{
"NDC": [
{
"NDCCode": "59651-097-62",
"PackageDescription": "3000 TABLET in 1 BAG (59651-097-62) ",
"NDC11Code": "59651-0097-62",
"ProductNDC": "59651-097",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"StartMarketingDate": "20170228",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-11-08",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "28-FEB-17"
},
{
"NDCCode": "59651-098-62",
"PackageDescription": "3000 TABLET in 1 BAG (59651-098-62) ",
"NDC11Code": "59651-0098-62",
"ProductNDC": "59651-098",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"StartMarketingDate": "20170228",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-11-08",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "28-FEB-17"
},
{
"NDCCode": "59651-608-62",
"PackageDescription": "30000 TABLET, FILM COATED in 1 BAG (59651-608-62) ",
"NDC11Code": "59651-0608-62",
"ProductNDC": "59651-608",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20240213",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-02-06",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "13-FEB-24"
},
{
"NDCCode": "59651-689-62",
"PackageDescription": "30000 TABLET in 1 BAG (59651-689-62) ",
"NDC11Code": "59651-0689-62",
"ProductNDC": "59651-689",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Fluphenazine Hydrochloride",
"DosageFormName": "TABLET",
"StartMarketingDate": "20230818",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "FLUPHENAZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2023-08-25",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "18-AUG-23"
},
{
"NDCCode": "59651-692-62",
"PackageDescription": "30000 TABLET, COATED in 1 BAG (59651-692-62) ",
"NDC11Code": "59651-0692-62",
"ProductNDC": "59651-692",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ibuprofen And Diphenhydramine Citrate",
"DosageFormName": "TABLET, COATED",
"StartMarketingDate": "20220531",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DIPHENHYDRAMINE CITRATE; IBUPROFEN",
"StrengthNumber": "38; 200",
"StrengthUnit": "mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-06-23",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "31-MAY-22"
},
{
"NDCCode": "59651-798-62",
"PackageDescription": "30000 TABLET in 1 BAG (59651-798-62) ",
"NDC11Code": "59651-0798-62",
"ProductNDC": "59651-798",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"StartMarketingDate": "20250717",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-07-29",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "17-JUL-25"
},
{
"NDCCode": "59651-825-62",
"PackageDescription": "30000 TABLET, FILM COATED in 1 BAG (59651-825-62) ",
"NDC11Code": "59651-0825-62",
"ProductNDC": "59651-825",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Cimetidine",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20241112",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CIMETIDINE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-12-10",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "12-NOV-24"
},
{
"NDCCode": "51060-097-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (51060-097-01) > 30 mL in 1 BOTTLE",
"NDC11Code": "51060-0097-01",
"ProductNDC": "51060-097",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rainforest Of The Sea Water Foundation Broad Spectrum Spf 15 Sunscreen",
"ProprietaryNameSuffix": "Tan Sand",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150901",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Tarte, Inc",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "62.3; 38.4",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "58503-097-01",
"PackageDescription": "53 mL in 1 BOTTLE (58503-097-01) ",
"NDC11Code": "58503-0097-01",
"ProductNDC": "58503-097",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170425",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "China Ningbo Shangge Cosmetic Technology Corp.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170425",
"SamplePackage": "N",
"IndicationAndUsage": "Use: 1 for handwashing to decrease bacteria on the skin, 2 recommended for repeated use."
},
{
"NDCCode": "68025-097-10",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-097-10) ",
"NDC11Code": "68025-0097-10",
"ProductNDC": "68025-097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Relexxii",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220623",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216117",
"LabelerName": "Vertical Pharmaceuticals, LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "36",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "N",
"IndicationAndUsage": "RELEXXII is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [see Clinical Studies (14)]. Limitations of Use. The use of RELEXXII is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "RELEXXII contains methylphenidate, a CNS stimulant, present as methylphenidate hydrochloride salt. Chemically, methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. It has a pKa of 8.71 (at 21.5°C). Its molecular weight is 269.77. RELEXXII is for oral administration and is available in the following strengths: 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, and 72 mg containing methylphenidate hydrochloride (equivalent to 15.6 mg, 23.4 mg, 31.1 mg, 38.9 mg, 46.7 mg, 54.5 mg, and 62.3 mg methylphenidate respectively). RELEXXII contains the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, triacetin. RELEXXII also contains the following color additives:. 27 mg: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake. 45 mg: FD&C Red #40 Aluminum Lake. 54 mg: FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. 18 and 63 mg: iron oxide red, iron oxide yellow. 72 mg: FD&C Blue #1 Aluminum Lake. System Components and Performance. RELEXXII uses osmotic pressure to deliver methylphenidate hydrochloride at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of core of RELEXXII. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that RELEXXII may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized."
},
{
"NDCCode": "68025-097-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-097-30) ",
"NDC11Code": "68025-0097-30",
"ProductNDC": "68025-097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Relexxii",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220623",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216117",
"LabelerName": "Vertical Pharmaceuticals, LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "36",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240812",
"SamplePackage": "N",
"IndicationAndUsage": "RELEXXII is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [see Clinical Studies (14)]. Limitations of Use. The use of RELEXXII is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "RELEXXII contains methylphenidate, a CNS stimulant, present as methylphenidate hydrochloride salt. Chemically, methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. It has a pKa of 8.71 (at 21.5°C). Its molecular weight is 269.77. RELEXXII is for oral administration and is available in the following strengths: 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, and 72 mg containing methylphenidate hydrochloride (equivalent to 15.6 mg, 23.4 mg, 31.1 mg, 38.9 mg, 46.7 mg, 54.5 mg, and 62.3 mg methylphenidate respectively). RELEXXII contains the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, triacetin. RELEXXII also contains the following color additives:. 27 mg: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake. 45 mg: FD&C Red #40 Aluminum Lake. 54 mg: FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. 18 and 63 mg: iron oxide red, iron oxide yellow. 72 mg: FD&C Blue #1 Aluminum Lake. System Components and Performance. RELEXXII uses osmotic pressure to deliver methylphenidate hydrochloride at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of core of RELEXXII. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that RELEXXII may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized."
},
{
"NDCCode": "73928-097-01",
"PackageDescription": "35 mL in 1 BOTTLE (73928-097-01) ",
"NDC11Code": "73928-0097-01",
"ProductNDC": "73928-097",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Swedish Fish Sanitizer Mix Berry",
"NonProprietaryName": "Alcohol Antiseptic",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Kingkey MBC Life Technology Group Co.,Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250201",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "76176-097-01",
"PackageDescription": "473 mL in 1 BOTTLE, PUMP (76176-097-01) ",
"NDC11Code": "76176-0097-01",
"ProductNDC": "76176-097",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Hand Sanitizer 16oz",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Ningbo Liyuan Daily Chemical Products Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "59651-026-01",
"PackageDescription": "100 mL in 1 BOTTLE (59651-026-01) ",
"NDC11Code": "59651-0026-01",
"ProductNDC": "59651-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20190419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209371",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "250; 62.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190419",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and clavulanate potassium for oral suspension is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for the treatment of infections caused by designated susceptible (confirmed or suspected) beta-lactamase-producing microorganisms (1). Lower Respiratory Tract Infections (1.1): 1 Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets.",
"Description": "Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). : 1 In amoxicillin and clavulanate potassium for oral suspension, USP, amoxicillin is present as amoxicillin trihydrate."
},
{
"NDCCode": "59651-026-55",
"PackageDescription": "150 mL in 1 BOTTLE (59651-026-55) ",
"NDC11Code": "59651-0026-55",
"ProductNDC": "59651-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20190419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209371",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "250; 62.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190419",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and clavulanate potassium for oral suspension is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for the treatment of infections caused by designated susceptible (confirmed or suspected) beta-lactamase-producing microorganisms (1). Lower Respiratory Tract Infections (1.1): 1 Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets.",
"Description": "Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). : 1 In amoxicillin and clavulanate potassium for oral suspension, USP, amoxicillin is present as amoxicillin trihydrate."
