{
"NDC": [
{
"NDCCode": "10122-820-04",
"PackageDescription": "4 AMPULE in 1 POUCH (10122-820-04) / 4 mL in 1 AMPULE",
"NDC11Code": "10122-0820-04",
"ProductNDC": "10122-820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bethkis",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130415",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201820",
"LabelerName": "Chiesi USA, Inc.",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2023-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130415",
"SamplePackage": "N",
"IndicationAndUsage": "BETHKIS is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].",
"Description": "BETHKIS is a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous solution with pH and salinity adjusted. BETHKIS is administered by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.52. Tobramycin is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino- 2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L‑streptamine. The structural formula for tobramycin is. Each single-use 4 mL ampule of BETHKIS contains one 300 mg dose of tobramycin, with sodium chloride and sulfuric acid in water for injection. Sulfuric acid and sodium hydroxide are used, as needed, to adjust the pH to 5.0. Nitrogen is used for sparging, filling and pouching. The formulation contains no preservatives."
},
{
"NDCCode": "10122-212-04",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (10122-212-04) / 10 CAPSULE in 1 BLISTER PACK (10122-212-01) ",
"NDC11Code": "10122-0212-04",
"ProductNDC": "10122-212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bronchitol",
"NonProprietaryName": "Mannitol",
"DosageFormName": "CAPSULE",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20210201",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202049",
"LabelerName": "Chiesi USA, Inc.",
"SubstanceName": "MANNITOL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210201",
"EndMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "BRONCHITOL is indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years and older with Cystic Fibrosis. Use BRONCHITOL only for adults who have passed the BRONCHITOL Tolerance Test [see Dosage and Administration (2.1)].",
"Description": "BRONCHITOL (mannitol) inhalation powder contains D-Mannitol (referred to throughout as mannitol) as the active ingredient. Mannitol is a hexahydric sugar alcohol, with the following chemical name hexane-1,2,3,4,5,6-hexol and chemical structure:. Mannitol is a white or almost white crystalline powder or free-flowing granules with an empirical formula of C6H14O6 and molecular weight of 182.2. Mannitol is freely soluble in water, and very slightly soluble in alcohol. Mannitol shows polymorphism. BRONCHITOL contains mannitol powder spray dried into particles of respirable size filled into clear, colorless hard gelatin capsules. There are no inactive ingredients in BRONCHITOL. The accompanying white plastic inhaler is comprised of a mouthpiece, blue piercing buttons, capsule chamber, and a removable cap. A blister pack consists of 10 capsules, each containing 40 mg mannitol. After a capsule is placed in the capsule chamber and pierced by firmly pressing and releasing the buttons on the side of the device, the powder within the capsule becomes exposed and ready for dispersion into the airstream generated by the patient upon inhalation through the mouthpiece. Under standardized in vitro test conditions, the inhaler delivers 32.2 mg of mannitol per inhalation when tested at a flow rate of 60 L/min for 2 seconds. The actual amount of drug delivered to the lungs will depend on patient factors, such as inspiratory flow profile."
},
{
"NDCCode": "10122-612-04",
"PackageDescription": "4 CARTON in 1 CARTON (10122-612-04) > 1 VIAL, SINGLE-USE in 1 CARTON (10122-612-01) > 250 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "10122-0612-04",
"ProductNDC": "10122-612",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cleviprex",
"NonProprietaryName": "Clevipidine",
"DosageFormName": "EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022156",
"LabelerName": "Chiesi USA, Inc.",
"SubstanceName": "CLEVIDIPINE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20080915",
"SamplePackage": "N"
},
{
"NDCCode": "10122-820-28",
"PackageDescription": "7 POUCH in 1 CARTON (10122-820-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE",
"NDC11Code": "10122-0820-28",
"ProductNDC": "10122-820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bethkis",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130415",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201820",
"LabelerName": "Chiesi USA, Inc.",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2023-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130415",
"SamplePackage": "N",
"IndicationAndUsage": "BETHKIS is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].",
"Description": "BETHKIS is a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous solution with pH and salinity adjusted. BETHKIS is administered by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.52. Tobramycin is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino- 2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L‑streptamine. The structural formula for tobramycin is. Each single-use 4 mL ampule of BETHKIS contains one 300 mg dose of tobramycin, with sodium chloride and sulfuric acid in water for injection. Sulfuric acid and sodium hydroxide are used, as needed, to adjust the pH to 5.0. Nitrogen is used for sparging, filling and pouching. The formulation contains no preservatives."
},
{
"NDCCode": "10122-820-56",
"PackageDescription": "14 POUCH in 1 CARTON (10122-820-56) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE",
"NDC11Code": "10122-0820-56",
"ProductNDC": "10122-820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bethkis",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130415",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201820",
"LabelerName": "Chiesi USA, Inc.",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2023-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130415",
"SamplePackage": "N",
"IndicationAndUsage": "BETHKIS is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].",
"Description": "BETHKIS is a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous solution with pH and salinity adjusted. BETHKIS is administered by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.52. Tobramycin is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino- 2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L‑streptamine. The structural formula for tobramycin is. Each single-use 4 mL ampule of BETHKIS contains one 300 mg dose of tobramycin, with sodium chloride and sulfuric acid in water for injection. Sulfuric acid and sodium hydroxide are used, as needed, to adjust the pH to 5.0. Nitrogen is used for sparging, filling and pouching. The formulation contains no preservatives."
},
{
"NDCCode": "15749-820-04",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (15749-820-04)",
"NDC11Code": "15749-0820-04",
"ProductNDC": "15749-820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062058",
"LabelerName": "American Antibiotics,Inc",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β- hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence. Triple Therapy. Amoxicillin/Clarithromycin/Lansoprazole. Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). Dual Therapy. Amoxicillin/Lansoprazole. Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY section.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.",
"Description": "Formulations of amoxicillin capsules, USP contain amoxicillin, a semi-synthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically, it is (2S, 5R, 6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl) acetamido] -3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S∙3H2O, and the molecular weight is 419.45. Capsules of Amoxicillin are intended for oral administration. Each capsule contains amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin. Caramel opaque cap and buff opaque body of the 250 mg capsule are imprinted with AA and 820 respectively. Each 250 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red No. 3, titanium dioxide and gelatin. Buff opaque cap and buff opaque body of the 500 mg capsule are imprinted with AA and 825 respectively. Each 500 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, titanium dioxide and gelatin."
