{
"NDC": [
{
"NDCCode": "63323-416-05",
"PackageDescription": "10 VIAL in 1 CARTON (63323-416-05) / 5 mL in 1 VIAL (63323-416-01) ",
"NDC11Code": "63323-0416-05",
"ProductNDC": "63323-416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cisatracurium",
"NonProprietaryName": "Cisatracurium Besylate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203182",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "CISATRACURIUM BESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150226",
"SamplePackage": "N",
"IndicationAndUsage": "Cisatracurium Besylate Injection is indicated: : 1 as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age, 2 to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU , 3 to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older .",
"Description": "Cisatracurium Besylate Injection, USP is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium Besylate Injection, USP contains cisatracurium besylate as the active pharmaceutical ingredient. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R-[1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.50. The structural formula of cisatracurium besylate is. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous solution provided in 5 mL, 10 mL, and 20 mL vials. The pH is adjusted to 3.25 to 3.65 with benzenesulfonic acid. The 5 mL and 10 mL vials each contain cisatracurium besylate, equivalent to 2 mg/mL cisatracurium. The 20 mL vial, intended for ICU use only, contains cisatracurium besylate, equivalent to 10 mg/mL cisatracurium. The 10 mL vial, intended for multiple dose use, contains 0.9% benzyl alcohol as a preservative. The 5 mL and 20 mL vials are single dose vials and do not contain benzyl alcohol. Cisatracurium besylate slowly loses potency with time at a rate of approximately 5% per year under refrigeration (5°C). Cisatracurium should be refrigerated at 2°C to 8°C (36°F to 46°F) in the tray to preserve potency. The rate of loss in potency increases to approximately 5% per month at 25°C (77°F). Upon removal from refrigeration to room temperature storage conditions (25°C/77°F), use cisatracurium within 21 days, even if re-refrigerated."
},
{
"NDCCode": "21695-416-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (21695-416-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "21695-0416-05",
"ProductNDC": "21695-416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin And Dexamethasone",
"NonProprietaryName": "Tobramycin And Dexamethasone",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19880818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050592",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "TOBRAMYCIN; DEXAMETHASONE",
"StrengthNumber": "3; 1",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tobramycin and dexamethasone ophthalmic suspension is indicated for steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens. Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.",
"Description": "Tobramycin and Dexamethasone Ophthalmic Suspension USP, 0.3%/0.1% is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. Tobramycin is represented by the following structural formula. C18H37N5O9. Mol. Wt. 467.52. Chemical Name: 0-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→4)-0-[(2,6-diamino-2,3,6-tridexoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine. Dexamethasone is represented by the following structural formula. C22H29FO5. Mol. Wt. 392.47. Chemical Name: 9-FIuoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. Each mL Contains: ACTIVES: Tobramycin 3 mg (0.3%) and Dexamethasone 1 mg (0.1%); INACTIVES: Sodium Sulfate, Sodium Chloride, Hydroxyethyl Cellulose, Tyloxapol, Edetate Disodium and Purified Water. Sulfuric Acid and/or Sodium Hydroxide may be added to adjust pH (5.0 – 6.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%."
},
{
"NDCCode": "24338-416-05",
"PackageDescription": "1 TUBE in 1 CARTON (24338-416-05) > 5 g in 1 TUBE",
"NDC11Code": "24338-0416-05",
"ProductNDC": "24338-416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19971126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040039",
"LabelerName": "Arbor Pharmaceuticals Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "42806-416-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42806-416-05) ",
"NDC11Code": "42806-0416-05",
"ProductNDC": "42806-416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210015",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230430",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major depressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).",
"Description": "Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used."
