{
"NDC": [
{
"NDCCode": "39822-1410-6",
"PackageDescription": "10 AMPULE in 1 CARTON (39822-1410-6) > 5 mL in 1 AMPULE (39822-1410-5) ",
"NDC11Code": "39822-1410-06",
"ProductNDC": "39822-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rezipres",
"NonProprietaryName": "Ephedrine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210614",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213536",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "EPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "4.7",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20211101",
"SamplePackage": "N"
},
{
"NDCCode": "59762-1410-7",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (59762-1410-7) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "59762-1410-07",
"ProductNDC": "59762-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20051208",
"EndMarketingDate": "20141231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077376",
"LabelerName": "Greenstone LLC",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-01-02"
},
{
"NDCCode": "60219-1410-6",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (60219-1410-6) ",
"NDC11Code": "60219-1410-06",
"ProductNDC": "60219-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apremilast",
"NonProprietaryName": "Apremilast",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211782",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "APREMILAST",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210705",
"SamplePackage": "N",
"IndicationAndUsage": "Apremilast, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: 1 Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. (1.2).",
"Description": "The active ingredient in apremilast tablets is apremilast. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor. Apremilast is known chemically as N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide. Its molecular formula is C22H24N2O7S and the molecular weight is 460.50 g/mol. The chemical structure is. Apremilast is a white to pale yellow powder. It is soluble in acetone and practically insoluble in water. Apremilast tablets are supplied in 10 mg, 20 mg, and 30 mg strengths for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: croscarmellose sodium, ferrosoferric oxide (30 mg), iron oxide red, iron oxide yellow (20 mg and 30 mg), lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "62991-1410-6",
"PackageDescription": "1 g in 1 JAR (62991-1410-6) ",
"NDC11Code": "62991-1410-06",
"ProductNDC": "62991-1410",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Oxycodone Hcl",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110125",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "LETCO MEDICAL, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"DEASchedule": "CII",
"Status": "Unfinished",
"LastUpdate": "2024-02-03",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "25-JAN-11"
},
{
"NDCCode": "39822-0127-6",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 BOX (39822-0127-6) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (39822-0127-5) ",
"NDC11Code": "39822-0127-06",
"ProductNDC": "39822-0127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin, Tazobactam",
"NonProprietaryName": "Piperacillin, Tazobactam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207847",
"LabelerName": "X-GEN Pharmaceuticals, Inc.",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "4; .5",
"StrengthUnit": "g/1; g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170201",
"SamplePackage": "N"
},
{
"NDCCode": "39822-0171-7",
"PackageDescription": "10 VIAL in 1 CARTON (39822-0171-7) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (39822-0171-6)",
"NDC11Code": "39822-0171-07",
"ProductNDC": "39822-0171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polymyxin B",
"NonProprietaryName": "Polymyxin B",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20140425",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202766",
"LabelerName": "X-GEN Pharmaceuticals, Inc.",
"SubstanceName": "POLYMYXIN B SULFATE",
"StrengthNumber": "500000",
"StrengthUnit": "[USP'U]/1",
"Pharm_Classes": "Polymyxin-class Antibacterial [EPC],Polymyxins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "39822-0353-6",
"PackageDescription": "10 mL in 1 VIAL (39822-0353-6) ",
"NDC11Code": "39822-0353-06",
"ProductNDC": "39822-0353",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lincomycin",
"NonProprietaryName": "Lincomycin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL",
"StartMarketingDate": "20150705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201746",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "LINCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2022-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150705",
"SamplePackage": "N",
"IndicationAndUsage": "Lincomycin Injection, USP is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. Lincomycin injection may be administered concomitantly with other antimicrobial agents when indicated. Lincomycin is not indicated in the treatment of minor bacterial infections or viral infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Lincomycin and other antibacterial drugs, Lincomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Lincomycin Injection, USP is a sterile solution containing lincomycin hydrochloride which is the monohydrated salt of lincomycin, a lincosamide antibacterial produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C 18H 34N 2O 6SHClH 2O and the molecular weight is 461.01. The structural formula is represented below. Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. Lincomycin Injection contains lincomycin hydrochloride in a sterile, clear, colorless solution with benzyl alcohol used as a preservative 9.45 mg/mL, and water for injection. Lincomycin Injection is a sterile solution for intramuscular and intravenous use. Lincomycin injection is supplied in 2 mL and 10 mL multiple-dose vials containing the equivalent of 300 mg/mL of lincomycin (equivalent to 340 mg/mL of lincomycin hydrochloride, USP)."
