{
"NDC": [
{
"NDCCode": "41163-526-21",
"PackageDescription": "20 TABLET in 1 BLISTER PACK (41163-526-21)",
"NDC11Code": "41163-0526-21",
"ProductNDC": "41163-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076134",
"LabelerName": "SUPERVALU INC.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "64980-526-21",
"PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE (64980-526-21) ",
"NDC11Code": "64980-0526-21",
"ProductNDC": "64980-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitazoxanide",
"NonProprietaryName": "Nitazoxanide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213820",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "NITAZOXANIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiprotozoal [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201127",
"SamplePackage": "N",
"IndicationAndUsage": "Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2)].",
"Description": "Nitazoxanide tablets contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide is a pale yellow to yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy-N-(5-nitro-2-thiazolyl) benzamide. The molecular formula is C12H9N3O5S and the molecular weight is 307.3. The structural formula is. Nitazoxanide tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, partially pregelatinized maize starch, sodium starch glycolate, hypromellose, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No.2 Aluminum Lake."
},
{
"NDCCode": "41163-526-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (41163-526-30)",
"NDC11Code": "41163-0526-30",
"ProductNDC": "41163-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076134",
"LabelerName": "SUPERVALU INC.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "41163-526-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (41163-526-60)",
"NDC11Code": "41163-0526-60",
"ProductNDC": "41163-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076134",
"LabelerName": "SUPERVALU INC.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "41163-526-69",
"PackageDescription": "10 TABLET in 1 BLISTER PACK (41163-526-69)",
"NDC11Code": "41163-0526-69",
"ProductNDC": "41163-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076134",
"LabelerName": "SUPERVALU INC.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "41163-526-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (41163-526-90)",
"NDC11Code": "41163-0526-90",
"ProductNDC": "41163-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076134",
"LabelerName": "SUPERVALU INC.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "41163-384-21",
"PackageDescription": "1 BOTTLE in 1 CARTON (41163-384-21) / 89 mL in 1 BOTTLE",
"NDC11Code": "41163-0384-21",
"ProductNDC": "41163-384",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equaline Cough Dm",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20121019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "United Natural Foods, Inc. dba UNFI",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121019",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves: 1 cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants, 2 the impulse to cough to help you get to sleep."
},
{
"NDCCode": "41163-404-21",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (41163-404-21) > 8 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "41163-0404-21",
"ProductNDC": "41163-404",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Motion Sickness Relief",
"NonProprietaryName": "Meclizine Hcl",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20020529",
"EndMarketingDate": "20190317",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part336",
"LabelerName": "SUPERVALU INC.",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-03-19",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "41163-411-21",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (41163-411-21) > 8 TABLET, SUGAR COATED in 1 BLISTER PACK",
"NDC11Code": "41163-0411-21",
"ProductNDC": "41163-411",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cough And Cold Relief Hbp",
"NonProprietaryName": "Chlorpheniramine Maleate And Dextromethorphan Hbr",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030503",
"EndMarketingDate": "20200606",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "SUPERVALU INC.",
"SubstanceName": "CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "4; 30",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-06-09",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "41163-698-21",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (41163-698-21) / 8 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "41163-0698-21",
"ProductNDC": "41163-698",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cough And Cold Relief Hbp",
"NonProprietaryName": "Chlorpheniramine Maleate, Dextromethorphan Hbr",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170331",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "United Natural Foods, Inc. dba UNFI",
"SubstanceName": "CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "4; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170331",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. temporarily relieves runny nose and sneezing due to the common cold."