},
{
"NDCCode": "49643-416-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-416-05) ",
"NDC11Code": "49643-0416-05",
"ProductNDC": "49643-416",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Dandelion Pollen",
"NonProprietaryName": "Taraxacum Officinale",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "TARAXACUM OFFICINALE POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "50742-416-05",
"PackageDescription": "1 VIAL in 1 CARTON (50742-416-05) > 5 mL in 1 VIAL",
"NDC11Code": "50742-0416-05",
"ProductNDC": "50742-416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoledronic Acid",
"NonProprietaryName": "Zoledronic Acid",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208968",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "ZOLEDRONIC ACID",
"StrengthNumber": "4",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200219",
"SamplePackage": "N"
},
{
"NDCCode": "51407-416-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (51407-416-05) ",
"NDC11Code": "51407-0416-05",
"ProductNDC": "51407-416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202330",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211201",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge\", irritability, impatience.",
"Description": "Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5] decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2.HCl is represented by the following structural formula. Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one- half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "59190-416-05",
"PackageDescription": "19.49 L in 1 DEWAR (59190-416-05) ",
"NDC11Code": "59190-0416-05",
"ProductNDC": "59190-416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20030515",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Ascension Via Christi Home Medical Wichita, LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030515",
"SamplePackage": "N"
},
{
"NDCCode": "62377-001-05",
"PackageDescription": "416 L in 1 CYLINDER (62377-001-05) ",
"NDC11Code": "62377-0001-05",
"ProductNDC": "62377-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19950101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205865",
"LabelerName": "EWS Welding Supply, Inc.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "995",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2022-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19950101",
"SamplePackage": "N"
},
{
"NDCCode": "65293-416-25",
"PackageDescription": "25 VIAL in 1 TRAY (65293-416-25) > 5 mL in 1 VIAL (65293-416-05)",
"NDC11Code": "65293-0416-25",
"ProductNDC": "65293-416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midazolam",
"NonProprietaryName": "Midazolam Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20000714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075154",
"LabelerName": "The Medicines Company",
"SubstanceName": "MIDAZOLAM HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-12-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "67877-416-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (67877-416-05) ",
"NDC11Code": "67877-0416-05",
"ProductNDC": "67877-416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205536",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190314",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure(NYHA class II-IV),to reduce hospitalization for heart failure in adults (1.2) , 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
"Description": "Valsartan Tablet, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1receptor subtype.Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white or almost white, hygroscopic powder. It is practically insoluble in water, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Valsartan Tablet, USP is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, corn starch, lactose monohydrate, croscarmellose sodium, hypromellose, magnesium stearate, titanium dioxide, polyethylene glycol and iron oxides (black, red and yellow). Meets USP Dissolution Test 2."
},
{
"NDCCode": "68428-416-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-416-05) ",
"NDC11Code": "68428-0416-05",
"ProductNDC": "68428-416",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guarea Trichilioides",
"NonProprietaryName": "Guarea Guidonia Bark",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101013",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "GUAREA GUIDONIA BARK",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20101013",
"SamplePackage": "N"
},
{
"NDCCode": "72205-416-05",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (72205-416-05) ",
"NDC11Code": "72205-0416-05",
"ProductNDC": "72205-416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208546",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260318",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 2 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8) .",
"Description": "Rivaroxaban, USP, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban, USP is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablet, USP contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets, USP 2.5 mg is Opadry® Yellow, containing hypromellose, titanium dioxide, polyethylene glycol 3350 and iron oxide yellow."
},
{
"NDCCode": "76420-416-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (76420-416-05) ",
"NDC11Code": "76420-0416-05",
"ProductNDC": "76420-416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078413",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250724",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)] . The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
"Description": "Zolpidem tartrate USP is a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate USP is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:. Zolpidem tartrate USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. Meets USP Dissolution Test-3."
},
{
"NDCCode": "81469-416-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (81469-416-05) ",
"NDC11Code": "81469-0416-05",
"ProductNDC": "81469-416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215710",
"LabelerName": "First Nation Group, LLC",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230111",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NOHCl having a molecular weight of 315.84. It is a white to almost white crystalline powder freely soluble in water, in alcohol and methylene chloride.Doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of. 1-Propanamine, 3- dibenz[b,e]oxepin-11 (6H)ylidene-N,N-dimethyl-hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively. Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow 6, the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green 3 and the 10 mg empty gelatin capsule shells contain FD&C Red 3. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Meets USP Dissolution Test 4."
