{
"NDC": [
{
"NDCCode": "64942-2505-1",
"PackageDescription": "850 g in 1 CARTON (64942-2505-1) ",
"NDC11Code": "64942-2505-01",
"ProductNDC": "64942-2505",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dove",
"NonProprietaryName": "Men Care Antibacterial Care Moisturizing Cream Bar",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260716",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Conopco d/b/a Unilever",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260716",
"SamplePackage": "N",
"IndicationAndUsage": " For washing to decrease bacteria on the skin.",
"Description": "Dove Men Care Antibacterial Care Moisturizing Cream Bar."
},
{
"NDCCode": "0517-2505-25",
"PackageDescription": "25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0517-2505-25) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0517-2505-01) ",
"NDC11Code": "00517-2505-25",
"ProductNDC": "0517-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216274",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231013",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Phosphates Injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.",
"Description": "Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL, and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
},
{
"NDCCode": "36987-2505-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-2505-1)",
"NDC11Code": "36987-2505-01",
"ProductNDC": "36987-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aspen",
"NonProprietaryName": "Aspen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "POPULUS TREMULOIDES POLLEN",
"StrengthNumber": "40000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-2505-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-2505-2)",
"NDC11Code": "36987-2505-02",
"ProductNDC": "36987-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aspen",
"NonProprietaryName": "Aspen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "POPULUS TREMULOIDES POLLEN",
"StrengthNumber": "40000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-2505-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-2505-3)",
"NDC11Code": "36987-2505-03",
"ProductNDC": "36987-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aspen",
"NonProprietaryName": "Aspen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "POPULUS TREMULOIDES POLLEN",
"StrengthNumber": "40000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-2505-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-2505-4)",
"NDC11Code": "36987-2505-04",
"ProductNDC": "36987-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aspen",
"NonProprietaryName": "Aspen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "POPULUS TREMULOIDES POLLEN",
"StrengthNumber": "40000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-2505-1",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-2505-1) ",
"NDC11Code": "37662-2505-01",
"ProductNDC": "37662-2505",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mercurius Bromatus",
"NonProprietaryName": "Mercurius Bromatus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230125",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "MERCUROUS BROMIDE",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230125",
"SamplePackage": "N"
},
{
"NDCCode": "37662-2505-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-2505-2) ",
"NDC11Code": "37662-2505-02",
"ProductNDC": "37662-2505",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mercurius Bromatus",
"NonProprietaryName": "Mercurius Bromatus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230125",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "MERCUROUS BROMIDE",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230125",
"SamplePackage": "N"
},
{
"NDCCode": "37662-2505-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-2505-3) ",
"NDC11Code": "37662-2505-03",
"ProductNDC": "37662-2505",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mercurius Bromatus",
"NonProprietaryName": "Mercurius Bromatus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230125",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "MERCUROUS BROMIDE",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230125",
"SamplePackage": "N"
},
{
"NDCCode": "37662-2505-4",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-2505-4) ",
"NDC11Code": "37662-2505-04",
"ProductNDC": "37662-2505",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mercurius Bromatus",
"NonProprietaryName": "Mercurius Bromatus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230125",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "MERCUROUS BROMIDE",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230125",
"SamplePackage": "N"
},
{
"NDCCode": "46324-2505-1",
"PackageDescription": "148 mL in 1 BOTTLE (46324-2505-1) ",
"NDC11Code": "46324-2505-01",
"ProductNDC": "46324-2505",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hands Free Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "AG Hair Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".73",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N"
},
{
"NDCCode": "46324-2505-5",
"PackageDescription": "53 mL in 1 BOTTLE (46324-2505-5) ",
"NDC11Code": "46324-2505-05",
"ProductNDC": "46324-2505",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hands Free Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "AG Hair Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".73",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N"
},
{
"NDCCode": "50090-2505-0",
"PackageDescription": "1 KIT in 1 KIT (50090-2505-0) ",
"NDC11Code": "50090-2505-00",
"ProductNDC": "50090-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levonest",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20101229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090719",
"LabelerName": "A-S Medication Solutions",
"Status": "Active",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161013",
"SamplePackage": "N",
"IndicationAndUsage": "Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Each LEVONEST (levonorgestrel and ethinyl estradiol tablets—triphasic regimen) cycle of 28 tablets consists of three different drug phases as follows:. Phase 1 comprised of 6 yellow tablets, each containing 0.050 mg of levonorgestrel (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17 -pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 green tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 light brown tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 white inert tablets. The inactive ingredients present in the yellow, green and light brown tablets are lactose, magnesium stearate and pregelatinized corn starch. Each yellow tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each green tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3000 NF, lecithin (soya), talc, and polyvinyl alcohol. Each light brown tablet also contains iron oxide yellow, iron oxide red, iron oxide black, titanium dioxide, macrogol/ polyethylene glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each inactive, white tablet (7) contains the following inactive ingredients: Titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "53002-2505-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (53002-2505-3) ",
"NDC11Code": "53002-2505-03",
"ProductNDC": "53002-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204319",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": ". Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
"Description": "Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is: Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 micromol), 5 mg (16 micromol), 7.5 mg (24 micromol), 10 mg (32 micromol), 15 mg (48 micromol), or 20 mg (64 micromol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry ® 03A18286 (Hypromellose, Titanium Dioxide and Sodium Lauryl Sulfate) for 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets, Opadry ® 03A605003 (Hypromellose, Titanium Dioxide, FD&C Blue #2/Indigo Carmine Aluminum Lake and FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake) for 15 mg tablets and Opadry ® 03A640001 (Hypromellose, Titanium Dioxide, Talc and Iron Oxide Red) for 20 mg tablets."