},
{
"NDCCode": "59651-026-75",
"PackageDescription": "75 mL in 1 BOTTLE (59651-026-75) ",
"NDC11Code": "59651-0026-75",
"ProductNDC": "59651-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20190419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209371",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "250; 62.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190419",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and clavulanate potassium for oral suspension is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for the treatment of infections caused by designated susceptible (confirmed or suspected) beta-lactamase-producing microorganisms (1). Lower Respiratory Tract Infections (1.1): 1 Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets.",
"Description": "Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). : 1 In amoxicillin and clavulanate potassium for oral suspension, USP, amoxicillin is present as amoxicillin trihydrate."
},
{
"NDCCode": "59651-299-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (59651-299-60) ",
"NDC11Code": "59651-0299-60",
"ProductNDC": "59651-299",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamoxifen Citrate",
"NonProprietaryName": "Tamoxifen Citrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213358",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "TAMOXIFEN CITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Active",
"LastUpdate": "2020-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200814",
"SamplePackage": "N",
"IndicationAndUsage": "Metastatic Breast Cancer. Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen citrate tablets are an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen citrate tablets therapy. Adjuvant Treatment of Breast Cancer. Tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. Tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. The estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen citrate tablets therapy are likely to be beneficial. Tamoxifen citrate tablets reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen citrate tablets therapy for breast cancer. Ductal Carcinoma in Situ (DCIS). In women with DCIS, following breast surgery and radiation, tamoxifen citrate tablets are indicated to reduce the risk of invasive breast cancer (see BOXED WARNING at the beginning of the label). The decision regarding therapy with tamoxifen citrate tablets for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen citrate tablets therapy. Current data from clinical trials support five years of adjuvant tamoxifen citrate tablets therapy for patients with breast cancer. Reduction in Breast Cancer Incidence in High Risk Women. Tamoxifen citrate tablets are indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. Twenty-five percent of the participants received drug for 5 years. The longer-term effects are not known. In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see BOXED WARNING at the beginning of the label). Tamoxifen citrate tablets are indicated only for high-risk women. “High risk” is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model. Examples of combinations of factors predicting a 5-year risk ≥ 1.67% are. Age 35 or older and any of the following combination of factors: 1 One first degree relative with a history of breast cancer, 2 or more benign biopsies, and a history of a breast biopsy showing atypical hyperplasia; or, 2 At least 2 first degree relatives with a history of breast cancer, and a personal history of at least one breast biopsy; or, 3 LCIS.",
"Description": "Tamoxifen citrate tablets, USP a nonsteroidal antiestrogen, are for oral administration. Tamoxifen citrate tablets are available as. 10 mg Tablets. Each tablet contains 15.2 mg of tamoxifen citrate USP equivalent to 10 mg of tamoxifen. 20 mg Tablets. Each tablet contains 30.4 mg of tamoxifen citrate USP equivalent to 20 mg of tamoxifen. Inactive Ingredients: corn starch (maize), croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone and titanium dioxide. Chemically, tamoxifen citrate is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl) phenoxy]-N, N-dimethylethanamine 2 hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and molecular formulas are. Tamoxifen citrate has a molecular weight of 563.62, the pKa' is 8.85, the equilibrium solubility in water at 37°C is 0.3159 mg/mL and in 0.02 N HCl at 37°C, it is 0.4045 mg/mL."
},
{
"NDCCode": "59651-300-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (59651-300-30) ",
"NDC11Code": "59651-0300-30",
"ProductNDC": "59651-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamoxifen Citrate",
"NonProprietaryName": "Tamoxifen Citrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213358",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "TAMOXIFEN CITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Active",
"LastUpdate": "2020-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200814",
"SamplePackage": "N",
"IndicationAndUsage": "Metastatic Breast Cancer. Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen citrate tablets are an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen citrate tablets therapy. Adjuvant Treatment of Breast Cancer. Tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. Tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. The estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen citrate tablets therapy are likely to be beneficial. Tamoxifen citrate tablets reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen citrate tablets therapy for breast cancer. Ductal Carcinoma in Situ (DCIS). In women with DCIS, following breast surgery and radiation, tamoxifen citrate tablets are indicated to reduce the risk of invasive breast cancer (see BOXED WARNING at the beginning of the label). The decision regarding therapy with tamoxifen citrate tablets for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen citrate tablets therapy. Current data from clinical trials support five years of adjuvant tamoxifen citrate tablets therapy for patients with breast cancer. Reduction in Breast Cancer Incidence in High Risk Women. Tamoxifen citrate tablets are indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. Twenty-five percent of the participants received drug for 5 years. The longer-term effects are not known. In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see BOXED WARNING at the beginning of the label). Tamoxifen citrate tablets are indicated only for high-risk women. “High risk” is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model. Examples of combinations of factors predicting a 5-year risk ≥ 1.67% are. Age 35 or older and any of the following combination of factors: 1 One first degree relative with a history of breast cancer, 2 or more benign biopsies, and a history of a breast biopsy showing atypical hyperplasia; or, 2 At least 2 first degree relatives with a history of breast cancer, and a personal history of at least one breast biopsy; or, 3 LCIS.",
"Description": "Tamoxifen citrate tablets, USP a nonsteroidal antiestrogen, are for oral administration. Tamoxifen citrate tablets are available as. 10 mg Tablets. Each tablet contains 15.2 mg of tamoxifen citrate USP equivalent to 10 mg of tamoxifen. 20 mg Tablets. Each tablet contains 30.4 mg of tamoxifen citrate USP equivalent to 20 mg of tamoxifen. Inactive Ingredients: corn starch (maize), croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone and titanium dioxide. Chemically, tamoxifen citrate is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl) phenoxy]-N, N-dimethylethanamine 2 hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and molecular formulas are. Tamoxifen citrate has a molecular weight of 563.62, the pKa' is 8.85, the equilibrium solubility in water at 37°C is 0.3159 mg/mL and in 0.02 N HCl at 37°C, it is 0.4045 mg/mL."
},
{
"NDCCode": "59651-300-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (59651-300-90) ",
"NDC11Code": "59651-0300-90",
"ProductNDC": "59651-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamoxifen Citrate",
"NonProprietaryName": "Tamoxifen Citrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213358",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "TAMOXIFEN CITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Active",
"LastUpdate": "2020-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200814",
"SamplePackage": "N",
"IndicationAndUsage": "Metastatic Breast Cancer. Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen citrate tablets are an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen citrate tablets therapy. Adjuvant Treatment of Breast Cancer. Tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. Tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. The estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen citrate tablets therapy are likely to be beneficial. Tamoxifen citrate tablets reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen citrate tablets therapy for breast cancer. Ductal Carcinoma in Situ (DCIS). In women with DCIS, following breast surgery and radiation, tamoxifen citrate tablets are indicated to reduce the risk of invasive breast cancer (see BOXED WARNING at the beginning of the label). The decision regarding therapy with tamoxifen citrate tablets for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen citrate tablets therapy. Current data from clinical trials support five years of adjuvant tamoxifen citrate tablets therapy for patients with breast cancer. Reduction in Breast Cancer Incidence in High Risk Women. Tamoxifen citrate tablets are indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. Twenty-five percent of the participants received drug for 5 years. The longer-term effects are not known. In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see BOXED WARNING at the beginning of the label). Tamoxifen citrate tablets are indicated only for high-risk women. “High risk” is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model. Examples of combinations of factors predicting a 5-year risk ≥ 1.67% are. Age 35 or older and any of the following combination of factors: 1 One first degree relative with a history of breast cancer, 2 or more benign biopsies, and a history of a breast biopsy showing atypical hyperplasia; or, 2 At least 2 first degree relatives with a history of breast cancer, and a personal history of at least one breast biopsy; or, 3 LCIS.",
"Description": "Tamoxifen citrate tablets, USP a nonsteroidal antiestrogen, are for oral administration. Tamoxifen citrate tablets are available as. 10 mg Tablets. Each tablet contains 15.2 mg of tamoxifen citrate USP equivalent to 10 mg of tamoxifen. 20 mg Tablets. Each tablet contains 30.4 mg of tamoxifen citrate USP equivalent to 20 mg of tamoxifen. Inactive Ingredients: corn starch (maize), croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone and titanium dioxide. Chemically, tamoxifen citrate is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl) phenoxy]-N, N-dimethylethanamine 2 hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and molecular formulas are. Tamoxifen citrate has a molecular weight of 563.62, the pKa' is 8.85, the equilibrium solubility in water at 37°C is 0.3159 mg/mL and in 0.02 N HCl at 37°C, it is 0.4045 mg/mL."
