{
"NDC": [
{
"NDCCode": "10596-340-35",
"PackageDescription": "103 mL in 1 BOTTLE, WITH APPLICATOR (10596-340-35) ",
"NDC11Code": "10596-0340-35",
"ProductNDC": "10596-340",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ban",
"ProprietaryNameSuffix": "Roll-on Antiperspirant Deodorant Fresh Cotton",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Kao USA Inc.",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "g/103mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120101",
"SamplePackage": "N",
"IndicationAndUsage": "Use. reduces underarm perspiration."
},
{
"NDCCode": "10596-340-70",
"PackageDescription": "2 BOTTLE, WITH APPLICATOR in 1 PACKAGE (10596-340-70) / 103 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "10596-0340-70",
"ProductNDC": "10596-340",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ban",
"ProprietaryNameSuffix": "Roll-on Antiperspirant Deodorant Fresh Cotton",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Kao USA Inc.",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "g/103mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191212",
"SamplePackage": "N",
"IndicationAndUsage": "Use. reduces underarm perspiration."
},
{
"NDCCode": "16477-340-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (16477-340-01) / 28.35 g in 1 BOTTLE, PLASTIC",
"NDC11Code": "16477-0340-01",
"ProductNDC": "16477-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Urea Cream 40%",
"NonProprietaryName": "Urea",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180504",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Laser Pharmaceuticals, LLC",
"SubstanceName": "UREA",
"StrengthNumber": "400",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180504",
"SamplePackage": "N",
"IndicationAndUsage": "Indications and Usage. For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.",
"Description": "Description. Urea 40% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 40% contains 40% urea as an active ingredient, and the following inactive ingredients: Ceteareth-6, Ceteareth-25, Cetyl Alcohol, Mineral Oil, Propylene Glycol, Purified Water, Sodium Hydroxide, Stearyl Alcohol, Xanthan Gum. Urea is a diamide of carbonic acid with the following chemical structure."
},
{
"NDCCode": "43744-340-35",
"PackageDescription": "100 g in 1 DRUM (43744-340-35)",
"NDC11Code": "43744-0340-35",
"ProductNDC": "43744-340",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110707",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "ENALAPRIL",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "67645-340-04",
"PackageDescription": "1 BAG in 1 CARTON (67645-340-04) / 11.35 kg in 1 BAG (67645-340-03) ",
"NDC11Code": "67645-0340-04",
"ProductNDC": "67645-340",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19971103",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Nouryon Chemicals, S.A. de C.V.",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "75",
"StrengthUnit": "kg/100kg",
"Status": "Unfinished",
"LastUpdate": "2026-05-18",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "03-NOV-97"
},
{
"NDCCode": "10596-336-35",
"PackageDescription": "103 mL in 1 BOTTLE, WITH APPLICATOR (10596-336-35) ",
"NDC11Code": "10596-0336-35",
"ProductNDC": "10596-336",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ban",
"ProprietaryNameSuffix": "Roll-on Antiperspirant Deodorant Regular",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Kao USA Inc.",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "g/103mL",
"Status": "Active",
"LastUpdate": "2024-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120101",
"SamplePackage": "N",
"IndicationAndUsage": "Use. reduces underarm perspiration."
},
{
"NDCCode": "10596-337-35",
"PackageDescription": "103 mL in 1 BOTTLE, WITH APPLICATOR (10596-337-35) ",
"NDC11Code": "10596-0337-35",
"ProductNDC": "10596-337",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ban",
"ProprietaryNameSuffix": "Roll-on Antiperspirant Deodorant Powder Fresh",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Kao USA Inc.",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "g/103mL",
"Status": "Active",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120101",
"SamplePackage": "N",
"IndicationAndUsage": "Use. reduces underarm perspiration."
},
{
"NDCCode": "10596-338-35",
"PackageDescription": "103 mL in 1 BOTTLE, WITH APPLICATOR (10596-338-35) ",
"NDC11Code": "10596-0338-35",
"ProductNDC": "10596-338",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ban",
"ProprietaryNameSuffix": "Roll-on Antiperspirant Deodorant Unscented",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Kao USA Inc.",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "g/103mL",
"Status": "Active",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120101",
"SamplePackage": "N",
"IndicationAndUsage": "Use. reduces underarm perspiration."
},
{
"NDCCode": "10596-339-35",
"PackageDescription": "103 mL in 1 BOTTLE, WITH APPLICATOR (10596-339-35) ",
"NDC11Code": "10596-0339-35",
"ProductNDC": "10596-339",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ban",
"ProprietaryNameSuffix": "Roll-on Antiperspirant Deodorant Satin Breeze",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Kao USA Inc.",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "g/103mL",
"Status": "Active",
"LastUpdate": "2024-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120101",
"SamplePackage": "N",
"IndicationAndUsage": "Use. reduces underarm perspiration."
},
{
"NDCCode": "10596-400-35",
"PackageDescription": "103 mL in 1 BOTTLE, WITH APPLICATOR (10596-400-35) ",
"NDC11Code": "10596-0400-35",
"ProductNDC": "10596-400",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ban",
"ProprietaryNameSuffix": "Roll-on Antiperspirant Deodorant Simple Clean",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111108",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Kao USA Inc",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "g/103mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20111108",
"SamplePackage": "N",
"IndicationAndUsage": "Use. reduces underarm perspiration."
},
{
"NDCCode": "10596-402-35",
"PackageDescription": "103 mL in 1 BOTTLE, WITH APPLICATOR (10596-402-35) ",
"NDC11Code": "10596-0402-35",
"ProductNDC": "10596-402",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ban Purely Gentle",
"ProprietaryNameSuffix": "Roll-on Antiperspirant Deodorant Unscented",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Kao USA Inc.",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "18",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Use. reduces underarm perspiration."