},
{
"NDCCode": "54565-2505-1",
"PackageDescription": "76 g in 1 CANISTER (54565-2505-1)",
"NDC11Code": "54565-2505-01",
"ProductNDC": "54565-2505",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sure Original Solid",
"ProprietaryNameSuffix": "Unscented",
"NonProprietaryName": "Aluminum Zirconium Tricholorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091222",
"MarketingCategoryName": "OTC MONOGRAPH DRUG PRODUCT MANUFACTURED UNDER CONTRACT",
"LabelerName": "Les Emballages Knowlton Inc.",
"SubstanceName": "ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY",
"StrengthNumber": "16",
"StrengthUnit": "g/76g",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "60681-2505-1",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (60681-2505-1) > 1 mL in 1 VIAL, GLASS",
"NDC11Code": "60681-2505-01",
"ProductNDC": "60681-2505",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pleo Pef",
"NonProprietaryName": "Candida Parapsilosis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19970319",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sanum Kehlbeck GmbH & Co. KG",
"SubstanceName": "CANDIDA PARAPSILOSIS",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For temporary relief of external anal itching and irritation."
},
{
"NDCCode": "60681-2505-2",
"PackageDescription": "50 VIAL, GLASS in 1 CARTON (60681-2505-2) > 1 mL in 1 VIAL, GLASS",
"NDC11Code": "60681-2505-02",
"ProductNDC": "60681-2505",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pleo Pef",
"NonProprietaryName": "Candida Parapsilosis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19970319",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sanum Kehlbeck GmbH & Co. KG",
"SubstanceName": "CANDIDA PARAPSILOSIS",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For temporary relief of external anal itching and irritation."
},
{
"NDCCode": "61958-2505-1",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (61958-2505-1) ",
"NDC11Code": "61958-2505-01",
"ProductNDC": "61958-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Biktarvy",
"NonProprietaryName": "Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211007",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210251",
"LabelerName": "Gilead Sciences, Inc.",
"SubstanceName": "BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE",
"StrengthNumber": "30; 120; 15",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211007",
"SamplePackage": "N",
"IndicationAndUsage": "BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg: : 1 with no antiretroviral treatment history, or, 2 with an antiretroviral treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir, or, 3 to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir [see Dosage and Administration (2.4), and Use in Specific Populations (8.1)].",
"Description": "BIKTARVY (bictegravir, emtricitabine, and tenofovir alafenamide) is a fixed dose combination tablet containing bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) for oral administration. : 1 BIC is an integrase strand transfer inhibitor (INSTI)., 2 FTC, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)., 3 TAF, an HIV NRTI, is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate."