},
{
"NDCCode": "41163-770-21",
"PackageDescription": "1 TUBE in 1 CARTON (41163-770-21) / 85 g in 1 TUBE",
"NDC11Code": "41163-0770-21",
"ProductNDC": "41163-770",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equaline Muscle Rub",
"NonProprietaryName": "Menthol, Methyl Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140103",
"EndMarketingDate": "20231031",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "United Natural Foods, Inc. dba UNFI",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE",
"StrengthNumber": "10; 15",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140103",
"EndMarketingDatePackage": "20231031",
"SamplePackage": "N"
},
{
"NDCCode": "41163-958-21",
"PackageDescription": "1 BOTTLE in 1 CARTON (41163-958-21) > 89 mL in 1 BOTTLE",
"NDC11Code": "41163-0958-21",
"ProductNDC": "41163-958",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equaline Cough Dm",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20130715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "Supervalu Inc",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20130715",
"SamplePackage": "N"
},
{
"NDCCode": "0338-0179-03",
"PackageDescription": "500 mL in 1 BAG (0338-0179-03) ",
"NDC11Code": "00338-0179-03",
"ProductNDC": "0338-0179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plasma-lyte 148",
"NonProprietaryName": "Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, And Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19790202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017378",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE",
"StrengthNumber": "30; 37; 368; 526; 502",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19790202",
"SamplePackage": "N",
"IndicationAndUsage": "PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is indicated as a source of water and electrolytes or as an alkalinizing agent.",
"Description": "PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO23H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl26H2O). It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid. The pH is 5.5 (4.0 to 8.0). PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. The caloric content is 21 kcal/L. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0338-0179-04",
"PackageDescription": "1000 mL in 1 BAG (0338-0179-04) ",
"NDC11Code": "00338-0179-04",
"ProductNDC": "0338-0179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plasma-lyte 148",
"NonProprietaryName": "Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, And Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19790202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017378",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE",
"StrengthNumber": "30; 37; 368; 526; 502",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19790202",
"SamplePackage": "N",
"IndicationAndUsage": "PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is indicated as a source of water and electrolytes or as an alkalinizing agent.",
"Description": "PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO23H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl26H2O). It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid. The pH is 5.5 (4.0 to 8.0). PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. The caloric content is 21 kcal/L. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0338-0221-03",
"PackageDescription": "500 mL in 1 BAG (0338-0221-03) ",
"NDC11Code": "00338-0221-03",
"ProductNDC": "0338-0221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plasma-lyte A",
"NonProprietaryName": "Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride And Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19790202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017378",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "526; 502; 368; 37; 30",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19790202",
"SamplePackage": "N",
"IndicationAndUsage": "PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is indicated as a source of water and electrolytes or as an alkalinizing agent.",
"Description": "PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO23H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl26H2O). It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide. The pH is 7.4 (6.5 to 8.0). PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc). Normal physiologic osmolarity range is 280 to 310 mOsmol/L. The caloric content is 21 kcal/L. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0338-0221-04",
"PackageDescription": "1000 mL in 1 BAG (0338-0221-04) ",
"NDC11Code": "00338-0221-04",
"ProductNDC": "0338-0221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plasma-lyte A",
"NonProprietaryName": "Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride And Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19790202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017378",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "526; 502; 368; 37; 30",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19790202",
"SamplePackage": "N",
"IndicationAndUsage": "PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is indicated as a source of water and electrolytes or as an alkalinizing agent.",
"Description": "PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO23H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl26H2O). It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide. The pH is 7.4 (6.5 to 8.0). PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc). Normal physiologic osmolarity range is 280 to 310 mOsmol/L. The caloric content is 21 kcal/L. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "10135-526-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (10135-526-05)",
"NDC11Code": "10135-0526-05",
"ProductNDC": "10135-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078552",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be use d alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)○ Amlodipine besylate tablets are indicate d for the treatment of hypertension, to lower blood pressure. Lowe ring blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2- chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, and sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "10135-526-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (10135-526-10)",
"NDC11Code": "10135-0526-10",
"ProductNDC": "10135-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078552",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be use d alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)○ Amlodipine besylate tablets are indicate d for the treatment of hypertension, to lower blood pressure. Lowe ring blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2- chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, and sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "10135-526-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (10135-526-90)",
"NDC11Code": "10135-0526-90",
"ProductNDC": "10135-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078552",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be use d alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)○ Amlodipine besylate tablets are indicate d for the treatment of hypertension, to lower blood pressure. Lowe ring blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2- chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, and sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "10882-526-30",
"PackageDescription": "30 PATCH in 1 BOX (10882-526-30) / 1 PATCH in 1 PATCH",
"NDC11Code": "10882-0526-30",
"ProductNDC": "10882-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidopatch",
"NonProprietaryName": "Lidocaine, Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151029",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "JAR Laboratories",
"SubstanceName": "LIDOCAINE; MENTHOL",
"StrengthNumber": "505; 175",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20151029",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises. LidoPatch contains lidocaine PAIN RELIEF PATCH. For minor pain associated with arthritis back pain muscle sprains & strains The only over the counter patch with lidocaine ultra thin, flexible, trim to fit."
