{
"NDC": [
{
"NDCCode": "65219-539-10",
"PackageDescription": "6 BAG in 1 CASE (65219-539-10) / 1000 mL in 1 BAG (65219-539-01) ",
"NDC11Code": "65219-0539-10",
"ProductNDC": "65219-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Intralipid",
"NonProprietaryName": "I.v. Fat Emulsion",
"DosageFormName": "EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20040401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020248",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "SOYBEAN OIL",
"StrengthNumber": "20",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Lipid Emulsion [EPC], Lipids [CS]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230217",
"SamplePackage": "N",
"IndicationAndUsage": "Intralipid® is indicated as a source of calories and essential fatty acids for adult and pediatric patients requiring parenteral nutrition (PN) and as a source of essential fatty acids for prevention of essential fatty acid deficiency (EFAD).",
"Description": "Intralipid is a sterile, non-pyrogenic, white, homogenous lipid emulsion for intravenous infusion as a source of calories and essential fatty acids. The lipid content of Intralipid is 0.2 g/mL and comprises soybean oil. The phosphate content is 15 mmol/L. The total energy content, including fat, phospholipids, and glycerin is 2,000 kcal/L. Each 100 mL of Intralipid contains approximately 20 g soybean oil, 1.2 g egg yolk phospholipids, 2.25 g glycerin, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 8.9). Intralipid has an osmolality of approximately 350 mOsmol/kg water (which represents an osmolarity of 260 mOsmoL/L). The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:. where are saturated and unsaturated fatty acid residues. The major component fatty acids in Intralipid are linoleic acid (44% to 62%), oleic acid (19% to 30%), palmitic acid (7% to 14%), alpha-linolenic acid (4% to 11%), and stearic acid (1.4% to 5.5%). These fatty acids have the following chemical and structural formulas:. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. Intralipid contains no more than 25 mcg/L of aluminum. The container is not made with natural rubber latex, PVC, or DEHP."
},
{
"NDCCode": "12634-539-00",
"PackageDescription": "10 TABLET in 1 BOTTLE (12634-539-00)",
"NDC11Code": "12634-0539-00",
"ProductNDC": "12634-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phendimetrazine Tartrate",
"NonProprietaryName": "Phendimetrazine Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20000705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089452",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "PHENDIMETRAZINE TARTRATE",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"IndicationAndUsage": "Phendimetrazine tartrate tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. Phendimetrazine tartrate is indicated for use as monotherapy only.",
"Description": "Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2 S, 3 S)-3, 4-Dimethyl-2-phenylmorpholine L-(+)-tartrate (1:1). The structural formula is. Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene. Each tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose and FD&C Yellow #6, D&C Yellow #10 as coloring."
},
{
"NDCCode": "12634-539-61",
"PackageDescription": "10 TABLET in 1 BLISTER PACK (12634-539-61)",
"NDC11Code": "12634-0539-61",
"ProductNDC": "12634-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phendimetrazine Tartrate",
"NonProprietaryName": "Phendimetrazine Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20000705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089452",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "PHENDIMETRAZINE TARTRATE",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"IndicationAndUsage": "Phendimetrazine tartrate tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. Phendimetrazine tartrate is indicated for use as monotherapy only.",
"Description": "Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2 S, 3 S)-3, 4-Dimethyl-2-phenylmorpholine L-(+)-tartrate (1:1). The structural formula is. Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene. Each tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose and FD&C Yellow #6, D&C Yellow #10 as coloring."
},
{
"NDCCode": "30142-539-10",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (30142-539-10) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "30142-0539-10",
"ProductNDC": "30142-539",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nasal",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20140218",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Kroger Company",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140218",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves nasal congestion due to:. common cold. hay fever. upper respiratory allergies."
},
{
"NDCCode": "43744-539-10",
"PackageDescription": "1 g in 1 DRUM (43744-539-10)",
"NDC11Code": "43744-0539-10",
"ProductNDC": "43744-539",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20111010",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "LEUPROLIDE ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "43744-539-15",
"PackageDescription": "10 g in 1 DRUM (43744-539-15)",
"NDC11Code": "43744-0539-15",
"ProductNDC": "43744-539",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20111010",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "LEUPROLIDE ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "46122-539-52",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (46122-539-52) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "46122-0539-52",
"ProductNDC": "46122-539",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine Odt",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20180709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208477",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2023-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180709",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing , 3 itchy, watery eyes , 4 itching of the nose or throat."
},
{
"NDCCode": "46122-539-65",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (46122-539-65) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "46122-0539-65",
"ProductNDC": "46122-539",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine Odt",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20180709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208477",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2023-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220810",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing , 3 itchy, watery eyes , 4 itching of the nose or throat."