},
{
"NDCCode": "59651-436-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (59651-436-01) ",
"NDC11Code": "59651-0436-01",
"ProductNDC": "59651-436",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214982",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DIGOXIN",
"StrengthNumber": ".0625",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220208",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin USP exists as clear to white, crystals or white crystalline powder that melt with decomposition above 230°C. The drug is practically insoluble in water, soluble in a mixture of equal volumes of methanol and methylene chloride, slightly soluble in ethanol (96 per cent). Digoxin tablets, USP are supplied as 62.5 mcg (unscored), 125 mcg (scored) and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). In addition the 62.5 mcg tablets contain FD & C Yellow No. 6 Lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59651-436-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (59651-436-99) ",
"NDC11Code": "59651-0436-99",
"ProductNDC": "59651-436",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214982",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DIGOXIN",
"StrengthNumber": ".0625",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220208",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin USP exists as clear to white, crystals or white crystalline powder that melt with decomposition above 230°C. The drug is practically insoluble in water, soluble in a mixture of equal volumes of methanol and methylene chloride, slightly soluble in ethanol (96 per cent). Digoxin tablets, USP are supplied as 62.5 mcg (unscored), 125 mcg (scored) and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). In addition the 62.5 mcg tablets contain FD & C Yellow No. 6 Lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59651-437-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (59651-437-01) ",
"NDC11Code": "59651-0437-01",
"ProductNDC": "59651-437",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214982",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DIGOXIN",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220208",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin USP exists as clear to white, crystals or white crystalline powder that melt with decomposition above 230°C. The drug is practically insoluble in water, soluble in a mixture of equal volumes of methanol and methylene chloride, slightly soluble in ethanol (96 per cent). Digoxin tablets, USP are supplied as 62.5 mcg (unscored), 125 mcg (scored) and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). In addition the 62.5 mcg tablets contain FD & C Yellow No. 6 Lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59651-437-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (59651-437-99) ",
"NDC11Code": "59651-0437-99",
"ProductNDC": "59651-437",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214982",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DIGOXIN",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220208",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin USP exists as clear to white, crystals or white crystalline powder that melt with decomposition above 230°C. The drug is practically insoluble in water, soluble in a mixture of equal volumes of methanol and methylene chloride, slightly soluble in ethanol (96 per cent). Digoxin tablets, USP are supplied as 62.5 mcg (unscored), 125 mcg (scored) and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). In addition the 62.5 mcg tablets contain FD & C Yellow No. 6 Lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59651-438-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (59651-438-01) ",
"NDC11Code": "59651-0438-01",
"ProductNDC": "59651-438",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214982",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DIGOXIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220208",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin USP exists as clear to white, crystals or white crystalline powder that melt with decomposition above 230°C. The drug is practically insoluble in water, soluble in a mixture of equal volumes of methanol and methylene chloride, slightly soluble in ethanol (96 per cent). Digoxin tablets, USP are supplied as 62.5 mcg (unscored), 125 mcg (scored) and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). In addition the 62.5 mcg tablets contain FD & C Yellow No. 6 Lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59651-438-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (59651-438-99) ",
"NDC11Code": "59651-0438-99",
"ProductNDC": "59651-438",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214982",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DIGOXIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220208",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin USP exists as clear to white, crystals or white crystalline powder that melt with decomposition above 230°C. The drug is practically insoluble in water, soluble in a mixture of equal volumes of methanol and methylene chloride, slightly soluble in ethanol (96 per cent). Digoxin tablets, USP are supplied as 62.5 mcg (unscored), 125 mcg (scored) and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). In addition the 62.5 mcg tablets contain FD & C Yellow No. 6 Lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0069-0600-01",
"PackageDescription": "1 KIT in 1 CARTON (0069-0600-01) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01) ",
"NDC11Code": "00069-0600-01",
"ProductNDC": "0069-0600",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Penbraya",
"NonProprietaryName": "Meningococcal Groups A, B, C, W, And Y Vaccine",
"DosageFormName": "KIT",
"StartMarketingDate": "20231127",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125770",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231127",
"SamplePackage": "N",
"IndicationAndUsage": "PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.",
"Description": "PENBRAYA (Meningococcal Groups A, B, C, W, and Y Vaccine) is a suspension for intramuscular injection. PENBRAYA is supplied as a sterile Lyophilized MenACWY Component to be reconstituted with the sterile MenB Component. The Lyophilized MenACWY Component consists of N. meningitidis serogroups A, C, W, and Y polysaccharides individually conjugated to TT. The polysaccharide for each group is grown in media containing dextrose, salt, and yeast extract, then purified by precipitation and filtration. The TT is produced by fermentation of Clostridium tetani in dextrose, salts, and tryptone N1 peptone followed by formalin detoxification, then purified by a series of physicochemical steps. The serogroups A and C polysaccharides are individually microfluidized, activated with 1-cyano-4(dimethylamino)-pyridinium tetrafluoroborate (CDAP), derivatized with adipic acid dihydrazide (ADH), and then conjugated with TT in the presence of 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide) (EDAC). The serogroups W and Y polysaccharides are individually microfluidized, activated with CDAP, and then conjugated with TT. The conjugates are purified by a series of physicochemical steps then sterile filtered. Trometamol/sucrose buffer is added, and the MenACWY-TT solution is lyophilized. The MenB Component is a sterile suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, 1 from fHbp subfamily A and 1 from fHbp subfamily B (A05 and B01, respectively). The proteins are individually produced in Escherichia coli. Production strains are grown to a specific density in chemically defined fermentation growth media without antibiotics or animal-derived components. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added and is present in the MenB Component. Each approximately 0.5 mL dose of PENBRAYA contains N. meningitidis serogroup A, C, W, and Y polysaccharide (5 mcg each; 20 mcg total) conjugated to tetanus toxoid (44 mcg tetanus toxoid), 2 recombinant lipidated factor H binding protein variants from N. meningitidis serogroup B (60 mcg each; total of 120 mcg protein), L-histidine (0.78 mg) , trometamol (0.097 mg), sucrose (28 mg), aluminum phosphate (0.25 mg aluminum), sodium chloride (4.65 mg), and PS80 80 (0.018 mg) at pH 6.0. PENBRAYA does not contain any preservatives."
