets, USP are available in two dosage strengths intended for sublingual administration as follows: 2 mg buprenorphine with 0.5 mg naloxone free bases and 8 mg buprenorphine with 2 mg naloxone free bases. Each tablet also contains citric acid anhydrous, corn starch, FD & C yellow no. 6, lactose monohydrate, lemon-lime flavor, magnesium stearate, mannitol, povidone, sodium citrate dihydrate and sucralose. Chemically, buprenorphine HCl is (6R, 7R, 14S)-17-Cyclopropylmethyl-7,8-dihydro-7-[(1S)-1-hydroxy-1,2,2-trimethylpropyl]-6-O--methyl-6,14-ethano-17-normorphine hydrochloride. It has the following chemical structure. Buprenorphine hydrochloride, USP has the molecular formula C 29H 41NO 4 HCl and the molecular weight is 504.1. It is a white to almost white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate, USP is 17-Allyl-4, 5 α-epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate has the molecular formula C 19H 22ClNO 4,2H 2O and the molecular weight is 399.9. It is a white to slightly off-white powder or almost white crystalline powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether."
    },
    {
      "NDCCode": "63629-1188-1",
      "PackageDescription": "500 TABLET in 1 BOTTLE (63629-1188-1) ",
      "NDC11Code": "63629-1188-01",
      "ProductNDC": "63629-1188",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetaminophen And Codeine Phosphate",
      "NonProprietaryName": "Acetaminophen And Codeine Phosphate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190802",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211610",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
      "StrengthNumber": "300; 30",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20190802",
      "SamplePackage": "N",
      "IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) · Have not provided adequate analgesia, or are not expected to provide adequate analgesia, · Have not been tolerated, or are not expected to be tolerated.",
      "Description": "Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula.  C8H9NO2             M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and  antitussive. It has the following structural formula. C18H21NO3 H3PO4 ½H2O                      M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only)."
    },
    {
      "NDCCode": "70677-1188-1",
      "PackageDescription": "6 POUCH in 1 CARTON (70677-1188-1)  / 1 g in 1 POUCH",
      "NDC11Code": "70677-1188-01",
      "ProductNDC": "70677-1188",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Foster And Thrive",
      "NonProprietaryName": "Lidocaine",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230901",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "STRATEGIC SOURCING SERVICES, LLC",
      "SubstanceName": "LIDOCAINE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-10-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions: 1 adults and children over 12 years:, 2 clean and dry affected area, 3 expose a portion of the patch by firmly grasping an edge or corner and gently pull apart until backing separates, 4 position and apply exposed portion of the patch to affected area, 5 once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area, 6 use 1 patch at a time, not more than 3 to 4 times daily, 7 children under 12 years or younger: ask a doctor."
    },
    {
      "NDCCode": "80830-1659-2",
      "PackageDescription": "25 VIAL, GLASS in 1 CARTON (80830-1659-2)  / 1 mL in 1 VIAL, GLASS (80830-1659-1) ",
      "NDC11Code": "80830-1659-02",
      "ProductNDC": "80830-1659",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Epinephrine",
      "NonProprietaryName": "Epinephrine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
      "StartMarketingDate": "20251208",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218208",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "EPINEPHRINE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251208",
      "SamplePackage": "N",
      "IndicationAndUsage": "Epinephrine is a non-selective alpha and beta adrenergic agonist indicated for: 1 Emergency treatment of allergic reactions (Type 1), including anaphylaxis. (1.1), 2 To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. (1.2).",
      "Description": "Epinephrine Injection, USP is a clear, colorless, sterile solution containing 1 mg/mL epinephrine USP, packaged as 1 mL of solution in a single-dose clear glass vial. In the 1 mL vial, each 1 mL of epinephrine injection, USP solution contains 1 mg epinephrine, USP; 9 mg sodium chloride; 1 mg sodium metabisulfite; hydrochloric acid to adjust pH and water for injection. The pH range is 2.2 to 5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[1-hydroxy-2-(methylamino)ethyl]-,(R)- or (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol. Its chemical structure is. The molecular weight of epinephrine is 183.2 g/mol and molecular formula is C9H13NO3. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin."