},
{
"NDCCode": "50742-539-10",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (50742-539-10) / 5 mL in 1 VIAL, GLASS (50742-539-01) ",
"NDC11Code": "50742-0539-10",
"ProductNDC": "50742-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dehydrated Alcohol",
"NonProprietaryName": "Dehydrated Alcohol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS",
"StartMarketingDate": "20250709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219569",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "DEHYDRATED ALCOHOL",
"StrengthNumber": "5",
"StrengthUnit": "mL/5mL",
"Status": "Active",
"LastUpdate": "2025-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250709",
"SamplePackage": "N",
"IndicationAndUsage": "Dehydrated alcohol injection is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.",
"Description": "Dehydrated alcohol injection, USP is a sterile, preservative free solution of ≥ 99% by volume ethyl alcohol and no excipients. Dehydrated alcohol injection, USP is for cardiac septal branch intra-arterial use. It has a molecular formula of C2H6O and a molecular weight of 46.07. Dehydrated alcohol injection, USP is a potent tissue toxin. Ethanol is a clear, colorless, volatile, and flammable liquid miscible with water and with practically all organic solvents. It has the following structural formula."
},
{
"NDCCode": "51346-539-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (51346-539-02) > 10 g in 1 CONTAINER (51346-539-01) ",
"NDC11Code": "51346-0539-02",
"ProductNDC": "51346-539",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Intense Multi Ampoule Balm Vita C",
"NonProprietaryName": "Tocopheryl Acetate, Bisabolol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "NATURE REPUBLIC CO., LTD.",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE; LEVOMENOL",
"StrengthNumber": ".3; .05",
"StrengthUnit": "g/10g; g/10g",
"Status": "Deprecated",
"LastUpdate": "2023-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N"
},
{
"NDCCode": "51655-539-53",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-539-53) ",
"NDC11Code": "51655-0539-53",
"ProductNDC": "51655-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208170",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220415",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake."
},
{
"NDCCode": "52125-539-10",
"PackageDescription": "6 TABLET, FILM COATED in 1 VIAL (52125-539-10)",
"NDC11Code": "52125-0539-10",
"ProductNDC": "52125-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065211",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-03-03"
},
{
"NDCCode": "52959-539-10",
"PackageDescription": "10 CAPSULE in 1 BOTTLE (52959-539-10)",
"NDC11Code": "52959-0539-10",
"ProductNDC": "52959-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celebrex",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19981002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020998",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].",
"Description": "CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. CELEBREX oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "58411-539-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (58411-539-10) / 35 mL in 1 BOTTLE",
"NDC11Code": "58411-0539-10",
"ProductNDC": "58411-539",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cle De Peau Beaute Radiant Fluid Foundation",
"ProprietaryNameSuffix": "O10",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "2.72118",
"StrengthUnit": "g/35mL",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "60923-539-48",
"PackageDescription": "1 KIT in 1 CARTON (60923-539-48) * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 48 POUCH in 1 BOX / 1 SWAB in 1 POUCH",
"NDC11Code": "60923-0539-48",
"ProductNDC": "60923-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elevidys",
"NonProprietaryName": "Delandistrogene Moxeparvovec-rokl",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230622",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125781",
"LabelerName": "Sarepta Therapeutics, Inc.",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230622",
"SamplePackage": "N",
"IndicationAndUsage": "ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology (12.2), Clinical Studies (14)].",
"Description": "ELEVIDYS (delandistrogene moxeparvovec-rokl) is a recombinant gene therapy designed to deliver the gene encoding the ELEVIDYS micro-dystrophin protein. ELEVIDYS is a non-replicating, recombinant, adeno-associated virus serotype rh74 (AAVrh74) based vector containing the ELEVIDYS micro-dystrophin transgene under the control of the MHCK7 promoter. The genome within the ELEVIDYS AAVrh74 vector contains no viral genes and consequently is incapable of replication or reversion to a replicating form. The micro-dystrophin protein expressed by ELEVIDYS is a shortened version (138 kDa, compared to 427 kDa size of dystrophin expressed in normal muscle cells) that contains selected domains of dystrophin expressed in normal muscle cells. ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles. ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 ×1013 vg/mL and supplied in a single-dose 10 mL vial. Each vial contains an extractable volume of 10 mL and the following excipients: 200mM sodium chloride, 13 mM tromethamine HCl, 7 mM tromethamine, 1mM magnesium chloride, 0.001% poloxamer 188, with a pH of 8.0 ± 0.3."