},
{
"NDCCode": "0338-9540-05",
"PackageDescription": "15 BAG in 1 CARTON (0338-9540-05) / 100 mL in 1 BAG (0338-9540-01) ",
"NDC11Code": "00338-9540-05",
"ProductNDC": "0338-9540",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinolipid",
"NonProprietaryName": "Olive Oil And Soybean Oil",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204508",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "OLIVE OIL; SOYBEAN OIL",
"StrengthNumber": "16; 4",
"StrengthUnit": "g/100mL; g/100mL",
"Pharm_Classes": "Lipid Emulsion [EPC], Lipid Emulsion [EPC], Lipids [CS], Lipids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160101",
"SamplePackage": "N",
"IndicationAndUsage": "CLINOLIPID is indicated in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "CLINOLIPID lipid injectable emulsion, USP is a sterile, non-pyrogenic, homogenous, white, milky lipid emulsion for intravenous infusion. The lipid content of CLINOLIPID is 0.2 g/mL and comprises a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35.8 mg/mL (range 27.6 to 44.0 mg/mL) and α-linolenic acid (an omega-3 essential fatty acid) is 4.7 mg/mL (range 1.0 to 8.4 mg/mL). The phospholipids provide 470 milligrams or 15 mmol of phosphorus per liter. The total energy content, including fat, phospholipids and glycerin is 2000 kcal/L. Each 100 mL of CLINOLIPID 20% contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, and Water for Injection USP. Sodium Hydroxide NF for pH adjustment, pH: 6.0 to 9.0. The olive and soybean oils are refined natural products consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. The major component fatty acids are linoleic (13.8 to 22.0%), oleic (44.3 to 79.5%), palmitic (7.6 to 19.3%), linolenic (0.5 to 4.2%), palmitoleic (0.0 to 3.2%) and stearic (0.7 to 5.0%). These fatty acids have the following chemical and structural formulas. CLINOLIPID has an osmolality of approximately 340 mOsmol/kg water (which represents an osmolarity of 260 mOsmol/liter of emulsion). CLINOLIPID contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-9540-06",
"PackageDescription": "10 BAG in 1 CARTON (0338-9540-06) / 250 mL in 1 BAG (0338-9540-02) ",
"NDC11Code": "00338-9540-06",
"ProductNDC": "0338-9540",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinolipid",
"NonProprietaryName": "Olive Oil And Soybean Oil",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204508",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "OLIVE OIL; SOYBEAN OIL",
"StrengthNumber": "16; 4",
"StrengthUnit": "g/100mL; g/100mL",
"Pharm_Classes": "Lipid Emulsion [EPC], Lipid Emulsion [EPC], Lipids [CS], Lipids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160101",
"SamplePackage": "N",
"IndicationAndUsage": "CLINOLIPID is indicated in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "CLINOLIPID lipid injectable emulsion, USP is a sterile, non-pyrogenic, homogenous, white, milky lipid emulsion for intravenous infusion. The lipid content of CLINOLIPID is 0.2 g/mL and comprises a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35.8 mg/mL (range 27.6 to 44.0 mg/mL) and α-linolenic acid (an omega-3 essential fatty acid) is 4.7 mg/mL (range 1.0 to 8.4 mg/mL). The phospholipids provide 470 milligrams or 15 mmol of phosphorus per liter. The total energy content, including fat, phospholipids and glycerin is 2000 kcal/L. Each 100 mL of CLINOLIPID 20% contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, and Water for Injection USP. Sodium Hydroxide NF for pH adjustment, pH: 6.0 to 9.0. The olive and soybean oils are refined natural products consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. The major component fatty acids are linoleic (13.8 to 22.0%), oleic (44.3 to 79.5%), palmitic (7.6 to 19.3%), linolenic (0.5 to 4.2%), palmitoleic (0.0 to 3.2%) and stearic (0.7 to 5.0%). These fatty acids have the following chemical and structural formulas. CLINOLIPID has an osmolality of approximately 340 mOsmol/kg water (which represents an osmolarity of 260 mOsmol/liter of emulsion). CLINOLIPID contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-9540-07",
"PackageDescription": "12 BAG in 1 CARTON (0338-9540-07) / 500 mL in 1 BAG (0338-9540-03) ",
"NDC11Code": "00338-9540-07",
"ProductNDC": "0338-9540",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinolipid",
"NonProprietaryName": "Olive Oil And Soybean Oil",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204508",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "OLIVE OIL; SOYBEAN OIL",
"StrengthNumber": "16; 4",
"StrengthUnit": "g/100mL; g/100mL",
"Pharm_Classes": "Lipid Emulsion [EPC], Lipid Emulsion [EPC], Lipids [CS], Lipids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160101",
"SamplePackage": "N",
"IndicationAndUsage": "CLINOLIPID is indicated in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "CLINOLIPID lipid injectable emulsion, USP is a sterile, non-pyrogenic, homogenous, white, milky lipid emulsion for intravenous infusion. The lipid content of CLINOLIPID is 0.2 g/mL and comprises a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35.8 mg/mL (range 27.6 to 44.0 mg/mL) and α-linolenic acid (an omega-3 essential fatty acid) is 4.7 mg/mL (range 1.0 to 8.4 mg/mL). The phospholipids provide 470 milligrams or 15 mmol of phosphorus per liter. The total energy content, including fat, phospholipids and glycerin is 2000 kcal/L. Each 100 mL of CLINOLIPID 20% contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, and Water for Injection USP. Sodium Hydroxide NF for pH adjustment, pH: 6.0 to 9.0. The olive and soybean oils are refined natural products consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. The major component fatty acids are linoleic (13.8 to 22.0%), oleic (44.3 to 79.5%), palmitic (7.6 to 19.3%), linolenic (0.5 to 4.2%), palmitoleic (0.0 to 3.2%) and stearic (0.7 to 5.0%). These fatty acids have the following chemical and structural formulas. CLINOLIPID has an osmolality of approximately 340 mOsmol/kg water (which represents an osmolarity of 260 mOsmol/liter of emulsion). CLINOLIPID contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-9540-08",
"PackageDescription": "6 BAG in 1 CARTON (0338-9540-08) / 1000 mL in 1 BAG (0338-9540-04) ",
"NDC11Code": "00338-9540-08",
"ProductNDC": "0338-9540",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinolipid",
"NonProprietaryName": "Olive Oil And Soybean Oil",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204508",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "OLIVE OIL; SOYBEAN OIL",
"StrengthNumber": "16; 4",
"StrengthUnit": "g/100mL; g/100mL",
"Pharm_Classes": "Lipid Emulsion [EPC], Lipid Emulsion [EPC], Lipids [CS], Lipids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160101",
"SamplePackage": "N",
"IndicationAndUsage": "CLINOLIPID is indicated in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "CLINOLIPID lipid injectable emulsion, USP is a sterile, non-pyrogenic, homogenous, white, milky lipid emulsion for intravenous infusion. The lipid content of CLINOLIPID is 0.2 g/mL and comprises a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35.8 mg/mL (range 27.6 to 44.0 mg/mL) and α-linolenic acid (an omega-3 essential fatty acid) is 4.7 mg/mL (range 1.0 to 8.4 mg/mL). The phospholipids provide 470 milligrams or 15 mmol of phosphorus per liter. The total energy content, including fat, phospholipids and glycerin is 2000 kcal/L. Each 100 mL of CLINOLIPID 20% contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, and Water for Injection USP. Sodium Hydroxide NF for pH adjustment, pH: 6.0 to 9.0. The olive and soybean oils are refined natural products consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. The major component fatty acids are linoleic (13.8 to 22.0%), oleic (44.3 to 79.5%), palmitic (7.6 to 19.3%), linolenic (0.5 to 4.2%), palmitoleic (0.0 to 3.2%) and stearic (0.7 to 5.0%). These fatty acids have the following chemical and structural formulas. CLINOLIPID has an osmolality of approximately 340 mOsmol/kg water (which represents an osmolarity of 260 mOsmol/liter of emulsion). CLINOLIPID contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0555-9032-70",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (0555-9032-70) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00555-9032-70",
"ProductNDC": "0555-9032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-legest Fe",
"ProprietaryNameSuffix": "28 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20071026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076105",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2023-03-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20071026",