},
{
"NDCCode": "37000-820-04",
"PackageDescription": "1 TUBE in 1 CARTON (37000-820-04) > 116 g in 1 TUBE",
"NDC11Code": "37000-0820-04",
"ProductNDC": "37000-820",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crest 3d White",
"ProprietaryNameSuffix": "Advanced Vivid Enamel Renewal",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Procter & Gamble Manufacturing Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "243",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "43063-820-04",
"PackageDescription": "4 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-04) ",
"NDC11Code": "43063-0820-04",
"ProductNDC": "43063-820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients. Adult Patients only. Triple therapy for Helicobacter pylori (H. pylori)with clarithromycin and lansoprazole :. Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pyloriinfection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylorihas been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pyloriwith lansoprazole : Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pyloriinfection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylorihas been shown to reduce the risk of duodenal ulcer recurrence. Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "50458-820-04",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (50458-820-04) ",
"NDC11Code": "50458-0820-04",
"ProductNDC": "50458-820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nucynta",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090601",
"EndMarketingDate": "20200331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022304",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2020-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090601",
"EndMarketingDatePackage": "20200131",
"SamplePackage": "N"
},
{
"NDCCode": "63323-820-74",
"PackageDescription": "10 BAG in 1 CASE (63323-820-74) / 250 mL in 1 BAG (63323-820-04) ",
"NDC11Code": "63323-0820-74",
"ProductNDC": "63323-820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Smoflipid",
"NonProprietaryName": "Smoflipid",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160713",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207648",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "SOYBEAN OIL; MEDIUM-CHAIN TRIGLYCERIDES; OLIVE OIL; FISH OIL",
"StrengthNumber": "6; 6; 5; 3",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Lipid Emulsion [EPC], Lipid Emulsion [EPC], Lipids [CS], Lipids [CS]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160713",
"SamplePackage": "N",
"IndicationAndUsage": "SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "SMOFlipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of SMOFlipid is 0.2 g/mL, and comprises a mixture of soybean oil, MCTs, olive oil, and fish oil. The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35 mg/mL (range of 28 to 50 mg/mL), and alpha-linolenic acid (an omega-3 essential fatty acid) is 4.5 mg/mL (range of 3 to 7 mg/mL). The phosphate content is 15 mmol/L. The total energy content, including fat, phospholipids, and glycerol is 2,000 kcal/L. Each 100 mL of SMOFlipid contains approximately 6 g soybean oil, 6 g MCT, 5 g olive oil, 3 g fish oil, 1.2 g egg phospholipids, 2.5 g glycerin, 16.3 to 22.5 mg all-rac-alpha-tocopherol, 0.03 g sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9). SMOFlipid has an osmolality of approximately 380 mOsm/kg water (which represents an osmolarity of 270 mOsm/L). The oils included in SMOFlipid consist of a mixture of triglycerides of predominantly unsaturated fatty acids with the following structure:. where , , and are saturated and unsaturated fatty acid residues. The major components of the fatty acids in SMOFlipid are oleic acid (23% to 35%), linoleic acid (14% to 25%), caprylic acid (13% to 24%), palmitic acid (7% to 12%), capric acid (5% to 15%), stearic acid (1.5% to 4%), alpha-linolenic acid (1.5% to 3.5%), eicosapentaenoic acid (EPA; 1% to 3.5%), and docosahexaenoic acid (DHA; 1% to 3.5%). SMOFlipid contains no more than 25 mcg/L of aluminum. The container is not made with natural rubber latex, PVC, or DEHP."
},
{
"NDCCode": "68982-820-04",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (68982-820-04) > 100 mL in 1 BOTTLE, GLASS (68982-820-84) ",
"NDC11Code": "68982-0820-04",
"ProductNDC": "68982-820",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Panzyga",
"NonProprietaryName": "Immune Globulin Intravenous (human)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20181112",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125587",
"LabelerName": "Octapharma USA Inc",
"SubstanceName": "HUMAN IMMUNOGLOBULIN G",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181112",
"SamplePackage": "N",
"Description": "Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 90% monomers and dimers, and not more than 3% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed."
},
{
"NDCCode": "69842-820-08",
"PackageDescription": "1 KIT in 1 KIT (69842-820-08) * 118 mL in 1 BOTTLE, PLASTIC (69842-607-04) * 118 mL in 1 BOTTLE, PLASTIC (69842-606-04) ",
"NDC11Code": "69842-0820-08",
"ProductNDC": "69842-820",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Multi Symptom Cold And Multi Symptom Nighttime Cold",
"ProprietaryNameSuffix": "Childrens",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci, Acetaminophen, Diphenhydramine Hci, Phenylephrine Hci",
"DosageFormName": "KIT",
"StartMarketingDate": "20170228",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "CVS Pharmacy",
"Status": "Active",
"LastUpdate": "2025-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170228",
"SamplePackage": "N",
"IndicationAndUsage": "Nighttime: 1 temporarily relieves these common cold and flu symptoms."
},
{
"NDCCode": "72012-820-04",
"PackageDescription": "20 kg in 1 DRUM (72012-820-04) ",
"NDC11Code": "72012-0820-04",
"ProductNDC": "72012-820",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "L-isoleucine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20221001",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Ajinomoto do Brasil Industria e Comercio de Alimentos Ltda.",
"SubstanceName": "ISOLEUCINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-11-06",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-OCT-22"
},
{
"NDCCode": "84756-820-04",
"PackageDescription": "50 mL in 1 BOTTLE (84756-820-04) ",
"NDC11Code": "84756-0820-04",
"ProductNDC": "84756-820",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Eye Serum",
"NonProprietaryName": "Trstay Eye Serum",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241209",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Luoxin E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241209",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "10122-100-12",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10122-100-12) ",
"NDC11Code": "10122-0100-12",
"ProductNDC": "10122-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ferriprox",
"NonProprietaryName": "Deferiprone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111125",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021825",
"LabelerName": "Chiesi USA, Inc.",
"SubstanceName": "DEFERIPRONE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210101",
"EndMarketingDatePackage": "20260331",
"SamplePackage": "N",
"IndicationAndUsage": "FERRIPROX Tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. Limitations of Use. Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.",
"Description": "FERRIPROX Tablets (deferiprone) contain 1,000 mg deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a synthetic, orally active, iron-chelating agent. The molecular formula for deferiprone is C7H9NO2 and its molecular weight is 139.15 g/mol. Deferiprone has the following structural formula. Deferiprone is a white to pinkish-white powder. It is sparingly soluble in deionized water (14.3 mg/mL) and has a melting point range of 272 °C - 278 °C. FERRIPROX Tablets (twice a day), 1,000 mg. White to off-white, capsule-shaped tablets, and imprinted with “FPX” score “DR” on one side and “APO” score “1000” on the other. The tablets can be broken in half along the score line. Each tablet contains 1,000 mg deferiprone and the following inactive ingredients: Tablet core - hypromellose acetate succinate, magnesium oxide, colloidal silicon dioxide and magnesium stearate; Coating - triethyl citrate, talc, titanium dioxide, and methacrylic acid and ethyl acrylate copolymer. FERRIPROX Tablets (three times a day), 1,000 mg. White to off-white, capsule-shaped tablets, and imprinted with “APO” score “1000” on one side and plain on the other. The tablets can be broken in half along the score line. Each tablet contains 1,000 mg deferiprone and the following inactive ingredients: Tablet core - methylcellulose, crospovidone, and magnesium stearate; Coating - hypromellose, hydroxypropyl cellulose, macrogol, and titanium dioxide."