},
{
"NDCCode": "62157-539-01",
"PackageDescription": "10 g in 1 JAR (62157-539-01)",
"NDC11Code": "62157-0539-01",
"ProductNDC": "62157-539",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Carbimazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180308",
"MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
"LabelerName": "AX Pharmaceutical Corp",
"SubstanceName": "CARBIMAZOLE",
"StrengthNumber": "9.9",
"StrengthUnit": "g/10g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "63304-539-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (63304-539-10)",
"NDC11Code": "63304-0539-10",
"ProductNDC": "63304-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090637",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol tablets reduce serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS). Allopurinol tablets are indicated in: 1 the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). , 2 the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol tablets should be discontinued when the potential for overproduction of uric acid is no longer present. , 3 the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks. .",
"Description": "Allopurinol has the following structural formula:. C5H4N4O M.W. = 136.11. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d] pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. Each scored white to off-white tablet contains 100 mg allopurinol and the inactive ingredients lactose monohydrate, corn starch, sodium starch glycolate, povidone and stearic acid. Each scored peach tablet contains 300 mg allopurinol and the inactive ingredients lactose monohydrate, corn starch, sodium starch glycolate , FD & C yellow no. 6, povidone and stearic acid."
},
{
"NDCCode": "68382-539-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (68382-539-10)",
"NDC11Code": "68382-0539-10",
"ProductNDC": "68382-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcium Acetate",
"NonProprietaryName": "Calcium Acetate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202315",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "CALCIUM ACETATE",
"StrengthNumber": "667",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Calcium Acetate Capsule is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. (1).",
"Description": "Calcium Acetate Capsule acts as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is. Calcium Acetate Capsules are Hard Gelatin Capsules with blue opaque cap and body both imprinted \"EP 115\" in black ink. Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium and following inactive ingredients crospovidone, FD & C Blue No. 1, FD & C Blue No. 3, gelatin, magnesium stearate, sodium lauryl sulfate and titanium dioxide. In addition to the ingredients listed above, each capsule contains following inactive ingredients from imprinting ink: butyl alcohol, iron oxide black, propylene glycol and shellac."
},
{
"NDCCode": "71919-539-10",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (71919-539-10) ",
"NDC11Code": "71919-0539-10",
"ProductNDC": "71919-539",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Piper Methysticum",
"NonProprietaryName": "Macropiper Methysticum Root",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090130",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "MACROPIPER METHYSTICUM ROOT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20090130",
"SamplePackage": "N"
},
{
"NDCCode": "65219-014-10",
"PackageDescription": "10 VIAL in 1 CARTON (65219-014-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-014-01) ",
"NDC11Code": "65219-0014-10",
"ProductNDC": "65219-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20191030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062719",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2022-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191030",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.",
"Description": "Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl) amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
},
{
"NDCCode": "65219-016-10",
"PackageDescription": "10 VIAL in 1 CARTON (65219-016-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-016-01) ",
"NDC11Code": "65219-0016-10",
"ProductNDC": "65219-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20200803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062719",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2022-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200803",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.",
"Description": "Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl) amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
},
{
"NDCCode": "65219-018-10",
"PackageDescription": "10 VIAL in 1 CARTON (65219-018-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-018-01) ",
"NDC11Code": "65219-0018-10",
"ProductNDC": "65219-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20200113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062719",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2022-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200113",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.",
"Description": "Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl) amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
},
{
"NDCCode": "65219-020-23",
"PackageDescription": "10 VIAL in 1 CARTON (65219-020-23) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-020-03) ",
"NDC11Code": "65219-0020-23",
"ProductNDC": "65219-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20191031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062797",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "2",
"StrengthUnit": "g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2022-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191031",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.",
"Description": "Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl) amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
},
{
"NDCCode": "65219-046-71",
"PackageDescription": "10 BAG in 1 CARTON (65219-046-71) / 100 mL in 1 BAG (65219-046-21) ",
"NDC11Code": "65219-0046-71",
"ProductNDC": "65219-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208619",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251212",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥ 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 bag with an over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag 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 bag 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 bag 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."
},
{
"NDCCode": "65219-065-05",
"PackageDescription": "10 VIAL in 1 TRAY (65219-065-05) > 5 mL in 1 VIAL (65219-065-02) ",
"NDC11Code": "65219-0065-05",
"ProductNDC": "65219-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rocuronium",
"NonProprietaryName": "Rocuronium Bromide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078651",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "ROCURONIUM BROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2022-03-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220307",
"SamplePackage": "N",
"IndicationAndUsage": "Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3 α-hydroxy-2β-(4-morpholinyl)-5 α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium bromide. The structural formula is. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide."