},
{
"NDCCode": "0069-0600-05",
"PackageDescription": "5 KIT in 1 CARTON (0069-0600-05) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01) ",
"NDC11Code": "00069-0600-05",
"ProductNDC": "0069-0600",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Penbraya",
"NonProprietaryName": "Meningococcal Groups A, B, C, W, And Y Vaccine",
"DosageFormName": "KIT",
"StartMarketingDate": "20231127",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125770",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231127",
"SamplePackage": "N",
"IndicationAndUsage": "PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.",
"Description": "PENBRAYA (Meningococcal Groups A, B, C, W, and Y Vaccine) is a suspension for intramuscular injection. PENBRAYA is supplied as a sterile Lyophilized MenACWY Component to be reconstituted with the sterile MenB Component. The Lyophilized MenACWY Component consists of N. meningitidis serogroups A, C, W, and Y polysaccharides individually conjugated to TT. The polysaccharide for each group is grown in media containing dextrose, salt, and yeast extract, then purified by precipitation and filtration. The TT is produced by fermentation of Clostridium tetani in dextrose, salts, and tryptone N1 peptone followed by formalin detoxification, then purified by a series of physicochemical steps. The serogroups A and C polysaccharides are individually microfluidized, activated with 1-cyano-4(dimethylamino)-pyridinium tetrafluoroborate (CDAP), derivatized with adipic acid dihydrazide (ADH), and then conjugated with TT in the presence of 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide) (EDAC). The serogroups W and Y polysaccharides are individually microfluidized, activated with CDAP, and then conjugated with TT. The conjugates are purified by a series of physicochemical steps then sterile filtered. Trometamol/sucrose buffer is added, and the MenACWY-TT solution is lyophilized. The MenB Component is a sterile suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, 1 from fHbp subfamily A and 1 from fHbp subfamily B (A05 and B01, respectively). The proteins are individually produced in Escherichia coli. Production strains are grown to a specific density in chemically defined fermentation growth media without antibiotics or animal-derived components. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added and is present in the MenB Component. Each approximately 0.5 mL dose of PENBRAYA contains N. meningitidis serogroup A, C, W, and Y polysaccharide (5 mcg each; 20 mcg total) conjugated to tetanus toxoid (44 mcg tetanus toxoid), 2 recombinant lipidated factor H binding protein variants from N. meningitidis serogroup B (60 mcg each; total of 120 mcg protein), L-histidine (0.78 mg) , trometamol (0.097 mg), sucrose (28 mg), aluminum phosphate (0.25 mg aluminum), sodium chloride (4.65 mg), and PS80 80 (0.018 mg) at pH 6.0. PENBRAYA does not contain any preservatives."
},
{
"NDCCode": "0069-0600-10",
"PackageDescription": "10 KIT in 1 CARTON (0069-0600-10) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01) ",
"NDC11Code": "00069-0600-10",
"ProductNDC": "0069-0600",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Penbraya",
"NonProprietaryName": "Meningococcal Groups A, B, C, W, And Y Vaccine",
"DosageFormName": "KIT",
"StartMarketingDate": "20231127",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125770",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231127",
"SamplePackage": "N",
"IndicationAndUsage": "PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.",
"Description": "PENBRAYA (Meningococcal Groups A, B, C, W, and Y Vaccine) is a suspension for intramuscular injection. PENBRAYA is supplied as a sterile Lyophilized MenACWY Component to be reconstituted with the sterile MenB Component. The Lyophilized MenACWY Component consists of N. meningitidis serogroups A, C, W, and Y polysaccharides individually conjugated to TT. The polysaccharide for each group is grown in media containing dextrose, salt, and yeast extract, then purified by precipitation and filtration. The TT is produced by fermentation of Clostridium tetani in dextrose, salts, and tryptone N1 peptone followed by formalin detoxification, then purified by a series of physicochemical steps. The serogroups A and C polysaccharides are individually microfluidized, activated with 1-cyano-4(dimethylamino)-pyridinium tetrafluoroborate (CDAP), derivatized with adipic acid dihydrazide (ADH), and then conjugated with TT in the presence of 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide) (EDAC). The serogroups W and Y polysaccharides are individually microfluidized, activated with CDAP, and then conjugated with TT. The conjugates are purified by a series of physicochemical steps then sterile filtered. Trometamol/sucrose buffer is added, and the MenACWY-TT solution is lyophilized. The MenB Component is a sterile suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, 1 from fHbp subfamily A and 1 from fHbp subfamily B (A05 and B01, respectively). The proteins are individually produced in Escherichia coli. Production strains are grown to a specific density in chemically defined fermentation growth media without antibiotics or animal-derived components. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added and is present in the MenB Component. Each approximately 0.5 mL dose of PENBRAYA contains N. meningitidis serogroup A, C, W, and Y polysaccharide (5 mcg each; 20 mcg total) conjugated to tetanus toxoid (44 mcg tetanus toxoid), 2 recombinant lipidated factor H binding protein variants from N. meningitidis serogroup B (60 mcg each; total of 120 mcg protein), L-histidine (0.78 mg) , trometamol (0.097 mg), sucrose (28 mg), aluminum phosphate (0.25 mg aluminum), sodium chloride (4.65 mg), and PS80 80 (0.018 mg) at pH 6.0. PENBRAYA does not contain any preservatives."
},
{
"NDCCode": "0143-9139-25",
"PackageDescription": "25 VIAL in 1 CARTON (0143-9139-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
"NDC11Code": "00143-9139-25",
"ProductNDC": "0143-9139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefazolin",
"NonProprietaryName": "Cefazolin",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216109",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "CEFAZOLIN SODIUM",
"StrengthNumber": "2",
"StrengthUnit": "g/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230301",
"SamplePackage": "N",
"IndicationAndUsage": "Cefazolin for Injection is a cephalosporin antibacterial indicated for: 1 Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved:Respiratory tract infections (1.1)Urinary tract infections (1.2)Skin and skin structure infections (1.3)Biliary tract infections (1.4) Bone and joint infections (1.5)Genital infections (1.6)Septicemia (1.7)Endocarditis (1.8), 2 Perioperative prophylaxis in adult patients (1.9).",
"Description": "Cefazolin for Injection contains cefazolin sodium, a semi-synthetic cephalosporin. It is the sodium salt of 3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio]-methyl}-8-oxo-7-[2-(1H-tetrazol-1-yl) acetamido]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid. The molecular formula is C14H13N8NaO4S3 and molecular weight is 476.49. Structural Formula. Cefazolin for Injection is supplied as a sterile powder in single-dose vials. The 2 g/vial Cefazolin for Injection contains 2 grams of cefazolin (equivalent to 2.097 g of cefazolin sodium). The 3 g/vial Cefazolin for Injection contains 3 grams of cefazolin (equivalent to 3.144 grams of cefazolin sodium). The 2 g/vial Cefazolin for Injection contains 96 mg of sodium. The 3 g/vial Cefazolin for Injection contains 144 mg of sodium. After reconstitution with sterile water for injection, the drug product solution has a pH of 4.0 to 6.0. Cefazolin for Injection, 2 grams/vial, is intended for intravenous infusion or intravenous bolus injection. Cefazolin for Injection, 2 grams/vial is not for intramuscular administration. Cefazolin for Injection, 3 grams/vial, is intended for intravenous infusion only. Cefazolin for Injection, 3 grams/vial is not for intravenous bolus injection or intramuscular administration in adult or pediatric patients [see Dosage and Administration (2.1, 2.2, 2.3)]."
},
{
"NDCCode": "0143-9140-25",
"PackageDescription": "25 VIAL in 1 CARTON (0143-9140-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
"NDC11Code": "00143-9140-25",
"ProductNDC": "0143-9140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefazolin",
"NonProprietaryName": "Cefazolin",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216109",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "CEFAZOLIN SODIUM",
"StrengthNumber": "3",
"StrengthUnit": "g/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230301",
"SamplePackage": "N",
"IndicationAndUsage": "Cefazolin for Injection is a cephalosporin antibacterial indicated for: 1 Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved:Respiratory tract infections (1.1)Urinary tract infections (1.2)Skin and skin structure infections (1.3)Biliary tract infections (1.4) Bone and joint infections (1.5)Genital infections (1.6)Septicemia (1.7)Endocarditis (1.8), 2 Perioperative prophylaxis in adult patients (1.9).",
"Description": "Cefazolin for Injection contains cefazolin sodium, a semi-synthetic cephalosporin. It is the sodium salt of 3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio]-methyl}-8-oxo-7-[2-(1H-tetrazol-1-yl) acetamido]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid. The molecular formula is C14H13N8NaO4S3 and molecular weight is 476.49. Structural Formula. Cefazolin for Injection is supplied as a sterile powder in single-dose vials. The 2 g/vial Cefazolin for Injection contains 2 grams of cefazolin (equivalent to 2.097 g of cefazolin sodium). The 3 g/vial Cefazolin for Injection contains 3 grams of cefazolin (equivalent to 3.144 grams of cefazolin sodium). The 2 g/vial Cefazolin for Injection contains 96 mg of sodium. The 3 g/vial Cefazolin for Injection contains 144 mg of sodium. After reconstitution with sterile water for injection, the drug product solution has a pH of 4.0 to 6.0. Cefazolin for Injection, 2 grams/vial, is intended for intravenous infusion or intravenous bolus injection. Cefazolin for Injection, 2 grams/vial is not for intramuscular administration. Cefazolin for Injection, 3 grams/vial, is intended for intravenous infusion only. Cefazolin for Injection, 3 grams/vial is not for intravenous bolus injection or intramuscular administration in adult or pediatric patients [see Dosage and Administration (2.1, 2.2, 2.3)]."