},
{
"NDCCode": "10122-321-05",
"PackageDescription": "5 TABLET in 1 BLISTER PACK (10122-321-05)",
"NDC11Code": "10122-0321-05",
"ProductNDC": "10122-321",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Factive",
"NonProprietaryName": "Gemifloxacin Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030404",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021158",
"LabelerName": "Cornerstone Therapeutics Inc.",
"SubstanceName": "GEMIFLOXACIN MESYLATE",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-04-03"
},
{
"NDCCode": "10122-321-07",
"PackageDescription": "7 TABLET in 1 BLISTER PACK (10122-321-07)",
"NDC11Code": "10122-0321-07",
"ProductNDC": "10122-321",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Factive",
"NonProprietaryName": "Gemifloxacin Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030404",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021158",
"LabelerName": "Cornerstone Therapeutics Inc.",
"SubstanceName": "GEMIFLOXACIN MESYLATE",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-04-03"
},
{
"NDCCode": "10122-402-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (10122-402-28) ",
"NDC11Code": "10122-0402-28",
"ProductNDC": "10122-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Juxtapid",
"NonProprietaryName": "Lomitapide Mesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260225",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203858",
"LabelerName": "Chiesi USA, Inc.",
"SubstanceName": "LOMITAPIDE MESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Microsomal Triglyceride Transfer Protein Inhibitor [EPC], Microsomal Triglyceride Transfer Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260225",
"SamplePackage": "N",
"IndicationAndUsage": "JUXTAPID is indicated as an adjunct to a low-fat diet and exercise and other low density lipoprotein cholesterol (LDL-C) therapies to reduce LDL-C in adults and pediatric patients aged 2 years and older with homozygous familial hypercholesterolemia (HoFH).",
"Description": "JUXTAPID capsules contain lomitapide mesylate, a synthetic lipid-lowering agent for oral administration. The chemical name of lomitapide mesylate is N-(2,2,2-trifluoroethyl)-9-[4-[4-[[[4'a-(trifluoromethyl)[1,1'-biphenyl]-2-yl]carbonyl]amino]-1-piperidinyl]butyl]-9H-fluorene-9-carboxamide, methanesulfonate salt. Its structural formula is. The empirical formula for lomitapide mesylate is C39H37F6N3O2 ∙ CH4O3S and its molecular weight is 789.8. Lomitapide mesylate is a white to off-white powder that is slightly soluble in aqueous solutions of pH 2 to 5. Lomitapide mesylate is freely soluble in acetone, ethanol, and methanol; soluble in 2-butanol, methylene chloride, and acetonitrile; sparingly soluble in 1-octanol and 2-propanol; slightly soluble in ethyl acetate; and insoluble in heptane. Each JUXTAPID capsule contains lomitapide mesylate equivalent to 2, 5, 10, 20, or 30 mg lomitapide free base and the following inactive ingredients: pregelatinized starch, sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, silicon dioxide and magnesium stearate. The capsule shells of all strengths contain gelatin and titanium dioxide; the 2 mg capsules contain black iron oxide; the 5 mg, 10 mg and 30 mg capsules also contain red iron oxide; and the 30 mg capsules also contain yellow iron oxide. The imprinting ink contains shellac, black iron oxide, and propylene glycol."
},
{
"NDCCode": "10122-405-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (10122-405-28) ",
"NDC11Code": "10122-0405-28",
"ProductNDC": "10122-405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Juxtapid",
"NonProprietaryName": "Lomitapide Mesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130103",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203858",
"LabelerName": "Chiesi USA, Inc.",
"SubstanceName": "LOMITAPIDE MESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Microsomal Triglyceride Transfer Protein Inhibitor [EPC], Microsomal Triglyceride Transfer Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130128",
"SamplePackage": "N",
"IndicationAndUsage": "JUXTAPID is indicated as an adjunct to a low-fat diet and exercise and other low density lipoprotein cholesterol (LDL-C) therapies to reduce LDL-C in adults and pediatric patients aged 2 years and older with homozygous familial hypercholesterolemia (HoFH).",
"Description": "JUXTAPID capsules contain lomitapide mesylate, a synthetic lipid-lowering agent for oral administration. The chemical name of lomitapide mesylate is N-(2,2,2-trifluoroethyl)-9-[4-[4-[[[4'a-(trifluoromethyl)[1,1'-biphenyl]-2-yl]carbonyl]amino]-1-piperidinyl]butyl]-9H-fluorene-9-carboxamide, methanesulfonate salt. Its structural formula is. The empirical formula for lomitapide mesylate is C39H37F6N3O2 ∙ CH4O3S and its molecular weight is 789.8. Lomitapide mesylate is a white to off-white powder that is slightly soluble in aqueous solutions of pH 2 to 5. Lomitapide mesylate is freely soluble in acetone, ethanol, and methanol; soluble in 2-butanol, methylene chloride, and acetonitrile; sparingly soluble in 1-octanol and 2-propanol; slightly soluble in ethyl acetate; and insoluble in heptane. Each JUXTAPID capsule contains lomitapide mesylate equivalent to 2, 5, 10, 20, or 30 mg lomitapide free base and the following inactive ingredients: pregelatinized starch, sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, silicon dioxide and magnesium stearate. The capsule shells of all strengths contain gelatin and titanium dioxide; the 2 mg capsules contain black iron oxide; the 5 mg, 10 mg and 30 mg capsules also contain red iron oxide; and the 30 mg capsules also contain yellow iron oxide. The imprinting ink contains shellac, black iron oxide, and propylene glycol."
},
{
"NDCCode": "10122-410-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (10122-410-28) ",
"NDC11Code": "10122-0410-28",
"ProductNDC": "10122-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Juxtapid",
"NonProprietaryName": "Lomitapide Mesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130103",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203858",
"LabelerName": "Chiesi USA, Inc.",
"SubstanceName": "LOMITAPIDE MESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Microsomal Triglyceride Transfer Protein Inhibitor [EPC], Microsomal Triglyceride Transfer Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130128",
"SamplePackage": "N",
"IndicationAndUsage": "JUXTAPID is indicated as an adjunct to a low-fat diet and exercise and other low density lipoprotein cholesterol (LDL-C) therapies to reduce LDL-C in adults and pediatric patients aged 2 years and older with homozygous familial hypercholesterolemia (HoFH).",
"Description": "JUXTAPID capsules contain lomitapide mesylate, a synthetic lipid-lowering agent for oral administration. The chemical name of lomitapide mesylate is N-(2,2,2-trifluoroethyl)-9-[4-[4-[[[4'a-(trifluoromethyl)[1,1'-biphenyl]-2-yl]carbonyl]amino]-1-piperidinyl]butyl]-9H-fluorene-9-carboxamide, methanesulfonate salt. Its structural formula is. The empirical formula for lomitapide mesylate is C39H37F6N3O2 ∙ CH4O3S and its molecular weight is 789.8. Lomitapide mesylate is a white to off-white powder that is slightly soluble in aqueous solutions of pH 2 to 5. Lomitapide mesylate is freely soluble in acetone, ethanol, and methanol; soluble in 2-butanol, methylene chloride, and acetonitrile; sparingly soluble in 1-octanol and 2-propanol; slightly soluble in ethyl acetate; and insoluble in heptane. Each JUXTAPID capsule contains lomitapide mesylate equivalent to 2, 5, 10, 20, or 30 mg lomitapide free base and the following inactive ingredients: pregelatinized starch, sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, silicon dioxide and magnesium stearate. The capsule shells of all strengths contain gelatin and titanium dioxide; the 2 mg capsules contain black iron oxide; the 5 mg, 10 mg and 30 mg capsules also contain red iron oxide; and the 30 mg capsules also contain yellow iron oxide. The imprinting ink contains shellac, black iron oxide, and propylene glycol."