},
{
"NDCCode": "39822-0409-6",
"PackageDescription": "6 CARTON in 1 CARTON (39822-0409-6) > 1 VIAL in 1 CARTON (39822-0409-1) > 30 mL in 1 VIAL",
"NDC11Code": "39822-0409-06",
"ProductNDC": "39822-0409",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20010817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065013",
"LabelerName": "X-GEN Pharmaceuticals, Inc.",
"SubstanceName": "TOBRAMYCIN SULFATE",
"StrengthNumber": "1.2",
"StrengthUnit": "g/30mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "39822-0412-6",
"PackageDescription": "6 VIAL in 1 CARTON (39822-0412-6) / 30 mL in 1 VIAL",
"NDC11Code": "39822-0412-06",
"ProductNDC": "39822-0412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20010817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065013",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "TOBRAMYCIN SULFATE",
"StrengthNumber": "1.2",
"StrengthUnit": "g/30mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010817",
"SamplePackage": "N",
"IndicationAndUsage": "Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below. - Septicemia in the neonate, child, and adult caused by P. aeruginosa, E. coli, and Klebsiella sp. - Lower respiratory tract infections caused by P. aeruginosa, Klebsiella sp, Enterobacter sp, Serratia sp, E. coli, and S. aureus (penicillinase and non-penicillinase-producing strains). - Serious central-nervous-system infections (meningitis) caused by susceptible organisms. - Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella sp, and Enterobacter sp. - Skin, bone, and skin-structure infections caused by P. aeruginosa,Proteus sp, E. coli, Klebsiella sp, Enterobacter sp, and S. aureus. - Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus sp (indole-positive and indole-negative), E. coli, Klebsiella sp, Enterobacter sp, Serratia sp, S. aureus, Providencia sp, and Citrobacter sp. Aminoglycosides, including tobramycin sulfate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use. Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulfate may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the WARNINGSbox above. To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Tobramycin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from the actinomycete Streptomyces tenebrarius. Tobramycin for injection, USP is supplied as a sterile dry powder and is intended for reconstitution with 30 mL of sterile water for injection, USP. Sulfuric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH. Each vial contains tobramycin sulfate equivalent to 1200 mg of tobramycin. After reconstitution, the solution will contain 40 mg of tobramycin per mL. The product contains no preservative or sodium bisulfite. Tobramycin sulfate is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)- O-[2,6-diamino-2,3,6-trideoxy-α-D- ribo-hexopyranosyl-(1→6)-2-deoxy-L-streptamine, sulfate (2:5)(salt) and has the chemical formula (C 18H 37N 5O 9) 25H 2SO 4. The molecular weight is 1,425.39. The structural formula for tobramycin is as follows:. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion (see DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package)."
},
{
"NDCCode": "39822-0650-6",
"PackageDescription": "6 VIAL in 1 CARTON (39822-0650-6) / 50 mL in 1 VIAL",
"NDC11Code": "39822-0650-06",
"ProductNDC": "39822-0650",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nelarabine",
"NonProprietaryName": "Nelarabine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216510",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "NELARABINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250217",
"SamplePackage": "N",
"IndicationAndUsage": "Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.",
"Description": "Nelarabine is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β- D-arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β- D-arabinofuranosyl-6-methoxy-9 H-purine. It has the molecular formula C 11H 15N 5O 5 and a molecular weight of 297.27. Nelarabine has the following structural formula:. Nelarabine is slightly soluble to soluble in water and melts with decomposition between 209°C and 217°C. Nelarabine injection is supplied as a clear, colorless, sterile solution in glass single-dose vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in 50 mL Water for Injection, USP. Nelarabine injection is intended for intravenous infusion. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0."
},
{
"NDCCode": "39822-1001-7",
"PackageDescription": "10 VIAL in 1 CARTON (39822-1001-7) > 10 mL in 1 VIAL (39822-1001-6) ",
"NDC11Code": "39822-1001-07",
"ProductNDC": "39822-1001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tranexamic Acid",
"NonProprietaryName": "Tranexamic Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201580",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "TRANEXAMIC ACID",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20120518",
"SamplePackage": "N"
},
{
"NDCCode": "39822-3015-6",
"PackageDescription": "60 g in 1 BOTTLE, PLASTIC (39822-3015-6) ",
"NDC11Code": "39822-3015-06",
"ProductNDC": "39822-3015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065175",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/g",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-03-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20040830",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Topical Powder is not indicated for systemic, oral, intravaginal or ophthalmic use.",
"Description": "Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for nystatin is C 47H 75NO 17. The molecular weight of nystatin is 926.1. Nystatin Topical Powder is for dermatologic use. Nystatin Topical Powder contains 100,000 USP nystatin units per gram dispersed in talc."
