{
"NDC": [
{
"NDCCode": "77118-824-25",
"PackageDescription": "250 mL in 1 BOTTLE (77118-824-25) ",
"NDC11Code": "77118-0824-25",
"ProductNDC": "77118-824",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ABC INTERNATIONAL",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "175",
"StrengthUnit": "mL/250mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "43744-824-25",
"PackageDescription": "25 g in 1 DRUM (43744-824-25)",
"NDC11Code": "43744-0824-25",
"ProductNDC": "43744-824",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Rifampin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20111010",
"EndMarketingDate": "20130630",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130630"
},
{
"NDCCode": "63323-824-75",
"PackageDescription": "20 BAG in 1 CASE (63323-824-75) / 500 mL in 1 BAG (63323-824-25) ",
"NDC11Code": "63323-0824-75",
"ProductNDC": "63323-824",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209448",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190329",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose Injection is indicated as source of water and calories.",
"Description": "10% Dextrose Injection, USP is a sterile, non-pyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5). Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:. Water for Injection, USP is chemically designated H2O. Dextrose is derived from corn. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration. The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication ([see Instructions for Use (2.3)]). The primary function of the overwrap is to protect the container from the physical environment."
},
{
"NDCCode": "69039-824-01",
"PackageDescription": "4.25 g in 1 TUBE, WITH APPLICATOR (69039-824-01) ",
"NDC11Code": "69039-0824-01",
"ProductNDC": "69039-824",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sun Bum Sunscreen Lip Balm Broad Spectrum Spf 30 - Pineapple",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Sun Bum, LLC",
"SubstanceName": "OCTOCRYLENE; AVOBENZONE; OCTISALATE; HOMOSALATE",
"StrengthNumber": "80; 30; 50; 100",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn if used as directed with other sun protection measures, (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "77118-305-25",
"PackageDescription": "250 mL in 1 BOTTLE, PUMP (77118-305-25) ",
"NDC11Code": "77118-0305-25",
"ProductNDC": "77118-305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"ProprietaryNameSuffix": "250",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ABC INTERNATIONAL LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/250mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "77118-306-25",
"PackageDescription": "250 mL in 1 BOTTLE, PLASTIC (77118-306-25) ",
"NDC11Code": "77118-0306-25",
"ProductNDC": "77118-306",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"ProprietaryNameSuffix": "250",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ABC INTERNATIONAL LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/250mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "77118-307-25",
"PackageDescription": "250 mL in 1 BOTTLE, PUMP (77118-307-25) ",
"NDC11Code": "77118-0307-25",
"ProductNDC": "77118-307",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"ProprietaryNameSuffix": "250",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ABC INTERNATIONAL LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/250mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "77118-308-25",
"PackageDescription": "250 mL in 1 BOTTLE, PUMP (77118-308-25) ",
"NDC11Code": "77118-0308-25",
"ProductNDC": "77118-308",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"ProprietaryNameSuffix": "250",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ABC INTERNATIONAL LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/250mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "77118-725-25",
"PackageDescription": "250 mL in 1 BOTTLE (77118-725-25) ",
"NDC11Code": "77118-0725-25",
"ProductNDC": "77118-725",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ABC INTERNATIONAL",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "175",
"StrengthUnit": "mL/250mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "77118-823-25",
"PackageDescription": "250 mL in 1 BOTTLE (77118-823-25) ",
"NDC11Code": "77118-0823-25",
"ProductNDC": "77118-823",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ABC INTERNATIONAL",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "175",
"StrengthUnit": "mL/250mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "77118-825-25",
"PackageDescription": "250 mL in 1 BOTTLE (77118-825-25) ",
"NDC11Code": "77118-0825-25",
"ProductNDC": "77118-825",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ABC INTERNATIONAL",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "175",
"StrengthUnit": "mL/250mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "77118-902-25",
"PackageDescription": "250 mL in 1 BOTTLE, PLASTIC (77118-902-25) ",
"NDC11Code": "77118-0902-25",
"ProductNDC": "77118-902",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"ProprietaryNameSuffix": "250ml",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ABC INTERNATIONAL LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "175",
"StrengthUnit": "mL/250mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "77118-904-25",
"PackageDescription": "250 mL in 1 BOTTLE, PLASTIC (77118-904-25) ",
"NDC11Code": "77118-0904-25",
"ProductNDC": "77118-904",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"ProprietaryNameSuffix": "250ml",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ABC INTERNATIONAL LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "175",
"StrengthUnit": "mL/250mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "0338-0180-06",
"PackageDescription": "6 BAG in 1 CARTON (0338-0180-06) / 1000 mL in 1 BAG (0338-0180-01) ",
"NDC11Code": "00338-0180-06",
"ProductNDC": "0338-0180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970929",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020734",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE",
"StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 14",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200921",
"SamplePackage": "N",