},
{
"NDCCode": "13537-526-01",
"PackageDescription": "50 mL in 1 BOTTLE, PLASTIC (13537-526-01)",
"NDC11Code": "13537-0526-01",
"ProductNDC": "13537-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika",
"ProprietaryNameSuffix": "Jadiss Glam Antiperspirant Roll-on Deodorant",
"NonProprietaryName": "Aluminum Sesquichlorohydrate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130527",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Ventura Corporation LTD.",
"SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
"StrengthNumber": ".136",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Reduces underarm perspiration."
},
{
"NDCCode": "16714-526-01",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (16714-526-01) / 345 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "16714-0526-01",
"ProductNDC": "16714-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20220222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076156",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": "21",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220222",
"SamplePackage": "N",
"IndicationAndUsage": "Ipratropium bromide nasal solution, 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Ipratropium bromide nasal solution, 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis.",
"Description": "The active ingredient in ipratropium bromide nasal solution is ipratropium bromide monohydrate. It is an anticholinergic agent chemically described as 8-azoniabicyclo (3.2.1) octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (+)-: a synthetic quaternary ammonium compound, chemically related to atropine. The structural formula is. ipratropium bromide C20H30BrNO3H2O. monohydrate Mol. Wt. 430.4. Ipratropium bromide is a white to off-white, crystalline substance. It is freely soluble in lower alcohols and water, existing in an ionized state in aqueous solutions, and relatively insoluble in non-polar media. Ipratropium bromide nasal solution, 0.03% is a metered-dose, manual pump spray unit which delivers 21 mcg (70 mcL) ipratropium bromide per spray on an anhydrous basis in an isotonic, aqueous solution. It also contains the following inactive ingredients: benzalkonium chloride, edetate disodium, purified water and sodium chloride. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH to 4.5 to 4.9. Each bottle contains 345 sprays."
},
{
"NDCCode": "21695-526-04",
"PackageDescription": "4 CAPSULE in 1 BLISTER PACK (21695-526-04)",
"NDC11Code": "21695-0526-04",
"ProductNDC": "21695-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vivotif-b",
"NonProprietaryName": "Vivotif-b",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19891215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103123",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI",
"StrengthNumber": "2",
"StrengthUnit": "[CFU]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Vivotif (Typhoid Vaccine Live Oral Ty21a) is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi. Routine typhoid vaccination is not recommended in the United States of America. Selective immunization against typhoid fever is recommended for the following groups: 1) travelers to areas in which there is a recognized risk of exposure to S. typhi, 2) persons with intimate exposure (e.g. household contact) to a S. typhi carrier, and 3) microbiology laboratorians who work frequently with S. typhi. (7). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disasters or in persons attending rural summer camps. Not all recipients of Vivotif will be fully protected against typhoid fever. Vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms. The vaccine will not afford protection against species of Salmonella other than Salmonella typhi or other bacteria that cause enteric disease. The vaccine is not suitable for treatment of acute infections with S. typhi.",
"Description": "Vivotif (Typhoid Vaccine Live Oral Ty21a) is a live attenuated vaccine for oral administration only. The vaccine contains the attenuated strain Salmonella typhi Ty21a (1,2). Vivotif is manufactured by the Berna Biotech Ltd. The vaccine strain is grown in fermentors under controlled conditions in medium containing a digest of yeast extract, an acid digest of casein, dextrose and galactose. The bacteria are collected by centrifugation, mixed with a stabilizer containing sucrose, ascorbic acid and amino acids, and lyophilized. The lyophilized bacteria are mixed with lactose and magnesium stearate and filled into gelatin capsules which are coated with an organic solution to render them resistant to dissolution in stomach acid. The. enteric-coated, salmon/white capsules are then packaged in 4-capsule blisters for distribution. The contents of each enteric-coated capsule are shown in Table 1. Table 1: Contents of one enteric-coated capsule of Vivotif (Typhoid Vaccine Live Oral Ty21a). Viable S. typhi Ty21a . . . . . . . . . . . . . . . . . . . . . . . . . 2–6.8x109 colony-forming units*. Non-viable S. typhi Ty21a . . . . . . . . . . . . . . . . . . . . . 5–50x109 bacterial cells. Sucrose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26–130 mg. Ascorbic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1–5 mg. Amino acid mixture . . . . . . . . . . . . . . . . . . . . . . . . . . 1.4–7 mg. Lactose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100–180 mg. Magnesium stearate . . . . . . . . . . . . . . . . . . . . . . . . . 3.6–4.4 mg. *Vaccine potency (viable cell counts per capsule) is determined by inoculation of agar plates with appropriate dilutions of the vaccine suspended in physiological saline."