},
{
"NDCCode": "39822-3030-2",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (39822-3030-2) / 6 mL in 1 VIAL, SINGLE-DOSE (39822-3030-1) ",
"NDC11Code": "39822-3030-02",
"ProductNDC": "39822-3030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pentamidine Isethionate",
"NonProprietaryName": "Pentamidine Isethionate",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20230404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206983",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "PENTAMIDINE ISETHIONATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/6mL",
"Pharm_Classes": "Antiprotozoal [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230404",
"SamplePackage": "N",
"IndicationAndUsage": "Pentamidine Isethionate is indicated for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients defined by one or both of the following criteria:. i. a history of one or more episodes of PJP. ii. a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm 3. These indications are based on the results of an 18-month randomized, dose-response trial in high risk HIV-infected patients and on existing epidemiological data from natural history studies. The patient population of the controlled trial consisted of 408 patients, 237 of whom had a history of one or more episodes of PJP. The remaining patients without a history of PJP included 55 patients with Kaposi’s sarcoma and 116 patients with other AIDS diagnoses, ARC or asymptomatic HIV infection. Patients were randomly assigned to receive Pentamidine isethionate via the Respirgard ® II nebulizer at one of the following three doses: 30 mg every two weeks (n=135), 150 mg every two weeks (n=134) or 300 mg every four weeks (n=139). The results of the trial demonstrated a significant protective effect (p<0.01) against PJP with the 300 mg every four week dosage regimen compared to the 30 mg every two week dosage regimen. The 300 mg dose regimen reduced the risk of developing PJP by 50 to 70% compared to the 30 mg regimen. A total of 293 patients (72% of all patients) also received zidovudine at sometime during the trial. The analysis of the data demonstrated the efficacy of the 300 mg dose even after adjusting for the effect of zidovudine. The results of the trial further demonstrate that the dose and frequency of dosing are important to the efficacy of Pentamidine Isethionate prophylaxis in that multiple analyses consistently demonstrated a trend toward greater efficacy with 300 mg every four weeks as compared to 150 mg every two weeks. No dose-response was observed for reduction in overall mortality; however, mortality from PJP was low in all three dosage groups.",
"Description": "Pentamidine Isethionate for inhalation, an antifungal agent, is a nonpyrogenic lyophilized product. After reconstitution with Sterile Water for Injection, USP, Pentamidine Isethionate is administered by inhalation via the Respirgard ® II nebulizer [Marquest, Englewood, CO] (see DOSAGE AND ADMINISTRATION). Pentamidine isethionate, 4,4’-[1,5-pentane-diylbis(oxy)]bis-benzenecarboximidamid, is a white crystalline powder soluble in water and glycerin and insoluble in ether, acetone, and chloroform. C 19H 24N 4O 22C 2H 6O 4S 592.68. Each vial contains 300 mg pentamidine isethionate."
},
{
"NDCCode": "39822-3030-3",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (39822-3030-3) / 6 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "39822-3030-03",
"ProductNDC": "39822-3030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pentamidine Isethionate",
"NonProprietaryName": "Pentamidine Isethionate",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20230404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206983",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "PENTAMIDINE ISETHIONATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/6mL",
"Pharm_Classes": "Antiprotozoal [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230404",
"SamplePackage": "N"
},
{
"NDCCode": "39822-4050-6",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (39822-4050-6) > 10 mL in 1 VIAL, SINGLE-DOSE (39822-4050-5)",
"NDC11Code": "39822-4050-06",
"ProductNDC": "39822-4050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenytoin Sodium",
"NonProprietaryName": "Phenytoin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20110502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040573",
"LabelerName": "X-GEN Pharmaceuticals, Inc.",
"SubstanceName": "PHENYTOIN SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "39822-4200-6",
"PackageDescription": "10 VIAL in 1 CARTON (39822-4200-6) > 10 mL in 1 VIAL (39822-4200-5) ",
"NDC11Code": "39822-4200-06",
"ProductNDC": "39822-4200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rocuronium Bromide",
"NonProprietaryName": "Rocuronium Bromide",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20121201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091115",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "ROCURONIUM BROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121201",
"SamplePackage": "N",
"IndicationAndUsage": "Rocuronium bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium bromide. The structural formula is. The chemical formula is C 32H 53BrN 2O 4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide."