},
{
"NDCCode": "65219-066-10",
"PackageDescription": "25 VIAL in 1 TRAY (65219-066-10) / 1 mL in 1 VIAL (65219-066-01) ",
"NDC11Code": "65219-0066-10",
"ProductNDC": "65219-066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium",
"NonProprietaryName": "Heparin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20220322",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017029",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "1000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220322",
"SamplePackage": "N",
"IndicationAndUsage": "Heparin Sodium Injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism; , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; , 3 Atrial fibrillation with embolization; , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 5 Prevention of clotting in arterial and cardiac surgery; , 6 Prophylaxis and treatment of peripheral arterial embolism. , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .",
"Description": "Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose 6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)> (1)> (4)> (3)> (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity, in water for injection. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits):."
},
{
"NDCCode": "65219-080-05",
"PackageDescription": "10 CARTON in 1 BOX (65219-080-05) / 1 VIAL in 1 CARTON (65219-080-01) / 5 mL in 1 VIAL",
"NDC11Code": "65219-0080-05",
"ProductNDC": "65219-080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gadoterate Meglumine",
"NonProprietaryName": "Gadoterate Meglumine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215304",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "GADOTERATE MEGLUMINE",
"StrengthNumber": "376.9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220620",
"SamplePackage": "N",
"IndicationAndUsage": "Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.",
"Description": "Gadoterate Meglumine Injection, USP is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C23H42O13N5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. Gadoterate Meglumine Injection, USP is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol per mL of gadoterate meglumine. No preservative is added. Each mL of Gadoterate Meglumine Injection, USP contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. Gadoterate Meglumine Injection USP has a pH of 6.5 to 8.0. The main physiochemical properties of Gadoterate Meglumine Injection, USP are provided below. The thermodynamic stability constants for gadoterate (log Ktherm and log Kcond at pH 7.4) are 25.6 and 19.3, respectively."
},
{
"NDCCode": "65219-082-10",
"PackageDescription": "10 CARTON in 1 BOX (65219-082-10) / 1 VIAL in 1 CARTON (65219-082-01) / 10 mL in 1 VIAL",
"NDC11Code": "65219-0082-10",
"ProductNDC": "65219-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gadoterate Meglumine",
"NonProprietaryName": "Gadoterate Meglumine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215304",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "GADOTERATE MEGLUMINE",
"StrengthNumber": "376.9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220620",
"SamplePackage": "N",
"IndicationAndUsage": "Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.",
"Description": "Gadoterate Meglumine Injection, USP is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C23H42O13N5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. Gadoterate Meglumine Injection, USP is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol per mL of gadoterate meglumine. No preservative is added. Each mL of Gadoterate Meglumine Injection, USP contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. Gadoterate Meglumine Injection USP has a pH of 6.5 to 8.0. The main physiochemical properties of Gadoterate Meglumine Injection, USP are provided below. The thermodynamic stability constants for gadoterate (log Ktherm and log Kcond at pH 7.4) are 25.6 and 19.3, respectively."
},
{
"NDCCode": "65219-084-15",
"PackageDescription": "10 CARTON in 1 BOX (65219-084-15) / 1 VIAL in 1 CARTON (65219-084-01) / 15 mL in 1 VIAL",
"NDC11Code": "65219-0084-15",
"ProductNDC": "65219-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gadoterate Meglumine",
"NonProprietaryName": "Gadoterate Meglumine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215304",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "GADOTERATE MEGLUMINE",
"StrengthNumber": "376.9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220620",
"SamplePackage": "N",
"IndicationAndUsage": "Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.",
"Description": "Gadoterate Meglumine Injection, USP is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C23H42O13N5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. Gadoterate Meglumine Injection, USP is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol per mL of gadoterate meglumine. No preservative is added. Each mL of Gadoterate Meglumine Injection, USP contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. Gadoterate Meglumine Injection USP has a pH of 6.5 to 8.0. The main physiochemical properties of Gadoterate Meglumine Injection, USP are provided below. The thermodynamic stability constants for gadoterate (log Ktherm and log Kcond at pH 7.4) are 25.6 and 19.3, respectively."
},
{
"NDCCode": "65219-086-20",
"PackageDescription": "10 CARTON in 1 BOX (65219-086-20) / 1 VIAL in 1 CARTON (65219-086-01) / 20 mL in 1 VIAL",
"NDC11Code": "65219-0086-20",
"ProductNDC": "65219-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gadoterate Meglumine",
"NonProprietaryName": "Gadoterate Meglumine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215304",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "GADOTERATE MEGLUMINE",
"StrengthNumber": "376.9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220620",
"SamplePackage": "N",
"IndicationAndUsage": "Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.",
"Description": "Gadoterate Meglumine Injection, USP is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C23H42O13N5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. Gadoterate Meglumine Injection, USP is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol per mL of gadoterate meglumine. No preservative is added. Each mL of Gadoterate Meglumine Injection, USP contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. Gadoterate Meglumine Injection USP has a pH of 6.5 to 8.0. The main physiochemical properties of Gadoterate Meglumine Injection, USP are provided below. The thermodynamic stability constants for gadoterate (log Ktherm and log Kcond at pH 7.4) are 25.6 and 19.3, respectively."