},
{
"NDCCode": "10122-420-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (10122-420-28) ",
"NDC11Code": "10122-0420-28",
"ProductNDC": "10122-420",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Juxtapid",
"NonProprietaryName": "Lomitapide Mesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130103",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203858",
"LabelerName": "Chiesi USA, Inc.",
"SubstanceName": "LOMITAPIDE MESYLATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Microsomal Triglyceride Transfer Protein Inhibitor [EPC], Microsomal Triglyceride Transfer Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130128",
"SamplePackage": "N",
"IndicationAndUsage": "JUXTAPID is indicated as an adjunct to a low-fat diet and exercise and other low density lipoprotein cholesterol (LDL-C) therapies to reduce LDL-C in adults and pediatric patients aged 2 years and older with homozygous familial hypercholesterolemia (HoFH).",
"Description": "JUXTAPID capsules contain lomitapide mesylate, a synthetic lipid-lowering agent for oral administration. The chemical name of lomitapide mesylate is N-(2,2,2-trifluoroethyl)-9-[4-[4-[[[4'a-(trifluoromethyl)[1,1'-biphenyl]-2-yl]carbonyl]amino]-1-piperidinyl]butyl]-9H-fluorene-9-carboxamide, methanesulfonate salt. Its structural formula is. The empirical formula for lomitapide mesylate is C39H37F6N3O2 ∙ CH4O3S and its molecular weight is 789.8. Lomitapide mesylate is a white to off-white powder that is slightly soluble in aqueous solutions of pH 2 to 5. Lomitapide mesylate is freely soluble in acetone, ethanol, and methanol; soluble in 2-butanol, methylene chloride, and acetonitrile; sparingly soluble in 1-octanol and 2-propanol; slightly soluble in ethyl acetate; and insoluble in heptane. Each JUXTAPID capsule contains lomitapide mesylate equivalent to 2, 5, 10, 20, or 30 mg lomitapide free base and the following inactive ingredients: pregelatinized starch, sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, silicon dioxide and magnesium stearate. The capsule shells of all strengths contain gelatin and titanium dioxide; the 2 mg capsules contain black iron oxide; the 5 mg, 10 mg and 30 mg capsules also contain red iron oxide; and the 30 mg capsules also contain yellow iron oxide. The imprinting ink contains shellac, black iron oxide, and propylene glycol."
},
{
"NDCCode": "10122-430-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (10122-430-28) ",
"NDC11Code": "10122-0430-28",
"ProductNDC": "10122-430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Juxtapid",
"NonProprietaryName": "Lomitapide Mesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130103",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203858",
"LabelerName": "Chiesi USA, Inc.",
"SubstanceName": "LOMITAPIDE MESYLATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Microsomal Triglyceride Transfer Protein Inhibitor [EPC], Microsomal Triglyceride Transfer Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150622",
"SamplePackage": "N",
"IndicationAndUsage": "JUXTAPID is indicated as an adjunct to a low-fat diet and exercise and other low density lipoprotein cholesterol (LDL-C) therapies to reduce LDL-C in adults and pediatric patients aged 2 years and older with homozygous familial hypercholesterolemia (HoFH).",
"Description": "JUXTAPID capsules contain lomitapide mesylate, a synthetic lipid-lowering agent for oral administration. The chemical name of lomitapide mesylate is N-(2,2,2-trifluoroethyl)-9-[4-[4-[[[4'a-(trifluoromethyl)[1,1'-biphenyl]-2-yl]carbonyl]amino]-1-piperidinyl]butyl]-9H-fluorene-9-carboxamide, methanesulfonate salt. Its structural formula is. The empirical formula for lomitapide mesylate is C39H37F6N3O2 ∙ CH4O3S and its molecular weight is 789.8. Lomitapide mesylate is a white to off-white powder that is slightly soluble in aqueous solutions of pH 2 to 5. Lomitapide mesylate is freely soluble in acetone, ethanol, and methanol; soluble in 2-butanol, methylene chloride, and acetonitrile; sparingly soluble in 1-octanol and 2-propanol; slightly soluble in ethyl acetate; and insoluble in heptane. Each JUXTAPID capsule contains lomitapide mesylate equivalent to 2, 5, 10, 20, or 30 mg lomitapide free base and the following inactive ingredients: pregelatinized starch, sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, silicon dioxide and magnesium stearate. The capsule shells of all strengths contain gelatin and titanium dioxide; the 2 mg capsules contain black iron oxide; the 5 mg, 10 mg and 30 mg capsules also contain red iron oxide; and the 30 mg capsules also contain yellow iron oxide. The imprinting ink contains shellac, black iron oxide, and propylene glycol."
},
{
"NDCCode": "10122-801-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BLISTER PACK (10122-801-20)",
"NDC11Code": "10122-0801-20",
"ProductNDC": "10122-801",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spectracef",
"NonProprietaryName": "Cefditoren Pivoxil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080721",
"EndMarketingDate": "20140331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021222",
"LabelerName": "Cornerstone Therapeutics Inc.",
"SubstanceName": "CEFDITOREN PIVOXIL",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-04-03"
},
{
"NDCCode": "10122-802-02",
"PackageDescription": "2 TABLET, FILM COATED in 1 BLISTER PACK (10122-802-02)",
"NDC11Code": "10122-0802-02",
"ProductNDC": "10122-802",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spectracef",
"NonProprietaryName": "Cefditoren Pivoxil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080721",
"EndMarketingDate": "20140331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021222",
"LabelerName": "Cornerstone Therapeutics Inc.",
"SubstanceName": "CEFDITOREN PIVOXIL",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-04-03"
},
{
"NDCCode": "10122-802-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BLISTER PACK (10122-802-20)",
"NDC11Code": "10122-0802-20",
"ProductNDC": "10122-802",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spectracef",
"NonProprietaryName": "Cefditoren Pivoxil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080721",
"EndMarketingDate": "20140331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021222",
"LabelerName": "Cornerstone Therapeutics Inc.",
"SubstanceName": "CEFDITOREN PIVOXIL",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-04-03"
},
{
"NDCCode": "10122-802-28",
"PackageDescription": "28 TABLET, FILM COATED in 1 BLISTER PACK (10122-802-28)",
"NDC11Code": "10122-0802-28",
"ProductNDC": "10122-802",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spectracef",
"NonProprietaryName": "Cefditoren Pivoxil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080721",
"EndMarketingDate": "20140331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021222",
"LabelerName": "Cornerstone Therapeutics Inc.",
"SubstanceName": "CEFDITOREN PIVOXIL",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-04-03"
},
{
"NDCCode": "0264-1009-90",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-1009-90) / 100 mL in 1 CONTAINER",
"NDC11Code": "00264-1009-90",
"ProductNDC": "0264-1009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209705",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240513",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3).",
"Description": "Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL fill container contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL fill container contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition. Each is covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports. No vapor barrier is necessary."
},
{
"NDCCode": "0264-1509-90",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-1509-90) / 100 mL in 1 CONTAINER",
"NDC11Code": "00264-1509-90",
"ProductNDC": "0264-1509",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209705",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240513",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3).",
"Description": "Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL fill container contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL fill container contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition. Each is covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports. No vapor barrier is necessary."
},
{
"NDCCode": "0264-5009-90",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-5009-90) / 100 mL in 1 CONTAINER",
"NDC11Code": "00264-5009-90",
"ProductNDC": "0264-5009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209705",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240513",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3).",
"Description": "Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL fill container contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL fill container contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition. Each is covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports. No vapor barrier is necessary."