},
{
"NDCCode": "39822-5500-6",
"PackageDescription": "25 AMPULE in 1 CARTON (39822-5500-6) > 2 mL in 1 AMPULE (39822-5500-5)",
"NDC11Code": "39822-5500-06",
"ProductNDC": "39822-5500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20110502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040737",
"LabelerName": "X-GEN Pharmaceuticals, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-12-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "39822-5550-6",
"PackageDescription": "25 AMPULE in 1 CARTON (39822-5550-6) / 1 mL in 1 AMPULE (39822-5550-5) ",
"NDC11Code": "39822-5550-06",
"ProductNDC": "39822-5550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20150130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040737",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2024-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150130",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride injection is indicated for the following conditions: 1 Amelioration of allergic reactions to blood or plasma., 2 In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled., 3 For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated., 4 For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused., 5 Active treatment of motion sickness., 6 Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery., 7 As an adjunct to analgesics for the control of postoperative pain., 8 Preoperative, postoperative, and obstetric (during labor) sedation., 9 Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.",
"Description": "Promethazine hydrochloride injection, USP is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine hydrochloride (10H-phenothiazine-10-ethanamine, N, N, α-trimethyl-, monohydrochloride, (±)-) is a racemic compound and has the following structural formula. Each mL contains promethazine hydrochloride, either 25 mg or 50 mg, edetate disodium 0.1 mg, calcium chloride 0.04 mg, sodium metabisulfite 0.25 mg and phenol 5 mg in Water for Injection, USP. pH 4.0 to 5.5; buffered with acetic acid-sodium acetate. Sealed under nitrogen. Promethazine hydrochloride injection is a clear, colorless solution. The product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed."
},
{
"NDCCode": "39822-9994-6",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 BOX (39822-9994-6) > 50 mL in 1 VIAL, SINGLE-USE (39822-9994-5)",
"NDC11Code": "39822-9994-06",
"ProductNDC": "39822-9994",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin, Tazobactam",
"NonProprietaryName": "Piperacillin, Tazobactam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170214",
"EndMarketingDate": "20171130",
"MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
"LabelerName": "X-GEN Pharmaceuticals, Inc.",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "4; .5",
"StrengthUnit": "g/50mL; g/50mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "0228-1410-03",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-1410-03) ",
"NDC11Code": "00228-1410-03",
"ProductNDC": "0228-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160401",
"EndMarketingDate": "20260831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200672",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160401",
"EndMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine extended-release tablets are indicated for: 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). (1.2).",
"Description": "Lamotrigine extended-release tablets, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 100 mg (gray, round), 200 mg (white to off-white, round), 250 mg (yellow, capsule-shaped), and 300 mg (gray, capsule-shaped) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: hypromellose, lactose monohydrate; magnesium stearate; methacrylic acid copolymer, silicon dioxide, talc, titanium dioxide, and triethyl citrate. In addition, the 100 mg and 300 mg tablets also contain FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake (Sunset Yellow Lake) and triacetin. The 200 mg tablets also contain polyethylene glycol 400. The 250 mg tablets also contain black iron oxide, medium chain triglycerides, copovidone, polydextrose, polyethylene glycol 3350, red iron oxide, and yellow iron oxide. Lamotrigine extended-release tablets, USP contain a modified-release formulation as the core. The tablets are coated with an enteric coat, dry coat and color coat, to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of time. Meets USP Dissolution Test 7."
},
{
"NDCCode": "0456-1410-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0456-1410-01) ",
"NDC11Code": "00456-1410-01",
"ProductNDC": "0456-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bystolic",
"NonProprietaryName": "Nebivolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080122",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021742",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "NEBIVOLOL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080122",
"SamplePackage": "N",
"IndicationAndUsage": "BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate."
},
{
"NDCCode": "0456-1410-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0456-1410-30) ",
"NDC11Code": "00456-1410-30",
"ProductNDC": "0456-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bystolic",
"NonProprietaryName": "Nebivolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080122",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021742",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "NEBIVOLOL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080122",
"SamplePackage": "N",
"IndicationAndUsage": "BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate."
},
{
"NDCCode": "0456-1410-63",
"PackageDescription": "100 TABLET in 1 BOX, UNIT-DOSE (0456-1410-63) ",
"NDC11Code": "00456-1410-63",
"ProductNDC": "0456-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bystolic",
"NonProprietaryName": "Nebivolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080122",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021742",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "NEBIVOLOL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080122",
"SamplePackage": "N",
"IndicationAndUsage": "BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate."