"IndicationAndUsage": "CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients.",
"Description": "CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8. The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-0184-04",
"PackageDescription": "4 BAG in 1 CARTON (0338-0184-04) / 2000 mL in 1 BAG (0338-0184-01) ",
"NDC11Code": "00338-0184-04",
"ProductNDC": "0338-0184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970929",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020734",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE",
"StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 14",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200921",
"SamplePackage": "N",
"IndicationAndUsage": "CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients.",
"Description": "CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8. The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-0194-04",
"PackageDescription": "4 BAG in 1 CARTON (0338-0194-04) / 2000 mL in 1 BAG (0338-0194-01) ",
"NDC11Code": "00338-0194-04",
"ProductNDC": "0338-0194",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970929",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020734",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE",
"StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 10",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200921",
"SamplePackage": "N",
"IndicationAndUsage": "CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients.",
"Description": "CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8. The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-0202-06",
"PackageDescription": "6 BAG in 1 CARTON (0338-0202-06) / 1000 mL in 1 BAG (0338-0202-01) ",
"NDC11Code": "00338-0202-06",
"ProductNDC": "0338-0202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix E",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020678",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
"StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 14",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200921",
"SamplePackage": "N",
"IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
"Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-0206-04",
"PackageDescription": "4 BAG in 1 CARTON (0338-0206-04) / 2000 mL in 1 BAG (0338-0206-01) ",
"NDC11Code": "00338-0206-04",
"ProductNDC": "0338-0206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix E",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020678",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
"StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 14",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200921",
"SamplePackage": "N",
"IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
"Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-0210-06",
"PackageDescription": "6 BAG in 1 CARTON (0338-0210-06) / 1000 mL in 1 BAG (0338-0210-01) ",
"NDC11Code": "00338-0210-06",
"ProductNDC": "0338-0210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix E",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020678",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
"StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 10",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200921",
"SamplePackage": "N",
"IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
"Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-0214-04",
"PackageDescription": "4 BAG in 1 CARTON (0338-0214-04) / 2000 mL in 1 BAG (0338-0214-01) ",
"NDC11Code": "00338-0214-04",
"ProductNDC": "0338-0214",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix E",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020678",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
"StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 10",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200921",
"SamplePackage": "N",
"IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
"Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "11673-824-02",
"PackageDescription": "1 KIT in 1 BOTTLE (11673-824-02) * 355 mL in 1 BOTTLE * 355 mL in 1 BOTTLE",
"NDC11Code": "11673-0824-02",
"ProductNDC": "11673-824",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime Severe And Nighttime Severe Cold And Flu",
"NonProprietaryName": "Daytime Severe - Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Nighttime Severe-acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl",
"DosageFormName": "KIT",
"StartMarketingDate": "20240501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "TARGET CORPORATION",
"Status": "Active",
"LastUpdate": "2024-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240501",
"SamplePackage": "N"
},
{
"NDCCode": "11712-824-01",
"PackageDescription": "5 kg in 1 DRUM (11712-824-01) ",
"NDC11Code": "11712-0824-01",
"ProductNDC": "11712-824",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Rilpivirine Free Base",
"DosageFormName": "POWDER",
"StartMarketingDate": "20251010",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Delmar Chemicals Inc",
"SubstanceName": "RILPIVIRINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-10-13",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "10-OCT-25"
},
{
"NDCCode": "13537-824-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-824-02) > 4 g in 1 TUBE (13537-824-01)",
"NDC11Code": "13537-0824-02",
"ProductNDC": "13537-824",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25",
"ProprietaryNameSuffix": "(nude Prisma) - Orange",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161109",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".0664; .0151",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16571-824-01",
"PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE (16571-824-01) ",
"NDC11Code": "16571-0824-01",
"ProductNDC": "16571-824",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meclizine Hcl",
"NonProprietaryName": "Meclizine Hydrochloride Chewable",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20220818",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009.50",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2024-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220818",
"SamplePackage": "N",
"IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness due to motion sickness."