},
{
"NDCCode": "11311-820-25",
"PackageDescription": "25 kg in 1 DRUM (11311-820-25)",
"NDC11Code": "11311-0820-25",
"ProductNDC": "11311-820",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tiamulin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20090529",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Biovet Joint Stock Company",
"SubstanceName": "TIAMULIN FUMARATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
}
]
}
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<NDCList>
<NDC>
<NDCCode>10122-820-04</NDCCode>
<PackageDescription>4 AMPULE in 1 POUCH (10122-820-04) / 4 mL in 1 AMPULE</PackageDescription>
<NDC11Code>10122-0820-04</NDC11Code>
<ProductNDC>10122-820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bethkis</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20130415</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201820</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BETHKIS is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].</IndicationAndUsage>
<Description>BETHKIS is a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous solution with pH and salinity adjusted. BETHKIS is administered by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.52. Tobramycin is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino- 2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L‑streptamine. The structural formula for tobramycin is. Each single-use 4 mL ampule of BETHKIS contains one 300 mg dose of tobramycin, with sodium chloride and sulfuric acid in water for injection. Sulfuric acid and sodium hydroxide are used, as needed, to adjust the pH to 5.0. Nitrogen is used for sparging, filling and pouching. The formulation contains no preservatives.</Description>
</NDC>
<NDC>
<NDCCode>10122-212-04</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (10122-212-04) / 10 CAPSULE in 1 BLISTER PACK (10122-212-01) </PackageDescription>
<NDC11Code>10122-0212-04</NDC11Code>
<ProductNDC>10122-212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bronchitol</ProprietaryName>
<NonProprietaryName>Mannitol</NonProprietaryName>
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<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20210201</StartMarketingDate>
<EndMarketingDate>20250930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202049</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>MANNITOL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<EndMarketingDatePackage>20250930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BRONCHITOL is indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years and older with Cystic Fibrosis. Use BRONCHITOL only for adults who have passed the BRONCHITOL Tolerance Test [see Dosage and Administration (2.1)].</IndicationAndUsage>
<Description>BRONCHITOL (mannitol) inhalation powder contains D-Mannitol (referred to throughout as mannitol) as the active ingredient. Mannitol is a hexahydric sugar alcohol, with the following chemical name hexane-1,2,3,4,5,6-hexol and chemical structure:. Mannitol is a white or almost white crystalline powder or free-flowing granules with an empirical formula of C6H14O6 and molecular weight of 182.2. Mannitol is freely soluble in water, and very slightly soluble in alcohol. Mannitol shows polymorphism. BRONCHITOL contains mannitol powder spray dried into particles of respirable size filled into clear, colorless hard gelatin capsules. There are no inactive ingredients in BRONCHITOL. The accompanying white plastic inhaler is comprised of a mouthpiece, blue piercing buttons, capsule chamber, and a removable cap. A blister pack consists of 10 capsules, each containing 40 mg mannitol. After a capsule is placed in the capsule chamber and pierced by firmly pressing and releasing the buttons on the side of the device, the powder within the capsule becomes exposed and ready for dispersion into the airstream generated by the patient upon inhalation through the mouthpiece. Under standardized in vitro test conditions, the inhaler delivers 32.2 mg of mannitol per inhalation when tested at a flow rate of 60 L/min for 2 seconds. The actual amount of drug delivered to the lungs will depend on patient factors, such as inspiratory flow profile.</Description>
</NDC>
<NDC>
<NDCCode>10122-612-04</NDCCode>
<PackageDescription>4 CARTON in 1 CARTON (10122-612-04) > 1 VIAL, SINGLE-USE in 1 CARTON (10122-612-01) > 250 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>10122-0612-04</NDC11Code>
<ProductNDC>10122-612</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cleviprex</ProprietaryName>
<NonProprietaryName>Clevipidine</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022156</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>CLEVIDIPINE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10122-820-28</NDCCode>
<PackageDescription>7 POUCH in 1 CARTON (10122-820-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE</PackageDescription>
<NDC11Code>10122-0820-28</NDC11Code>
<ProductNDC>10122-820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bethkis</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20130415</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201820</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BETHKIS is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].</IndicationAndUsage>
<Description>BETHKIS is a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous solution with pH and salinity adjusted. BETHKIS is administered by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.52. Tobramycin is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino- 2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L‑streptamine. The structural formula for tobramycin is. Each single-use 4 mL ampule of BETHKIS contains one 300 mg dose of tobramycin, with sodium chloride and sulfuric acid in water for injection. Sulfuric acid and sodium hydroxide are used, as needed, to adjust the pH to 5.0. Nitrogen is used for sparging, filling and pouching. The formulation contains no preservatives.</Description>
</NDC>
<NDC>
<NDCCode>10122-820-56</NDCCode>
<PackageDescription>14 POUCH in 1 CARTON (10122-820-56) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE</PackageDescription>
<NDC11Code>10122-0820-56</NDC11Code>
<ProductNDC>10122-820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bethkis</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20130415</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201820</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BETHKIS is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].</IndicationAndUsage>
<Description>BETHKIS is a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous solution with pH and salinity adjusted. BETHKIS is administered by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.52. Tobramycin is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino- 2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L‑streptamine. The structural formula for tobramycin is. Each single-use 4 mL ampule of BETHKIS contains one 300 mg dose of tobramycin, with sodium chloride and sulfuric acid in water for injection. Sulfuric acid and sodium hydroxide are used, as needed, to adjust the pH to 5.0. Nitrogen is used for sparging, filling and pouching. The formulation contains no preservatives.</Description>
</NDC>
<NDC>
<NDCCode>15749-820-04</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (15749-820-04)</PackageDescription>
<NDC11Code>15749-0820-04</NDC11Code>
<ProductNDC>15749-820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062058</ApplicationNumber>
<LabelerName>American Antibiotics,Inc</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β- hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence. Triple Therapy. Amoxicillin/Clarithromycin/Lansoprazole. Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). Dual Therapy. Amoxicillin/Lansoprazole. Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY section.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Formulations of amoxicillin capsules, USP contain amoxicillin, a semi-synthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically, it is (2S, 5R, 6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl) acetamido] -3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S∙3H2O, and the molecular weight is 419.45. Capsules of Amoxicillin are intended for oral administration. Each capsule contains amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin. Caramel opaque cap and buff opaque body of the 250 mg capsule are imprinted with AA and 820 respectively. Each 250 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red No. 3, titanium dioxide and gelatin. Buff opaque cap and buff opaque body of the 500 mg capsule are imprinted with AA and 825 respectively. Each 500 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, titanium dioxide and gelatin.</Description>
</NDC>
<NDC>
<NDCCode>37000-820-04</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (37000-820-04) > 116 g in 1 TUBE</PackageDescription>
<NDC11Code>37000-0820-04</NDC11Code>
<ProductNDC>37000-820</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crest 3d White</ProprietaryName>