    },
    {
      "NDCCode": "80830-1672-2",
      "PackageDescription": "10 VIAL in 1 CARTON (80830-1672-2)  / 10 mL in 1 VIAL (80830-1672-1) ",
      "NDC11Code": "80830-1672-02",
      "ProductNDC": "80830-1672",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Calcium Gluconate",
      "NonProprietaryName": "Calcium Gluconate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240513",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216611",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "CALCIUM GLUCONATE MONOHYDRATE",
      "StrengthNumber": "98",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240513",
      "SamplePackage": "N",
      "IndicationAndUsage": "Calcium gluconate injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use. The safety of calcium gluconate injection for long term use has not been established.",
      "Description": "Calcium gluconate injection USP, 100 mg per mL is a sterile, clear, colorless to slightly yellow, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. The chemical name of calcium gluconate monohydrate, USP is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14H2O. Molecular weight: 448.39 g/mol. Solubility in water: 3.5 g/100 mL at 25°C. Calcium gluconate monohydrate, USP is a white, crystalline granules or powder. It is soluble in boiling water, sparingly soluble in water and insoluble in alcohol. Calcium Gluconate Injection, USP is available as 1,000 mg per 10 mL (100 mg per mL) or 5,000 mg per 50 mL (100 mg per mL) in a single-dose vial or 10,000 mg per 100 mL (100 mg per mL) in a pharmacy bulk package. Each mL of calcium gluconate injection, USP contains: 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and sterile water for injection, q.s. It contains no antimicrobial agent. Each mL of calcium gluconate injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium."
    },
    {
      "NDCCode": "80830-1672-4",
      "PackageDescription": "10 VIAL in 1 CARTON (80830-1672-4)  / 10 mL in 1 VIAL",
      "NDC11Code": "80830-1672-04",
      "ProductNDC": "80830-1672",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Calcium Gluconate",
      "NonProprietaryName": "Calcium Gluconate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260413",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216611",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "CALCIUM GLUCONATE MONOHYDRATE",
      "StrengthNumber": "98",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260413",
      "SamplePackage": "N",
      "IndicationAndUsage": "Calcium gluconate injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use. The safety of calcium gluconate injection for long term use has not been established.",
      "Description": "Calcium gluconate injection USP, 100 mg per mL is a sterile, clear, colorless to slightly yellow, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. The chemical name of calcium gluconate monohydrate, USP is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14H2O. Molecular weight: 448.39 g/mol. Solubility in water: 3.5 g/100 mL at 25°C. Calcium gluconate monohydrate, USP is a white, crystalline granules or powder. It is soluble in boiling water, sparingly soluble in water and insoluble in alcohol. Calcium Gluconate Injection, USP is available as 1,000 mg per 10 mL (100 mg per mL) or 5,000 mg per 50 mL (100 mg per mL) in a single-dose vial or 10,000 mg per 100 mL (100 mg per mL) in a pharmacy bulk package. Each mL of calcium gluconate injection, USP contains: 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and sterile water for injection, q.s. It contains no antimicrobial agent. Each mL of calcium gluconate injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium."
    },
    {
      "NDCCode": "80830-1672-5",
      "PackageDescription": "25 VIAL in 1 CARTON (80830-1672-5)  / 10 mL in 1 VIAL (80830-1672-1) ",
      "NDC11Code": "80830-1672-05",
      "ProductNDC": "80830-1672",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Calcium Gluconate",
      "NonProprietaryName": "Calcium Gluconate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240513",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216611",
      "LabelerName": "Amneal Pharmaceuticals Private Limited",
      "SubstanceName": "CALCIUM GLUCONATE MONOHYDRATE",
      "StrengthNumber": "98",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240513",
      "SamplePackage": "N",
      "IndicationAndUsage": "Calcium gluconate injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use. The safety of calcium gluconate injection for long term use has not been established.",
      "Description": "Calcium gluconate injection USP, 100 mg per mL is a sterile, clear, colorless to slightly yellow, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. The chemical name of calcium gluconate monohydrate, USP is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14H2O. Molecular weight: 448.39 g/mol. Solubility in water: 3.5 g/100 mL at 25°C. Calcium gluconate monohydrate, USP is a white, crystalline granules or powder. It is soluble in boiling water, sparingly soluble in water and insoluble in alcohol. Calcium Gluconate Injection, USP is available as 1,000 mg per 10 mL (100 mg per mL) or 5,000 mg per 50 mL (100 mg per mL) in a single-dose vial or 10,000 mg per 100 mL (100 mg per mL) in a pharmacy bulk package. Each mL of calcium gluconate injection, USP contains: 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and sterile water for injection, q.s. It contains no antimicrobial agent. Each mL of calcium gluconate injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium."