},
{
"NDCCode": "84525-416-05",
"PackageDescription": "100 mL in 1 BOTTLE (84525-416-05) ",
"NDC11Code": "84525-0416-05",
"ProductNDC": "84525-416",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Retinol Serum",
"NonProprietaryName": "Retinol Serum",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250111",
"EndMarketingDate": "20310111",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Zhixin Trade Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250111",
"EndMarketingDatePackage": "20310111",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84756-416-05",
"PackageDescription": "100 g in 1 BOX (84756-416-05) ",
"NDC11Code": "84756-0416-05",
"ProductNDC": "84756-416",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Retinol Cream",
"NonProprietaryName": "Retinol Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241123",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Zhixin Trade Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241123",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84827-416-05",
"PackageDescription": "100 mL in 1 BOX (84827-416-05) ",
"NDC11Code": "84827-0416-05",
"ProductNDC": "84827-416",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Onion Oil",
"NonProprietaryName": "Trstay Onion Oil",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241106",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241106",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "63187-349-01",
"PackageDescription": "1 KIT in 1 CARTON (63187-349-01) * 10 mL in 1 VIAL, SINGLE-DOSE (0003-0293-05) * .3 mL in 1 AMPULE (39822-9900-2) * 2.2 g in 1 PACKET (10819-3883-3) * 10 mL in 1 AMPULE (63323-201-10)",
"NDC11Code": "63187-0349-01",
"ProductNDC": "63187-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Interarticular Joint Kit",
"NonProprietaryName": "Ammonia, Lidocaine Hydrochloride Anhydrous, Triamcinolone Acetonide, Povidone-iodine",
"DosageFormName": "KIT",
"StartMarketingDate": "20140205",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA014901",
"LabelerName": "Proficient Rx LP",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63323-026-05",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-026-05) > 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "63323-0026-05",
"ProductNDC": "63323-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20000810",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "APP Pharmaceuticals, LLC",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "42",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63323-083-05",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-083-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-083-03) ",
"NDC11Code": "63323-0083-05",
"ProductNDC": "63323-083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206688",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "42",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Alkalinizing Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250825",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis — e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial — e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.",
"Description": "Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solutions are offered in concentrations of 4.2% and 8.4%. See table in HOW SUPPLIED/STORAGE AND HANDLING section for contents and characteristics. The solution has an approximate pH of 8.0 (7.0 – 8.5). The solutions contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit. Sodium Bicarbonate, 84 mg is equal to one milliequivalent each of Na+ and HCO3-. Sodium Bicarbonate, 42 mg is equal to 0.5 milliequivalents each of Na+ and HCO3-. Sodium Bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water.Water for Injection, USP is chemically designated H2O."
},
{
"NDCCode": "63323-086-05",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-086-05) > 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "63323-0086-05",
"ProductNDC": "63323-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphate, Monobasic And Potassium Phosphate, Dibasic",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20000808",
"EndMarketingDate": "20221130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC",
"StrengthNumber": "236; 224",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20000808",
"EndMarketingDatePackage": "20221031",
"SamplePackage": "N"
},
{
"NDCCode": "63323-104-05",
"PackageDescription": "10 BOX in 1 CARTON (63323-104-05) / 1 VIAL, MULTI-DOSE in 1 BOX (63323-104-01) / 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "63323-0104-05",
"ProductNDC": "63323-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etoposide",
"NonProprietaryName": "Etoposide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20010718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074983",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "ETOPOSIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010718",
"SamplePackage": "N",
"Description": "Etoposide (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4’-demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside]. It is very soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble in water and ether. It is made more miscible with water by means of organic solvents. Etoposide Injection, USP is available for intravenous use as a 20 mg/mL solution in 100 mg (5 mL), 500 mg (25 mL), or 1 gram (50 mL) sterile, multiple dose vials. The pH of the clear, nearly colorless to yellow liquid is 3 to 4. Each mL contains 20 mg etoposide, 2 mg citric acid, 30 mg benzyl alcohol, 80 mg polysorbate 80/tween 80, 650 mg polyethylene glycol 300, and 30.5 percent (v/v) alcohol. Vial headspace contains nitrogen. The structural formula is. C 29H 32O 13 M.W. 588.56."
},
{
"NDCCode": "63323-106-05",
"PackageDescription": "24 BAG in 1 CASE (63323-106-05) / 50 mL in 1 BAG (63323-106-02) ",
"NDC11Code": "63323-0106-05",
"ProductNDC": "63323-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Magnesium Sulfate",
"NonProprietaryName": "Magnesium Sulfate Heptahydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206485",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2024-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160315",
"SamplePackage": "N",
"IndicationAndUsage": "Magnesium sulfate in water for injection is indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.",
"Description": "Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes. Magnesium sulfate, USP heptahydrate is chemically designated MgSO 4 7H 2O, colorless crystals or white powder freely soluble in water. Water for injection, USP is chemically designated H 2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( freeflex ® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. Exposure to temperatures above 25ºC/77ºF during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
},
{
"NDCCode": "63323-107-05",
"PackageDescription": "24 BAG in 1 CASE (63323-107-05) / 50 mL in 1 BAG (63323-107-01) ",
"NDC11Code": "63323-0107-05",
"ProductNDC": "63323-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Magnesium Sulfate",
"NonProprietaryName": "Magnesium Sulfate Heptahydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206485",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2024-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160315",
"SamplePackage": "N",
"IndicationAndUsage": "Magnesium sulfate in water for injection is indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.",
"Description": "Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes. Magnesium sulfate, USP heptahydrate is chemically designated MgSO 4 7H 2O, colorless crystals or white powder freely soluble in water. Water for injection, USP is chemically designated H 2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( freeflex ® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. Exposure to temperatures above 25ºC/77ºF during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
},
{
"NDCCode": "63323-118-05",
"PackageDescription": "24 BLISTER PACK in 1 CARTON (63323-118-05) / 1 SYRINGE in 1 BLISTER PACK (63323-118-01) / .5 mL in 1 SYRINGE",
"NDC11Code": "63323-0118-05",
"ProductNDC": "63323-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium",
"NonProprietaryName": "Heparin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20181116",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017029",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "5000",
"StrengthUnit": "[USP'U]/.5mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181116",
"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, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of heparin sodium (representative subunits):. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. 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. Each 0.5 mL of Heparin Sodium Injection, USP contains:. pH 5.0-7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment."