}
]
}
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<NDC>
<NDCCode>65219-539-10</NDCCode>
<PackageDescription>6 BAG in 1 CASE (65219-539-10) / 1000 mL in 1 BAG (65219-539-01) </PackageDescription>
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<ProductNDC>65219-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Intralipid</ProprietaryName>
<NonProprietaryName>I.v. Fat Emulsion</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020248</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>SOYBEAN OIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Lipid Emulsion [EPC], Lipids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Intralipid® is indicated as a source of calories and essential fatty acids for adult and pediatric patients requiring parenteral nutrition (PN) and as a source of essential fatty acids for prevention of essential fatty acid deficiency (EFAD).</IndicationAndUsage>
<Description>Intralipid is a sterile, non-pyrogenic, white, homogenous lipid emulsion for intravenous infusion as a source of calories and essential fatty acids. The lipid content of Intralipid is 0.2 g/mL and comprises soybean oil. The phosphate content is 15 mmol/L. The total energy content, including fat, phospholipids, and glycerin is 2,000 kcal/L. Each 100 mL of Intralipid contains approximately 20 g soybean oil, 1.2 g egg yolk phospholipids, 2.25 g glycerin, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 8.9). Intralipid has an osmolality of approximately 350 mOsmol/kg water (which represents an osmolarity of 260 mOsmoL/L). The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:. where are saturated and unsaturated fatty acid residues. The major component fatty acids in Intralipid are linoleic acid (44% to 62%), oleic acid (19% to 30%), palmitic acid (7% to 14%), alpha-linolenic acid (4% to 11%), and stearic acid (1.4% to 5.5%). These fatty acids have the following chemical and structural formulas:. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. Intralipid contains no more than 25 mcg/L of aluminum. The container is not made with natural rubber latex, PVC, or DEHP.</Description>
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<NDCCode>12634-539-00</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (12634-539-00)</PackageDescription>
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<ProductNDC>12634-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phendimetrazine Tartrate</ProprietaryName>
<NonProprietaryName>Phendimetrazine Tartrate</NonProprietaryName>
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<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
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<LastUpdate>2021-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Phendimetrazine tartrate tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. Phendimetrazine tartrate is indicated for use as monotherapy only.</IndicationAndUsage>
<Description>Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2 S, 3 S)-3, 4-Dimethyl-2-phenylmorpholine L-(+)-tartrate (1:1). The structural formula is. Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene. Each tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose and FD&C Yellow #6, D&C Yellow #10 as coloring.</Description>
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<NDC>
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<PackageDescription>10 TABLET in 1 BLISTER PACK (12634-539-61)</PackageDescription>
<NDC11Code>12634-0539-61</NDC11Code>
<ProductNDC>12634-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phendimetrazine Tartrate</ProprietaryName>
<NonProprietaryName>Phendimetrazine Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089452</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>PHENDIMETRAZINE TARTRATE</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phendimetrazine tartrate tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. Phendimetrazine tartrate is indicated for use as monotherapy only.</IndicationAndUsage>
<Description>Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2 S, 3 S)-3, 4-Dimethyl-2-phenylmorpholine L-(+)-tartrate (1:1). The structural formula is. Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene. Each tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose and FD&C Yellow #6, D&C Yellow #10 as coloring.</Description>
</NDC>
<NDC>
<NDCCode>30142-539-10</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (30142-539-10) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>30142-0539-10</NDC11Code>
<ProductNDC>30142-539</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nasal</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20140218</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves nasal congestion due to:. common cold. hay fever. upper respiratory allergies.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43744-539-10</NDCCode>
<PackageDescription>1 g in 1 DRUM (43744-539-10)</PackageDescription>
<NDC11Code>43744-0539-10</NDC11Code>
<ProductNDC>43744-539</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20111010</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>LEUPROLIDE ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43744-539-15</NDCCode>
<PackageDescription>10 g in 1 DRUM (43744-539-15)</PackageDescription>
<NDC11Code>43744-0539-15</NDC11Code>
<ProductNDC>43744-539</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20111010</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>LEUPROLIDE ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>46122-539-52</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (46122-539-52) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>46122-0539-52</NDC11Code>
<ProductNDC>46122-539</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine Odt</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208477</ApplicationNumber>
<LabelerName>Amerisource Bergen</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing , 3 itchy, watery eyes , 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>46122-539-65</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (46122-539-65) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>46122-0539-65</NDC11Code>
<ProductNDC>46122-539</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine Odt</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208477</ApplicationNumber>