},
{
"NDCCode": "0456-1410-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (0456-1410-90) ",
"NDC11Code": "00456-1410-90",
"ProductNDC": "0456-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bystolic",
"NonProprietaryName": "Nebivolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080122",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021742",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "NEBIVOLOL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080122",
"SamplePackage": "N",
"IndicationAndUsage": "BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate."
},
{
"NDCCode": "0574-1410-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (0574-1410-28) ",
"NDC11Code": "00574-1410-28",
"ProductNDC": "0574-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lenalidomide",
"NonProprietaryName": "Lenalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217265",
"LabelerName": "Padagis US LLC",
"SubstanceName": "LENALIDOMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "Lenalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients with. Multiple myeloma (MM), in combination with dexamethasone (1.1). MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1). Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2). Limitations of Use. Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials (1.6).",
"Description": "Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H- isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is a white to slight yellow crystalline powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide capsules are available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 2.5 mg capsule shell contains gelatin, FD&C blue #1, yellow iron oxide, titanium dioxide and black ink. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 10 mg capsule shell contains gelatin, FD&C blue #1, FD&C yellow #6, red iron oxide, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #1, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #1, yellow iron oxide, titanium dioxide and black ink. The black ink contains dewaxed shellac, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "0641-1410-35",
"PackageDescription": "25 AMPULE in 1 CARTON (0641-1410-35) / 2 mL in 1 AMPULE (0641-1410-31) ",
"NDC11Code": "00641-1410-35",
"ProductNDC": "0641-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19751024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083391",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DIGOXIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19751024",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Control of resting ventricular rate in adults with chronic atrial fibrillation. (1.3) .",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin has the chemical name: 3β-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide, and the following structural formula. C41H64O14 MW 780.94. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Injection, USP is a sterile solution for slow intravenous or deep intramuscular injection. Each mL contains digoxin 250 mcg (0.25 mg), alcohol 0.1 mL, propylene glycol 0.4 mL, dibasic sodium phosphate, anhydrous 3 mg and citric acid, anhydrous 0.8 mg in Water for Injection. pH 6.7-7.3; citric acid and/or sodium phosphate added, if necessary, for pH adjustment. Dilution is not required."
},
{
"NDCCode": "0832-1410-03",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0832-1410-03) / 3 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00832-1410-03",
"ProductNDC": "0832-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Moxifloxacin Hydrochloride",
"NonProprietaryName": "Moxifloxacin Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20210210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212616",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2023-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210210",
"SamplePackage": "N",
"IndicationAndUsage": "Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms. Corynebacterium speciesEfficacy for this organism was studied in fewer than 10 infections.Micrococcus luteusStaphylococcus aureusStaphylococcus epidermidisStaphylococcus haemolyticusStaphylococcus hominisStaphylococcus warneriStreptococcus pneumoniaeStreptococcus viridans groupAcinetobacter lwoffiiHaemophilus influenzaHaemophilus parainfluenzaeChlamydia trachomatis.",
"Description": "Moxifloxacin ophthalmic solution, USP 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. Chemical Name: 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4b]pyridin6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride. The molecular formula for moxifloxacin hydrochloride, USP is C21H24FN3O4∙HCl and its molecular weight is 437.9 g/mol. The chemical structure is presented below. Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. Each mL of moxifloxacin ophthalmic solution contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base. Moxifloxacin ophthalmic solution contains: Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, purified water and sodium chloride. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8. Moxifloxacin ophthalmic solution, USP is an isotonic solution with an osmolality of approximately 290 mOsm/kg."
},
{
"NDCCode": "51662-1410-1",
"PackageDescription": "1 mL in 1 VIAL (51662-1410-1) ",
"NDC11Code": "51662-1410-01",
"ProductNDC": "51662-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyridoxine Hci",
"NonProprietaryName": "Pyridoxine Hci",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20191008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080618",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191008",
"SamplePackage": "N",
"IndicationAndUsage": "Pyridoxine Hydrochloride Injection is effective for the treatment of pyridoxine deficiency as seen in the following. Inadequate dietary intake. Drug-induced deficiency, as from isoniazid (INH) or oral contraceptives. Inborn errors of metabolism, e.g., vitamin B6 dependent convulsions or vitamin B6 responsive anemia. The parenteral route is indicated when oral administration is not feasible as in anorexia, nausea and vomiting, and preoperative and postoperative conditions. It is also indicated when gastrointestinal absorption is impaired.",
"Description": "Pyridoxine Hydrochloride Injection, USP is a sterile solution of pyridoxine hydrochloride in Water for Injection. Each mL contains 100 mg pyridoxine hydrochloride and 0.5% chlorobutanol anhydrous (chloral deriv.). pH adjusted with sodium hydroxide if necessary (2.0 to 3.8). Pyridoxine hydrochloride is a colorless or white crystal or a white crystalline powder. One gram dissolves in 5 mL of water. It is stable in air and is slowly affected by sunlight. The chemical name is 2-methyl-3-hydroxy-4,5-bis (hydroxymethyl) pyridine hydrochloride. The structural formula is."