}
]
}
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<NDCCode>59651-097-62</NDCCode>
<PackageDescription>3000 TABLET in 1 BAG (59651-097-62) </PackageDescription>
<NDC11Code>59651-0097-62</NDC11Code>
<ProductNDC>59651-097</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20170228</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-11-08</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>28-FEB-17</StartMarketingDatePackage>
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<NDC>
<NDCCode>59651-098-62</NDCCode>
<PackageDescription>3000 TABLET in 1 BAG (59651-098-62) </PackageDescription>
<NDC11Code>59651-0098-62</NDC11Code>
<ProductNDC>59651-098</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20170228</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-11-08</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>28-FEB-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-608-62</NDCCode>
<PackageDescription>30000 TABLET, FILM COATED in 1 BAG (59651-608-62) </PackageDescription>
<NDC11Code>59651-0608-62</NDC11Code>
<ProductNDC>59651-608</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20240213</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-02-06</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-FEB-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-689-62</NDCCode>
<PackageDescription>30000 TABLET in 1 BAG (59651-689-62) </PackageDescription>
<NDC11Code>59651-0689-62</NDC11Code>
<ProductNDC>59651-689</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Fluphenazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20230818</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>FLUPHENAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-08-25</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-AUG-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-692-62</NDCCode>
<PackageDescription>30000 TABLET, COATED in 1 BAG (59651-692-62) </PackageDescription>
<NDC11Code>59651-0692-62</NDC11Code>
<ProductNDC>59651-692</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Ibuprofen And Diphenhydramine Citrate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<StartMarketingDate>20220531</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DIPHENHYDRAMINE CITRATE; IBUPROFEN</SubstanceName>
<StrengthNumber>38; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-06-23</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>31-MAY-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-798-62</NDCCode>
<PackageDescription>30000 TABLET in 1 BAG (59651-798-62) </PackageDescription>
<NDC11Code>59651-0798-62</NDC11Code>
<ProductNDC>59651-798</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20250717</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-07-29</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>17-JUL-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-825-62</NDCCode>
<PackageDescription>30000 TABLET, FILM COATED in 1 BAG (59651-825-62) </PackageDescription>
<NDC11Code>59651-0825-62</NDC11Code>
<ProductNDC>59651-825</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Cimetidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20241112</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CIMETIDINE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-12-10</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-NOV-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51060-097-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (51060-097-01) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>51060-0097-01</NDC11Code>
<ProductNDC>51060-097</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rainforest Of The Sea Water Foundation Broad Spectrum Spf 15 Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Tan Sand</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Tarte, Inc</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>62.3; 38.4</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>58503-097-01</NDCCode>
<PackageDescription>53 mL in 1 BOTTLE (58503-097-01) </PackageDescription>
<NDC11Code>58503-0097-01</NDC11Code>
<ProductNDC>58503-097</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170425</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>China Ningbo Shangge Cosmetic Technology Corp.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use: 1 for handwashing to decrease bacteria on the skin, 2 recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68025-097-10</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-097-10) </PackageDescription>
<NDC11Code>68025-0097-10</NDC11Code>
<ProductNDC>68025-097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Relexxii</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220623</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216117</ApplicationNumber>
<LabelerName>Vertical Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>36</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RELEXXII is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [see Clinical Studies (14)]. Limitations of Use. The use of RELEXXII is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>RELEXXII contains methylphenidate, a CNS stimulant, present as methylphenidate hydrochloride salt. Chemically, methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. It has a pKa of 8.71 (at 21.5°C). Its molecular weight is 269.77. RELEXXII is for oral administration and is available in the following strengths: 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, and 72 mg containing methylphenidate hydrochloride (equivalent to 15.6 mg, 23.4 mg, 31.1 mg, 38.9 mg, 46.7 mg, 54.5 mg, and 62.3 mg methylphenidate respectively). RELEXXII contains the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, triacetin. RELEXXII also contains the following color additives:. 27 mg: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake. 45 mg: FD&C Red #40 Aluminum Lake. 54 mg: FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. 18 and 63 mg: iron oxide red, iron oxide yellow. 72 mg: FD&C Blue #1 Aluminum Lake. System Components and Performance. RELEXXII uses osmotic pressure to deliver methylphenidate hydrochloride at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of core of RELEXXII. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that RELEXXII may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.</Description>
</NDC>
<NDC>
<NDCCode>68025-097-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-097-30) </PackageDescription>
<NDC11Code>68025-0097-30</NDC11Code>
<ProductNDC>68025-097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Relexxii</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220623</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216117</ApplicationNumber>
<LabelerName>Vertical Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>36</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RELEXXII is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [see Clinical Studies (14)]. Limitations of Use. The use of RELEXXII is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>RELEXXII contains methylphenidate, a CNS stimulant, present as methylphenidate hydrochloride salt. Chemically, methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. It has a pKa of 8.71 (at 21.5°C). Its molecular weight is 269.77. RELEXXII is for oral administration and is available in the following strengths: 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, and 72 mg containing methylphenidate hydrochloride (equivalent to 15.6 mg, 23.4 mg, 31.1 mg, 38.9 mg, 46.7 mg, 54.5 mg, and 62.3 mg methylphenidate respectively). RELEXXII contains the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, triacetin. RELEXXII also contains the following color additives:. 27 mg: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake. 45 mg: FD&C Red #40 Aluminum Lake. 54 mg: FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. 18 and 63 mg: iron oxide red, iron oxide yellow. 72 mg: FD&C Blue #1 Aluminum Lake. System Components and Performance. RELEXXII uses osmotic pressure to deliver methylphenidate hydrochloride at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of core of RELEXXII. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that RELEXXII may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.</Description>
</NDC>
<NDC>
<NDCCode>73928-097-01</NDCCode>
<PackageDescription>35 mL in 1 BOTTLE (73928-097-01) </PackageDescription>
<NDC11Code>73928-0097-01</NDC11Code>
<ProductNDC>73928-097</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Swedish Fish Sanitizer Mix Berry</ProprietaryName>
<NonProprietaryName>Alcohol Antiseptic</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Kingkey MBC Life Technology Group Co.,Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76176-097-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PUMP (76176-097-01) </PackageDescription>
<NDC11Code>76176-0097-01</NDC11Code>
<ProductNDC>76176-097</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Hand Sanitizer 16oz</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Ningbo Liyuan Daily Chemical Products Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59651-026-01</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (59651-026-01) </PackageDescription>
<NDC11Code>59651-0026-01</NDC11Code>