<LabelerName>Amerisource Bergen</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing , 3 itchy, watery eyes , 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50742-539-10</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (50742-539-10) / 5 mL in 1 VIAL, GLASS (50742-539-01) </PackageDescription>
<NDC11Code>50742-0539-10</NDC11Code>
<ProductNDC>50742-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dehydrated Alcohol</ProprietaryName>
<NonProprietaryName>Dehydrated Alcohol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS</RouteName>
<StartMarketingDate>20250709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219569</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DEHYDRATED ALCOHOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mL/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dehydrated alcohol injection is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.</IndicationAndUsage>
<Description>Dehydrated alcohol injection, USP is a sterile, preservative free solution of ≥ 99% by volume ethyl alcohol and no excipients. Dehydrated alcohol injection, USP is for cardiac septal branch intra-arterial use. It has a molecular formula of C2H6O and a molecular weight of 46.07. Dehydrated alcohol injection, USP is a potent tissue toxin. Ethanol is a clear, colorless, volatile, and flammable liquid miscible with water and with practically all organic solvents. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>51346-539-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (51346-539-02) > 10 g in 1 CONTAINER (51346-539-01) </PackageDescription>
<NDC11Code>51346-0539-02</NDC11Code>
<ProductNDC>51346-539</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Intense Multi Ampoule Balm Vita C</ProprietaryName>
<NonProprietaryName>Tocopheryl Acetate, Bisabolol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE; LEVOMENOL</SubstanceName>
<StrengthNumber>.3; .05</StrengthNumber>
<StrengthUnit>g/10g; g/10g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51655-539-53</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-539-53) </PackageDescription>
<NDC11Code>51655-0539-53</NDC11Code>
<ProductNDC>51655-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208170</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>52125-539-10</NDCCode>
<PackageDescription>6 TABLET, FILM COATED in 1 VIAL (52125-539-10)</PackageDescription>
<NDC11Code>52125-0539-10</NDC11Code>
<ProductNDC>52125-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065211</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-03-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>52959-539-10</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE (52959-539-10)</PackageDescription>
<NDC11Code>52959-0539-10</NDC11Code>
<ProductNDC>52959-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celebrex</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020998</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. CELEBREX oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>58411-539-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (58411-539-10) / 35 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58411-0539-10</NDC11Code>
<ProductNDC>58411-539</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cle De Peau Beaute Radiant Fluid Foundation</ProprietaryName>
<ProprietaryNameSuffix>O10</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>2.72118</StrengthNumber>
<StrengthUnit>g/35mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60923-539-48</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (60923-539-48) * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 48 POUCH in 1 BOX / 1 SWAB in 1 POUCH</PackageDescription>
<NDC11Code>60923-0539-48</NDC11Code>
<ProductNDC>60923-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elevidys</ProprietaryName>
<NonProprietaryName>Delandistrogene Moxeparvovec-rokl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230622</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125781</ApplicationNumber>
<LabelerName>Sarepta Therapeutics, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology (12.2), Clinical Studies (14)].</IndicationAndUsage>
<Description>ELEVIDYS (delandistrogene moxeparvovec-rokl) is a recombinant gene therapy designed to deliver the gene encoding the ELEVIDYS micro-dystrophin protein. ELEVIDYS is a non-replicating, recombinant, adeno-associated virus serotype rh74 (AAVrh74) based vector containing the ELEVIDYS micro-dystrophin transgene under the control of the MHCK7 promoter. The genome within the ELEVIDYS AAVrh74 vector contains no viral genes and consequently is incapable of replication or reversion to a replicating form. The micro-dystrophin protein expressed by ELEVIDYS is a shortened version (138 kDa, compared to 427 kDa size of dystrophin expressed in normal muscle cells) that contains selected domains of dystrophin expressed in normal muscle cells. ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles. ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 ×1013 vg/mL and supplied in a single-dose 10 mL vial. Each vial contains an extractable volume of 10 mL and the following excipients: 200mM sodium chloride, 13 mM tromethamine HCl, 7 mM tromethamine, 1mM magnesium chloride, 0.001% poloxamer 188, with a pH of 8.0 ± 0.3.</Description>
</NDC>
<NDC>
<NDCCode>62157-539-01</NDCCode>
<PackageDescription>10 g in 1 JAR (62157-539-01)</PackageDescription>
<NDC11Code>62157-0539-01</NDC11Code>
<ProductNDC>62157-539</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Carbimazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180308</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</MarketingCategoryName>
<LabelerName>AX Pharmaceutical Corp</LabelerName>
<SubstanceName>CARBIMAZOLE</SubstanceName>
<StrengthNumber>9.9</StrengthNumber>
<StrengthUnit>g/10g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63304-539-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (63304-539-10)</PackageDescription>
<NDC11Code>63304-0539-10</NDC11Code>