"SamplePackage": "N",
"IndicationAndUsage": "Tri-Legest® Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets [not USP]) is indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Tri-Legest® Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tri-Legest® Fe should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months. Combined oral contraceptives are highly effective for pregnancy prevention. Table 2 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Norethindrone acetate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28-day) cycle studies. A total of 296 patients received norethindrone acetate and ethinyl estradiol tablets and 295 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator’s global evaluation. Patients with severe androgen excess were not studied. Norethindrone acetate and ethinyl estradiol tablets users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment. Figure 2. Mean Percent Reduction in Total Lesion Counts From Baseline to Each 28-Day Cycle and Mean Total Lesion Counts at Each Cycle Following Administration of Norethindrone acetate and ethinyl estradiol tablets and Placebo (Statistically significant differences were not found in both studies individually until cycle 6).",
"Description": "Tri-Legest® Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets [not USP]) is a graduated estrophasic combined oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tri-Legest® Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light pink tablet contains 1 mg norethindrone acetate [(17α)-17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol] Each light pink tablet contains the following inactive ingredients: calcium stearate, FD&C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. Each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. Each light yellow tablet contains the following inactive ingredients: calcium stearate, D&C yellow no.10 aluminum lake, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. Each light blue tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. Each light blue tablet contains the following inactive ingredients: calcium stearate, FD&C blue no. 2 aluminum lake, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. Each brown tablet contains crospovidone, ferrous fumarate, hydrogenated vegetable oil, and microcrystalline cellulose. The structural formulas are as follows. Norethindrone Acetate Ethinyl Estradiol. C22H28O3 Molecular Weight: 340.46 C20H24O2 Molecular Weight: 296.40. Each Tri-Legest® Fe tablet dispenser contains five light pink tablets, seven light yellow tablets, nine light blue tablets, and seven brown tablets. These tablets are to be taken in the following order: one light pink tablet each day for five days, then one light yellow tablet each day for seven days, followed by one light blue tablet each day for nine days, and then one brown tablet each day for seven days."
},
{
"NDCCode": "21695-685-28",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (21695-685-28) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "21695-0685-28",
"ProductNDC": "21695-685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tilia Fe",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20101201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076629",
"LabelerName": "Rebel Distributors Corp",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tilia Fe is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tilia Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tilia Fe should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months. Oral contraceptives are highly effective for pregnancy prevention. Table 2 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Norethindrone acetate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies. A total of 295 patients received norethindrone acetate and ethinyl estradiol tablets and 296 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator’s global evaluation. Patients with severe androgen excess were not studied. Norethindrone acetate and ethinyl estradiol tablets users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment.",
"Description": "Tilia Fe is a graduated estrophasic providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tilia Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and 7 ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white tablet contains 1 mg norethindrone acetate, (17α) 17-(acetyloxy)-19-norpregn-4-en-20-yn-3-one, and 20 mcg ethinyl estradiol, (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. Each light-green tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. The light-green tablets also contain D&C Yellow #10 and FD&C Blue #1. Each green tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. The green tablets also contain D&C Yellow #10 and FD&C Blue #1. The structural formulas are as follows. Norethindrone Acetate C22H28O3 M.W. 340.46 Ethinyl Es tradiol C20H24O2 M.W. 296.4. Each inactive, brown tablet contains microcrystalline cellulose, ferrous fumarate, magnesium stearate and sodium starch glycolate. Ferrous fumarate tablets are not USP for dissolution and assay. Each dispenser of Tilia Fe, contains 5 white tablets, 7 light-green tablets, 9 green tablets, and 7 brown tablets. These tablets are to be taken in the following order: one white tablet each day for five days, then one light-green tablet each day for seven days, followed by one green tablet each day for nine days, and then one brown tablet each day for seven days."
},
{
"NDCCode": "51346-340-01",
"PackageDescription": "15 mL in 1 CARTON (51346-340-01)",
"NDC11Code": "51346-0340-01",
"ProductNDC": "51346-340",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pure Foundation",
"ProprietaryNameSuffix": "35 Tan Brown",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "NATURE REPUBLIC CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "1.63; .86",
"StrengthUnit": "mg/15mL; mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2018-09-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "54868-6274-0",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (54868-6274-0) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "54868-6274-00",
"ProductNDC": "54868-6274",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tilia Fe",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20110621",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076629",
"LabelerName": "Physicians Total Care, Inc.",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tilia Fe is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tilia Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tilia Fe should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months. Oral contraceptives are highly effective for pregnancy prevention. Table 2 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Norethindrone acetate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies. A total of 295 patients received norethindrone acetate and ethinyl estradiol tablets and 296 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator’s global evaluation. Patients with severe androgen excess were not studied. Norethindrone acetate and ethinyl estradiol tablets users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment.",
"Description": "Tilia Fe is a graduated estrophasic providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tilia Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and 7 ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white tablet contains 1 mg norethindrone acetate, (17α) 17-(acetyloxy)-19-norpregn-4-en-20-yn-3-one, and 20 mcg ethinyl estradiol, (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. Each light-green tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. The light-green tablets also contain D&C Yellow #10 and FD&C Blue #1. Each green tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. The green tablets also contain D&C Yellow #10 and FD&C Blue #1. The structural formulas are as follows. Norethindrone Acetate C22H28O3 M.W. 340.46 Ethinyl Es tradiol C20H24O2 M.W. 296.4. Each inactive, brown tablet contains microcrystalline cellulose, ferrous fumarate, magnesium stearate and sodium starch glycolate. Ferrous fumarate tablets are not USP for dissolution and assay. Each dispenser of Tilia Fe, contains 5 white tablets, 7 light-green tablets, 9 green tablets, and 7 brown tablets. These tablets are to be taken in the following order: one white tablet each day for five days, then one light-green tablet each day for seven days, followed by one green tablet each day for nine days, and then one brown tablet each day for seven days."