<ProductNDC>59651-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209371</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>250; 62.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and clavulanate potassium for oral suspension is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for the treatment of infections caused by designated susceptible (confirmed or suspected) beta-lactamase-producing microorganisms (1). Lower Respiratory Tract Infections (1.1): 1 Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). : 1 In amoxicillin and clavulanate potassium for oral suspension, USP, amoxicillin is present as amoxicillin trihydrate.</Description>
</NDC>
<NDC>
<NDCCode>59651-026-55</NDCCode>
<PackageDescription>150 mL in 1 BOTTLE (59651-026-55) </PackageDescription>
<NDC11Code>59651-0026-55</NDC11Code>
<ProductNDC>59651-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209371</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>250; 62.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and clavulanate potassium for oral suspension is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for the treatment of infections caused by designated susceptible (confirmed or suspected) beta-lactamase-producing microorganisms (1). Lower Respiratory Tract Infections (1.1): 1 Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). : 1 In amoxicillin and clavulanate potassium for oral suspension, USP, amoxicillin is present as amoxicillin trihydrate.</Description>
</NDC>
<NDC>
<NDCCode>59651-026-75</NDCCode>
<PackageDescription>75 mL in 1 BOTTLE (59651-026-75) </PackageDescription>
<NDC11Code>59651-0026-75</NDC11Code>
<ProductNDC>59651-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209371</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>250; 62.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and clavulanate potassium for oral suspension is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for the treatment of infections caused by designated susceptible (confirmed or suspected) beta-lactamase-producing microorganisms (1). Lower Respiratory Tract Infections (1.1): 1 Amoxicillin and Clavulanate Potassium for Oral Suspension: pediatric patients weighing less than 40 kg, and in adult and pediatric patients who cannot swallow tablets.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). : 1 In amoxicillin and clavulanate potassium for oral suspension, USP, amoxicillin is present as amoxicillin trihydrate.</Description>
</NDC>
<NDC>
<NDCCode>59651-299-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (59651-299-60) </PackageDescription>
<NDC11Code>59651-0299-60</NDC11Code>
<ProductNDC>59651-299</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tamoxifen Citrate</ProprietaryName>
<NonProprietaryName>Tamoxifen Citrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200814</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213358</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>TAMOXIFEN CITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metastatic Breast Cancer. Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen citrate tablets are an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen citrate tablets therapy. Adjuvant Treatment of Breast Cancer. Tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. Tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. The estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen citrate tablets therapy are likely to be beneficial. Tamoxifen citrate tablets reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen citrate tablets therapy for breast cancer. Ductal Carcinoma in Situ (DCIS). In women with DCIS, following breast surgery and radiation, tamoxifen citrate tablets are indicated to reduce the risk of invasive breast cancer (see BOXED WARNING at the beginning of the label). The decision regarding therapy with tamoxifen citrate tablets for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen citrate tablets therapy. Current data from clinical trials support five years of adjuvant tamoxifen citrate tablets therapy for patients with breast cancer. Reduction in Breast Cancer Incidence in High Risk Women. Tamoxifen citrate tablets are indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. Twenty-five percent of the participants received drug for 5 years. The longer-term effects are not known. In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see BOXED WARNING at the beginning of the label). Tamoxifen citrate tablets are indicated only for high-risk women. “High risk” is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model. Examples of combinations of factors predicting a 5-year risk ≥ 1.67% are. Age 35 or older and any of the following combination of factors: 1 One first degree relative with a history of breast cancer, 2 or more benign biopsies, and a history of a breast biopsy showing atypical hyperplasia; or, 2 At least 2 first degree relatives with a history of breast cancer, and a personal history of at least one breast biopsy; or, 3 LCIS.</IndicationAndUsage>
<Description>Tamoxifen citrate tablets, USP a nonsteroidal antiestrogen, are for oral administration. Tamoxifen citrate tablets are available as. 10 mg Tablets. Each tablet contains 15.2 mg of tamoxifen citrate USP equivalent to 10 mg of tamoxifen. 20 mg Tablets. Each tablet contains 30.4 mg of tamoxifen citrate USP equivalent to 20 mg of tamoxifen. Inactive Ingredients: corn starch (maize), croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone and titanium dioxide. Chemically, tamoxifen citrate is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl) phenoxy]-N, N-dimethylethanamine 2 hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and molecular formulas are. Tamoxifen citrate has a molecular weight of 563.62, the pKa' is 8.85, the equilibrium solubility in water at 37°C is 0.3159 mg/mL and in 0.02 N HCl at 37°C, it is 0.4045 mg/mL.</Description>
</NDC>
<NDC>
<NDCCode>59651-300-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (59651-300-30) </PackageDescription>
<NDC11Code>59651-0300-30</NDC11Code>
<ProductNDC>59651-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tamoxifen Citrate</ProprietaryName>
<NonProprietaryName>Tamoxifen Citrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200814</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213358</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>TAMOXIFEN CITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metastatic Breast Cancer. Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen citrate tablets are an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen citrate tablets therapy. Adjuvant Treatment of Breast Cancer. Tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. Tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. The estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen citrate tablets therapy are likely to be beneficial. Tamoxifen citrate tablets reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen citrate tablets therapy for breast cancer. Ductal Carcinoma in Situ (DCIS). In women with DCIS, following breast surgery and radiation, tamoxifen citrate tablets are indicated to reduce the risk of invasive breast cancer (see BOXED WARNING at the beginning of the label). The decision regarding therapy with tamoxifen citrate tablets for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen citrate tablets therapy. Current data from clinical trials support five years of adjuvant tamoxifen citrate tablets therapy for patients with breast cancer. Reduction in Breast Cancer Incidence in High Risk Women. Tamoxifen citrate tablets are indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. Twenty-five percent of the participants received drug for 5 years. The longer-term effects are not known. In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see BOXED WARNING at the beginning of the label). Tamoxifen citrate tablets are indicated only for high-risk women. “High risk” is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model. Examples of combinations of factors predicting a 5-year risk ≥ 1.67% are. Age 35 or older and any of the following combination of factors: 1 One first degree relative with a history of breast cancer, 2 or more benign biopsies, and a history of a breast biopsy showing atypical hyperplasia; or, 2 At least 2 first degree relatives with a history of breast cancer, and a personal history of at least one breast biopsy; or, 3 LCIS.</IndicationAndUsage>
<Description>Tamoxifen citrate tablets, USP a nonsteroidal antiestrogen, are for oral administration. Tamoxifen citrate tablets are available as. 10 mg Tablets. Each tablet contains 15.2 mg of tamoxifen citrate USP equivalent to 10 mg of tamoxifen. 20 mg Tablets. Each tablet contains 30.4 mg of tamoxifen citrate USP equivalent to 20 mg of tamoxifen. Inactive Ingredients: corn starch (maize), croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone and titanium dioxide. Chemically, tamoxifen citrate is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl) phenoxy]-N, N-dimethylethanamine 2 hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and molecular formulas are. Tamoxifen citrate has a molecular weight of 563.62, the pKa' is 8.85, the equilibrium solubility in water at 37°C is 0.3159 mg/mL and in 0.02 N HCl at 37°C, it is 0.4045 mg/mL.</Description>
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<StartMarketingDate>20200814</StartMarketingDate>
