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{
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"PackageDescription": "240 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (58602-858-98) ",
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"IndicationAndUsage": "temporarily relieves minor aches and pains due to:headachetoothachebackachemenstrual crampsthe common coldmuscular achesminor pain of arthritis. temporarily reduces fever."
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{
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"PackageDescription": "5 BLISTER PACK in 1 CARTON (58602-864-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin",
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"MarketingCategoryName": "ANDA",
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"LabelerName": "Aurohealth LLC",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
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"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20210311",
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{
"NDCCode": "58602-810-12",
"PackageDescription": "1 BOTTLE in 1 CARTON (58602-810-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE",
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"ProductTypeName": "HUMAN OTC DRUG",
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"StartMarketingDate": "20191021",
"MarketingCategoryName": "ANDA",
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"LabelerName": "Aurohealth LLC",
"SubstanceName": "GUAIFENESIN",
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"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191021",
"SamplePackage": "N"
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{
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"PackageDescription": "1 BOTTLE in 1 CARTON (58602-810-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE",
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"ProductNDC": "58602-810",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210453",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191021",
"SamplePackage": "N"
},
{
"NDCCode": "58602-810-38",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (58602-810-38) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "58602-0810-38",
"ProductNDC": "58602-810",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210453",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221207",
"SamplePackage": "N"
},
{
"NDCCode": "58602-810-73",
"PackageDescription": "1 BOTTLE in 1 CARTON (58602-810-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "58602-0810-73",
"ProductNDC": "58602-810",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210453",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191021",
"SamplePackage": "N"
},
{
"NDCCode": "58602-810-96",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (58602-810-96) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "58602-0810-96",
"ProductNDC": "58602-810",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210453",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191021",
"SamplePackage": "N"
},
{
"NDCCode": "58602-810-97",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (58602-810-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "58602-0810-97",
"ProductNDC": "58602-810",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210453",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191021",
"SamplePackage": "N"
},
{
"NDCCode": "0187-5100-01",
"PackageDescription": "1 TUBE in 1 CARTON (0187-5100-01) > 30 g in 1 TUBE",
"NDC11Code": "00187-5100-01",
"ProductNDC": "0187-5100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elidel",
"NonProprietaryName": "Pimecrolimus",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20011202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021302",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "PIMECROLIMUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20011202",
"SamplePackage": "N",
"IndicationAndUsage": "ELIDEL® (pimecrolimus) Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. ELIDEL Cream, 1% is not indicated for use in children less than 2 years of age[see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].",
"Description": "ELIDEL Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone. The compound has the empirical formula C43H68ClNO11 and the molecular weight of 810.47. The structural formula is. Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water. Each gram of ELIDEL Cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and diglycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides and water."
},
{
"NDCCode": "0187-5101-02",
"PackageDescription": "1 TUBE in 1 CARTON (0187-5101-02) > 60 g in 1 TUBE",
"NDC11Code": "00187-5101-02",
"ProductNDC": "0187-5101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elidel",
"NonProprietaryName": "Pimecrolimus",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20011202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021302",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "PIMECROLIMUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20011202",
"SamplePackage": "N",
"IndicationAndUsage": "ELIDEL® (pimecrolimus) Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. ELIDEL Cream, 1% is not indicated for use in children less than 2 years of age[see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].",
"Description": "ELIDEL Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone. The compound has the empirical formula C43H68ClNO11 and the molecular weight of 810.47. The structural formula is. Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water. Each gram of ELIDEL Cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and diglycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides and water."
},
{
"NDCCode": "0187-5102-03",
"PackageDescription": "1 TUBE in 1 CARTON (0187-5102-03) > 100 g in 1 TUBE",
"NDC11Code": "00187-5102-03",
"ProductNDC": "0187-5102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elidel",
"NonProprietaryName": "Pimecrolimus",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20011202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021302",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "PIMECROLIMUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20011202",
"SamplePackage": "N",
"IndicationAndUsage": "ELIDEL® (pimecrolimus) Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. ELIDEL Cream, 1% is not indicated for use in children less than 2 years of age[see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].",
"Description": "ELIDEL Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone. The compound has the empirical formula C43H68ClNO11 and the molecular weight of 810.47. The structural formula is. Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water. Each gram of ELIDEL Cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and diglycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides and water."