},
{
"NDCCode": "63479-2505-1",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (63479-2505-1) ",
"NDC11Code": "63479-2505-01",
"ProductNDC": "63479-2505",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Liver Plus Formula",
"NonProprietaryName": "Adenosine Triphosphate, Ignatia Amara, Kali Phosphoricum, Natrum Muriaticum, Nux Vomica, Sulphur",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20220322",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Apex Energetics Inc.",
"SubstanceName": "ADENOSINE TRIPHOSPHATE; STRYCHNOS IGNATII SEED; DIBASIC POTASSIUM PHOSPHATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR",
"StrengthNumber": "5; 2; 1; 2; 1; 7",
"StrengthUnit": "[hp_X]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [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], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2024-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220322",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of minor. tiredness*. headache*. nausea*. difficulty falling asleep*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "63629-2505-1",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (63629-2505-1) ",
"NDC11Code": "63629-2505-01",
"ProductNDC": "63629-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076635",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210309",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1)., 2 For treatment of adult patients with severe hypertriglyceridemia (1.2).",
"Description": "Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79-82°C. Fenofibrate, USP is a white or almost white crystalline powder. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, crospovidone, microcrystalline cellulose, polyvinyl alcohol (part-hydrolyzed), polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium stearyl fumarate, talc and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "68071-2505-6",
"PackageDescription": "1 CANISTER in 1 CARTON (68071-2505-6) > 200 AEROSOL, METERED in 1 CANISTER",
"NDC11Code": "68071-2505-06",
"ProductNDC": "68071-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20210315",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020503",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "108",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210819",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol Sulfate Inhalation Aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.",
"Description": "The active component of Albuterol Sulfate Inhalation Aerosol is albuterol sulfate, USP racemic α 1 [( tert-Butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diol sulfate (2:1)(salt), a relatively selective beta 2-adrenergic bronchodilator having the following chemical structure:. Albuterol sulfate is the official generic name in the United States. The World Health Organization recommended name for the drug is salbutamol sulfate. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C 13H 21NO 3) 2H 2SO 4. Albuterol sulfate is a white to off-white crystalline solid. It is soluble in water and slightly soluble in ethanol. Albuterol Sulfate Inhalation Aerosol is a pressurized metered-dose aerosol unit for oral inhalation. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane), ethanol, and oleic acid. Each actuation delivers 120 mcg albuterol sulfate, USP from the valve and 108 mcg albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Each canister provides 200 inhalations. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four “test sprays” into the air, away from the face. This product does not contain chlorofluorocarbons (CFCs) as the propellant."
},
{
"NDCCode": "68254-2505-1",
"PackageDescription": "2 kg in 1 DRUM (68254-2505-1) ",
"NDC11Code": "68254-2505-01",
"ProductNDC": "68254-2505",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mupirocin Calcium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Concord Biotech Limited",
"SubstanceName": "MUPIROCIN CALCIUM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-01-11",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-MAR-13"
},
{
"NDCCode": "70121-2505-2",
"PackageDescription": "2 AMPULE in 1 BOX (70121-2505-2) / 1 KIT in 1 AMPULE",
"NDC11Code": "70121-2505-02",
"ProductNDC": "70121-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lioresal (baclofen)",
"NonProprietaryName": "Baclofen",
"DosageFormName": "KIT",
"RouteName": "INTRATHECAL",
"StartMarketingDate": "20220612",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020075",
"LabelerName": "Amneal Pharmaceuticals LLC",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220612",
"SamplePackage": "N",
"IndicationAndUsage": "LIORESAL INTRATHECAL (baclofen injection) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of LIORESAL INTRATHECAL via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. LIORESAL INTRATHECAL is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the FDA specifically for the administration of LIORESAL INTRATHECAL into the intrathecal space.",
"Description": "LIORESAL INTRATHECAL (baclofen injection) is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid, and its structural formula is. Baclofen is a white to off-white, odorless or practically odorless crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. LIORESAL INTRATHECAL is a sterile, pyrogen-free, isotonic solution free of antioxidants, preservatives or other potentially neurotoxic additives indicated only for intrathecal administration. The drug is stable in solution at 37° C and compatible with CSF. Each milliliter of LIORESAL INTRATHECAL contains baclofen U. S. P. 50 mcg, 500 mcg or 2000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.0 - 7.0. Each ampule is intended for SINGLE USE ONLY. Discard any unused portion. DO NOT AUTOCLAVE."
},
{
"NDCCode": "70518-2505-0",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (70518-2505-0) ",
"NDC11Code": "70518-2505-00",
"ProductNDC": "70518-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191224",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076056",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191224",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.",
"Description": "Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S- [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. C 23H 35NaO 7M.W. 446.52. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP for oral use contain 10 mg, 20 mg and 40 mg pravastatin sodium USP, which is equivalent to 9.50 mg, 19.01 mg and 38.03 mg of pravastatin, respectively. Inactive ingredients include: calcium phosphate dibasic anhydrous, croscarmellose sodium, crospovidone, lactose anhydrous, microcrystalline cellulose, povidone and sodium stearyl fumarate. Additionally, the 10 mg tablet contains ferric oxide red; the 20 mg tablet contains ferric oxide yellow; and the 40 mg tablet contains FD&C Blue No. 1 Aluminum Lake and D&C Yellow No.10."