},
{
"NDCCode": "16571-824-10",
"PackageDescription": "1000 TABLET, CHEWABLE in 1 BOTTLE (16571-824-10) ",
"NDC11Code": "16571-0824-10",
"ProductNDC": "16571-824",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meclizine Hcl",
"NonProprietaryName": "Meclizine Hydrochloride Chewable",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20220818",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009.50",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2024-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220818",
"SamplePackage": "N",
"IndicationAndUsage": "prevents and treats nausea, vomiting or dizziness due to motion sickness."
},
{
"NDCCode": "16590-824-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (16590-824-30)",
"NDC11Code": "16590-0824-30",
"ProductNDC": "16590-824",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079153",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Topiramate is an antiepileptic (AED) agent indicated for: : 1 Monotherapy epilepsy: Initial monotherapy in patients ≥2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1). , 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2). .",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (200 mg tablets), ferric oxide yellow (50, 100, and 200 mg tablets), hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "16590-824-45",
"PackageDescription": "45 TABLET in 1 BOTTLE, PLASTIC (16590-824-45)",
"NDC11Code": "16590-0824-45",
"ProductNDC": "16590-824",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079153",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Topiramate is an antiepileptic (AED) agent indicated for: : 1 Monotherapy epilepsy: Initial monotherapy in patients ≥2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1). , 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2). .",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (200 mg tablets), ferric oxide yellow (50, 100, and 200 mg tablets), hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "16590-824-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (16590-824-60)",
"NDC11Code": "16590-0824-60",
"ProductNDC": "16590-824",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079153",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Topiramate is an antiepileptic (AED) agent indicated for: : 1 Monotherapy epilepsy: Initial monotherapy in patients ≥2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1). , 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2). .",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (200 mg tablets), ferric oxide yellow (50, 100, and 200 mg tablets), hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "16590-824-62",
"PackageDescription": "84 TABLET in 1 BOTTLE, PLASTIC (16590-824-62)",
"NDC11Code": "16590-0824-62",
"ProductNDC": "16590-824",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079153",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Topiramate is an antiepileptic (AED) agent indicated for: : 1 Monotherapy epilepsy: Initial monotherapy in patients ≥2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1). , 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2). .",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (200 mg tablets), ferric oxide yellow (50, 100, and 200 mg tablets), hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "16590-824-71",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (16590-824-71)",
"NDC11Code": "16590-0824-71",
"ProductNDC": "16590-824",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079153",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Topiramate is an antiepileptic (AED) agent indicated for: : 1 Monotherapy epilepsy: Initial monotherapy in patients ≥2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1). , 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2). .",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (200 mg tablets), ferric oxide yellow (50, 100, and 200 mg tablets), hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. Meets USP Dissolution Test 3."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>77118-824-25</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE (77118-824-25) </PackageDescription>
<NDC11Code>77118-0824-25</NDC11Code>
<ProductNDC>77118-824</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ABC INTERNATIONAL</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>175</StrengthNumber>
<StrengthUnit>mL/250mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43744-824-25</NDCCode>
<PackageDescription>25 g in 1 DRUM (43744-824-25)</PackageDescription>
<NDC11Code>43744-0824-25</NDC11Code>
<ProductNDC>43744-824</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20111010</StartMarketingDate>
<EndMarketingDate>20130630</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130630</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63323-824-75</NDCCode>
<PackageDescription>20 BAG in 1 CASE (63323-824-75) / 500 mL in 1 BAG (63323-824-25) </PackageDescription>
<NDC11Code>63323-0824-75</NDC11Code>
<ProductNDC>63323-824</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209448</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose Injection is indicated as source of water and calories.</IndicationAndUsage>
<Description>10% Dextrose Injection, USP is a sterile, non-pyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5). Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:. Water for Injection, USP is chemically designated H2O. Dextrose is derived from corn. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration. The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication ([see Instructions for Use (2.3)]). The primary function of the overwrap is to protect the container from the physical environment.</Description>
</NDC>
<NDC>
<NDCCode>69039-824-01</NDCCode>
<PackageDescription>4.25 g in 1 TUBE, WITH APPLICATOR (69039-824-01) </PackageDescription>
<NDC11Code>69039-0824-01</NDC11Code>
<ProductNDC>69039-824</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sun Bum Sunscreen Lip Balm Broad Spectrum Spf 30 - Pineapple</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Sun Bum, LLC</LabelerName>
<SubstanceName>OCTOCRYLENE; AVOBENZONE; OCTISALATE; HOMOSALATE</SubstanceName>
<StrengthNumber>80; 30; 50; 100</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn if used as directed with other sun protection measures, (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77118-305-25</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, PUMP (77118-305-25) </PackageDescription>