},
{
"NDCCode": "0187-5103-04",
"PackageDescription": "1 TUBE in 1 CARTON (0187-5103-04) > 5 g in 1 TUBE",
"NDC11Code": "00187-5103-04",
"ProductNDC": "0187-5103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elidel",
"NonProprietaryName": "Pimecrolimus",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20011202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021302",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "PIMECROLIMUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20011202",
"SamplePackage": "Y",
"IndicationAndUsage": "ELIDEL® (pimecrolimus) Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. ELIDEL Cream, 1% is not indicated for use in children less than 2 years of age[see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].",
"Description": "ELIDEL Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone. The compound has the empirical formula C43H68ClNO11 and the molecular weight of 810.47. The structural formula is. Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water. Each gram of ELIDEL Cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and diglycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides and water."
},
{
"NDCCode": "0409-4187-03",
"PackageDescription": "12 POUCH in 1 CASE (0409-4187-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG",
"NDC11Code": "00409-4187-03",
"ProductNDC": "0409-4187",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, And Glycine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120306",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017673",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE",
"StrengthNumber": "620; 810; 624; 340; 380; 460; 150; 680; 1100; 850; 260; 750; 370; 44; 1100",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-04-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0409-4203-03",
"PackageDescription": "12 POUCH in 1 CASE (0409-4203-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG",
"NDC11Code": "00409-4203-03",
"ProductNDC": "0409-4203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, Glycine, Sodium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110323",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017673",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; POTASSIUM CHLORIDE",
"StrengthNumber": "620; 810; 624; 340; 380; 460; 150; 680; 1100; 850; 260; 750; 370; 44; 1100; 28; 102; 425; 487",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Amino Acid [EPC],Amino Acids [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-04-20",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0409-4203-05",
"PackageDescription": "6 POUCH in 1 CASE (0409-4203-05) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG",
"NDC11Code": "00409-4203-05",
"ProductNDC": "0409-4203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, Glycine, Sodium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110323",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017673",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; POTASSIUM CHLORIDE",
"StrengthNumber": "620; 810; 624; 340; 380; 460; 150; 680; 1100; 850; 260; 750; 370; 44; 1100; 28; 102; 425; 487",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Amino Acid [EPC],Amino Acids [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-04-20",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0591-2944-30",
"PackageDescription": "30 g in 1 TUBE (0591-2944-30) ",
"NDC11Code": "00591-2944-30",
"ProductNDC": "0591-2944",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pimecrolimus",
"NonProprietaryName": "Pimecrolimus",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209345",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "PIMECROLIMUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2019-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181227",
"SamplePackage": "N",
"IndicationAndUsage": "Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].",
"Description": "Pimecrolimus cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone. The compound has the molecular formula C43H68CINO11 and the molecular weight of 810.47. The structural formula is. Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water. Each gram of pimecrolimus cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, cetostearyl alcohol (type A), citric acid anhydrous, medium-chain triglycerides, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium hydroxide, stearyl alcohol, and water."
},
{
"NDCCode": "0591-2944-60",
"PackageDescription": "60 g in 1 TUBE (0591-2944-60) ",
"NDC11Code": "00591-2944-60",
"ProductNDC": "0591-2944",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pimecrolimus",
"NonProprietaryName": "Pimecrolimus",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209345",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "PIMECROLIMUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2019-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181227",
"SamplePackage": "N",
"IndicationAndUsage": "Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].",
"Description": "Pimecrolimus cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone. The compound has the molecular formula C43H68CINO11 and the molecular weight of 810.47. The structural formula is. Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water. Each gram of pimecrolimus cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, cetostearyl alcohol (type A), citric acid anhydrous, medium-chain triglycerides, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium hydroxide, stearyl alcohol, and water."
},
{
"NDCCode": "0591-2944-87",
"PackageDescription": "100 g in 1 TUBE (0591-2944-87) ",
"NDC11Code": "00591-2944-87",
"ProductNDC": "0591-2944",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pimecrolimus",
"NonProprietaryName": "Pimecrolimus",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209345",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "PIMECROLIMUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2019-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181227",
"SamplePackage": "N",
"IndicationAndUsage": "Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].",
"Description": "Pimecrolimus cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone. The compound has the molecular formula C43H68CINO11 and the molecular weight of 810.47. The structural formula is. Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water. Each gram of pimecrolimus cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, cetostearyl alcohol (type A), citric acid anhydrous, medium-chain triglycerides, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium hydroxide, stearyl alcohol, and water."