},
{
"NDCCode": "70518-2505-1",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (70518-2505-1) ",
"NDC11Code": "70518-2505-01",
"ProductNDC": "70518-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191224",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076056",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210112",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.",
"Description": "Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S- [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. C 23H 35NaO 7M.W. 446.52. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP for oral use contain 10 mg, 20 mg and 40 mg pravastatin sodium USP, which is equivalent to 9.50 mg, 19.01 mg and 38.03 mg of pravastatin, respectively. Inactive ingredients include: calcium phosphate dibasic anhydrous, croscarmellose sodium, crospovidone, lactose anhydrous, microcrystalline cellulose, povidone and sodium stearyl fumarate. Additionally, the 10 mg tablet contains ferric oxide red; the 20 mg tablet contains ferric oxide yellow; and the 40 mg tablet contains FD&C Blue No. 1 Aluminum Lake and D&C Yellow No.10."
},
{
"NDCCode": "71335-2505-1",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-1) ",
"NDC11Code": "71335-2505-01",
"ProductNDC": "71335-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213859",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241205",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the:. Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1). Maintenance of healing of EE in adults. ( 1.2). Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3). Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4). Helicobacter pylorieradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. ( 1.5). Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. ( 1.6).",
"Description": "The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17H 18N 3O 3S) 2Mg × 3 H 2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, sugar spheres (composed of corn starch and sucrose), talc, and triethyl citrate. The capsule shells have the following inactive ingredients: FD&C Blue 1, FD&C Red 3, ferrosoferric oxide, gelatin, potassium hydroxide, shellac, sodium lauryl sulfate and titanium dioxide. Esomeprazole Magnesium Delayed-Release Capsules, USP meets USP Dissolution Test 2."
},
{
"NDCCode": "71335-2505-2",
"PackageDescription": "10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-2) ",
"NDC11Code": "71335-2505-02",
"ProductNDC": "71335-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213859",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241212",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the:. Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1). Maintenance of healing of EE in adults. ( 1.2). Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3). Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4). Helicobacter pylorieradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. ( 1.5). Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. ( 1.6).",
"Description": "The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17H 18N 3O 3S) 2Mg × 3 H 2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, sugar spheres (composed of corn starch and sucrose), talc, and triethyl citrate. The capsule shells have the following inactive ingredients: FD&C Blue 1, FD&C Red 3, ferrosoferric oxide, gelatin, potassium hydroxide, shellac, sodium lauryl sulfate and titanium dioxide. Esomeprazole Magnesium Delayed-Release Capsules, USP meets USP Dissolution Test 2."
},
{
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"ProductNDC": "71335-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
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"RouteName": "ORAL",
"StartMarketingDate": "20230815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213859",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the:. Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1). Maintenance of healing of EE in adults. ( 1.2). Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3). Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4). Helicobacter pylorieradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. ( 1.5). Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. ( 1.6).",
"Description": "The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17H 18N 3O 3S) 2Mg × 3 H 2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, sugar spheres (composed of corn starch and sucrose), talc, and triethyl citrate. The capsule shells have the following inactive ingredients: FD&C Blue 1, FD&C Red 3, ferrosoferric oxide, gelatin, potassium hydroxide, shellac, sodium lauryl sulfate and titanium dioxide. Esomeprazole Magnesium Delayed-Release Capsules, USP meets USP Dissolution Test 2."
},
{
"NDCCode": "71335-2505-4",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-4) ",
"NDC11Code": "71335-2505-04",
"ProductNDC": "71335-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
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"RouteName": "ORAL",
"StartMarketingDate": "20230815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213859",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241212",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the:. Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1). Maintenance of healing of EE in adults. ( 1.2). Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3). Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4). Helicobacter pylorieradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. ( 1.5). Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. ( 1.6).",
"Description": "The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17H 18N 3O 3S) 2Mg × 3 H 2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, sugar spheres (composed of corn starch and sucrose), talc, and triethyl citrate. The capsule shells have the following inactive ingredients: FD&C Blue 1, FD&C Red 3, ferrosoferric oxide, gelatin, potassium hydroxide, shellac, sodium lauryl sulfate and titanium dioxide. Esomeprazole Magnesium Delayed-Release Capsules, USP meets USP Dissolution Test 2."
},
{
"NDCCode": "71335-2505-5",
"PackageDescription": "42 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-5) ",
"NDC11Code": "71335-2505-05",
"ProductNDC": "71335-2505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213859",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241212",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the:. Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1). Maintenance of healing of EE in adults. ( 1.2). Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3). Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4). Helicobacter pylorieradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. ( 1.5). Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. ( 1.6).",
"Description": "The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17H 18N 3O 3S) 2Mg × 3 H 2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, sugar spheres (composed of corn starch and sucrose), talc, and triethyl citrate. The capsule shells have the following inactive ingredients: FD&C Blue 1, FD&C Red 3, ferrosoferric oxide, gelatin, potassium hydroxide, shellac, sodium lauryl sulfate and titanium dioxide. Esomeprazole Magnesium Delayed-Release Capsules, USP meets USP Dissolution Test 2."