<ProprietaryNameSuffix>Advanced Vivid Enamel Renewal</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>243</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>43063-820-04</NDCCode>
<PackageDescription>4 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-04) </PackageDescription>
<NDC11Code>43063-0820-04</NDC11Code>
<ProductNDC>43063-820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients. Adult Patients only. Triple therapy for Helicobacter pylori (H. pylori)with clarithromycin and lansoprazole :. Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pyloriinfection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylorihas been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pyloriwith lansoprazole : Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pyloriinfection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylorihas been shown to reduce the risk of duodenal ulcer recurrence. Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>50458-820-04</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (50458-820-04) </PackageDescription>
<NDC11Code>50458-0820-04</NDC11Code>
<ProductNDC>50458-820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nucynta</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090601</StartMarketingDate>
<EndMarketingDate>20200331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022304</ApplicationNumber>
<LabelerName>Janssen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090601</StartMarketingDatePackage>
<EndMarketingDatePackage>20200131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63323-820-74</NDCCode>
<PackageDescription>10 BAG in 1 CASE (63323-820-74) / 250 mL in 1 BAG (63323-820-04) </PackageDescription>
<NDC11Code>63323-0820-74</NDC11Code>
<ProductNDC>63323-820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Smoflipid</ProprietaryName>
<NonProprietaryName>Smoflipid</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160713</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207648</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>SOYBEAN OIL; MEDIUM-CHAIN TRIGLYCERIDES; OLIVE OIL; FISH OIL</SubstanceName>
<StrengthNumber>6; 6; 5; 3</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Lipid Emulsion [EPC], Lipid Emulsion [EPC], Lipids [CS], Lipids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>SMOFlipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of SMOFlipid is 0.2 g/mL, and comprises a mixture of soybean oil, MCTs, olive oil, and fish oil. The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35 mg/mL (range of 28 to 50 mg/mL), and alpha-linolenic acid (an omega-3 essential fatty acid) is 4.5 mg/mL (range of 3 to 7 mg/mL). The phosphate content is 15 mmol/L. The total energy content, including fat, phospholipids, and glycerol is 2,000 kcal/L. Each 100 mL of SMOFlipid contains approximately 6 g soybean oil, 6 g MCT, 5 g olive oil, 3 g fish oil, 1.2 g egg phospholipids, 2.5 g glycerin, 16.3 to 22.5 mg all-rac-alpha-tocopherol, 0.03 g sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9). SMOFlipid has an osmolality of approximately 380 mOsm/kg water (which represents an osmolarity of 270 mOsm/L). The oils included in SMOFlipid consist of a mixture of triglycerides of predominantly unsaturated fatty acids with the following structure:. where , , and are saturated and unsaturated fatty acid residues. The major components of the fatty acids in SMOFlipid are oleic acid (23% to 35%), linoleic acid (14% to 25%), caprylic acid (13% to 24%), palmitic acid (7% to 12%), capric acid (5% to 15%), stearic acid (1.5% to 4%), alpha-linolenic acid (1.5% to 3.5%), eicosapentaenoic acid (EPA; 1% to 3.5%), and docosahexaenoic acid (DHA; 1% to 3.5%). SMOFlipid contains no more than 25 mcg/L of aluminum. The container is not made with natural rubber latex, PVC, or DEHP.</Description>
</NDC>
<NDC>
<NDCCode>68982-820-04</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (68982-820-04) > 100 mL in 1 BOTTLE, GLASS (68982-820-84) </PackageDescription>
<NDC11Code>68982-0820-04</NDC11Code>
<ProductNDC>68982-820</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Panzyga</ProprietaryName>
<NonProprietaryName>Immune Globulin Intravenous (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20181112</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125587</ApplicationNumber>
<LabelerName>Octapharma USA Inc</LabelerName>
<SubstanceName>HUMAN IMMUNOGLOBULIN G</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously. This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 90% monomers and dimers, and not more than 3% fragments. On average, the product contains 100 µg/mL of IgA, and lower amounts of IgM. PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg. The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 28%, IgG 3 is 3% and IgG 4 is 4%. PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies ( Table 4 ). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm). Table 4 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean log 10 reduction factor (LRF). Table 4: Virus Reduction by PANZYGA Manufacturing Process. HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;. PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (e.g., herpes virus);. BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);. MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);. PPV: Porcine Parvovirus, a model for Human Parvovirus B19;. n.a.: not applicable;. n.d: not done. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [ 10 ]. Several of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.</Description>
</NDC>
<NDC>
<NDCCode>69842-820-08</NDCCode>
<PackageDescription>1 KIT in 1 KIT (69842-820-08) * 118 mL in 1 BOTTLE, PLASTIC (69842-607-04) * 118 mL in 1 BOTTLE, PLASTIC (69842-606-04) </PackageDescription>
<NDC11Code>69842-0820-08</NDC11Code>
<ProductNDC>69842-820</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Multi Symptom Cold And Multi Symptom Nighttime Cold</ProprietaryName>
<ProprietaryNameSuffix>Childrens</ProprietaryNameSuffix>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci, Acetaminophen, Diphenhydramine Hci, Phenylephrine Hci</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170228</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nighttime: 1 temporarily relieves these common cold and flu symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72012-820-04</NDCCode>
<PackageDescription>20 kg in 1 DRUM (72012-820-04) </PackageDescription>
<NDC11Code>72012-0820-04</NDC11Code>
<ProductNDC>72012-820</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>L-isoleucine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20221001</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Ajinomoto do Brasil Industria e Comercio de Alimentos Ltda.</LabelerName>
<SubstanceName>ISOLEUCINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-06</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-OCT-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>84756-820-04</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (84756-820-04) </PackageDescription>
<NDC11Code>84756-0820-04</NDC11Code>
<ProductNDC>84756-820</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Eye Serum</ProprietaryName>
<NonProprietaryName>Trstay Eye Serum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Luoxin E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10122-100-12</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10122-100-12) </PackageDescription>
<NDC11Code>10122-0100-12</NDC11Code>
<ProductNDC>10122-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ferriprox</ProprietaryName>
<NonProprietaryName>Deferiprone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111125</StartMarketingDate>
<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021825</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>DEFERIPRONE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<EndMarketingDatePackage>20260331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FERRIPROX Tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. Limitations of Use. Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.</IndicationAndUsage>
<Description>FERRIPROX Tablets (deferiprone) contain 1,000 mg deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a synthetic, orally active, iron-chelating agent. The molecular formula for deferiprone is C7H9NO2 and its molecular weight is 139.15 g/mol. Deferiprone has the following structural formula. Deferiprone is a white to pinkish-white powder. It is sparingly soluble in deionized water (14.3 mg/mL) and has a melting point range of 272 °C - 278 °C. FERRIPROX Tablets (twice a day), 1,000 mg. White to off-white, capsule-shaped tablets, and imprinted with “FPX” score “DR” on one side and “APO” score “1000” on the other. The tablets can be broken in half along the score line. Each tablet contains 1,000 mg deferiprone and the following inactive ingredients: Tablet core - hypromellose acetate succinate, magnesium oxide, colloidal silicon dioxide and magnesium stearate; Coating - triethyl citrate, talc, titanium dioxide, and methacrylic acid and ethyl acrylate copolymer. FERRIPROX Tablets (three times a day), 1,000 mg. White to off-white, capsule-shaped tablets, and imprinted with “APO” score “1000” on one side and plain on the other. The tablets can be broken in half along the score line. Each tablet contains 1,000 mg deferiprone and the following inactive ingredients: Tablet core - methylcellulose, crospovidone, and magnesium stearate; Coating - hypromellose, hydroxypropyl cellulose, macrogol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>10122-321-05</NDCCode>