},
{
"NDCCode": "10135-810-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (10135-810-01) ",
"NDC11Code": "10135-0810-01",
"ProductNDC": "10135-810",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207121",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "HYDROXYZINE DIHYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250301",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis .Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C 21H 27CIN 2O 2. 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. lnactive ingredients include: carnauba wax, colloidal sllicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
},
{
"NDCCode": "10135-810-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (10135-810-10) ",
"NDC11Code": "10135-0810-10",
"ProductNDC": "10135-810",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207121",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "HYDROXYZINE DIHYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250301",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis .Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C 21H 27CIN 2O 2. 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. lnactive ingredients include: carnauba wax, colloidal sllicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
},
{
"NDCCode": "10237-810-10",
"PackageDescription": "28 g in 1 CANISTER (10237-810-10)",
"NDC11Code": "10237-0810-10",
"ProductNDC": "10237-810",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arrid Xx Extra Extra Dry",
"ProprietaryNameSuffix": "Antiperspirant Deodorant Regular",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly 19%",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20011001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "19",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2016-02-12"
},
{
"NDCCode": "10237-810-20",
"PackageDescription": "56 g in 1 CANISTER (10237-810-20)",
"NDC11Code": "10237-0810-20",
"ProductNDC": "10237-810",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arrid Xx Extra Extra Dry",
"ProprietaryNameSuffix": "Antiperspirant Deodorant Regular",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly 19%",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20011001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "19",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2016-02-12"
},
{
"NDCCode": "10237-810-27",
"PackageDescription": "76 g in 1 CANISTER (10237-810-27)",
"NDC11Code": "10237-0810-27",
"ProductNDC": "10237-810",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arrid Xx Extra Extra Dry",
"ProprietaryNameSuffix": "Antiperspirant Deodorant Regular",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly 19%",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20011001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "19",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2016-02-12"
},
{
"NDCCode": "10893-810-15",
"PackageDescription": "15 mL in 1 BOTTLE (10893-810-15) ",
"NDC11Code": "10893-0810-15",
"ProductNDC": "10893-810",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naturasil Molluscalm",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230821",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nature's Innovation, Inc.",
"SubstanceName": "THUJA OCCIDENTALIS LEAF",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/15mL",
"Status": "Deprecated",
"LastUpdate": "2024-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230821",
"SamplePackage": "N",
"IndicationAndUsage": "Symptomatic treatment of Water Warts and Itching Bumps."
},
{
"NDCCode": "10893-840-02",
"PackageDescription": "1 KIT in 1 KIT (10893-840-02) * 15 mL in 1 BOTTLE (10893-810-15) * 118.3 g in 1 BOX (10893-830-04) ",
"NDC11Code": "10893-0840-02",
"ProductNDC": "10893-840",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naturasil Molluscalm Treatment Kit",
"NonProprietaryName": "Sulfur, Thuja Occidentalis",
"DosageFormName": "KIT",
"StartMarketingDate": "20230821",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nature's Innovation, Inc.",
"Status": "Deprecated",
"LastUpdate": "2024-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230821",
"SamplePackage": "N"
},
{
"NDCCode": "11084-810-13",
"PackageDescription": "444 mL in 1 BOTTLE (11084-810-13) ",
"NDC11Code": "11084-0810-13",
"ProductNDC": "11084-810",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medicated Soft N Sure",
"ProprietaryNameSuffix": "Healthcare Personnel Handwash",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180201",
"EndMarketingDate": "20200625",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Deb USA, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".5",
"StrengthUnit": "g/1000mL",
"Status": "Deprecated",
"LastUpdate": "2020-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180201",
"EndMarketingDatePackage": "20200402",
"SamplePackage": "N"
},
{
"NDCCode": "11084-810-41",
"PackageDescription": "1000 mL in 1 BOTTLE (11084-810-41) ",
"NDC11Code": "11084-0810-41",
"ProductNDC": "11084-810",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medicated Soft N Sure",
"ProprietaryNameSuffix": "Healthcare Personnel Handwash",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180201",
"EndMarketingDate": "20200625",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Deb USA, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".5",
"StrengthUnit": "g/1000mL",
"Status": "Deprecated",
"LastUpdate": "2020-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180201",
"EndMarketingDatePackage": "20200625",
"SamplePackage": "N"
},
{
"NDCCode": "11344-810-08",
"PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (11344-810-08) ",
"NDC11Code": "11344-0810-08",
"ProductNDC": "11344-810",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopropyl Alcohol",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "19890715",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Nice-Pak Products, LLC",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19890715",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent the risk of infection in: 1 minor cuts, 2 scrapes, 3 burns."