},
{
"NDCCode": "63323-165-05",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 TRAY (63323-165-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-165-03) ",
"NDC11Code": "63323-0165-05",
"ProductNDC": "63323-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone Sodium Phosphate",
"NonProprietaryName": "Dexamethasone Sodium Phosphate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20000907",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084916",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "DEXAMETHASONE SODIUM PHOSPHATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20000907",
"SamplePackage": "N",
"Description": "Dexamethasone sodium phosphate is a water-soluble inorganic ester of dexamethasone. It occurs as a white or slightly yellow crystalline powder, is odorless or has a slight odor of alcohol, is exceedingly hygroscopic and is freely soluble in water. Dexamethasone sodium phosphate is an adrenocortical steroid anti-inflammatory drug. Chemically, dexamethasone sodium phosphate is 9-Fluoro-11ß,17,21-trihydroxy-16α-methylpregna-1, 4-diene-3,20-dione 21-(dihydrogen phosphate) disodium salt and has the following structural formula. Dexamethasone Sodium Phosphate Injection, USP is a sterile solution of dexamethasone sodium phosphate in water for injection for intravenous (IV), intramuscular (IM), intra-articular, soft-tissue or intralesional use. Each mL contains dexamethasone sodium phosphate equivalent to dexamethasone phosphate 4 mg or dexamethasone 3.33 mg; benzyl alcohol 10 mg added as preservative; sodium citrate dihydrate 11 mg; sodium sulfite 1 mg as an antioxidant; Water for Injection q.s. Citric acid and/or sodium hydroxide may have been added for pH adjustment (7.0 to 8.5). Air in the container is displaced by nitrogen."
},
{
"NDCCode": "63323-170-05",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-170-05) > 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "63323-0170-05",
"ProductNDC": "63323-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Phosphates",
"NonProprietaryName": "Sodium Phosphate, Monobasic, Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20000906",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS",
"StrengthNumber": "276; 142",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2021-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20000906",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Phosphates Injection, USP is indicated as a source of phosphate, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.",
"Description": "Sodium Phosphates Injection, USP, 3 mmol/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in Water for Injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains: Monobasic sodium phosphate, monohydrate, 276 mg; dibasic sodium phosphate, anhydrous, 142 mg (equivalent to dibasic sodium phosphate, heptahydrate, 268 mg); Water for Injection q.s. In the 5 mL and 15 mL product, phosphoric acid and/or NaOH may have been added for pH adjustment. Each mL provides 3 mmol of phosphorus and 4 mEq sodium. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.7 (approx.). The osmolar concentration is 7 mOsmol/mL (calc.). The solution is intended as an alternative to potassium phosphate to provide phosphate ion (PO 43-) for addition to large volume infusion fluids for intravenous use. Sodium Phosphates, USP, monohydrate monobasic is chemically designated NaH 2PO 4 H 2O. Occurs as white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP, anhydrous, is chemically designated Na 2HPO 4. Occurs as a colorless or white granular salt freely soluble in water."