<PackageDescription>5 TABLET in 1 BLISTER PACK (10122-321-05)</PackageDescription>
<NDC11Code>10122-0321-05</NDC11Code>
<ProductNDC>10122-321</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Factive</ProprietaryName>
<NonProprietaryName>Gemifloxacin Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030404</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021158</ApplicationNumber>
<LabelerName>Cornerstone Therapeutics Inc.</LabelerName>
<SubstanceName>GEMIFLOXACIN MESYLATE</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>10122-321-07</NDCCode>
<PackageDescription>7 TABLET in 1 BLISTER PACK (10122-321-07)</PackageDescription>
<NDC11Code>10122-0321-07</NDC11Code>
<ProductNDC>10122-321</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Factive</ProprietaryName>
<NonProprietaryName>Gemifloxacin Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030404</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021158</ApplicationNumber>
<LabelerName>Cornerstone Therapeutics Inc.</LabelerName>
<SubstanceName>GEMIFLOXACIN MESYLATE</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>10122-402-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (10122-402-28) </PackageDescription>
<NDC11Code>10122-0402-28</NDC11Code>
<ProductNDC>10122-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Juxtapid</ProprietaryName>
<NonProprietaryName>Lomitapide Mesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260225</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203858</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>LOMITAPIDE MESYLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Microsomal Triglyceride Transfer Protein Inhibitor [EPC], Microsomal Triglyceride Transfer Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JUXTAPID is indicated as an adjunct to a low-fat diet and exercise and other low density lipoprotein cholesterol (LDL-C) therapies to reduce LDL-C in adults and pediatric patients aged 2 years and older with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>JUXTAPID capsules contain lomitapide mesylate, a synthetic lipid-lowering agent for oral administration. The chemical name of lomitapide mesylate is N-(2,2,2-trifluoroethyl)-9-[4-[4-[[[4'a-(trifluoromethyl)[1,1'-biphenyl]-2-yl]carbonyl]amino]-1-piperidinyl]butyl]-9H-fluorene-9-carboxamide, methanesulfonate salt. Its structural formula is. The empirical formula for lomitapide mesylate is C39H37F6N3O2 ∙ CH4O3S and its molecular weight is 789.8. Lomitapide mesylate is a white to off-white powder that is slightly soluble in aqueous solutions of pH 2 to 5. Lomitapide mesylate is freely soluble in acetone, ethanol, and methanol; soluble in 2-butanol, methylene chloride, and acetonitrile; sparingly soluble in 1-octanol and 2-propanol; slightly soluble in ethyl acetate; and insoluble in heptane. Each JUXTAPID capsule contains lomitapide mesylate equivalent to 2, 5, 10, 20, or 30 mg lomitapide free base and the following inactive ingredients: pregelatinized starch, sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, silicon dioxide and magnesium stearate. The capsule shells of all strengths contain gelatin and titanium dioxide; the 2 mg capsules contain black iron oxide; the 5 mg, 10 mg and 30 mg capsules also contain red iron oxide; and the 30 mg capsules also contain yellow iron oxide. The imprinting ink contains shellac, black iron oxide, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>10122-405-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (10122-405-28) </PackageDescription>
<NDC11Code>10122-0405-28</NDC11Code>
<ProductNDC>10122-405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Juxtapid</ProprietaryName>
<NonProprietaryName>Lomitapide Mesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130103</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203858</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>LOMITAPIDE MESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Microsomal Triglyceride Transfer Protein Inhibitor [EPC], Microsomal Triglyceride Transfer Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JUXTAPID is indicated as an adjunct to a low-fat diet and exercise and other low density lipoprotein cholesterol (LDL-C) therapies to reduce LDL-C in adults and pediatric patients aged 2 years and older with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>JUXTAPID capsules contain lomitapide mesylate, a synthetic lipid-lowering agent for oral administration. The chemical name of lomitapide mesylate is N-(2,2,2-trifluoroethyl)-9-[4-[4-[[[4'a-(trifluoromethyl)[1,1'-biphenyl]-2-yl]carbonyl]amino]-1-piperidinyl]butyl]-9H-fluorene-9-carboxamide, methanesulfonate salt. Its structural formula is. The empirical formula for lomitapide mesylate is C39H37F6N3O2 ∙ CH4O3S and its molecular weight is 789.8. Lomitapide mesylate is a white to off-white powder that is slightly soluble in aqueous solutions of pH 2 to 5. Lomitapide mesylate is freely soluble in acetone, ethanol, and methanol; soluble in 2-butanol, methylene chloride, and acetonitrile; sparingly soluble in 1-octanol and 2-propanol; slightly soluble in ethyl acetate; and insoluble in heptane. Each JUXTAPID capsule contains lomitapide mesylate equivalent to 2, 5, 10, 20, or 30 mg lomitapide free base and the following inactive ingredients: pregelatinized starch, sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, silicon dioxide and magnesium stearate. The capsule shells of all strengths contain gelatin and titanium dioxide; the 2 mg capsules contain black iron oxide; the 5 mg, 10 mg and 30 mg capsules also contain red iron oxide; and the 30 mg capsules also contain yellow iron oxide. The imprinting ink contains shellac, black iron oxide, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>10122-410-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (10122-410-28) </PackageDescription>
<NDC11Code>10122-0410-28</NDC11Code>
<ProductNDC>10122-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Juxtapid</ProprietaryName>
<NonProprietaryName>Lomitapide Mesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130103</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203858</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>LOMITAPIDE MESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Microsomal Triglyceride Transfer Protein Inhibitor [EPC], Microsomal Triglyceride Transfer Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JUXTAPID is indicated as an adjunct to a low-fat diet and exercise and other low density lipoprotein cholesterol (LDL-C) therapies to reduce LDL-C in adults and pediatric patients aged 2 years and older with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>JUXTAPID capsules contain lomitapide mesylate, a synthetic lipid-lowering agent for oral administration. The chemical name of lomitapide mesylate is N-(2,2,2-trifluoroethyl)-9-[4-[4-[[[4'a-(trifluoromethyl)[1,1'-biphenyl]-2-yl]carbonyl]amino]-1-piperidinyl]butyl]-9H-fluorene-9-carboxamide, methanesulfonate salt. Its structural formula is. The empirical formula for lomitapide mesylate is C39H37F6N3O2 ∙ CH4O3S and its molecular weight is 789.8. Lomitapide mesylate is a white to off-white powder that is slightly soluble in aqueous solutions of pH 2 to 5. Lomitapide mesylate is freely soluble in acetone, ethanol, and methanol; soluble in 2-butanol, methylene chloride, and acetonitrile; sparingly soluble in 1-octanol and 2-propanol; slightly soluble in ethyl acetate; and insoluble in heptane. Each JUXTAPID capsule contains lomitapide mesylate equivalent to 2, 5, 10, 20, or 30 mg lomitapide free base and the following inactive ingredients: pregelatinized starch, sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, silicon dioxide and magnesium stearate. The capsule shells of all strengths contain gelatin and titanium dioxide; the 2 mg capsules contain black iron oxide; the 5 mg, 10 mg and 30 mg capsules also contain red iron oxide; and the 30 mg capsules also contain yellow iron oxide. The imprinting ink contains shellac, black iron oxide, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>10122-420-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (10122-420-28) </PackageDescription>
<NDC11Code>10122-0420-28</NDC11Code>
<ProductNDC>10122-420</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Juxtapid</ProprietaryName>