},
{
"NDCCode": "55150-340-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-340-01) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55150-0340-01",
"ProductNDC": "55150-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20201020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212939",
"LabelerName": "Eugia US LLC",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201020",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.",
"Description": "Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color."
},
{
"NDCCode": "55150-340-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (55150-340-10) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55150-0340-10",
"ProductNDC": "55150-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20201020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212939",
"LabelerName": "Eugia US LLC",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201020",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.",
"Description": "Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color."
},
{
"NDCCode": "55150-340-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (55150-340-25) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55150-0340-25",
"ProductNDC": "55150-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20201020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212939",
"LabelerName": "Eugia US LLC",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201020",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.",
"Description": "Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color."
},
{
"NDCCode": "59651-504-88",
"PackageDescription": "3 POUCH in 1 CARTON (59651-504-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "59651-0504-88",
"ProductNDC": "59651-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oshih",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20231206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216558",
"LabelerName": "Aurobindo Pharma Limited",
"Status": "Active",
"LastUpdate": "2024-02-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231206",
"SamplePackage": "N",
"IndicationAndUsage": "Oshih is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of Oshih in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.",
"Description": "Oshih provides an oral contraceptive regimen consisting of 24 white to off-white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below. Each white to off-white active chewable tablet also contains the following inactive ingredients: compressible sugar, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, modified food starch (corn), nat spearmint FL, povidone, sucralose and vitamin E. Each brown placebo tablet contains croscarmellose sodium, ferrous fumarate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, modified food starch (corn), nat spearmint FL, povidone and sucralose. The ferrous fumarate tablets do not serve any therapeutic purpose. The molecular formula of ethinyl estradiol is C20H24O2 and the structural formula is. The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The molecular weight of ethinyl estradiol is 296.40. The molecular formula of norethindrone acetate is C22H28O3 and the structural formula is. The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The molecular weight of norethindrone acetate is 340.46."
},
{
"NDCCode": "64980-340-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (64980-340-01) ",
"NDC11Code": "64980-0340-01",
"ProductNDC": "64980-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090124",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080804",
"SamplePackage": "N",
"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."
},
{
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"PackageDescription": "30 TABLET in 1 BOTTLE (64980-340-03) ",
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"ProductNDC": "64980-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090124",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."
},
{
"NDCCode": "67457-340-01",
"PackageDescription": "10 VIAL in 1 CARTON (67457-340-01) / 20 mL in 1 VIAL (67457-340-00) ",
"NDC11Code": "67457-0340-01",
"ProductNDC": "67457-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20131205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065397",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-27",
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"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131205",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin Hydrochloride for Injection, USP is an off white to light tan colored lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of base is equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL, it forms a clear, colorless or light to dark tan solution with the pH of the solution is between 2.5 and 4.5. It may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30, 32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m] [10,2,16]benzoxadiazacyclotetracosine -26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula."
},
{
"NDCCode": "70108-340-01",
"PackageDescription": "1 KIT in 1 BOX (70108-340-01) * 40 mL in 1 BOTTLE, SPRAY (70108-366-01) * 40 mL in 1 BOTTLE, SPRAY (70108-367-01) * 40 mL in 1 BOTTLE, SPRAY (70108-368-01) * 40 mL in 1 BOTTLE, SPRAY (70108-119-04) ",
"NDC11Code": "70108-0340-01",
"ProductNDC": "70108-340",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Care 4 Hand Sanitizers 1.35 Fl Oz (cherry Blossom, Gardenia, Coconut Honey, Lavender Vanilla)",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20260511",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Ashtel Studios, Inc.",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260511",
"SamplePackage": "N"
},
{
"NDCCode": "70756-649-35",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70756-649-35) / 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "70756-0649-35",
"ProductNDC": "70756-649",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20230315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216859",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230315",
"SamplePackage": "N",
"IndicationAndUsage": "Phenylephrine Hydrochloride Ophthalmic Solution 2.5% and 10%, is indicated to dilate the pupil.",
"Description": "Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow color solution, topical α -adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride, USP 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%)."
},
{
"NDCCode": "72495-601-28",
"PackageDescription": "1 POUCH in 1 CARTON (72495-601-28) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "72495-0601-28",
"ProductNDC": "72495-601",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Femlyv",
"NonProprietaryName": "Norethindrone Acetate/ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20241101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218718",
"LabelerName": "Millicent US, Inc.",
"Status": "Active",
"LastUpdate": "2025-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "FEMLYV is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)]. Limitations of Use. The efficacy of FEMLYV in females with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.",
"Description": "FEMLYV (norethindrone acetate and ethinyl estradiol orally disintegrating tablets) is a combined oral contraceptive. FEMLYV consists of 24 green, round ODTs each containing 1 mg norethindrone acetate and 0.020 mg ethinyl estradiol and 4 white, round inert ODTs. Each green ODT also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, mint green lake blend, pregelatinized starch, spearmint flavor, sucralose, vitamin E (DL-alpha-tocopherol). Each white ODT contains, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, spearmint flavor, sucralose. The empirical formula of norethindrone acetate is C22H28O3 and the structural formula is. The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The molecular weight of norethindrone acetate is 340.46. It is a neutral molecule and is practically insoluble in water. The empirical formula of ethinyl estradiol is C20H24O2 and the structural formula is. The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The molecular weight of ethinyl estradiol is 296.40. It is a neutral molecule and is practically insoluble in water."