}
]
}
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<Description>ELIDEL Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone. The compound has the empirical formula C43H68ClNO11 and the molecular weight of 810.47. The structural formula is. Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water. Each gram of ELIDEL Cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and diglycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides and water.</Description>
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<Status>Deprecated</Status>
<LastUpdate>2026-01-22</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<Description>ELIDEL Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone. The compound has the empirical formula C43H68ClNO11 and the molecular weight of 810.47. The structural formula is. Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water. Each gram of ELIDEL Cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and diglycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides and water.</Description>
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<LastUpdate>2026-01-22</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<Description>ELIDEL Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone. The compound has the empirical formula C43H68ClNO11 and the molecular weight of 810.47. The structural formula is. Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water. Each gram of ELIDEL Cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and diglycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides and water.</Description>
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<Status>Deprecated</Status>
<LastUpdate>2026-01-22</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20011202</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ELIDEL® (pimecrolimus) Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. ELIDEL Cream, 1% is not indicated for use in children less than 2 years of age[see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>ELIDEL Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone. The compound has the empirical formula C43H68ClNO11 and the molecular weight of 810.47. The structural formula is. Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water. Each gram of ELIDEL Cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and diglycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides and water.</Description>
</NDC>
<NDC>
<NDCCode>0409-4187-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4187-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4187-03</NDC11Code>
<ProductNDC>0409-4187</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120306</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017673</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>620; 810; 624; 340; 380; 460; 150; 680; 1100; 850; 260; 750; 370; 44; 1100</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-4203-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4203-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4203-03</NDC11Code>
<ProductNDC>0409-4203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, Glycine, Sodium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110323</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017673</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>620; 810; 624; 340; 380; 460; 150; 680; 1100; 850; 260; 750; 370; 44; 1100; 28; 102; 425; 487</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Amino Acid [EPC],Amino Acids [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-20</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-4203-05</NDCCode>
<PackageDescription>6 POUCH in 1 CASE (0409-4203-05) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4203-05</NDC11Code>
<ProductNDC>0409-4203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, Glycine, Sodium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110323</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017673</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>620; 810; 624; 340; 380; 460; 150; 680; 1100; 850; 260; 750; 370; 44; 1100; 28; 102; 425; 487</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Amino Acid [EPC],Amino Acids [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-20</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0591-2944-30</NDCCode>
<PackageDescription>30 g in 1 TUBE (0591-2944-30) </PackageDescription>
<NDC11Code>00591-2944-30</NDC11Code>
<ProductNDC>0591-2944</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pimecrolimus</ProprietaryName>
<NonProprietaryName>Pimecrolimus</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209345</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>PIMECROLIMUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Pimecrolimus cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone. The compound has the molecular formula C43H68CINO11 and the molecular weight of 810.47. The structural formula is. Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water. Each gram of pimecrolimus cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, cetostearyl alcohol (type A), citric acid anhydrous, medium-chain triglycerides, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium hydroxide, stearyl alcohol, and water.</Description>
</NDC>
<NDC>
<NDCCode>0591-2944-60</NDCCode>
<PackageDescription>60 g in 1 TUBE (0591-2944-60) </PackageDescription>
<NDC11Code>00591-2944-60</NDC11Code>
<ProductNDC>0591-2944</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pimecrolimus</ProprietaryName>
<NonProprietaryName>Pimecrolimus</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209345</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>PIMECROLIMUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Pimecrolimus cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone. The compound has the molecular formula C43H68CINO11 and the molecular weight of 810.47. The structural formula is. Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water. Each gram of pimecrolimus cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, cetostearyl alcohol (type A), citric acid anhydrous, medium-chain triglycerides, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium hydroxide, stearyl alcohol, and water.</Description>
</NDC>
<NDC>
<NDCCode>0591-2944-87</NDCCode>
<PackageDescription>100 g in 1 TUBE (0591-2944-87) </PackageDescription>
<NDC11Code>00591-2944-87</NDC11Code>
<ProductNDC>0591-2944</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pimecrolimus</ProprietaryName>