},
{
"NDCCode": "51662-1410-3",
"PackageDescription": "25 POUCH in 1 CASE (51662-1410-3) / 1 VIAL in 1 POUCH (51662-1410-2) / 1 mL in 1 VIAL",
"NDC11Code": "51662-1410-03",
"ProductNDC": "51662-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyridoxine Hci",
"NonProprietaryName": "Pyridoxine Hci",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20191008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080618",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221211",
"SamplePackage": "N",
"IndicationAndUsage": "Pyridoxine Hydrochloride Injection is effective for the treatment of pyridoxine deficiency as seen in the following. Inadequate dietary intake. Drug-induced deficiency, as from isoniazid (INH) or oral contraceptives. Inborn errors of metabolism, e.g., vitamin B6 dependent convulsions or vitamin B6 responsive anemia. The parenteral route is indicated when oral administration is not feasible as in anorexia, nausea and vomiting, and preoperative and postoperative conditions. It is also indicated when gastrointestinal absorption is impaired.",
"Description": "Pyridoxine Hydrochloride Injection, USP is a sterile solution of pyridoxine hydrochloride in Water for Injection. Each mL contains 100 mg pyridoxine hydrochloride and 0.5% chlorobutanol anhydrous (chloral deriv.). pH adjusted with sodium hydroxide if necessary (2.0 to 3.8). Pyridoxine hydrochloride is a colorless or white crystal or a white crystalline powder. One gram dissolves in 5 mL of water. It is stable in air and is slowly affected by sunlight. The chemical name is 2-methyl-3-hydroxy-4,5-bis (hydroxymethyl) pyridine hydrochloride. The structural formula is."
},
{
"NDCCode": "63479-1410-1",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (63479-1410-1) ",
"NDC11Code": "63479-1410-01",
"ProductNDC": "63479-1410",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "N10",
"ProprietaryNameSuffix": "Paraklenz",
"NonProprietaryName": "Allium Cepa, Allium Sativum, Baryta Iodata, Berberis Vulgaris, Carduus Marianus, Chenopodium Anthelminticum, Chininum Arsenicosum, Cina, Cinchona Officinalis, Croton Tiglium, Echinacea Angustifolia, Hydrastis Canadensis, Illicium Anisatum, Lycopodium Clavatum, Natrum Phosphoricum, Rhamnus Purshiana, Santoninum, Scrophularia Nodosa, Senna, Sulphur, Tanacetum Vulgare, Teucrium Marum",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "19941215",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Apex Energetics Inc.",
"SubstanceName": "TEUCRIUM MARUM; ONION; GARLIC; SCROPHULARIA NODOSA; TANACETUM VULGARE TOP; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; STAR ANISE; FRANGULA PURSHIANA BARK; SANTONIN; ARTEMISIA CINA FLOWER; MILK THISTLE; CHENOPODIUM AMBROSIOIDES; QUININE ARSENITE; CINCHONA OFFICINALIS BARK; CROTON TIGLIUM SEED; SENNA LEAF; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SULFUR; BARIUM IODIDE; BERBERIS VULGARIS ROOT BARK; LYCOPODIUM CLAVATUM SPORE",
"StrengthNumber": "8; 1; 1; 3; 8; 1; 1; 2; 1; 8; 6; 1; 1; 9; 9; 3; 1; 12; 9; 10; 1; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2024-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19941215",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of minor. digestive discomfort* diarrhea*. skin rash*. gas*. fatigue*. abdominal pain*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
}
]
}
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<NDCList>
<NDC>
<NDCCode>39822-1410-6</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (39822-1410-6) > 5 mL in 1 AMPULE (39822-1410-5) </PackageDescription>
<NDC11Code>39822-1410-06</NDC11Code>
<ProductNDC>39822-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rezipres</ProprietaryName>
<NonProprietaryName>Ephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210614</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213536</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>EPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4.7</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59762-1410-7</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (59762-1410-7) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59762-1410-07</NDC11Code>
<ProductNDC>59762-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051208</StartMarketingDate>
<EndMarketingDate>20141231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077376</ApplicationNumber>
<LabelerName>Greenstone LLC</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-01-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>60219-1410-6</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (60219-1410-6) </PackageDescription>
<NDC11Code>60219-1410-06</NDC11Code>
<ProductNDC>60219-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apremilast</ProprietaryName>
<NonProprietaryName>Apremilast</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211782</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>APREMILAST</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apremilast, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: 1 Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. (1.2).</IndicationAndUsage>