},
{
"NDCCode": "63323-172-05",
"PackageDescription": "1 VIAL in 1 BOX (63323-172-05) > 5 mL in 1 VIAL",
"NDC11Code": "63323-0172-05",
"ProductNDC": "63323-172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carboplatin",
"NonProprietaryName": "Carboplatin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077432",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "CARBOPLATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20090915",
"SamplePackage": "N"
},
{
"NDCCode": "63323-185-05",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-05) > 5 mL in 1 VIAL, SINGLE-DOSE (63323-185-04) ",
"NDC11Code": "63323-0185-05",
"ProductNDC": "63323-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sterile Water",
"NonProprietaryName": "Water",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20000905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088400",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "WATER",
"StrengthNumber": "1",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2022-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220430",
"SamplePackage": "N",
"IndicationAndUsage": "This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.",
"Description": "This preparation is designed solely for parenteral use only after addition to drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers to dilute or dissolve drugs for injection. For IV injection, add sufficient amount to a solute to make an approximately isotonic solution. pH 5.0 to 7.0. Water for Injection, USP is chemically designated H 2O."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>63323-416-05</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (63323-416-05) / 5 mL in 1 VIAL (63323-416-01) </PackageDescription>
<NDC11Code>63323-0416-05</NDC11Code>
<ProductNDC>63323-416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cisatracurium</ProprietaryName>
<NonProprietaryName>Cisatracurium Besylate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203182</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>CISATRACURIUM BESYLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cisatracurium Besylate Injection is indicated: : 1 as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age, 2 to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU , 3 to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older .</IndicationAndUsage>
<Description>Cisatracurium Besylate Injection, USP is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium Besylate Injection, USP contains cisatracurium besylate as the active pharmaceutical ingredient. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R-[1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.50. The structural formula of cisatracurium besylate is. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous solution provided in 5 mL, 10 mL, and 20 mL vials. The pH is adjusted to 3.25 to 3.65 with benzenesulfonic acid. The 5 mL and 10 mL vials each contain cisatracurium besylate, equivalent to 2 mg/mL cisatracurium. The 20 mL vial, intended for ICU use only, contains cisatracurium besylate, equivalent to 10 mg/mL cisatracurium. The 10 mL vial, intended for multiple dose use, contains 0.9% benzyl alcohol as a preservative. The 5 mL and 20 mL vials are single dose vials and do not contain benzyl alcohol. Cisatracurium besylate slowly loses potency with time at a rate of approximately 5% per year under refrigeration (5°C). Cisatracurium should be refrigerated at 2°C to 8°C (36°F to 46°F) in the tray to preserve potency. The rate of loss in potency increases to approximately 5% per month at 25°C (77°F). Upon removal from refrigeration to room temperature storage conditions (25°C/77°F), use cisatracurium within 21 days, even if re-refrigerated.</Description>
</NDC>
<NDC>
<NDCCode>21695-416-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (21695-416-05) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>21695-0416-05</NDC11Code>
<ProductNDC>21695-416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin And Dexamethasone</ProprietaryName>
<NonProprietaryName>Tobramycin And Dexamethasone</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19880818</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050592</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>TOBRAMYCIN; DEXAMETHASONE</SubstanceName>
<StrengthNumber>3; 1</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tobramycin and dexamethasone ophthalmic suspension is indicated for steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens. Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.</IndicationAndUsage>
<Description>Tobramycin and Dexamethasone Ophthalmic Suspension USP, 0.3%/0.1% is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. Tobramycin is represented by the following structural formula. C18H37N5O9. Mol. Wt. 467.52. Chemical Name: 0-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→4)-0-[(2,6-diamino-2,3,6-tridexoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine. Dexamethasone is represented by the following structural formula. C22H29FO5. Mol. Wt. 392.47. Chemical Name: 9-FIuoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. Each mL Contains: ACTIVES: Tobramycin 3 mg (0.3%) and Dexamethasone 1 mg (0.1%); INACTIVES: Sodium Sulfate, Sodium Chloride, Hydroxyethyl Cellulose, Tyloxapol, Edetate Disodium and Purified Water. Sulfuric Acid and/or Sodium Hydroxide may be added to adjust pH (5.0 – 6.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.</Description>
</NDC>
<NDC>
<NDCCode>24338-416-05</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (24338-416-05) > 5 g in 1 TUBE</PackageDescription>
<NDC11Code>24338-0416-05</NDC11Code>
<ProductNDC>24338-416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19971126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040039</ApplicationNumber>
<LabelerName>Arbor Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42806-416-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42806-416-05) </PackageDescription>
<NDC11Code>42806-0416-05</NDC11Code>
<ProductNDC>42806-416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210015</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major depressive disorder (MDD) ( 1.1) prevention of seasonal affective disorder (SAD) ( 1.2).</IndicationAndUsage>
<Description>Bupropion Hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion Hydrochloride Extended-Release Tablets USP (XL) are supplied for oral administration as 150 mg and 300 mg white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: cysteine hydrochloride, ethylcellulose, methacrylic acid copolymer dispersion, lecithin, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, talc, triethyl citrate and titanium dioxide. The tablets are printed with black ink containing ammonium hydroxide, ferrosoferric oxide, propylene glycol, shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test 22 is used.</Description>