<ProductNDC>63304-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090637</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol tablets reduce serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS). Allopurinol tablets are indicated in: 1 the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). , 2 the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol tablets should be discontinued when the potential for overproduction of uric acid is no longer present. , 3 the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks. .</IndicationAndUsage>
<Description>Allopurinol has the following structural formula:. C5H4N4O M.W. = 136.11. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d] pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. Each scored white to off-white tablet contains 100 mg allopurinol and the inactive ingredients lactose monohydrate, corn starch, sodium starch glycolate, povidone and stearic acid. Each scored peach tablet contains 300 mg allopurinol and the inactive ingredients lactose monohydrate, corn starch, sodium starch glycolate , FD & C yellow no. 6, povidone and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>68382-539-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (68382-539-10)</PackageDescription>
<NDC11Code>68382-0539-10</NDC11Code>
<ProductNDC>68382-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcium Acetate</ProprietaryName>
<NonProprietaryName>Calcium Acetate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202315</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>CALCIUM ACETATE</SubstanceName>
<StrengthNumber>667</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Calcium Acetate Capsule is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. (1).</IndicationAndUsage>
<Description>Calcium Acetate Capsule acts as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is. Calcium Acetate Capsules are Hard Gelatin Capsules with blue opaque cap and body both imprinted "EP 115" in black ink. Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium and following inactive ingredients crospovidone, FD & C Blue No. 1, FD & C Blue No. 3, gelatin, magnesium stearate, sodium lauryl sulfate and titanium dioxide. In addition to the ingredients listed above, each capsule contains following inactive ingredients from imprinting ink: butyl alcohol, iron oxide black, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>71919-539-10</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (71919-539-10) </PackageDescription>
<NDC11Code>71919-0539-10</NDC11Code>
<ProductNDC>71919-539</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Piper Methysticum</ProprietaryName>
<NonProprietaryName>Macropiper Methysticum Root</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090130</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>MACROPIPER METHYSTICUM ROOT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65219-014-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (65219-014-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-014-01) </PackageDescription>
<NDC11Code>65219-0014-10</NDC11Code>
<ProductNDC>65219-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20191030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062719</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl) amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10.</Description>
</NDC>
<NDC>
<NDCCode>65219-016-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (65219-016-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-016-01) </PackageDescription>
<NDC11Code>65219-0016-10</NDC11Code>
<ProductNDC>65219-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20200803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062719</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl) amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10.</Description>
</NDC>
<NDC>
<NDCCode>65219-018-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (65219-018-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-018-01) </PackageDescription>
<NDC11Code>65219-0018-10</NDC11Code>
<ProductNDC>65219-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20200113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062719</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl) amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10.</Description>
</NDC>
<NDC>
<NDCCode>65219-020-23</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (65219-020-23) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-020-03) </PackageDescription>
<NDC11Code>65219-0020-23</NDC11Code>
<ProductNDC>65219-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20191031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062797</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl) amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10.</Description>
</NDC>
<NDC>
<NDCCode>65219-046-71</NDCCode>
<PackageDescription>10 BAG in 1 CARTON (65219-046-71) / 100 mL in 1 BAG (65219-046-21) </PackageDescription>
<NDC11Code>65219-0046-71</NDC11Code>
<ProductNDC>65219-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208619</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</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>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥ 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 bag with an over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag 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 bag 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 bag 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.</Description>
</NDC>
<NDC>
<NDCCode>65219-065-05</NDCCode>
<PackageDescription>10 VIAL in 1 TRAY (65219-065-05) > 5 mL in 1 VIAL (65219-065-02) </PackageDescription>
<NDC11Code>65219-0065-05</NDC11Code>
<ProductNDC>65219-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rocuronium</ProprietaryName>
<NonProprietaryName>Rocuronium Bromide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078651</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>ROCURONIUM BROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3 α-hydroxy-2β-(4-morpholinyl)-5 α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium bromide. The structural formula is. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>65219-066-10</NDCCode>
<PackageDescription>25 VIAL in 1 TRAY (65219-066-10) / 1 mL in 1 VIAL (65219-066-01) </PackageDescription>
<NDC11Code>65219-0066-10</NDC11Code>