},
{
"NDCCode": "72495-601-84",
"PackageDescription": "3 POUCH in 1 CARTON (72495-601-84) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "72495-0601-84",
"ProductNDC": "72495-601",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Femlyv",
"NonProprietaryName": "Norethindrone Acetate/ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20241101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218718",
"LabelerName": "Millicent US, Inc.",
"Status": "Active",
"LastUpdate": "2025-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "FEMLYV is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)]. Limitations of Use. The efficacy of FEMLYV in females with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.",
"Description": "FEMLYV (norethindrone acetate and ethinyl estradiol orally disintegrating tablets) is a combined oral contraceptive. FEMLYV consists of 24 green, round ODTs each containing 1 mg norethindrone acetate and 0.020 mg ethinyl estradiol and 4 white, round inert ODTs. Each green ODT also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, mint green lake blend, pregelatinized starch, spearmint flavor, sucralose, vitamin E (DL-alpha-tocopherol). Each white ODT contains, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, spearmint flavor, sucralose. The empirical formula of norethindrone acetate is C22H28O3 and the structural formula is. The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The molecular weight of norethindrone acetate is 340.46. It is a neutral molecule and is practically insoluble in water. The empirical formula of ethinyl estradiol is C20H24O2 and the structural formula is. The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The molecular weight of ethinyl estradiol is 296.40. It is a neutral molecule and is practically insoluble in water."
}
]
}
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<LabelerName>Kao USA Inc.</LabelerName>
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<LastUpdate>2026-01-02</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. reduces underarm perspiration.</IndicationAndUsage>
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<LabelerName>Kao USA Inc.</LabelerName>
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<Status>Deprecated</Status>
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<IndicationAndUsage>Use. reduces underarm perspiration.</IndicationAndUsage>
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<ProprietaryName>Urea Cream 40%</ProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<StrengthUnit>mg/g</StrengthUnit>
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<IndicationAndUsage>Indications and Usage. For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.</IndicationAndUsage>
<Description>Description. Urea 40% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 40% contains 40% urea as an active ingredient, and the following inactive ingredients: Ceteareth-6, Ceteareth-25, Cetyl Alcohol, Mineral Oil, Propylene Glycol, Purified Water, Sodium Hydroxide, Stearyl Alcohol, Xanthan Gum. Urea is a diamide of carbonic acid with the following chemical structure.</Description>
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<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
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<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>ENALAPRIL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
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<PackageDescription>1 BAG in 1 CARTON (67645-340-04) / 11.35 kg in 1 BAG (67645-340-03) </PackageDescription>
<NDC11Code>67645-0340-04</NDC11Code>
<ProductNDC>67645-340</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19971103</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Nouryon Chemicals, S.A. de C.V.</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-05-18</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-NOV-97</StartMarketingDatePackage>
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<PackageDescription>103 mL in 1 BOTTLE, WITH APPLICATOR (10596-336-35) </PackageDescription>
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<ProductNDC>10596-336</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ban</ProprietaryName>
<ProprietaryNameSuffix>Roll-on Antiperspirant Deodorant Regular</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
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<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Kao USA Inc.</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
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<StrengthUnit>g/103mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. reduces underarm perspiration.</IndicationAndUsage>
</NDC>
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<NDCCode>10596-337-35</NDCCode>
<PackageDescription>103 mL in 1 BOTTLE, WITH APPLICATOR (10596-337-35) </PackageDescription>
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<ProductNDC>10596-337</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ban</ProprietaryName>
<ProprietaryNameSuffix>Roll-on Antiperspirant Deodorant Powder Fresh</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Kao USA Inc.</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/103mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. reduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10596-338-35</NDCCode>
<PackageDescription>103 mL in 1 BOTTLE, WITH APPLICATOR (10596-338-35) </PackageDescription>
<NDC11Code>10596-0338-35</NDC11Code>
<ProductNDC>10596-338</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ban</ProprietaryName>
<ProprietaryNameSuffix>Roll-on Antiperspirant Deodorant Unscented</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Kao USA Inc.</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/103mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. reduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10596-339-35</NDCCode>
<PackageDescription>103 mL in 1 BOTTLE, WITH APPLICATOR (10596-339-35) </PackageDescription>
<NDC11Code>10596-0339-35</NDC11Code>
<ProductNDC>10596-339</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ban</ProprietaryName>
<ProprietaryNameSuffix>Roll-on Antiperspirant Deodorant Satin Breeze</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Kao USA Inc.</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/103mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. reduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10596-400-35</NDCCode>
<PackageDescription>103 mL in 1 BOTTLE, WITH APPLICATOR (10596-400-35) </PackageDescription>
<NDC11Code>10596-0400-35</NDC11Code>
<ProductNDC>10596-400</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ban</ProprietaryName>
<ProprietaryNameSuffix>Roll-on Antiperspirant Deodorant Simple Clean</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111108</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Kao USA Inc</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/103mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. reduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10596-402-35</NDCCode>
<PackageDescription>103 mL in 1 BOTTLE, WITH APPLICATOR (10596-402-35) </PackageDescription>
<NDC11Code>10596-0402-35</NDC11Code>
<ProductNDC>10596-402</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ban Purely Gentle</ProprietaryName>
<ProprietaryNameSuffix>Roll-on Antiperspirant Deodorant Unscented</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Kao USA Inc.</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. reduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0338-9540-05</NDCCode>
<PackageDescription>15 BAG in 1 CARTON (0338-9540-05) / 100 mL in 1 BAG (0338-9540-01) </PackageDescription>
<NDC11Code>00338-9540-05</NDC11Code>
<ProductNDC>0338-9540</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinolipid</ProprietaryName>
<NonProprietaryName>Olive Oil And Soybean Oil</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204508</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>OLIVE OIL; SOYBEAN OIL</SubstanceName>