<NDC11Code>77118-0305-25</NDC11Code>
<ProductNDC>77118-305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>250</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ABC INTERNATIONAL LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/250mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77118-306-25</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, PLASTIC (77118-306-25) </PackageDescription>
<NDC11Code>77118-0306-25</NDC11Code>
<ProductNDC>77118-306</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>250</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ABC INTERNATIONAL LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/250mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77118-307-25</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, PUMP (77118-307-25) </PackageDescription>
<NDC11Code>77118-0307-25</NDC11Code>
<ProductNDC>77118-307</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>250</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ABC INTERNATIONAL LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/250mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77118-308-25</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, PUMP (77118-308-25) </PackageDescription>
<NDC11Code>77118-0308-25</NDC11Code>
<ProductNDC>77118-308</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>250</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ABC INTERNATIONAL LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/250mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77118-725-25</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE (77118-725-25) </PackageDescription>
<NDC11Code>77118-0725-25</NDC11Code>
<ProductNDC>77118-725</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ABC INTERNATIONAL</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>175</StrengthNumber>
<StrengthUnit>mL/250mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77118-823-25</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE (77118-823-25) </PackageDescription>
<NDC11Code>77118-0823-25</NDC11Code>
<ProductNDC>77118-823</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ABC INTERNATIONAL</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>175</StrengthNumber>
<StrengthUnit>mL/250mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77118-825-25</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE (77118-825-25) </PackageDescription>
<NDC11Code>77118-0825-25</NDC11Code>
<ProductNDC>77118-825</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ABC INTERNATIONAL</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>175</StrengthNumber>
<StrengthUnit>mL/250mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77118-902-25</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, PLASTIC (77118-902-25) </PackageDescription>
<NDC11Code>77118-0902-25</NDC11Code>
<ProductNDC>77118-902</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>250ml</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ABC INTERNATIONAL LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>175</StrengthNumber>
<StrengthUnit>mL/250mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77118-904-25</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, PLASTIC (77118-904-25) </PackageDescription>
<NDC11Code>77118-0904-25</NDC11Code>
<ProductNDC>77118-904</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>250ml</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ABC INTERNATIONAL LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>175</StrengthNumber>
<StrengthUnit>mL/250mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0338-0180-06</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0338-0180-06) / 1000 mL in 1 BAG (0338-0180-01) </PackageDescription>
<NDC11Code>00338-0180-06</NDC11Code>
<ProductNDC>0338-0180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970929</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020734</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 14</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8. The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0184-04</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (0338-0184-04) / 2000 mL in 1 BAG (0338-0184-01) </PackageDescription>
<NDC11Code>00338-0184-04</NDC11Code>
<ProductNDC>0338-0184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970929</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020734</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 14</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8. The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0194-04</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (0338-0194-04) / 2000 mL in 1 BAG (0338-0194-01) </PackageDescription>
<NDC11Code>00338-0194-04</NDC11Code>
<ProductNDC>0338-0194</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970929</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020734</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 10</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8. The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0202-06</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0338-0202-06) / 1000 mL in 1 BAG (0338-0202-01) </PackageDescription>
<NDC11Code>00338-0202-06</NDC11Code>
<ProductNDC>0338-0202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix E</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020678</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 14</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0206-04</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (0338-0206-04) / 2000 mL in 1 BAG (0338-0206-01) </PackageDescription>
<NDC11Code>00338-0206-04</NDC11Code>
<ProductNDC>0338-0206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix E</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020678</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 14</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0210-06</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0338-0210-06) / 1000 mL in 1 BAG (0338-0210-01) </PackageDescription>
<NDC11Code>00338-0210-06</NDC11Code>
<ProductNDC>0338-0210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix E</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020678</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 10</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0214-04</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (0338-0214-04) / 2000 mL in 1 BAG (0338-0214-01) </PackageDescription>
<NDC11Code>00338-0214-04</NDC11Code>