<Description>The active ingredient in apremilast tablets is apremilast. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor. Apremilast is known chemically as N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide. Its molecular formula is C22H24N2O7S and the molecular weight is 460.50 g/mol. The chemical structure is. Apremilast is a white to pale yellow powder. It is soluble in acetone and practically insoluble in water. Apremilast tablets are supplied in 10 mg, 20 mg, and 30 mg strengths for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: croscarmellose sodium, ferrosoferric oxide (30 mg), iron oxide red, iron oxide yellow (20 mg and 30 mg), lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>62991-1410-6</NDCCode>
<PackageDescription>1 g in 1 JAR (62991-1410-6) </PackageDescription>
<NDC11Code>62991-1410-06</NDC11Code>
<ProductNDC>62991-1410</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Oxycodone Hcl</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110125</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>LETCO MEDICAL, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2024-02-03</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>25-JAN-11</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>39822-0127-6</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 BOX (39822-0127-6) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (39822-0127-5) </PackageDescription>
<NDC11Code>39822-0127-06</NDC11Code>
<ProductNDC>39822-0127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin, Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin, Tazobactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207847</ApplicationNumber>
<LabelerName>X-GEN Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>4; .5</StrengthNumber>
<StrengthUnit>g/1; g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>39822-0171-7</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (39822-0171-7) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (39822-0171-6)</PackageDescription>
<NDC11Code>39822-0171-07</NDC11Code>
<ProductNDC>39822-0171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polymyxin B</ProprietaryName>
<NonProprietaryName>Polymyxin B</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20140425</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202766</ApplicationNumber>
<LabelerName>X-GEN Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>500000</StrengthNumber>
<StrengthUnit>[USP'U]/1</StrengthUnit>
<Pharm_Classes>Polymyxin-class Antibacterial [EPC],Polymyxins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>39822-0353-6</NDCCode>
<PackageDescription>10 mL in 1 VIAL (39822-0353-6) </PackageDescription>
<NDC11Code>39822-0353-06</NDC11Code>
<ProductNDC>39822-0353</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lincomycin</ProprietaryName>
<NonProprietaryName>Lincomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL</RouteName>
<StartMarketingDate>20150705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201746</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>LINCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lincomycin Injection, USP is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. Lincomycin injection may be administered concomitantly with other antimicrobial agents when indicated. Lincomycin is not indicated in the treatment of minor bacterial infections or viral infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Lincomycin and other antibacterial drugs, Lincomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Lincomycin Injection, USP is a sterile solution containing lincomycin hydrochloride which is the monohydrated salt of lincomycin, a lincosamide antibacterial produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C 18H 34N 2O 6SHClH 2O and the molecular weight is 461.01. The structural formula is represented below. Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. Lincomycin Injection contains lincomycin hydrochloride in a sterile, clear, colorless solution with benzyl alcohol used as a preservative 9.45 mg/mL, and water for injection. Lincomycin Injection is a sterile solution for intramuscular and intravenous use. Lincomycin injection is supplied in 2 mL and 10 mL multiple-dose vials containing the equivalent of 300 mg/mL of lincomycin (equivalent to 340 mg/mL of lincomycin hydrochloride, USP).</Description>
</NDC>
<NDC>
<NDCCode>39822-0409-6</NDCCode>
<PackageDescription>6 CARTON in 1 CARTON (39822-0409-6) > 1 VIAL in 1 CARTON (39822-0409-1) > 30 mL in 1 VIAL</PackageDescription>
<NDC11Code>39822-0409-06</NDC11Code>
<ProductNDC>39822-0409</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20010817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065013</ApplicationNumber>
<LabelerName>X-GEN Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOBRAMYCIN SULFATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>g/30mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>39822-0412-6</NDCCode>
<PackageDescription>6 VIAL in 1 CARTON (39822-0412-6) / 30 mL in 1 VIAL</PackageDescription>
<NDC11Code>39822-0412-06</NDC11Code>