    }
  ]
}
                    

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<NDCList><NDC><NDCCode>80830-1188-7</NDCCode><ProprietaryName>Propofol</ProprietaryName><NonProprietaryName>Propofol</NonProprietaryName></NDC><NDC><NDCCode>80830-1691-7</NDCCode><ProprietaryName>Potassium Phosphates</ProprietaryName><NonProprietaryName>Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,</NonProprietaryName></NDC><NDC><NDCCode>80830-2365-7</NDCCode><ProprietaryName>Propofol</ProprietaryName><NonProprietaryName>Propofol</NonProprietaryName></NDC><NDC><NDCCode>80830-1683-3</NDCCode><ProprietaryName>Phytonadione</ProprietaryName><NonProprietaryName>Phytonadione</NonProprietaryName></NDC><NDC><NDCCode>80830-1691-2</NDCCode><ProprietaryName>Potassium Phosphates</ProprietaryName><NonProprietaryName>Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,</NonProprietaryName></NDC><NDC><NDCCode>80830-1691-5</NDCCode><ProprietaryName>Potassium Phosphates</ProprietaryName><NonProprietaryName>Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,</NonProprietaryName></NDC><NDC><NDCCode>80830-1691-9</NDCCode><ProprietaryName>Potassium Phosphates</ProprietaryName><NonProprietaryName>Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,</NonProprietaryName></NDC><NDC><NDCCode>80830-1692-2</NDCCode><ProprietaryName>Potassium Phosphates</ProprietaryName><NonProprietaryName>Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,</NonProprietaryName></NDC><NDC><NDCCode>80830-1692-5</NDCCode><ProprietaryName>Potassium Phosphates</ProprietaryName><NonProprietaryName>Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,</NonProprietaryName></NDC><NDC><NDCCode>80830-1693-3</NDCCode><ProprietaryName>Potassium Phosphates</ProprietaryName><NonProprietaryName>Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,</NonProprietaryName></NDC><NDC><NDCCode>80830-1693-5</NDCCode><ProprietaryName>Potassium Phosphates</ProprietaryName><NonProprietaryName>Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,</NonProprietaryName></NDC><NDC><NDCCode>80830-2305-2</NDCCode><ProprietaryName>Sodium Bicarbonate</ProprietaryName><NonProprietaryName>Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>80830-2364-8</NDCCode><ProprietaryName>Propofol</ProprietaryName><NonProprietaryName>Propofol</NonProprietaryName></NDC><NDC><NDCCode>80830-2435-2</NDCCode><ProprietaryName>Sodium Acetate</ProprietaryName><NonProprietaryName>Sodium Acetate</NonProprietaryName></NDC><NDC><NDCCode>80830-2436-2</NDCCode><ProprietaryName>Sodium Acetate</ProprietaryName><NonProprietaryName>Sodium Acetate</NonProprietaryName></NDC><NDC><NDCCode>80830-2437-2</NDCCode><ProprietaryName>Sodium Acetate</ProprietaryName><NonProprietaryName>Sodium Acetate</NonProprietaryName></NDC><NDC><NDCCode>80830-2465-9</NDCCode><ProprietaryName>Metronidazole</ProprietaryName><NonProprietaryName>Metronidazole</NonProprietaryName></NDC><NDC><NDCCode>80830-2613-2</NDCCode><ProprietaryName>Sodium Bicarbonate</ProprietaryName><NonProprietaryName>Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>0019-1188-27</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0019-1188-81</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>50090-1188-0</NDCCode><ProprietaryName>Cefprozil</ProprietaryName><NonProprietaryName>Cefprozil</NonProprietaryName></NDC><NDC><NDCCode>53002-1188-1</NDCCode><ProprietaryName>Cryselle</ProprietaryName><NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>53002-1188-3</NDCCode><ProprietaryName>Cryselle</ProprietaryName><NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>58118-1188-8</NDCCode><ProprietaryName>Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate</ProprietaryName><NonProprietaryName>Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>63629-1188-1</NDCCode><ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName><NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName></NDC><NDC><NDCCode>70677-1188-1</NDCCode><ProprietaryName>Foster And Thrive</ProprietaryName><NonProprietaryName>Lidocaine</NonProprietaryName></NDC><NDC><NDCCode>80830-1659-2</NDCCode><ProprietaryName>Epinephrine</ProprietaryName><NonProprietaryName>Epinephrine</NonProprietaryName></NDC><NDC><NDCCode>80830-1672-2</NDCCode><ProprietaryName>Calcium Gluconate</ProprietaryName><NonProprietaryName>Calcium Gluconate</NonProprietaryName></NDC><NDC><NDCCode>80830-1672-4</NDCCode><ProprietaryName>Calcium Gluconate</ProprietaryName><NonProprietaryName>Calcium Gluconate</NonProprietaryName></NDC><NDC><NDCCode>80830-1672-5</NDCCode><ProprietaryName>Calcium Gluconate</ProprietaryName><NonProprietaryName>Calcium Gluconate</NonProprietaryName></NDC></NDCList>