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<ApplicationNumber>ANDA213358</ApplicationNumber>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metastatic Breast Cancer. Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen citrate tablets are an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen citrate tablets therapy. Adjuvant Treatment of Breast Cancer. Tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. Tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. The estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen citrate tablets therapy are likely to be beneficial. Tamoxifen citrate tablets reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen citrate tablets therapy for breast cancer. Ductal Carcinoma in Situ (DCIS). In women with DCIS, following breast surgery and radiation, tamoxifen citrate tablets are indicated to reduce the risk of invasive breast cancer (see BOXED WARNING at the beginning of the label). The decision regarding therapy with tamoxifen citrate tablets for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen citrate tablets therapy. Current data from clinical trials support five years of adjuvant tamoxifen citrate tablets therapy for patients with breast cancer. Reduction in Breast Cancer Incidence in High Risk Women. Tamoxifen citrate tablets are indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. Twenty-five percent of the participants received drug for 5 years. The longer-term effects are not known. In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see BOXED WARNING at the beginning of the label). Tamoxifen citrate tablets are indicated only for high-risk women. “High risk” is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model. Examples of combinations of factors predicting a 5-year risk ≥ 1.67% are. Age 35 or older and any of the following combination of factors: 1 One first degree relative with a history of breast cancer, 2 or more benign biopsies, and a history of a breast biopsy showing atypical hyperplasia; or, 2 At least 2 first degree relatives with a history of breast cancer, and a personal history of at least one breast biopsy; or, 3 LCIS.</IndicationAndUsage>
<Description>Tamoxifen citrate tablets, USP a nonsteroidal antiestrogen, are for oral administration. Tamoxifen citrate tablets are available as. 10 mg Tablets. Each tablet contains 15.2 mg of tamoxifen citrate USP equivalent to 10 mg of tamoxifen. 20 mg Tablets. Each tablet contains 30.4 mg of tamoxifen citrate USP equivalent to 20 mg of tamoxifen. Inactive Ingredients: corn starch (maize), croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone and titanium dioxide. Chemically, tamoxifen citrate is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl) phenoxy]-N, N-dimethylethanamine 2 hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and molecular formulas are. Tamoxifen citrate has a molecular weight of 563.62, the pKa' is 8.85, the equilibrium solubility in water at 37°C is 0.3159 mg/mL and in 0.02 N HCl at 37°C, it is 0.4045 mg/mL.</Description>
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<ApplicationNumber>ANDA214982</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
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<LastUpdate>2024-06-01</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin USP exists as clear to white, crystals or white crystalline powder that melt with decomposition above 230°C. The drug is practically insoluble in water, soluble in a mixture of equal volumes of methanol and methylene chloride, slightly soluble in ethanol (96 per cent). Digoxin tablets, USP are supplied as 62.5 mcg (unscored), 125 mcg (scored) and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). In addition the 62.5 mcg tablets contain FD & C Yellow No. 6 Lake. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin USP exists as clear to white, crystals or white crystalline powder that melt with decomposition above 230°C. The drug is practically insoluble in water, soluble in a mixture of equal volumes of methanol and methylene chloride, slightly soluble in ethanol (96 per cent). Digoxin tablets, USP are supplied as 62.5 mcg (unscored), 125 mcg (scored) and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). In addition the 62.5 mcg tablets contain FD & C Yellow No. 6 Lake. FDA approved dissolution test specifications differ from USP.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin USP exists as clear to white, crystals or white crystalline powder that melt with decomposition above 230°C. The drug is practically insoluble in water, soluble in a mixture of equal volumes of methanol and methylene chloride, slightly soluble in ethanol (96 per cent). Digoxin tablets, USP are supplied as 62.5 mcg (unscored), 125 mcg (scored) and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). In addition the 62.5 mcg tablets contain FD & C Yellow No. 6 Lake. FDA approved dissolution test specifications differ from USP.</Description>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin USP exists as clear to white, crystals or white crystalline powder that melt with decomposition above 230°C. The drug is practically insoluble in water, soluble in a mixture of equal volumes of methanol and methylene chloride, slightly soluble in ethanol (96 per cent). Digoxin tablets, USP are supplied as 62.5 mcg (unscored), 125 mcg (scored) and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). In addition the 62.5 mcg tablets contain FD & C Yellow No. 6 Lake. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin USP exists as clear to white, crystals or white crystalline powder that melt with decomposition above 230°C. The drug is practically insoluble in water, soluble in a mixture of equal volumes of methanol and methylene chloride, slightly soluble in ethanol (96 per cent). Digoxin tablets, USP are supplied as 62.5 mcg (unscored), 125 mcg (scored) and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). In addition the 62.5 mcg tablets contain FD & C Yellow No. 6 Lake. FDA approved dissolution test specifications differ from USP.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin USP exists as clear to white, crystals or white crystalline powder that melt with decomposition above 230°C. The drug is practically insoluble in water, soluble in a mixture of equal volumes of methanol and methylene chloride, slightly soluble in ethanol (96 per cent). Digoxin tablets, USP are supplied as 62.5 mcg (unscored), 125 mcg (scored) and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). In addition the 62.5 mcg tablets contain FD & C Yellow No. 6 Lake. FDA approved dissolution test specifications differ from USP.</Description>
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<StartMarketingDatePackage>20231127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.</IndicationAndUsage>
<Description>PENBRAYA (Meningococcal Groups A, B, C, W, and Y Vaccine) is a suspension for intramuscular injection. PENBRAYA is supplied as a sterile Lyophilized MenACWY Component to be reconstituted with the sterile MenB Component. The Lyophilized MenACWY Component consists of N. meningitidis serogroups A, C, W, and Y polysaccharides individually conjugated to TT. The polysaccharide for each group is grown in media containing dextrose, salt, and yeast extract, then purified by precipitation and filtration. The TT is produced by fermentation of Clostridium tetani in dextrose, salts, and tryptone N1 peptone followed by formalin detoxification, then purified by a series of physicochemical steps. The serogroups A and C polysaccharides are individually microfluidized, activated with 1-cyano-4(dimethylamino)-pyridinium tetrafluoroborate (CDAP), derivatized with adipic acid dihydrazide (ADH), and then conjugated with TT in the presence of 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide) (EDAC). The serogroups W and Y polysaccharides are individually microfluidized, activated with CDAP, and then conjugated with TT. The conjugates are purified by a series of physicochemical steps then sterile filtered. Trometamol/sucrose buffer is added, and the MenACWY-TT solution is lyophilized. The MenB Component is a sterile suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, 1 from fHbp subfamily A and 1 from fHbp subfamily B (A05 and B01, respectively). The proteins are individually produced in Escherichia coli. Production strains are grown to a specific density in chemically defined fermentation growth media without antibiotics or animal-derived components. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added and is present in the MenB Component. Each approximately 0.5 mL dose of PENBRAYA contains N. meningitidis serogroup A, C, W, and Y polysaccharide (5 mcg each; 20 mcg total) conjugated to tetanus toxoid (44 mcg tetanus toxoid), 2 recombinant lipidated factor H binding protein variants from N. meningitidis serogroup B (60 mcg each; total of 120 mcg protein), L-histidine (0.78 mg) , trometamol (0.097 mg), sucrose (28 mg), aluminum phosphate (0.25 mg aluminum), sodium chloride (4.65 mg), and PS80 80 (0.018 mg) at pH 6.0. PENBRAYA does not contain any preservatives.</Description>
</NDC>
<NDC>
<NDCCode>0069-0600-05</NDCCode>
<PackageDescription>5 KIT in 1 CARTON (0069-0600-05) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01) </PackageDescription>
<NDC11Code>00069-0600-05</NDC11Code>
<ProductNDC>0069-0600</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Penbraya</ProprietaryName>
<NonProprietaryName>Meningococcal Groups A, B, C, W, And Y Vaccine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231127</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125770</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.</IndicationAndUsage>