</NDC>
<NDC>
<NDCCode>49643-416-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49643-416-05) </PackageDescription>
<NDC11Code>49643-0416-05</NDC11Code>
<ProductNDC>49643-416</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Dandelion Pollen</ProprietaryName>
<NonProprietaryName>Taraxacum Officinale</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>TARAXACUM OFFICINALE POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>50742-416-05</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (50742-416-05) > 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>50742-0416-05</NDC11Code>
<ProductNDC>50742-416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoledronic Acid</ProprietaryName>
<NonProprietaryName>Zoledronic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208968</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ZOLEDRONIC ACID</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51407-416-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (51407-416-05) </PackageDescription>
<NDC11Code>51407-0416-05</NDC11Code>
<ProductNDC>51407-416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202330</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge", irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5] decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2.HCl is represented by the following structural formula. Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one- half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>59190-416-05</NDCCode>
<PackageDescription>19.49 L in 1 DEWAR (59190-416-05) </PackageDescription>
<NDC11Code>59190-0416-05</NDC11Code>
<ProductNDC>59190-416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20030515</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Ascension Via Christi Home Medical Wichita, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62377-001-05</NDCCode>
<PackageDescription>416 L in 1 CYLINDER (62377-001-05) </PackageDescription>
<NDC11Code>62377-0001-05</NDC11Code>
<ProductNDC>62377-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19950101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205865</ApplicationNumber>
<LabelerName>EWS Welding Supply, Inc.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>995</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65293-416-25</NDCCode>
<PackageDescription>25 VIAL in 1 TRAY (65293-416-25) > 5 mL in 1 VIAL (65293-416-05)</PackageDescription>
<NDC11Code>65293-0416-25</NDC11Code>
<ProductNDC>65293-416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midazolam</ProprietaryName>
<NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20000714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075154</ApplicationNumber>
<LabelerName>The Medicines Company</LabelerName>
<SubstanceName>MIDAZOLAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-12-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67877-416-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (67877-416-05) </PackageDescription>
<NDC11Code>67877-0416-05</NDC11Code>
<ProductNDC>67877-416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205536</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure(NYHA class II-IV),to reduce hospitalization for heart failure in adults (1.2) , 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan Tablet, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1receptor subtype.Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white or almost white, hygroscopic powder. It is practically insoluble in water, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Valsartan Tablet, USP is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, corn starch, lactose monohydrate, croscarmellose sodium, hypromellose, magnesium stearate, titanium dioxide, polyethylene glycol and iron oxides (black, red and yellow). Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68428-416-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-416-05) </PackageDescription>
<NDC11Code>68428-0416-05</NDC11Code>
<ProductNDC>68428-416</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guarea Trichilioides</ProprietaryName>
<NonProprietaryName>Guarea Guidonia Bark</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101013</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>GUAREA GUIDONIA BARK</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72205-416-05</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (72205-416-05) </PackageDescription>
<NDC11Code>72205-0416-05</NDC11Code>
<ProductNDC>72205-416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivaroxaban</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208546</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivaroxaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 2 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8) .</IndicationAndUsage>
<Description>Rivaroxaban, USP, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban, USP is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablet, USP contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets, USP 2.5 mg is Opadry® Yellow, containing hypromellose, titanium dioxide, polyethylene glycol 3350 and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>76420-416-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (76420-416-05) </PackageDescription>
<NDC11Code>76420-0416-05</NDC11Code>
<ProductNDC>76420-416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078413</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)] . The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Zolpidem tartrate USP is a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate USP is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:. Zolpidem tartrate USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. Meets USP Dissolution Test-3.</Description>
</NDC>
<NDC>
<NDCCode>81469-416-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (81469-416-05) </PackageDescription>
<NDC11Code>81469-0416-05</NDC11Code>
<ProductNDC>81469-416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215710</ApplicationNumber>
<LabelerName>First Nation Group, LLC</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NOHCl having a molecular weight of 315.84. It is a white to almost white crystalline powder freely soluble in water, in alcohol and methylene chloride.Doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of. 1-Propanamine, 3- dibenz[b,e]oxepin-11 (6H)ylidene-N,N-dimethyl-hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively. Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow 6, the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green 3 and the 10 mg empty gelatin capsule shells contain FD&C Red 3. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>84525-416-05</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (84525-416-05) </PackageDescription>