},
{
"NDCCode": "50580-526-01",
"PackageDescription": "1 KIT in 1 PACKAGE (50580-526-01) * 240 mL in 1 BOTTLE (50580-369-01) * 240 mL in 1 BOTTLE, PLASTIC (50580-403-08) ",
"NDC11Code": "50580-0526-01",
"ProductNDC": "50580-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol Cold Plus Flu Severe Day And Tylenol Cold Plus Flu Plus Cough Night 2-pack",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20191028",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Kenvue Brands LLC",
"Status": "Active",
"LastUpdate": "2025-02-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191028",
"SamplePackage": "N"
},
{
"NDCCode": "55111-526-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (55111-526-01) / 100 CAPSULE in 1 BOTTLE",
"NDC11Code": "55111-0526-01",
"ProductNDC": "55111-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090509",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "N",
"Description": "Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2."
},
{
"NDCCode": "55111-526-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (55111-526-05) / 500 CAPSULE in 1 BOTTLE",
"NDC11Code": "55111-0526-05",
"ProductNDC": "55111-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090509",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "N",
"Description": "Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2."
},
{
"NDCCode": "55111-526-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (55111-526-30) / 30 CAPSULE in 1 BOTTLE",
"NDC11Code": "55111-0526-30",
"ProductNDC": "55111-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090509",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "N",
"Description": "Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2."
},
{
"NDCCode": "55111-526-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-526-78) / 10 CAPSULE in 1 BLISTER PACK (55111-526-79) ",
"NDC11Code": "55111-0526-78",
"ProductNDC": "55111-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090509",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "N",
"Description": "Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2."
},
{
"NDCCode": "59779-526-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (59779-526-02) > 12 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "59779-0526-02",
"ProductNDC": "59779-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Severe Cold Relief Pe",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050621",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "WOONSOCKET PRESCRIPTION CENTER, INCORPORATED",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 12.5; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "temporarily relieves these symptoms of the common cold: . runny nose. sneezing. headache. minor aches and pains. nasal congestion. cough. sore throat. temporarily reduces fever."
},
{
"NDCCode": "59779-526-08",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (59779-526-08) > 24 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "59779-0526-08",
"ProductNDC": "59779-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Severe Cold Relief Pe",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050621",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "WOONSOCKET PRESCRIPTION CENTER, INCORPORATED",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 12.5; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "temporarily relieves these symptoms of the common cold: . runny nose. sneezing. headache. minor aches and pains. nasal congestion. cough. sore throat. temporarily reduces fever."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>41163-526-21</NDCCode>
<PackageDescription>20 TABLET in 1 BLISTER PACK (41163-526-21)</PackageDescription>
<NDC11Code>41163-0526-21</NDC11Code>
<ProductNDC>41163-526</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076134</ApplicationNumber>
<LabelerName>SUPERVALU INC.</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64980-526-21</NDCCode>
<PackageDescription>12 TABLET, FILM COATED in 1 BOTTLE (64980-526-21) </PackageDescription>
<NDC11Code>64980-0526-21</NDC11Code>
<ProductNDC>64980-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitazoxanide</ProprietaryName>
<NonProprietaryName>Nitazoxanide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213820</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>NITAZOXANIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiprotozoal [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Nitazoxanide tablets contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide is a pale yellow to yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy-N-(5-nitro-2-thiazolyl) benzamide. The molecular formula is C12H9N3O5S and the molecular weight is 307.3. The structural formula is. Nitazoxanide tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, partially pregelatinized maize starch, sodium starch glycolate, hypromellose, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No.2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>41163-526-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (41163-526-30)</PackageDescription>
<NDC11Code>41163-0526-30</NDC11Code>
<ProductNDC>41163-526</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076134</ApplicationNumber>
<LabelerName>SUPERVALU INC.</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>41163-526-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (41163-526-60)</PackageDescription>
<NDC11Code>41163-0526-60</NDC11Code>
<ProductNDC>41163-526</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076134</ApplicationNumber>
<LabelerName>SUPERVALU INC.</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>41163-526-69</NDCCode>
<PackageDescription>10 TABLET in 1 BLISTER PACK (41163-526-69)</PackageDescription>
<NDC11Code>41163-0526-69</NDC11Code>
<ProductNDC>41163-526</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076134</ApplicationNumber>
<LabelerName>SUPERVALU INC.</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>41163-526-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (41163-526-90)</PackageDescription>
<NDC11Code>41163-0526-90</NDC11Code>
<ProductNDC>41163-526</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076134</ApplicationNumber>
<LabelerName>SUPERVALU INC.</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>41163-384-21</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41163-384-21) / 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>41163-0384-21</NDC11Code>