<Description>PENBRAYA (Meningococcal Groups A, B, C, W, and Y Vaccine) is a suspension for intramuscular injection. PENBRAYA is supplied as a sterile Lyophilized MenACWY Component to be reconstituted with the sterile MenB Component. The Lyophilized MenACWY Component consists of N. meningitidis serogroups A, C, W, and Y polysaccharides individually conjugated to TT. The polysaccharide for each group is grown in media containing dextrose, salt, and yeast extract, then purified by precipitation and filtration. The TT is produced by fermentation of Clostridium tetani in dextrose, salts, and tryptone N1 peptone followed by formalin detoxification, then purified by a series of physicochemical steps. The serogroups A and C polysaccharides are individually microfluidized, activated with 1-cyano-4(dimethylamino)-pyridinium tetrafluoroborate (CDAP), derivatized with adipic acid dihydrazide (ADH), and then conjugated with TT in the presence of 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide) (EDAC). The serogroups W and Y polysaccharides are individually microfluidized, activated with CDAP, and then conjugated with TT. The conjugates are purified by a series of physicochemical steps then sterile filtered. Trometamol/sucrose buffer is added, and the MenACWY-TT solution is lyophilized. The MenB Component is a sterile suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, 1 from fHbp subfamily A and 1 from fHbp subfamily B (A05 and B01, respectively). The proteins are individually produced in Escherichia coli. Production strains are grown to a specific density in chemically defined fermentation growth media without antibiotics or animal-derived components. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added and is present in the MenB Component. Each approximately 0.5 mL dose of PENBRAYA contains N. meningitidis serogroup A, C, W, and Y polysaccharide (5 mcg each; 20 mcg total) conjugated to tetanus toxoid (44 mcg tetanus toxoid), 2 recombinant lipidated factor H binding protein variants from N. meningitidis serogroup B (60 mcg each; total of 120 mcg protein), L-histidine (0.78 mg) , trometamol (0.097 mg), sucrose (28 mg), aluminum phosphate (0.25 mg aluminum), sodium chloride (4.65 mg), and PS80 80 (0.018 mg) at pH 6.0. PENBRAYA does not contain any preservatives.</Description>
</NDC>
<NDC>
<NDCCode>0069-0600-10</NDCCode>
<PackageDescription>10 KIT in 1 CARTON (0069-0600-10) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01) </PackageDescription>
<NDC11Code>00069-0600-10</NDC11Code>
<ProductNDC>0069-0600</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Penbraya</ProprietaryName>
<NonProprietaryName>Meningococcal Groups A, B, C, W, And Y Vaccine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231127</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125770</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.</IndicationAndUsage>
<Description>PENBRAYA (Meningococcal Groups A, B, C, W, and Y Vaccine) is a suspension for intramuscular injection. PENBRAYA is supplied as a sterile Lyophilized MenACWY Component to be reconstituted with the sterile MenB Component. The Lyophilized MenACWY Component consists of N. meningitidis serogroups A, C, W, and Y polysaccharides individually conjugated to TT. The polysaccharide for each group is grown in media containing dextrose, salt, and yeast extract, then purified by precipitation and filtration. The TT is produced by fermentation of Clostridium tetani in dextrose, salts, and tryptone N1 peptone followed by formalin detoxification, then purified by a series of physicochemical steps. The serogroups A and C polysaccharides are individually microfluidized, activated with 1-cyano-4(dimethylamino)-pyridinium tetrafluoroborate (CDAP), derivatized with adipic acid dihydrazide (ADH), and then conjugated with TT in the presence of 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide) (EDAC). The serogroups W and Y polysaccharides are individually microfluidized, activated with CDAP, and then conjugated with TT. The conjugates are purified by a series of physicochemical steps then sterile filtered. Trometamol/sucrose buffer is added, and the MenACWY-TT solution is lyophilized. The MenB Component is a sterile suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, 1 from fHbp subfamily A and 1 from fHbp subfamily B (A05 and B01, respectively). The proteins are individually produced in Escherichia coli. Production strains are grown to a specific density in chemically defined fermentation growth media without antibiotics or animal-derived components. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added and is present in the MenB Component. Each approximately 0.5 mL dose of PENBRAYA contains N. meningitidis serogroup A, C, W, and Y polysaccharide (5 mcg each; 20 mcg total) conjugated to tetanus toxoid (44 mcg tetanus toxoid), 2 recombinant lipidated factor H binding protein variants from N. meningitidis serogroup B (60 mcg each; total of 120 mcg protein), L-histidine (0.78 mg) , trometamol (0.097 mg), sucrose (28 mg), aluminum phosphate (0.25 mg aluminum), sodium chloride (4.65 mg), and PS80 80 (0.018 mg) at pH 6.0. PENBRAYA does not contain any preservatives.</Description>
</NDC>
<NDC>
<NDCCode>0143-9139-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (0143-9139-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>00143-9139-25</NDC11Code>
<ProductNDC>0143-9139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefazolin</ProprietaryName>
<NonProprietaryName>Cefazolin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216109</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>CEFAZOLIN SODIUM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefazolin for Injection is a cephalosporin antibacterial indicated for: 1 Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved:Respiratory tract infections (1.1)Urinary tract infections (1.2)Skin and skin structure infections (1.3)Biliary tract infections (1.4) Bone and joint infections (1.5)Genital infections (1.6)Septicemia (1.7)Endocarditis (1.8), 2 Perioperative prophylaxis in adult patients (1.9).</IndicationAndUsage>
<Description>Cefazolin for Injection contains cefazolin sodium, a semi-synthetic cephalosporin. It is the sodium salt of 3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio]-methyl}-8-oxo-7-[2-(1H-tetrazol-1-yl) acetamido]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid. The molecular formula is C14H13N8NaO4S3 and molecular weight is 476.49. Structural Formula. Cefazolin for Injection is supplied as a sterile powder in single-dose vials. The 2 g/vial Cefazolin for Injection contains 2 grams of cefazolin (equivalent to 2.097 g of cefazolin sodium). The 3 g/vial Cefazolin for Injection contains 3 grams of cefazolin (equivalent to 3.144 grams of cefazolin sodium). The 2 g/vial Cefazolin for Injection contains 96 mg of sodium. The 3 g/vial Cefazolin for Injection contains 144 mg of sodium. After reconstitution with sterile water for injection, the drug product solution has a pH of 4.0 to 6.0. Cefazolin for Injection, 2 grams/vial, is intended for intravenous infusion or intravenous bolus injection. Cefazolin for Injection, 2 grams/vial is not for intramuscular administration. Cefazolin for Injection, 3 grams/vial, is intended for intravenous infusion only. Cefazolin for Injection, 3 grams/vial is not for intravenous bolus injection or intramuscular administration in adult or pediatric patients [see Dosage and Administration (2.1, 2.2, 2.3)].</Description>
</NDC>
<NDC>
<NDCCode>0143-9140-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (0143-9140-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>00143-9140-25</NDC11Code>
<ProductNDC>0143-9140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefazolin</ProprietaryName>
<NonProprietaryName>Cefazolin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216109</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>CEFAZOLIN SODIUM</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefazolin for Injection is a cephalosporin antibacterial indicated for: 1 Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved:Respiratory tract infections (1.1)Urinary tract infections (1.2)Skin and skin structure infections (1.3)Biliary tract infections (1.4) Bone and joint infections (1.5)Genital infections (1.6)Septicemia (1.7)Endocarditis (1.8), 2 Perioperative prophylaxis in adult patients (1.9).</IndicationAndUsage>
<Description>Cefazolin for Injection contains cefazolin sodium, a semi-synthetic cephalosporin. It is the sodium salt of 3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio]-methyl}-8-oxo-7-[2-(1H-tetrazol-1-yl) acetamido]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid. The molecular formula is C14H13N8NaO4S3 and molecular weight is 476.49. Structural Formula. Cefazolin for Injection is supplied as a sterile powder in single-dose vials. The 2 g/vial Cefazolin for Injection contains 2 grams of cefazolin (equivalent to 2.097 g of cefazolin sodium). The 3 g/vial Cefazolin for Injection contains 3 grams of cefazolin (equivalent to 3.144 grams of cefazolin sodium). The 2 g/vial Cefazolin for Injection contains 96 mg of sodium. The 3 g/vial Cefazolin for Injection contains 144 mg of sodium. After reconstitution with sterile water for injection, the drug product solution has a pH of 4.0 to 6.0. Cefazolin for Injection, 2 grams/vial, is intended for intravenous infusion or intravenous bolus injection. Cefazolin for Injection, 2 grams/vial is not for intramuscular administration. Cefazolin for Injection, 3 grams/vial, is intended for intravenous infusion only. Cefazolin for Injection, 3 grams/vial is not for intravenous bolus injection or intramuscular administration in adult or pediatric patients [see Dosage and Administration (2.1, 2.2, 2.3)].</Description>
</NDC>
</NDCList>