<NDC11Code>84525-0416-05</NDC11Code>
<ProductNDC>84525-416</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Retinol Serum</ProprietaryName>
<NonProprietaryName>Retinol Serum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250111</StartMarketingDate>
<EndMarketingDate>20310111</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Zhixin Trade Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250111</StartMarketingDatePackage>
<EndMarketingDatePackage>20310111</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-416-05</NDCCode>
<PackageDescription>100 g in 1 BOX (84756-416-05) </PackageDescription>
<NDC11Code>84756-0416-05</NDC11Code>
<ProductNDC>84756-416</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Retinol Cream</ProprietaryName>
<NonProprietaryName>Retinol Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241123</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Zhixin Trade Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84827-416-05</NDCCode>
<PackageDescription>100 mL in 1 BOX (84827-416-05) </PackageDescription>
<NDC11Code>84827-0416-05</NDC11Code>
<ProductNDC>84827-416</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Onion Oil</ProprietaryName>
<NonProprietaryName>Trstay Onion Oil</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241106</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63187-349-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (63187-349-01) * 10 mL in 1 VIAL, SINGLE-DOSE (0003-0293-05) * .3 mL in 1 AMPULE (39822-9900-2) * 2.2 g in 1 PACKET (10819-3883-3) * 10 mL in 1 AMPULE (63323-201-10)</PackageDescription>
<NDC11Code>63187-0349-01</NDC11Code>
<ProductNDC>63187-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Interarticular Joint Kit</ProprietaryName>
<NonProprietaryName>Ammonia, Lidocaine Hydrochloride Anhydrous, Triamcinolone Acetonide, Povidone-iodine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20140205</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA014901</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63323-026-05</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (63323-026-05) > 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>63323-0026-05</NDC11Code>
<ProductNDC>63323-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20000810</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>APP Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>42</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63323-083-05</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (63323-083-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-083-03) </PackageDescription>
<NDC11Code>63323-0083-05</NDC11Code>
<ProductNDC>63323-083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206688</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>42</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Alkalinizing Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis — e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial — e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.</IndicationAndUsage>
<Description>Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solutions are offered in concentrations of 4.2% and 8.4%. See table in HOW SUPPLIED/STORAGE AND HANDLING section for contents and characteristics. The solution has an approximate pH of 8.0 (7.0 – 8.5). The solutions contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit. Sodium Bicarbonate, 84 mg is equal to one milliequivalent each of Na+ and HCO3-. Sodium Bicarbonate, 42 mg is equal to 0.5 milliequivalents each of Na+ and HCO3-. Sodium Bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water.Water for Injection, USP is chemically designated H2O.</Description>
</NDC>
<NDC>
<NDCCode>63323-086-05</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (63323-086-05) > 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>63323-0086-05</NDC11Code>
<ProductNDC>63323-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphate, Monobasic And Potassium Phosphate, Dibasic</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20000808</StartMarketingDate>
<EndMarketingDate>20221130</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC</SubstanceName>
<StrengthNumber>236; 224</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20000808</StartMarketingDatePackage>
<EndMarketingDatePackage>20221031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63323-104-05</NDCCode>
<PackageDescription>10 BOX in 1 CARTON (63323-104-05) / 1 VIAL, MULTI-DOSE in 1 BOX (63323-104-01) / 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>63323-0104-05</NDC11Code>
<ProductNDC>63323-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etoposide</ProprietaryName>
<NonProprietaryName>Etoposide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20010718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074983</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>ETOPOSIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Etoposide (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4’-demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside]. It is very soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble in water and ether. It is made more miscible with water by means of organic solvents. Etoposide Injection, USP is available for intravenous use as a 20 mg/mL solution in 100 mg (5 mL), 500 mg (25 mL), or 1 gram (50 mL) sterile, multiple dose vials. The pH of the clear, nearly colorless to yellow liquid is 3 to 4. Each mL contains 20 mg etoposide, 2 mg citric acid, 30 mg benzyl alcohol, 80 mg polysorbate 80/tween 80, 650 mg polyethylene glycol 300, and 30.5 percent (v/v) alcohol. Vial headspace contains nitrogen. The structural formula is. C 29H 32O 13 M.W. 588.56.</Description>
</NDC>
<NDC>
<NDCCode>63323-106-05</NDCCode>
<PackageDescription>24 BAG in 1 CASE (63323-106-05) / 50 mL in 1 BAG (63323-106-02) </PackageDescription>
<NDC11Code>63323-0106-05</NDC11Code>
<ProductNDC>63323-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Magnesium Sulfate</ProprietaryName>
<NonProprietaryName>Magnesium Sulfate Heptahydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206485</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Magnesium sulfate in water for injection is indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.</IndicationAndUsage>
<Description>Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes. Magnesium sulfate, USP heptahydrate is chemically designated MgSO 4 7H 2O, colorless crystals or white powder freely soluble in water. Water for injection, USP is chemically designated H 2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( freeflex ® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. Exposure to temperatures above 25ºC/77ºF during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
</NDC>
<NDC>
<NDCCode>63323-107-05</NDCCode>