<ProductNDC>41163-384</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equaline Cough Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Polistirex</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091135</ApplicationNumber>
<LabelerName>United Natural Foods, Inc. dba UNFI</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: 1 cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants, 2 the impulse to cough to help you get to sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41163-404-21</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (41163-404-21) > 8 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41163-0404-21</NDC11Code>
<ProductNDC>41163-404</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Motion Sickness Relief</ProprietaryName>
<NonProprietaryName>Meclizine Hcl</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020529</StartMarketingDate>
<EndMarketingDate>20190317</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part336</ApplicationNumber>
<LabelerName>SUPERVALU INC.</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-03-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>41163-411-21</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (41163-411-21) > 8 TABLET, SUGAR COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41163-0411-21</NDC11Code>
<ProductNDC>41163-411</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cough And Cold Relief Hbp</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate And Dextromethorphan Hbr</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030503</StartMarketingDate>
<EndMarketingDate>20200606</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>SUPERVALU INC.</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>4; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-09</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>41163-698-21</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (41163-698-21) / 8 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41163-0698-21</NDC11Code>
<ProductNDC>41163-698</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cough And Cold Relief Hbp</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate, Dextromethorphan Hbr</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>United Natural Foods, Inc. dba UNFI</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>4; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. temporarily relieves runny nose and sneezing due to the common cold.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41163-770-21</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (41163-770-21) / 85 g in 1 TUBE</PackageDescription>
<NDC11Code>41163-0770-21</NDC11Code>
<ProductNDC>41163-770</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equaline Muscle Rub</ProprietaryName>
<NonProprietaryName>Menthol, Methyl Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140103</StartMarketingDate>
<EndMarketingDate>20231031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>United Natural Foods, Inc. dba UNFI</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>10; 15</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140103</StartMarketingDatePackage>
<EndMarketingDatePackage>20231031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41163-958-21</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41163-958-21) > 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>41163-0958-21</NDC11Code>
<ProductNDC>41163-958</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equaline Cough Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Polistirex</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091135</ApplicationNumber>
<LabelerName>Supervalu Inc</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0338-0179-03</NDCCode>
<PackageDescription>500 mL in 1 BAG (0338-0179-03) </PackageDescription>
<NDC11Code>00338-0179-03</NDC11Code>
<ProductNDC>0338-0179</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plasma-lyte 148</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, And Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19790202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017378</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE</SubstanceName>
<StrengthNumber>30; 37; 368; 526; 502</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19790202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is indicated as a source of water and electrolytes or as an alkalinizing agent.</IndicationAndUsage>
<Description>PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO23H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl26H2O). It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid. The pH is 5.5 (4.0 to 8.0). PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. The caloric content is 21 kcal/L. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0338-0179-04</NDCCode>
<PackageDescription>1000 mL in 1 BAG (0338-0179-04) </PackageDescription>
<NDC11Code>00338-0179-04</NDC11Code>
<ProductNDC>0338-0179</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plasma-lyte 148</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, And Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19790202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017378</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE</SubstanceName>
<StrengthNumber>30; 37; 368; 526; 502</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19790202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is indicated as a source of water and electrolytes or as an alkalinizing agent.</IndicationAndUsage>
<Description>PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO23H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl26H2O). It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid. The pH is 5.5 (4.0 to 8.0). PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. The caloric content is 21 kcal/L. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0338-0221-03</NDCCode>
<PackageDescription>500 mL in 1 BAG (0338-0221-03) </PackageDescription>
<NDC11Code>00338-0221-03</NDC11Code>
<ProductNDC>0338-0221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plasma-lyte A</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride And Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19790202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017378</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>526; 502; 368; 37; 30</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19790202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is indicated as a source of water and electrolytes or as an alkalinizing agent.</IndicationAndUsage>