<NonProprietaryName>Lomitapide Mesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130103</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203858</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>LOMITAPIDE MESYLATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Microsomal Triglyceride Transfer Protein Inhibitor [EPC], Microsomal Triglyceride Transfer Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JUXTAPID is indicated as an adjunct to a low-fat diet and exercise and other low density lipoprotein cholesterol (LDL-C) therapies to reduce LDL-C in adults and pediatric patients aged 2 years and older with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>JUXTAPID capsules contain lomitapide mesylate, a synthetic lipid-lowering agent for oral administration. The chemical name of lomitapide mesylate is N-(2,2,2-trifluoroethyl)-9-[4-[4-[[[4'a-(trifluoromethyl)[1,1'-biphenyl]-2-yl]carbonyl]amino]-1-piperidinyl]butyl]-9H-fluorene-9-carboxamide, methanesulfonate salt. Its structural formula is. The empirical formula for lomitapide mesylate is C39H37F6N3O2 ∙ CH4O3S and its molecular weight is 789.8. Lomitapide mesylate is a white to off-white powder that is slightly soluble in aqueous solutions of pH 2 to 5. Lomitapide mesylate is freely soluble in acetone, ethanol, and methanol; soluble in 2-butanol, methylene chloride, and acetonitrile; sparingly soluble in 1-octanol and 2-propanol; slightly soluble in ethyl acetate; and insoluble in heptane. Each JUXTAPID capsule contains lomitapide mesylate equivalent to 2, 5, 10, 20, or 30 mg lomitapide free base and the following inactive ingredients: pregelatinized starch, sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, silicon dioxide and magnesium stearate. The capsule shells of all strengths contain gelatin and titanium dioxide; the 2 mg capsules contain black iron oxide; the 5 mg, 10 mg and 30 mg capsules also contain red iron oxide; and the 30 mg capsules also contain yellow iron oxide. The imprinting ink contains shellac, black iron oxide, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>10122-430-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (10122-430-28) </PackageDescription>
<NDC11Code>10122-0430-28</NDC11Code>
<ProductNDC>10122-430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Juxtapid</ProprietaryName>
<NonProprietaryName>Lomitapide Mesylate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130103</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203858</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>LOMITAPIDE MESYLATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Microsomal Triglyceride Transfer Protein Inhibitor [EPC], Microsomal Triglyceride Transfer Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JUXTAPID is indicated as an adjunct to a low-fat diet and exercise and other low density lipoprotein cholesterol (LDL-C) therapies to reduce LDL-C in adults and pediatric patients aged 2 years and older with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>JUXTAPID capsules contain lomitapide mesylate, a synthetic lipid-lowering agent for oral administration. The chemical name of lomitapide mesylate is N-(2,2,2-trifluoroethyl)-9-[4-[4-[[[4'a-(trifluoromethyl)[1,1'-biphenyl]-2-yl]carbonyl]amino]-1-piperidinyl]butyl]-9H-fluorene-9-carboxamide, methanesulfonate salt. Its structural formula is. The empirical formula for lomitapide mesylate is C39H37F6N3O2 ∙ CH4O3S and its molecular weight is 789.8. Lomitapide mesylate is a white to off-white powder that is slightly soluble in aqueous solutions of pH 2 to 5. Lomitapide mesylate is freely soluble in acetone, ethanol, and methanol; soluble in 2-butanol, methylene chloride, and acetonitrile; sparingly soluble in 1-octanol and 2-propanol; slightly soluble in ethyl acetate; and insoluble in heptane. Each JUXTAPID capsule contains lomitapide mesylate equivalent to 2, 5, 10, 20, or 30 mg lomitapide free base and the following inactive ingredients: pregelatinized starch, sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, silicon dioxide and magnesium stearate. The capsule shells of all strengths contain gelatin and titanium dioxide; the 2 mg capsules contain black iron oxide; the 5 mg, 10 mg and 30 mg capsules also contain red iron oxide; and the 30 mg capsules also contain yellow iron oxide. The imprinting ink contains shellac, black iron oxide, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>10122-801-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BLISTER PACK (10122-801-20)</PackageDescription>
<NDC11Code>10122-0801-20</NDC11Code>
<ProductNDC>10122-801</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spectracef</ProprietaryName>
<NonProprietaryName>Cefditoren Pivoxil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080721</StartMarketingDate>
<EndMarketingDate>20140331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021222</ApplicationNumber>
<LabelerName>Cornerstone Therapeutics Inc.</LabelerName>
<SubstanceName>CEFDITOREN PIVOXIL</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>10122-802-02</NDCCode>
<PackageDescription>2 TABLET, FILM COATED in 1 BLISTER PACK (10122-802-02)</PackageDescription>
<NDC11Code>10122-0802-02</NDC11Code>
<ProductNDC>10122-802</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spectracef</ProprietaryName>
<NonProprietaryName>Cefditoren Pivoxil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080721</StartMarketingDate>
<EndMarketingDate>20140331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021222</ApplicationNumber>
<LabelerName>Cornerstone Therapeutics Inc.</LabelerName>
<SubstanceName>CEFDITOREN PIVOXIL</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>10122-802-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BLISTER PACK (10122-802-20)</PackageDescription>
<NDC11Code>10122-0802-20</NDC11Code>
<ProductNDC>10122-802</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spectracef</ProprietaryName>
<NonProprietaryName>Cefditoren Pivoxil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080721</StartMarketingDate>
<EndMarketingDate>20140331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021222</ApplicationNumber>
<LabelerName>Cornerstone Therapeutics Inc.</LabelerName>
<SubstanceName>CEFDITOREN PIVOXIL</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>10122-802-28</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BLISTER PACK (10122-802-28)</PackageDescription>
<NDC11Code>10122-0802-28</NDC11Code>
<ProductNDC>10122-802</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spectracef</ProprietaryName>
<NonProprietaryName>Cefditoren Pivoxil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080721</StartMarketingDate>
<EndMarketingDate>20140331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021222</ApplicationNumber>
<LabelerName>Cornerstone Therapeutics Inc.</LabelerName>
<SubstanceName>CEFDITOREN PIVOXIL</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>0264-1009-90</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-1009-90) / 100 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-1009-90</NDC11Code>
<ProductNDC>0264-1009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209705</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3).</IndicationAndUsage>
<Description>Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL fill container contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL fill container contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition. Each is covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports. No vapor barrier is necessary.</Description>
</NDC>
<NDC>
<NDCCode>0264-1509-90</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-1509-90) / 100 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-1509-90</NDC11Code>
<ProductNDC>0264-1509</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209705</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3).</IndicationAndUsage>
<Description>Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL fill container contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL fill container contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition. Each is covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports. No vapor barrier is necessary.</Description>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209705</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
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<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3).</IndicationAndUsage>
<Description>Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg/100 mL: One 100 mL fill container contains 1,000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg/100 mL: One 100 mL fill container contains 1,500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition. Each is covered by a tamperproof barrier. Refer to the DIRECTIONS FOR USE of the container to properly identify the ports. No vapor barrier is necessary.</Description>
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<PackageDescription>25 kg in 1 DRUM (11311-820-25)</PackageDescription>
<NDC11Code>11311-0820-25</NDC11Code>
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<NonProprietaryName>Tiamulin</NonProprietaryName>
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<StartMarketingDate>20090529</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Biovet Joint Stock Company</LabelerName>
<SubstanceName>TIAMULIN FUMARATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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