<PackageDescription>24 BAG in 1 CASE (63323-107-05) / 50 mL in 1 BAG (63323-107-01) </PackageDescription>
<NDC11Code>63323-0107-05</NDC11Code>
<ProductNDC>63323-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Magnesium Sulfate</ProprietaryName>
<NonProprietaryName>Magnesium Sulfate Heptahydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206485</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Magnesium sulfate in water for injection is indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.</IndicationAndUsage>
<Description>Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes. Magnesium sulfate, USP heptahydrate is chemically designated MgSO 4 7H 2O, colorless crystals or white powder freely soluble in water. Water for injection, USP is chemically designated H 2O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( freeflex ® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. Exposure to temperatures above 25ºC/77ºF during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
</NDC>
<NDC>
<NDCCode>63323-118-05</NDCCode>
<PackageDescription>24 BLISTER PACK in 1 CARTON (63323-118-05) / 1 SYRINGE in 1 BLISTER PACK (63323-118-01) / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>63323-0118-05</NDC11Code>
<ProductNDC>63323-118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium</ProprietaryName>
<NonProprietaryName>Heparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20181116</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017029</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>5000</StrengthNumber>
<StrengthUnit>[USP'U]/.5mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181116</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, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of heparin sodium (representative subunits):. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. 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. Each 0.5 mL of Heparin Sodium Injection, USP contains:. pH 5.0-7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>63323-165-05</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (63323-165-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-165-03) </PackageDescription>
<NDC11Code>63323-0165-05</NDC11Code>
<ProductNDC>63323-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
<NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20000907</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084916</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000907</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Dexamethasone sodium phosphate is a water-soluble inorganic ester of dexamethasone. It occurs as a white or slightly yellow crystalline powder, is odorless or has a slight odor of alcohol, is exceedingly hygroscopic and is freely soluble in water. Dexamethasone sodium phosphate is an adrenocortical steroid anti-inflammatory drug. Chemically, dexamethasone sodium phosphate is 9-Fluoro-11ß,17,21-trihydroxy-16α-methylpregna-1, 4-diene-3,20-dione 21-(dihydrogen phosphate) disodium salt and has the following structural formula. Dexamethasone Sodium Phosphate Injection, USP is a sterile solution of dexamethasone sodium phosphate in water for injection for intravenous (IV), intramuscular (IM), intra-articular, soft-tissue or intralesional use. Each mL contains dexamethasone sodium phosphate equivalent to dexamethasone phosphate 4 mg or dexamethasone 3.33 mg; benzyl alcohol 10 mg added as preservative; sodium citrate dihydrate 11 mg; sodium sulfite 1 mg as an antioxidant; Water for Injection q.s. Citric acid and/or sodium hydroxide may have been added for pH adjustment (7.0 to 8.5). Air in the container is displaced by nitrogen.</Description>
</NDC>
<NDC>
<NDCCode>63323-170-05</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (63323-170-05) > 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>63323-0170-05</NDC11Code>
<ProductNDC>63323-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Phosphates</ProprietaryName>
<NonProprietaryName>Sodium Phosphate, Monobasic, Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20000906</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS</SubstanceName>
<StrengthNumber>276; 142</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Phosphates Injection, USP is indicated as a source of phosphate, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.</IndicationAndUsage>
<Description>Sodium Phosphates Injection, USP, 3 mmol/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in Water for Injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains: Monobasic sodium phosphate, monohydrate, 276 mg; dibasic sodium phosphate, anhydrous, 142 mg (equivalent to dibasic sodium phosphate, heptahydrate, 268 mg); Water for Injection q.s. In the 5 mL and 15 mL product, phosphoric acid and/or NaOH may have been added for pH adjustment. Each mL provides 3 mmol of phosphorus and 4 mEq sodium. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.7 (approx.). The osmolar concentration is 7 mOsmol/mL (calc.). The solution is intended as an alternative to potassium phosphate to provide phosphate ion (PO 43-) for addition to large volume infusion fluids for intravenous use. Sodium Phosphates, USP, monohydrate monobasic is chemically designated NaH 2PO 4 H 2O. Occurs as white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP, anhydrous, is chemically designated Na 2HPO 4. Occurs as a colorless or white granular salt freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>63323-172-05</NDCCode>
<PackageDescription>1 VIAL in 1 BOX (63323-172-05) > 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>63323-0172-05</NDC11Code>
<ProductNDC>63323-172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carboplatin</ProprietaryName>
<NonProprietaryName>Carboplatin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077432</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>CARBOPLATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63323-185-05</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-05) > 5 mL in 1 VIAL, SINGLE-DOSE (63323-185-04) </PackageDescription>
<NDC11Code>63323-0185-05</NDC11Code>
<ProductNDC>63323-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sterile Water</ProprietaryName>
<NonProprietaryName>Water</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20000905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088400</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.</IndicationAndUsage>
<Description>This preparation is designed solely for parenteral use only after addition to drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers to dilute or dissolve drugs for injection. For IV injection, add sufficient amount to a solute to make an approximately isotonic solution. pH 5.0 to 7.0. Water for Injection, USP is chemically designated H 2O.</Description>
</NDC>
</NDCList>