}
]
}
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<NDCList>
<NDC>
<NDCCode>64942-2505-1</NDCCode>
<PackageDescription>850 g in 1 CARTON (64942-2505-1) </PackageDescription>
<NDC11Code>64942-2505-01</NDC11Code>
<ProductNDC>64942-2505</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dove</ProprietaryName>
<NonProprietaryName>Men Care Antibacterial Care Moisturizing Cream Bar</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260716</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Conopco d/b/a Unilever</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> For washing to decrease bacteria on the skin.</IndicationAndUsage>
<Description>Dove Men Care Antibacterial Care Moisturizing Cream Bar.</Description>
</NDC>
<NDC>
<NDCCode>0517-2505-25</NDCCode>
<PackageDescription>25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0517-2505-25) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0517-2505-01) </PackageDescription>
<NDC11Code>00517-2505-25</NDC11Code>
<ProductNDC>0517-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216274</ApplicationNumber>
<LabelerName>American Regent, Inc.</LabelerName>
<SubstanceName>POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Phosphates Injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.</IndicationAndUsage>
<Description>Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL, and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>36987-2505-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-2505-1)</PackageDescription>
<NDC11Code>36987-2505-01</NDC11Code>
<ProductNDC>36987-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aspen</ProprietaryName>
<NonProprietaryName>Aspen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>POPULUS TREMULOIDES POLLEN</SubstanceName>
<StrengthNumber>40000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-2505-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-2505-2)</PackageDescription>
<NDC11Code>36987-2505-02</NDC11Code>
<ProductNDC>36987-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aspen</ProprietaryName>
<NonProprietaryName>Aspen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>POPULUS TREMULOIDES POLLEN</SubstanceName>
<StrengthNumber>40000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-2505-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-2505-3)</PackageDescription>
<NDC11Code>36987-2505-03</NDC11Code>
<ProductNDC>36987-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aspen</ProprietaryName>
<NonProprietaryName>Aspen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>POPULUS TREMULOIDES POLLEN</SubstanceName>
<StrengthNumber>40000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-2505-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-2505-4)</PackageDescription>
<NDC11Code>36987-2505-04</NDC11Code>
<ProductNDC>36987-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aspen</ProprietaryName>
<NonProprietaryName>Aspen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>POPULUS TREMULOIDES POLLEN</SubstanceName>
<StrengthNumber>40000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-2505-1</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-2505-1) </PackageDescription>
<NDC11Code>37662-2505-01</NDC11Code>
<ProductNDC>37662-2505</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mercurius Bromatus</ProprietaryName>
<NonProprietaryName>Mercurius Bromatus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230125</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>MERCUROUS BROMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-2505-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-2505-2) </PackageDescription>
<NDC11Code>37662-2505-02</NDC11Code>
<ProductNDC>37662-2505</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mercurius Bromatus</ProprietaryName>
<NonProprietaryName>Mercurius Bromatus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230125</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>MERCUROUS BROMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-2505-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-2505-3) </PackageDescription>
<NDC11Code>37662-2505-03</NDC11Code>
<ProductNDC>37662-2505</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mercurius Bromatus</ProprietaryName>
<NonProprietaryName>Mercurius Bromatus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230125</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>MERCUROUS BROMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-2505-4</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-2505-4) </PackageDescription>
<NDC11Code>37662-2505-04</NDC11Code>
<ProductNDC>37662-2505</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mercurius Bromatus</ProprietaryName>
<NonProprietaryName>Mercurius Bromatus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230125</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>MERCUROUS BROMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46324-2505-1</NDCCode>
<PackageDescription>148 mL in 1 BOTTLE (46324-2505-1) </PackageDescription>
<NDC11Code>46324-2505-01</NDC11Code>
<ProductNDC>46324-2505</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hands Free Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>AG Hair Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.73</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46324-2505-5</NDCCode>
<PackageDescription>53 mL in 1 BOTTLE (46324-2505-5) </PackageDescription>
<NDC11Code>46324-2505-05</NDC11Code>
<ProductNDC>46324-2505</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hands Free Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>AG Hair Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.73</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-2505-0</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50090-2505-0) </PackageDescription>
<NDC11Code>50090-2505-00</NDC11Code>