<StrengthNumber>16; 4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Lipid Emulsion [EPC], Lipid Emulsion [EPC], Lipids [CS], Lipids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINOLIPID is indicated in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>CLINOLIPID lipid injectable emulsion, USP is a sterile, non-pyrogenic, homogenous, white, milky lipid emulsion for intravenous infusion. The lipid content of CLINOLIPID is 0.2 g/mL and comprises a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35.8 mg/mL (range 27.6 to 44.0 mg/mL) and α-linolenic acid (an omega-3 essential fatty acid) is 4.7 mg/mL (range 1.0 to 8.4 mg/mL). The phospholipids provide 470 milligrams or 15 mmol of phosphorus per liter. The total energy content, including fat, phospholipids and glycerin is 2000 kcal/L. Each 100 mL of CLINOLIPID 20% contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, and Water for Injection USP. Sodium Hydroxide NF for pH adjustment, pH: 6.0 to 9.0. The olive and soybean oils are refined natural products consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. The major component fatty acids are linoleic (13.8 to 22.0%), oleic (44.3 to 79.5%), palmitic (7.6 to 19.3%), linolenic (0.5 to 4.2%), palmitoleic (0.0 to 3.2%) and stearic (0.7 to 5.0%). These fatty acids have the following chemical and structural formulas. CLINOLIPID has an osmolality of approximately 340 mOsmol/kg water (which represents an osmolarity of 260 mOsmol/liter of emulsion). CLINOLIPID contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-9540-06</NDCCode>
<PackageDescription>10 BAG in 1 CARTON (0338-9540-06) / 250 mL in 1 BAG (0338-9540-02) </PackageDescription>
<NDC11Code>00338-9540-06</NDC11Code>
<ProductNDC>0338-9540</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinolipid</ProprietaryName>
<NonProprietaryName>Olive Oil And Soybean Oil</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204508</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>OLIVE OIL; SOYBEAN OIL</SubstanceName>
<StrengthNumber>16; 4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Lipid Emulsion [EPC], Lipid Emulsion [EPC], Lipids [CS], Lipids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINOLIPID is indicated in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>CLINOLIPID lipid injectable emulsion, USP is a sterile, non-pyrogenic, homogenous, white, milky lipid emulsion for intravenous infusion. The lipid content of CLINOLIPID is 0.2 g/mL and comprises a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35.8 mg/mL (range 27.6 to 44.0 mg/mL) and α-linolenic acid (an omega-3 essential fatty acid) is 4.7 mg/mL (range 1.0 to 8.4 mg/mL). The phospholipids provide 470 milligrams or 15 mmol of phosphorus per liter. The total energy content, including fat, phospholipids and glycerin is 2000 kcal/L. Each 100 mL of CLINOLIPID 20% contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, and Water for Injection USP. Sodium Hydroxide NF for pH adjustment, pH: 6.0 to 9.0. The olive and soybean oils are refined natural products consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. The major component fatty acids are linoleic (13.8 to 22.0%), oleic (44.3 to 79.5%), palmitic (7.6 to 19.3%), linolenic (0.5 to 4.2%), palmitoleic (0.0 to 3.2%) and stearic (0.7 to 5.0%). These fatty acids have the following chemical and structural formulas. CLINOLIPID has an osmolality of approximately 340 mOsmol/kg water (which represents an osmolarity of 260 mOsmol/liter of emulsion). CLINOLIPID contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-9540-07</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (0338-9540-07) / 500 mL in 1 BAG (0338-9540-03) </PackageDescription>
<NDC11Code>00338-9540-07</NDC11Code>
<ProductNDC>0338-9540</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinolipid</ProprietaryName>
<NonProprietaryName>Olive Oil And Soybean Oil</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204508</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>OLIVE OIL; SOYBEAN OIL</SubstanceName>
<StrengthNumber>16; 4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Lipid Emulsion [EPC], Lipid Emulsion [EPC], Lipids [CS], Lipids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINOLIPID is indicated in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>CLINOLIPID lipid injectable emulsion, USP is a sterile, non-pyrogenic, homogenous, white, milky lipid emulsion for intravenous infusion. The lipid content of CLINOLIPID is 0.2 g/mL and comprises a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35.8 mg/mL (range 27.6 to 44.0 mg/mL) and α-linolenic acid (an omega-3 essential fatty acid) is 4.7 mg/mL (range 1.0 to 8.4 mg/mL). The phospholipids provide 470 milligrams or 15 mmol of phosphorus per liter. The total energy content, including fat, phospholipids and glycerin is 2000 kcal/L. Each 100 mL of CLINOLIPID 20% contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, and Water for Injection USP. Sodium Hydroxide NF for pH adjustment, pH: 6.0 to 9.0. The olive and soybean oils are refined natural products consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. The major component fatty acids are linoleic (13.8 to 22.0%), oleic (44.3 to 79.5%), palmitic (7.6 to 19.3%), linolenic (0.5 to 4.2%), palmitoleic (0.0 to 3.2%) and stearic (0.7 to 5.0%). These fatty acids have the following chemical and structural formulas. CLINOLIPID has an osmolality of approximately 340 mOsmol/kg water (which represents an osmolarity of 260 mOsmol/liter of emulsion). CLINOLIPID contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-9540-08</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0338-9540-08) / 1000 mL in 1 BAG (0338-9540-04) </PackageDescription>
<NDC11Code>00338-9540-08</NDC11Code>
<ProductNDC>0338-9540</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinolipid</ProprietaryName>
<NonProprietaryName>Olive Oil And Soybean Oil</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204508</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>OLIVE OIL; SOYBEAN OIL</SubstanceName>
<StrengthNumber>16; 4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Lipid Emulsion [EPC], Lipid Emulsion [EPC], Lipids [CS], Lipids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINOLIPID is indicated in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>CLINOLIPID lipid injectable emulsion, USP is a sterile, non-pyrogenic, homogenous, white, milky lipid emulsion for intravenous infusion. The lipid content of CLINOLIPID is 0.2 g/mL and comprises a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35.8 mg/mL (range 27.6 to 44.0 mg/mL) and α-linolenic acid (an omega-3 essential fatty acid) is 4.7 mg/mL (range 1.0 to 8.4 mg/mL). The phospholipids provide 470 milligrams or 15 mmol of phosphorus per liter. The total energy content, including fat, phospholipids and glycerin is 2000 kcal/L. Each 100 mL of CLINOLIPID 20% contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, and Water for Injection USP. Sodium Hydroxide NF for pH adjustment, pH: 6.0 to 9.0. The olive and soybean oils are refined natural products consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. The major component fatty acids are linoleic (13.8 to 22.0%), oleic (44.3 to 79.5%), palmitic (7.6 to 19.3%), linolenic (0.5 to 4.2%), palmitoleic (0.0 to 3.2%) and stearic (0.7 to 5.0%). These fatty acids have the following chemical and structural formulas. CLINOLIPID has an osmolality of approximately 340 mOsmol/kg water (which represents an osmolarity of 260 mOsmol/liter of emulsion). CLINOLIPID contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0555-9032-70</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (0555-9032-70) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9032-70</NDC11Code>
<ProductNDC>0555-9032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-legest Fe</ProprietaryName>
<ProprietaryNameSuffix>28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20071026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076105</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-03-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tri-Legest® Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets [not USP]) is indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Tri-Legest® Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tri-Legest® Fe should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months. Combined oral contraceptives are highly effective for pregnancy prevention. Table 2 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Norethindrone acetate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28-day) cycle studies. A total of 296 patients received norethindrone acetate and ethinyl estradiol tablets and 295 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator’s global evaluation. Patients with severe androgen excess were not studied. Norethindrone acetate and ethinyl estradiol tablets users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment. Figure 2. Mean Percent Reduction in Total Lesion Counts From Baseline to Each 28-Day Cycle and Mean Total Lesion Counts at Each Cycle Following Administration of Norethindrone acetate and ethinyl estradiol tablets and Placebo (Statistically significant differences were not found in both studies individually until cycle 6).</IndicationAndUsage>