<NonProprietaryName>Pimecrolimus</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209345</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>PIMECROLIMUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Pimecrolimus cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone. The compound has the molecular formula C43H68CINO11 and the molecular weight of 810.47. The structural formula is. Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water. Each gram of pimecrolimus cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, cetostearyl alcohol (type A), citric acid anhydrous, medium-chain triglycerides, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium hydroxide, stearyl alcohol, and water.</Description>
</NDC>
<NDC>
<NDCCode>10135-810-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (10135-810-01) </PackageDescription>
<NDC11Code>10135-0810-01</NDC11Code>
<ProductNDC>10135-810</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207121</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis .Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C 21H 27CIN 2O 2. 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. lnactive ingredients include: carnauba wax, colloidal sllicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>10135-810-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (10135-810-10) </PackageDescription>
<NDC11Code>10135-0810-10</NDC11Code>
<ProductNDC>10135-810</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207121</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis .Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C 21H 27CIN 2O 2. 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. lnactive ingredients include: carnauba wax, colloidal sllicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>10237-810-10</NDCCode>
<PackageDescription>28 g in 1 CANISTER (10237-810-10)</PackageDescription>
<NDC11Code>10237-0810-10</NDC11Code>
<ProductNDC>10237-810</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arrid Xx Extra Extra Dry</ProprietaryName>
<ProprietaryNameSuffix>Antiperspirant Deodorant Regular</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly 19%</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20011001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>19</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-02-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>10237-810-20</NDCCode>
<PackageDescription>56 g in 1 CANISTER (10237-810-20)</PackageDescription>
<NDC11Code>10237-0810-20</NDC11Code>
<ProductNDC>10237-810</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arrid Xx Extra Extra Dry</ProprietaryName>
<ProprietaryNameSuffix>Antiperspirant Deodorant Regular</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly 19%</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20011001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>19</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-02-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>10237-810-27</NDCCode>
<PackageDescription>76 g in 1 CANISTER (10237-810-27)</PackageDescription>
<NDC11Code>10237-0810-27</NDC11Code>
<ProductNDC>10237-810</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arrid Xx Extra Extra Dry</ProprietaryName>
<ProprietaryNameSuffix>Antiperspirant Deodorant Regular</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly 19%</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20011001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>19</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-02-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>10893-810-15</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (10893-810-15) </PackageDescription>
<NDC11Code>10893-0810-15</NDC11Code>
<ProductNDC>10893-810</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naturasil Molluscalm</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230821</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nature's Innovation, Inc.</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAF</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Symptomatic treatment of Water Warts and Itching Bumps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10893-840-02</NDCCode>
<PackageDescription>1 KIT in 1 KIT (10893-840-02) * 15 mL in 1 BOTTLE (10893-810-15) * 118.3 g in 1 BOX (10893-830-04) </PackageDescription>
<NDC11Code>10893-0840-02</NDC11Code>
<ProductNDC>10893-840</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naturasil Molluscalm Treatment Kit</ProprietaryName>
<NonProprietaryName>Sulfur, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230821</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nature's Innovation, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11084-810-13</NDCCode>
<PackageDescription>444 mL in 1 BOTTLE (11084-810-13) </PackageDescription>
<NDC11Code>11084-0810-13</NDC11Code>
<ProductNDC>11084-810</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medicated Soft N Sure</ProprietaryName>
<ProprietaryNameSuffix>Healthcare Personnel Handwash</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180201</StartMarketingDate>
<EndMarketingDate>20200625</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Deb USA, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/1000mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180201</StartMarketingDatePackage>
<EndMarketingDatePackage>20200402</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11084-810-41</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (11084-810-41) </PackageDescription>
<NDC11Code>11084-0810-41</NDC11Code>
<ProductNDC>11084-810</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medicated Soft N Sure</ProprietaryName>
<ProprietaryNameSuffix>Healthcare Personnel Handwash</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180201</StartMarketingDate>
<EndMarketingDate>20200625</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Deb USA, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/1000mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180201</StartMarketingDatePackage>
<EndMarketingDatePackage>20200625</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11344-810-08</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (11344-810-08) </PackageDescription>
<NDC11Code>11344-0810-08</NDC11Code>
<ProductNDC>11344-810</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isopropyl Alcohol</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19890715</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Nice-Pak Products, LLC</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19890715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help prevent the risk of infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
</NDCList>