<ProductNDC>0338-0214</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix E</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020678</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 10</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>11673-824-02</NDCCode>
<PackageDescription>1 KIT in 1 BOTTLE (11673-824-02) * 355 mL in 1 BOTTLE * 355 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11673-0824-02</NDC11Code>
<ProductNDC>11673-824</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime Severe And Nighttime Severe Cold And Flu</ProprietaryName>
<NonProprietaryName>Daytime Severe - Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Nighttime Severe-acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>TARGET CORPORATION</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11712-824-01</NDCCode>
<PackageDescription>5 kg in 1 DRUM (11712-824-01) </PackageDescription>
<NDC11Code>11712-0824-01</NDC11Code>
<ProductNDC>11712-824</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Rilpivirine Free Base</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20251010</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Delmar Chemicals Inc</LabelerName>
<SubstanceName>RILPIVIRINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-10-13</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>10-OCT-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>13537-824-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-824-02) > 4 g in 1 TUBE (13537-824-01)</PackageDescription>
<NDC11Code>13537-0824-02</NDC11Code>
<ProductNDC>13537-824</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25</ProprietaryName>
<ProprietaryNameSuffix>(nude Prisma) - Orange</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.0664; .0151</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16571-824-01</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE (16571-824-01) </PackageDescription>
<NDC11Code>16571-0824-01</NDC11Code>
<ProductNDC>16571-824</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hcl</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride Chewable</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220818</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M009.50</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>prevents and treats nausea, vomiting or dizziness due to motion sickness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16571-824-10</NDCCode>
<PackageDescription>1000 TABLET, CHEWABLE in 1 BOTTLE (16571-824-10) </PackageDescription>
<NDC11Code>16571-0824-10</NDC11Code>
<ProductNDC>16571-824</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hcl</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride Chewable</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220818</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M009.50</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>prevents and treats nausea, vomiting or dizziness due to motion sickness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16590-824-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (16590-824-30)</PackageDescription>
<NDC11Code>16590-0824-30</NDC11Code>
<ProductNDC>16590-824</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079153</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Topiramate is an antiepileptic (AED) agent indicated for: : 1 Monotherapy epilepsy: Initial monotherapy in patients ≥2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1). , 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2). .</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (200 mg tablets), ferric oxide yellow (50, 100, and 200 mg tablets), hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>16590-824-45</NDCCode>
<PackageDescription>45 TABLET in 1 BOTTLE, PLASTIC (16590-824-45)</PackageDescription>
<NDC11Code>16590-0824-45</NDC11Code>
<ProductNDC>16590-824</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079153</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Topiramate is an antiepileptic (AED) agent indicated for: : 1 Monotherapy epilepsy: Initial monotherapy in patients ≥2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1). , 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2). .</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (200 mg tablets), ferric oxide yellow (50, 100, and 200 mg tablets), hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>16590-824-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (16590-824-60)</PackageDescription>
<NDC11Code>16590-0824-60</NDC11Code>
<ProductNDC>16590-824</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079153</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Topiramate is an antiepileptic (AED) agent indicated for: : 1 Monotherapy epilepsy: Initial monotherapy in patients ≥2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1). , 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2). .</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (200 mg tablets), ferric oxide yellow (50, 100, and 200 mg tablets), hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>16590-824-62</NDCCode>
<PackageDescription>84 TABLET in 1 BOTTLE, PLASTIC (16590-824-62)</PackageDescription>
<NDC11Code>16590-0824-62</NDC11Code>
<ProductNDC>16590-824</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079153</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Topiramate is an antiepileptic (AED) agent indicated for: : 1 Monotherapy epilepsy: Initial monotherapy in patients ≥2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1). , 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2). .</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (200 mg tablets), ferric oxide yellow (50, 100, and 200 mg tablets), hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>16590-824-71</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (16590-824-71)</PackageDescription>
<NDC11Code>16590-0824-71</NDC11Code>
<ProductNDC>16590-824</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079153</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Topiramate is an antiepileptic (AED) agent indicated for: : 1 Monotherapy epilepsy: Initial monotherapy in patients ≥2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1). , 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2). .</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (200 mg tablets), ferric oxide yellow (50, 100, and 200 mg tablets), hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. Meets USP Dissolution Test 3.</Description>
</NDC>
</NDCList>