<ProductNDC>65219-066</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium</ProprietaryName>
<NonProprietaryName>Heparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220322</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017029</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Heparin Sodium Injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism; , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; , 3 Atrial fibrillation with embolization; , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 5 Prevention of clotting in arterial and cardiac surgery; , 6 Prophylaxis and treatment of peripheral arterial embolism. , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .</IndicationAndUsage>
<Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose 6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)> (1)> (4)> (3)> (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity, in water for injection. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits):.</Description>
</NDC>
<NDC>
<NDCCode>65219-080-05</NDCCode>
<PackageDescription>10 CARTON in 1 BOX (65219-080-05) / 1 VIAL in 1 CARTON (65219-080-01) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>65219-0080-05</NDC11Code>
<ProductNDC>65219-080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gadoterate Meglumine</ProprietaryName>
<NonProprietaryName>Gadoterate Meglumine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215304</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>GADOTERATE MEGLUMINE</SubstanceName>
<StrengthNumber>376.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.</IndicationAndUsage>
<Description>Gadoterate Meglumine Injection, USP is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C23H42O13N5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. Gadoterate Meglumine Injection, USP is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol per mL of gadoterate meglumine. No preservative is added. Each mL of Gadoterate Meglumine Injection, USP contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. Gadoterate Meglumine Injection USP has a pH of 6.5 to 8.0. The main physiochemical properties of Gadoterate Meglumine Injection, USP are provided below. The thermodynamic stability constants for gadoterate (log Ktherm and log Kcond at pH 7.4) are 25.6 and 19.3, respectively.</Description>
</NDC>
<NDC>
<NDCCode>65219-082-10</NDCCode>
<PackageDescription>10 CARTON in 1 BOX (65219-082-10) / 1 VIAL in 1 CARTON (65219-082-01) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>65219-0082-10</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gadoterate Meglumine</ProprietaryName>
<NonProprietaryName>Gadoterate Meglumine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215304</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>GADOTERATE MEGLUMINE</SubstanceName>
<StrengthNumber>376.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.</IndicationAndUsage>
<Description>Gadoterate Meglumine Injection, USP is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C23H42O13N5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. Gadoterate Meglumine Injection, USP is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol per mL of gadoterate meglumine. No preservative is added. Each mL of Gadoterate Meglumine Injection, USP contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. Gadoterate Meglumine Injection USP has a pH of 6.5 to 8.0. The main physiochemical properties of Gadoterate Meglumine Injection, USP are provided below. The thermodynamic stability constants for gadoterate (log Ktherm and log Kcond at pH 7.4) are 25.6 and 19.3, respectively.</Description>
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<NDCCode>65219-084-15</NDCCode>
<PackageDescription>10 CARTON in 1 BOX (65219-084-15) / 1 VIAL in 1 CARTON (65219-084-01) / 15 mL in 1 VIAL</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gadoterate Meglumine</ProprietaryName>
<NonProprietaryName>Gadoterate Meglumine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215304</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>GADOTERATE MEGLUMINE</SubstanceName>
<StrengthNumber>376.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.</IndicationAndUsage>
<Description>Gadoterate Meglumine Injection, USP is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C23H42O13N5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. Gadoterate Meglumine Injection, USP is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol per mL of gadoterate meglumine. No preservative is added. Each mL of Gadoterate Meglumine Injection, USP contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. Gadoterate Meglumine Injection USP has a pH of 6.5 to 8.0. The main physiochemical properties of Gadoterate Meglumine Injection, USP are provided below. The thermodynamic stability constants for gadoterate (log Ktherm and log Kcond at pH 7.4) are 25.6 and 19.3, respectively.</Description>
</NDC>
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<NDCCode>65219-086-20</NDCCode>
<PackageDescription>10 CARTON in 1 BOX (65219-086-20) / 1 VIAL in 1 CARTON (65219-086-01) / 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>65219-0086-20</NDC11Code>
<ProductNDC>65219-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gadoterate Meglumine</ProprietaryName>
<NonProprietaryName>Gadoterate Meglumine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215304</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>GADOTERATE MEGLUMINE</SubstanceName>
<StrengthNumber>376.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.</IndicationAndUsage>
<Description>Gadoterate Meglumine Injection, USP is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C23H42O13N5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. Gadoterate Meglumine Injection, USP is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol per mL of gadoterate meglumine. No preservative is added. Each mL of Gadoterate Meglumine Injection, USP contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. Gadoterate Meglumine Injection USP has a pH of 6.5 to 8.0. The main physiochemical properties of Gadoterate Meglumine Injection, USP are provided below. The thermodynamic stability constants for gadoterate (log Ktherm and log Kcond at pH 7.4) are 25.6 and 19.3, respectively.</Description>
</NDC>
</NDCList>