<Description>PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO23H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl26H2O). It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide. The pH is 7.4 (6.5 to 8.0). PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc). Normal physiologic osmolarity range is 280 to 310 mOsmol/L. The caloric content is 21 kcal/L. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0338-0221-04</NDCCode>
<PackageDescription>1000 mL in 1 BAG (0338-0221-04) </PackageDescription>
<NDC11Code>00338-0221-04</NDC11Code>
<ProductNDC>0338-0221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plasma-lyte A</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride And Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19790202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017378</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>526; 502; 368; 37; 30</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19790202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is indicated as a source of water and electrolytes or as an alkalinizing agent.</IndicationAndUsage>
<Description>PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO23H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl26H2O). It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide. The pH is 7.4 (6.5 to 8.0). PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc). Normal physiologic osmolarity range is 280 to 310 mOsmol/L. The caloric content is 21 kcal/L. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>10135-526-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (10135-526-05)</PackageDescription>
<NDC11Code>10135-0526-05</NDC11Code>
<ProductNDC>10135-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078552</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be use d alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)○ Amlodipine besylate tablets are indicate d for the treatment of hypertension, to lower blood pressure. Lowe ring blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2- chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, and sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>10135-526-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (10135-526-10)</PackageDescription>
<NDC11Code>10135-0526-10</NDC11Code>
<ProductNDC>10135-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078552</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be use d alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)○ Amlodipine besylate tablets are indicate d for the treatment of hypertension, to lower blood pressure. Lowe ring blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2- chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, and sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>10135-526-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (10135-526-90)</PackageDescription>
<NDC11Code>10135-0526-90</NDC11Code>
<ProductNDC>10135-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078552</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be use d alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)○ Amlodipine besylate tablets are indicate d for the treatment of hypertension, to lower blood pressure. Lowe ring blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2- chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, and sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>10882-526-30</NDCCode>
<PackageDescription>30 PATCH in 1 BOX (10882-526-30) / 1 PATCH in 1 PATCH</PackageDescription>
<NDC11Code>10882-0526-30</NDC11Code>
<ProductNDC>10882-526</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidopatch</ProprietaryName>
<NonProprietaryName>Lidocaine, Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151029</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>JAR Laboratories</LabelerName>
<SubstanceName>LIDOCAINE; MENTHOL</SubstanceName>
<StrengthNumber>505; 175</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises. LidoPatch contains lidocaine PAIN RELIEF PATCH. For minor pain associated with arthritis back pain muscle sprains & strains The only over the counter patch with lidocaine ultra thin, flexible, trim to fit.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13537-526-01</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, PLASTIC (13537-526-01)</PackageDescription>
<NDC11Code>13537-0526-01</NDC11Code>
<ProductNDC>13537-526</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika</ProprietaryName>
<ProprietaryNameSuffix>Jadiss Glam Antiperspirant Roll-on Deodorant</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Ventura Corporation LTD.</LabelerName>
<SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
<StrengthNumber>.136</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Reduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-526-01</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (16714-526-01) / 345 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>16714-0526-01</NDC11Code>
<ProductNDC>16714-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20220222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076156</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>21</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ipratropium bromide nasal solution, 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Ipratropium bromide nasal solution, 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis.</IndicationAndUsage>
<Description>The active ingredient in ipratropium bromide nasal solution is ipratropium bromide monohydrate. It is an anticholinergic agent chemically described as 8-azoniabicyclo (3.2.1) octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (+)-: a synthetic quaternary ammonium compound, chemically related to atropine. The structural formula is. ipratropium bromide C20H30BrNO3H2O. monohydrate Mol. Wt. 430.4. Ipratropium bromide is a white to off-white, crystalline substance. It is freely soluble in lower alcohols and water, existing in an ionized state in aqueous solutions, and relatively insoluble in non-polar media. Ipratropium bromide nasal solution, 0.03% is a metered-dose, manual pump spray unit which delivers 21 mcg (70 mcL) ipratropium bromide per spray on an anhydrous basis in an isotonic, aqueous solution. It also contains the following inactive ingredients: benzalkonium chloride, edetate disodium, purified water and sodium chloride. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH to 4.5 to 4.9. Each bottle contains 345 sprays.</Description>