<ProductNDC>50090-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levonest</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20101229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090719</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Each LEVONEST (levonorgestrel and ethinyl estradiol tablets—triphasic regimen) cycle of 28 tablets consists of three different drug phases as follows:. Phase 1 comprised of 6 yellow tablets, each containing 0.050 mg of levonorgestrel (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17 -pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 green tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 light brown tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 white inert tablets. The inactive ingredients present in the yellow, green and light brown tablets are lactose, magnesium stearate and pregelatinized corn starch. Each yellow tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each green tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3000 NF, lecithin (soya), talc, and polyvinyl alcohol. Each light brown tablet also contains iron oxide yellow, iron oxide red, iron oxide black, titanium dioxide, macrogol/ polyethylene glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each inactive, white tablet (7) contains the following inactive ingredients: Titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>53002-2505-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (53002-2505-3) </PackageDescription>
<NDC11Code>53002-2505-03</NDC11Code>
<ProductNDC>53002-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204319</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. Olanzapine is an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
<Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is: Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 micromol), 5 mg (16 micromol), 7.5 mg (24 micromol), 10 mg (32 micromol), 15 mg (48 micromol), or 20 mg (64 micromol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry ® 03A18286 (Hypromellose, Titanium Dioxide and Sodium Lauryl Sulfate) for 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets, Opadry ® 03A605003 (Hypromellose, Titanium Dioxide, FD&C Blue #2/Indigo Carmine Aluminum Lake and FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake) for 15 mg tablets and Opadry ® 03A640001 (Hypromellose, Titanium Dioxide, Talc and Iron Oxide Red) for 20 mg tablets.</Description>
</NDC>
<NDC>
<NDCCode>54565-2505-1</NDCCode>
<PackageDescription>76 g in 1 CANISTER (54565-2505-1)</PackageDescription>
<NDC11Code>54565-2505-01</NDC11Code>
<ProductNDC>54565-2505</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sure Original Solid</ProprietaryName>
<ProprietaryNameSuffix>Unscented</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tricholorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091222</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG PRODUCT MANUFACTURED UNDER CONTRACT</MarketingCategoryName>
<LabelerName>Les Emballages Knowlton Inc.</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>g/76g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>60681-2505-1</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (60681-2505-1) > 1 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>60681-2505-01</NDC11Code>
<ProductNDC>60681-2505</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pleo Pef</ProprietaryName>
<NonProprietaryName>Candida Parapsilosis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970319</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sanum Kehlbeck GmbH & Co. KG</LabelerName>
<SubstanceName>CANDIDA PARAPSILOSIS</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For temporary relief of external anal itching and irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60681-2505-2</NDCCode>
<PackageDescription>50 VIAL, GLASS in 1 CARTON (60681-2505-2) > 1 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>60681-2505-02</NDC11Code>
<ProductNDC>60681-2505</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pleo Pef</ProprietaryName>
<NonProprietaryName>Candida Parapsilosis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970319</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sanum Kehlbeck GmbH & Co. KG</LabelerName>
<SubstanceName>CANDIDA PARAPSILOSIS</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For temporary relief of external anal itching and irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61958-2505-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (61958-2505-1) </PackageDescription>
<NDC11Code>61958-2505-01</NDC11Code>
<ProductNDC>61958-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Biktarvy</ProprietaryName>
<NonProprietaryName>Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211007</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210251</ApplicationNumber>
<LabelerName>Gilead Sciences, Inc.</LabelerName>
<SubstanceName>BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE</SubstanceName>
<StrengthNumber>30; 120; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg: : 1 with no antiretroviral treatment history, or, 2 with an antiretroviral treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir, or, 3 to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir [see Dosage and Administration (2.4), and Use in Specific Populations (8.1)].</IndicationAndUsage>
<Description>BIKTARVY (bictegravir, emtricitabine, and tenofovir alafenamide) is a fixed dose combination tablet containing bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) for oral administration. : 1 BIC is an integrase strand transfer inhibitor (INSTI)., 2 FTC, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)., 3 TAF, an HIV NRTI, is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate.</Description>
</NDC>
<NDC>
<NDCCode>63479-2505-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (63479-2505-1) </PackageDescription>
<NDC11Code>63479-2505-01</NDC11Code>
<ProductNDC>63479-2505</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Liver Plus Formula</ProprietaryName>
<NonProprietaryName>Adenosine Triphosphate, Ignatia Amara, Kali Phosphoricum, Natrum Muriaticum, Nux Vomica, Sulphur</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20220322</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Apex Energetics Inc.</LabelerName>
<SubstanceName>ADENOSINE TRIPHOSPHATE; STRYCHNOS IGNATII SEED; DIBASIC POTASSIUM PHOSPHATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR</SubstanceName>
<StrengthNumber>5; 2; 1; 2; 1; 7</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [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], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of minor. tiredness*. headache*. nausea*. difficulty falling asleep*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63629-2505-1</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (63629-2505-1) </PackageDescription>
<NDC11Code>63629-2505-01</NDC11Code>