<Description>Tri-Legest® Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets [not USP]) is a graduated estrophasic combined oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tri-Legest® Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light pink tablet contains 1 mg norethindrone acetate [(17α)-17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol] Each light pink tablet contains the following inactive ingredients: calcium stearate, FD&C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. Each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. Each light yellow tablet contains the following inactive ingredients: calcium stearate, D&C yellow no.10 aluminum lake, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. Each light blue tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. Each light blue tablet contains the following inactive ingredients: calcium stearate, FD&C blue no. 2 aluminum lake, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. Each brown tablet contains crospovidone, ferrous fumarate, hydrogenated vegetable oil, and microcrystalline cellulose. The structural formulas are as follows. Norethindrone Acetate Ethinyl Estradiol. C22H28O3 Molecular Weight: 340.46 C20H24O2 Molecular Weight: 296.40. Each Tri-Legest® Fe tablet dispenser contains five light pink tablets, seven light yellow tablets, nine light blue tablets, and seven brown tablets. These tablets are to be taken in the following order: one light pink tablet each day for five days, then one light yellow tablet each day for seven days, followed by one light blue tablet each day for nine days, and then one brown tablet each day for seven days.</Description>
</NDC>
<NDC>
<NDCCode>21695-685-28</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (21695-685-28) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21695-0685-28</NDC11Code>
<ProductNDC>21695-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tilia Fe</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20101201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076629</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tilia Fe is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tilia Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tilia Fe should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months. Oral contraceptives are highly effective for pregnancy prevention. Table 2 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Norethindrone acetate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies. A total of 295 patients received norethindrone acetate and ethinyl estradiol tablets and 296 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator’s global evaluation. Patients with severe androgen excess were not studied. Norethindrone acetate and ethinyl estradiol tablets users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment.</IndicationAndUsage>
<Description>Tilia Fe is a graduated estrophasic providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tilia Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and 7 ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white tablet contains 1 mg norethindrone acetate, (17α) 17-(acetyloxy)-19-norpregn-4-en-20-yn-3-one, and 20 mcg ethinyl estradiol, (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. Each light-green tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. The light-green tablets also contain D&C Yellow #10 and FD&C Blue #1. Each green tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. The green tablets also contain D&C Yellow #10 and FD&C Blue #1. The structural formulas are as follows. Norethindrone Acetate C22H28O3 M.W. 340.46 Ethinyl Es tradiol C20H24O2 M.W. 296.4. Each inactive, brown tablet contains microcrystalline cellulose, ferrous fumarate, magnesium stearate and sodium starch glycolate. Ferrous fumarate tablets are not USP for dissolution and assay. Each dispenser of Tilia Fe, contains 5 white tablets, 7 light-green tablets, 9 green tablets, and 7 brown tablets. These tablets are to be taken in the following order: one white tablet each day for five days, then one light-green tablet each day for seven days, followed by one green tablet each day for nine days, and then one brown tablet each day for seven days.</Description>
</NDC>
<NDC>
<NDCCode>51346-340-01</NDCCode>
<PackageDescription>15 mL in 1 CARTON (51346-340-01)</PackageDescription>
<NDC11Code>51346-0340-01</NDC11Code>
<ProductNDC>51346-340</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pure Foundation</ProprietaryName>
<ProprietaryNameSuffix>35 Tan Brown</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>1.63; .86</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-09-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54868-6274-0</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (54868-6274-0) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>54868-6274-00</NDC11Code>
<ProductNDC>54868-6274</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tilia Fe</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110621</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076629</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tilia Fe is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tilia Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tilia Fe should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months. Oral contraceptives are highly effective for pregnancy prevention. Table 2 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Norethindrone acetate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies. A total of 295 patients received norethindrone acetate and ethinyl estradiol tablets and 296 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator’s global evaluation. Patients with severe androgen excess were not studied. Norethindrone acetate and ethinyl estradiol tablets users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment.</IndicationAndUsage>
<Description>Tilia Fe is a graduated estrophasic providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tilia Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and 7 ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white tablet contains 1 mg norethindrone acetate, (17α) 17-(acetyloxy)-19-norpregn-4-en-20-yn-3-one, and 20 mcg ethinyl estradiol, (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. Each light-green tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. The light-green tablets also contain D&C Yellow #10 and FD&C Blue #1. Each green tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. The inactive ingredients present are anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, and povidone. The green tablets also contain D&C Yellow #10 and FD&C Blue #1. The structural formulas are as follows. Norethindrone Acetate C22H28O3 M.W. 340.46 Ethinyl Es tradiol C20H24O2 M.W. 296.4. Each inactive, brown tablet contains microcrystalline cellulose, ferrous fumarate, magnesium stearate and sodium starch glycolate. Ferrous fumarate tablets are not USP for dissolution and assay. Each dispenser of Tilia Fe, contains 5 white tablets, 7 light-green tablets, 9 green tablets, and 7 brown tablets. These tablets are to be taken in the following order: one white tablet each day for five days, then one light-green tablet each day for seven days, followed by one green tablet each day for nine days, and then one brown tablet each day for seven days.</Description>
</NDC>
<NDC>
<NDCCode>55150-340-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (55150-340-01) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55150-0340-01</NDC11Code>
<ProductNDC>55150-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20201020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212939</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</IndicationAndUsage>
<Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.</Description>
</NDC>
<NDC>
<NDCCode>55150-340-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (55150-340-10) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55150-0340-10</NDC11Code>
<ProductNDC>55150-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20201020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212939</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</IndicationAndUsage>
<Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.</Description>
</NDC>
<NDC>
<NDCCode>55150-340-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (55150-340-25) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55150-0340-25</NDC11Code>