</NDC>
<NDC>
<NDCCode>21695-526-04</NDCCode>
<PackageDescription>4 CAPSULE in 1 BLISTER PACK (21695-526-04)</PackageDescription>
<NDC11Code>21695-0526-04</NDC11Code>
<ProductNDC>21695-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vivotif-b</ProprietaryName>
<NonProprietaryName>Vivotif-b</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19891215</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103123</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>[CFU]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Vivotif (Typhoid Vaccine Live Oral Ty21a) is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi. Routine typhoid vaccination is not recommended in the United States of America. Selective immunization against typhoid fever is recommended for the following groups: 1) travelers to areas in which there is a recognized risk of exposure to S. typhi, 2) persons with intimate exposure (e.g. household contact) to a S. typhi carrier, and 3) microbiology laboratorians who work frequently with S. typhi. (7). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disasters or in persons attending rural summer camps. Not all recipients of Vivotif will be fully protected against typhoid fever. Vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms. The vaccine will not afford protection against species of Salmonella other than Salmonella typhi or other bacteria that cause enteric disease. The vaccine is not suitable for treatment of acute infections with S. typhi.</IndicationAndUsage>
<Description>Vivotif (Typhoid Vaccine Live Oral Ty21a) is a live attenuated vaccine for oral administration only. The vaccine contains the attenuated strain Salmonella typhi Ty21a (1,2). Vivotif is manufactured by the Berna Biotech Ltd. The vaccine strain is grown in fermentors under controlled conditions in medium containing a digest of yeast extract, an acid digest of casein, dextrose and galactose. The bacteria are collected by centrifugation, mixed with a stabilizer containing sucrose, ascorbic acid and amino acids, and lyophilized. The lyophilized bacteria are mixed with lactose and magnesium stearate and filled into gelatin capsules which are coated with an organic solution to render them resistant to dissolution in stomach acid. The. enteric-coated, salmon/white capsules are then packaged in 4-capsule blisters for distribution. The contents of each enteric-coated capsule are shown in Table 1. Table 1: Contents of one enteric-coated capsule of Vivotif (Typhoid Vaccine Live Oral Ty21a). Viable S. typhi Ty21a . . . . . . . . . . . . . . . . . . . . . . . . . 2–6.8x109 colony-forming units*. Non-viable S. typhi Ty21a . . . . . . . . . . . . . . . . . . . . . 5–50x109 bacterial cells. Sucrose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26–130 mg. Ascorbic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1–5 mg. Amino acid mixture . . . . . . . . . . . . . . . . . . . . . . . . . . 1.4–7 mg. Lactose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100–180 mg. Magnesium stearate . . . . . . . . . . . . . . . . . . . . . . . . . 3.6–4.4 mg. *Vaccine potency (viable cell counts per capsule) is determined by inoculation of agar plates with appropriate dilutions of the vaccine suspended in physiological saline.</Description>
</NDC>
<NDC>
<NDCCode>50580-526-01</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (50580-526-01) * 240 mL in 1 BOTTLE (50580-369-01) * 240 mL in 1 BOTTLE, PLASTIC (50580-403-08) </PackageDescription>
<NDC11Code>50580-0526-01</NDC11Code>
<ProductNDC>50580-526</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tylenol Cold Plus Flu Severe Day And Tylenol Cold Plus Flu Plus Cough Night 2-pack</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20191028</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-02-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55111-526-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55111-526-01) / 100 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>55111-0526-01</NDC11Code>
<ProductNDC>55111-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090509</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-526-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55111-526-05) / 500 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>55111-0526-05</NDC11Code>
<ProductNDC>55111-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090509</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-526-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55111-526-30) / 30 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>55111-0526-30</NDC11Code>
<ProductNDC>55111-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090509</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-526-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-526-78) / 10 CAPSULE in 1 BLISTER PACK (55111-526-79) </PackageDescription>
<NDC11Code>55111-0526-78</NDC11Code>
<ProductNDC>55111-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090509</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2.</Description>
</NDC>
<NDC>
<NDCCode>59779-526-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (59779-526-02) > 12 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59779-0526-02</NDC11Code>
<ProductNDC>59779-526</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Severe Cold Relief Pe</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050621</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>WOONSOCKET PRESCRIPTION CENTER, INCORPORATED</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 12.5; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves these symptoms of the common cold: . runny nose. sneezing. headache. minor aches and pains. nasal congestion. cough. sore throat. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59779-526-08</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (59779-526-08) > 24 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59779-0526-08</NDC11Code>
<ProductNDC>59779-526</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Severe Cold Relief Pe</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050621</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>WOONSOCKET PRESCRIPTION CENTER, INCORPORATED</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 12.5; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves these symptoms of the common cold: . runny nose. sneezing. headache. minor aches and pains. nasal congestion. cough. sore throat. temporarily reduces fever.</IndicationAndUsage>
</NDC>
</NDCList>