<ProductNDC>63629-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200918</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076635</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1)., 2 For treatment of adult patients with severe hypertriglyceridemia (1.2).</IndicationAndUsage>
<Description>Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79-82°C. Fenofibrate, USP is a white or almost white crystalline powder. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, crospovidone, microcrystalline cellulose, polyvinyl alcohol (part-hydrolyzed), polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium stearyl fumarate, talc and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68071-2505-6</NDCCode>
<PackageDescription>1 CANISTER in 1 CARTON (68071-2505-6) > 200 AEROSOL, METERED in 1 CANISTER</PackageDescription>
<NDC11Code>68071-2505-06</NDC11Code>
<ProductNDC>68071-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20210315</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020503</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>108</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albuterol Sulfate Inhalation Aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.</IndicationAndUsage>
<Description>The active component of Albuterol Sulfate Inhalation Aerosol is albuterol sulfate, USP racemic α 1 [( tert-Butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diol sulfate (2:1)(salt), a relatively selective beta 2-adrenergic bronchodilator having the following chemical structure:. Albuterol sulfate is the official generic name in the United States. The World Health Organization recommended name for the drug is salbutamol sulfate. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C 13H 21NO 3) 2H 2SO 4. Albuterol sulfate is a white to off-white crystalline solid. It is soluble in water and slightly soluble in ethanol. Albuterol Sulfate Inhalation Aerosol is a pressurized metered-dose aerosol unit for oral inhalation. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane), ethanol, and oleic acid. Each actuation delivers 120 mcg albuterol sulfate, USP from the valve and 108 mcg albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Each canister provides 200 inhalations. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four “test sprays” into the air, away from the face. This product does not contain chlorofluorocarbons (CFCs) as the propellant.</Description>
</NDC>
<NDC>
<NDCCode>68254-2505-1</NDCCode>
<PackageDescription>2 kg in 1 DRUM (68254-2505-1) </PackageDescription>
<NDC11Code>68254-2505-01</NDC11Code>
<ProductNDC>68254-2505</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mupirocin Calcium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Concord Biotech Limited</LabelerName>
<SubstanceName>MUPIROCIN CALCIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-11</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-MAR-13</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>70121-2505-2</NDCCode>
<PackageDescription>2 AMPULE in 1 BOX (70121-2505-2) / 1 KIT in 1 AMPULE</PackageDescription>
<NDC11Code>70121-2505-02</NDC11Code>
<ProductNDC>70121-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lioresal (baclofen)</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRATHECAL</RouteName>
<StartMarketingDate>20220612</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020075</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIORESAL INTRATHECAL (baclofen injection) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of LIORESAL INTRATHECAL via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. LIORESAL INTRATHECAL is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the FDA specifically for the administration of LIORESAL INTRATHECAL into the intrathecal space.</IndicationAndUsage>
<Description>LIORESAL INTRATHECAL (baclofen injection) is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid, and its structural formula is. Baclofen is a white to off-white, odorless or practically odorless crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. LIORESAL INTRATHECAL is a sterile, pyrogen-free, isotonic solution free of antioxidants, preservatives or other potentially neurotoxic additives indicated only for intrathecal administration. The drug is stable in solution at 37° C and compatible with CSF. Each milliliter of LIORESAL INTRATHECAL contains baclofen U. S. P. 50 mcg, 500 mcg or 2000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.0 - 7.0. Each ampule is intended for SINGLE USE ONLY. Discard any unused portion. DO NOT AUTOCLAVE.</Description>
</NDC>
<NDC>
<NDCCode>70518-2505-0</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (70518-2505-0) </PackageDescription>
<NDC11Code>70518-2505-00</NDC11Code>
<ProductNDC>70518-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191224</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076056</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191224</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
<Description>Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S- [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. C 23H 35NaO 7M.W. 446.52. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP for oral use contain 10 mg, 20 mg and 40 mg pravastatin sodium USP, which is equivalent to 9.50 mg, 19.01 mg and 38.03 mg of pravastatin, respectively. Inactive ingredients include: calcium phosphate dibasic anhydrous, croscarmellose sodium, crospovidone, lactose anhydrous, microcrystalline cellulose, povidone and sodium stearyl fumarate. Additionally, the 10 mg tablet contains ferric oxide red; the 20 mg tablet contains ferric oxide yellow; and the 40 mg tablet contains FD&C Blue No. 1 Aluminum Lake and D&C Yellow No.10.</Description>
</NDC>
<NDC>
<NDCCode>70518-2505-1</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (70518-2505-1) </PackageDescription>
<NDC11Code>70518-2505-01</NDC11Code>
<ProductNDC>70518-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191224</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076056</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210112</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