<ProductNDC>55150-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20201020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212939</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</IndicationAndUsage>
<Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.</Description>
</NDC>
<NDC>
<NDCCode>59651-504-88</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (59651-504-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59651-0504-88</NDC11Code>
<ProductNDC>59651-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oshih</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216558</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-02-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oshih is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of Oshih in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.</IndicationAndUsage>
<Description>Oshih provides an oral contraceptive regimen consisting of 24 white to off-white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below. Each white to off-white active chewable tablet also contains the following inactive ingredients: compressible sugar, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, modified food starch (corn), nat spearmint FL, povidone, sucralose and vitamin E. Each brown placebo tablet contains croscarmellose sodium, ferrous fumarate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, modified food starch (corn), nat spearmint FL, povidone and sucralose. The ferrous fumarate tablets do not serve any therapeutic purpose. The molecular formula of ethinyl estradiol is C20H24O2 and the structural formula is. The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The molecular weight of ethinyl estradiol is 296.40. The molecular formula of norethindrone acetate is C22H28O3 and the structural formula is. The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The molecular weight of norethindrone acetate is 340.46.</Description>
</NDC>
<NDC>
<NDCCode>64980-340-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (64980-340-01) </PackageDescription>
<NDC11Code>64980-0340-01</NDC11Code>
<ProductNDC>64980-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090124</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).</IndicationAndUsage>
<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>64980-340-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (64980-340-03) </PackageDescription>
<NDC11Code>64980-0340-03</NDC11Code>
<ProductNDC>64980-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090124</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).</IndicationAndUsage>
<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
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<NDC>
<NDCCode>67457-340-01</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (67457-340-01) / 20 mL in 1 VIAL (67457-340-00) </PackageDescription>
<NDC11Code>67457-0340-01</NDC11Code>
<ProductNDC>67457-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20131205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065397</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection, USP is an off white to light tan colored lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of base is equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL, it forms a clear, colorless or light to dark tan solution with the pH of the solution is between 2.5 and 4.5. It may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30, 32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m] [10,2,16]benzoxadiazacyclotetracosine -26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>70108-340-01</NDCCode>
<PackageDescription>1 KIT in 1 BOX (70108-340-01) * 40 mL in 1 BOTTLE, SPRAY (70108-366-01) * 40 mL in 1 BOTTLE, SPRAY (70108-367-01) * 40 mL in 1 BOTTLE, SPRAY (70108-368-01) * 40 mL in 1 BOTTLE, SPRAY (70108-119-04) </PackageDescription>
<NDC11Code>70108-0340-01</NDC11Code>
<ProductNDC>70108-340</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Care 4 Hand Sanitizers 1.35 Fl Oz (cherry Blossom, Gardenia, Coconut Honey, Lavender Vanilla)</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260511</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Ashtel Studios, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70756-649-35</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70756-649-35) / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>70756-0649-35</NDC11Code>
<ProductNDC>70756-649</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20230315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216859</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenylephrine Hydrochloride Ophthalmic Solution 2.5% and 10%, is indicated to dilate the pupil.</IndicationAndUsage>
<Description>Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow color solution, topical α -adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride, USP 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
</NDC>
<NDC>
<NDCCode>72495-601-28</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (72495-601-28) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>72495-0601-28</NDC11Code>
<ProductNDC>72495-601</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Femlyv</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate/ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20241101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218718</ApplicationNumber>
<LabelerName>Millicent US, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FEMLYV is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)]. Limitations of Use. The efficacy of FEMLYV in females with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.</IndicationAndUsage>
<Description>FEMLYV (norethindrone acetate and ethinyl estradiol orally disintegrating tablets) is a combined oral contraceptive. FEMLYV consists of 24 green, round ODTs each containing 1 mg norethindrone acetate and 0.020 mg ethinyl estradiol and 4 white, round inert ODTs. Each green ODT also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, mint green lake blend, pregelatinized starch, spearmint flavor, sucralose, vitamin E (DL-alpha-tocopherol). Each white ODT contains, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, spearmint flavor, sucralose. The empirical formula of norethindrone acetate is C22H28O3 and the structural formula is. The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The molecular weight of norethindrone acetate is 340.46. It is a neutral molecule and is practically insoluble in water. The empirical formula of ethinyl estradiol is C20H24O2 and the structural formula is. The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The molecular weight of ethinyl estradiol is 296.40. It is a neutral molecule and is practically insoluble in water.</Description>
</NDC>
<NDC>
<NDCCode>72495-601-84</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (72495-601-84) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>72495-0601-84</NDC11Code>
<ProductNDC>72495-601</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Femlyv</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate/ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20241101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218718</ApplicationNumber>
<LabelerName>Millicent US, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FEMLYV is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)]. Limitations of Use. The efficacy of FEMLYV in females with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.</IndicationAndUsage>
<Description>FEMLYV (norethindrone acetate and ethinyl estradiol orally disintegrating tablets) is a combined oral contraceptive. FEMLYV consists of 24 green, round ODTs each containing 1 mg norethindrone acetate and 0.020 mg ethinyl estradiol and 4 white, round inert ODTs. Each green ODT also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, mint green lake blend, pregelatinized starch, spearmint flavor, sucralose, vitamin E (DL-alpha-tocopherol). Each white ODT contains, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, spearmint flavor, sucralose. The empirical formula of norethindrone acetate is C22H28O3 and the structural formula is. The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The molecular weight of norethindrone acetate is 340.46. It is a neutral molecule and is practically insoluble in water. The empirical formula of ethinyl estradiol is C20H24O2 and the structural formula is. The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The molecular weight of ethinyl estradiol is 296.40. It is a neutral molecule and is practically insoluble in water.</Description>
</NDC>
</NDCList>