<Description>Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S- [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. C 23H 35NaO 7M.W. 446.52. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP for oral use contain 10 mg, 20 mg and 40 mg pravastatin sodium USP, which is equivalent to 9.50 mg, 19.01 mg and 38.03 mg of pravastatin, respectively. Inactive ingredients include: calcium phosphate dibasic anhydrous, croscarmellose sodium, crospovidone, lactose anhydrous, microcrystalline cellulose, povidone and sodium stearyl fumarate. Additionally, the 10 mg tablet contains ferric oxide red; the 20 mg tablet contains ferric oxide yellow; and the 40 mg tablet contains FD&C Blue No. 1 Aluminum Lake and D&C Yellow No.10.</Description>
</NDC>
<NDC>
<NDCCode>71335-2505-1</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-1) </PackageDescription>
<NDC11Code>71335-2505-01</NDC11Code>
<ProductNDC>71335-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213859</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the:. Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1). Maintenance of healing of EE in adults. ( 1.2). Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3). Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4). Helicobacter pylorieradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. ( 1.5). Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. ( 1.6).</IndicationAndUsage>
<Description>The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17H 18N 3O 3S) 2Mg × 3 H 2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, sugar spheres (composed of corn starch and sucrose), talc, and triethyl citrate. The capsule shells have the following inactive ingredients: FD&C Blue 1, FD&C Red 3, ferrosoferric oxide, gelatin, potassium hydroxide, shellac, sodium lauryl sulfate and titanium dioxide. Esomeprazole Magnesium Delayed-Release Capsules, USP meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>71335-2505-2</NDCCode>
<PackageDescription>10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-2) </PackageDescription>
<NDC11Code>71335-2505-02</NDC11Code>
<ProductNDC>71335-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213859</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the:. Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1). Maintenance of healing of EE in adults. ( 1.2). Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3). Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4). Helicobacter pylorieradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. ( 1.5). Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. ( 1.6).</IndicationAndUsage>
<Description>The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17H 18N 3O 3S) 2Mg × 3 H 2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, sugar spheres (composed of corn starch and sucrose), talc, and triethyl citrate. The capsule shells have the following inactive ingredients: FD&C Blue 1, FD&C Red 3, ferrosoferric oxide, gelatin, potassium hydroxide, shellac, sodium lauryl sulfate and titanium dioxide. Esomeprazole Magnesium Delayed-Release Capsules, USP meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>71335-2505-3</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-3) </PackageDescription>
<NDC11Code>71335-2505-03</NDC11Code>
<ProductNDC>71335-2505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
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<LabelerName>Bryant Ranch Prepack</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2024-12-27</LastUpdate>
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<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the:. Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1). Maintenance of healing of EE in adults. ( 1.2). Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3). Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4). Helicobacter pylorieradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. ( 1.5). Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. ( 1.6).</IndicationAndUsage>
<Description>The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17H 18N 3O 3S) 2Mg × 3 H 2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, sugar spheres (composed of corn starch and sucrose), talc, and triethyl citrate. The capsule shells have the following inactive ingredients: FD&C Blue 1, FD&C Red 3, ferrosoferric oxide, gelatin, potassium hydroxide, shellac, sodium lauryl sulfate and titanium dioxide. Esomeprazole Magnesium Delayed-Release Capsules, USP meets USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the:. Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1). Maintenance of healing of EE in adults. ( 1.2). Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3). Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4). Helicobacter pylorieradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. ( 1.5). Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. ( 1.6).</IndicationAndUsage>
<Description>The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17H 18N 3O 3S) 2Mg × 3 H 2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, sugar spheres (composed of corn starch and sucrose), talc, and triethyl citrate. The capsule shells have the following inactive ingredients: FD&C Blue 1, FD&C Red 3, ferrosoferric oxide, gelatin, potassium hydroxide, shellac, sodium lauryl sulfate and titanium dioxide. Esomeprazole Magnesium Delayed-Release Capsules, USP meets USP Dissolution Test 2.</Description>
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<ApplicationNumber>ANDA213859</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
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<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the:. Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1). Maintenance of healing of EE in adults. ( 1.2). Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3). Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4). Helicobacter pylorieradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. ( 1.5). Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. ( 1.6).</IndicationAndUsage>
<Description>The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17H 18N 3O 3S) 2Mg × 3 H 2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, sugar spheres (composed of corn starch and sucrose), talc, and triethyl citrate. The capsule shells have the following inactive ingredients: FD&C Blue 1, FD&C Red 3, ferrosoferric oxide, gelatin, potassium hydroxide, shellac, sodium lauryl sulfate and titanium dioxide. Esomeprazole Magnesium Delayed-Release Capsules, USP meets USP Dissolution Test 2.</Description>
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