<ProductNDC>39822-0412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20010817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065013</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>TOBRAMYCIN SULFATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>g/30mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below. - Septicemia in the neonate, child, and adult caused by P. aeruginosa, E. coli, and Klebsiella sp. - Lower respiratory tract infections caused by P. aeruginosa, Klebsiella sp, Enterobacter sp, Serratia sp, E. coli, and S. aureus (penicillinase and non-penicillinase-producing strains). - Serious central-nervous-system infections (meningitis) caused by susceptible organisms. - Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella sp, and Enterobacter sp. - Skin, bone, and skin-structure infections caused by P. aeruginosa,Proteus sp, E. coli, Klebsiella sp, Enterobacter sp, and S. aureus. - Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus sp (indole-positive and indole-negative), E. coli, Klebsiella sp, Enterobacter sp, Serratia sp, S. aureus, Providencia sp, and Citrobacter sp. Aminoglycosides, including tobramycin sulfate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use. Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulfate may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the WARNINGSbox above. To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Tobramycin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from the actinomycete Streptomyces tenebrarius. Tobramycin for injection, USP is supplied as a sterile dry powder and is intended for reconstitution with 30 mL of sterile water for injection, USP. Sulfuric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH. Each vial contains tobramycin sulfate equivalent to 1200 mg of tobramycin. After reconstitution, the solution will contain 40 mg of tobramycin per mL. The product contains no preservative or sodium bisulfite. Tobramycin sulfate is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)- O-[2,6-diamino-2,3,6-trideoxy-α-D- ribo-hexopyranosyl-(1→6)-2-deoxy-L-streptamine, sulfate (2:5)(salt) and has the chemical formula (C 18H 37N 5O 9) 25H 2SO 4. The molecular weight is 1,425.39. The structural formula for tobramycin is as follows:. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion (see DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package).</Description>
</NDC>
<NDC>
<NDCCode>39822-0650-6</NDCCode>
<PackageDescription>6 VIAL in 1 CARTON (39822-0650-6) / 50 mL in 1 VIAL</PackageDescription>
<NDC11Code>39822-0650-06</NDC11Code>
<ProductNDC>39822-0650</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nelarabine</ProprietaryName>
<NonProprietaryName>Nelarabine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216510</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>NELARABINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.</IndicationAndUsage>
<Description>Nelarabine is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β- D-arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β- D-arabinofuranosyl-6-methoxy-9 H-purine. It has the molecular formula C 11H 15N 5O 5 and a molecular weight of 297.27. Nelarabine has the following structural formula:. Nelarabine is slightly soluble to soluble in water and melts with decomposition between 209°C and 217°C. Nelarabine injection is supplied as a clear, colorless, sterile solution in glass single-dose vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in 50 mL Water for Injection, USP. Nelarabine injection is intended for intravenous infusion. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0.</Description>
</NDC>
<NDC>
<NDCCode>39822-1001-7</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (39822-1001-7) > 10 mL in 1 VIAL (39822-1001-6) </PackageDescription>
<NDC11Code>39822-1001-07</NDC11Code>
<ProductNDC>39822-1001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tranexamic Acid</ProprietaryName>
<NonProprietaryName>Tranexamic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201580</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>TRANEXAMIC ACID</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>39822-3015-6</NDCCode>
<PackageDescription>60 g in 1 BOTTLE, PLASTIC (39822-3015-6) </PackageDescription>
<NDC11Code>39822-3015-06</NDC11Code>
<ProductNDC>39822-3015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20040830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065175</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Topical Powder is not indicated for systemic, oral, intravaginal or ophthalmic use.</IndicationAndUsage>
<Description>Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for nystatin is C 47H 75NO 17. The molecular weight of nystatin is 926.1. Nystatin Topical Powder is for dermatologic use. Nystatin Topical Powder contains 100,000 USP nystatin units per gram dispersed in talc.</Description>
</NDC>
<NDC>
<NDCCode>39822-3030-2</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (39822-3030-2) / 6 mL in 1 VIAL, SINGLE-DOSE (39822-3030-1) </PackageDescription>
<NDC11Code>39822-3030-02</NDC11Code>
<ProductNDC>39822-3030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pentamidine Isethionate</ProprietaryName>
<NonProprietaryName>Pentamidine Isethionate</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20230404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206983</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>PENTAMIDINE ISETHIONATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/6mL</StrengthUnit>
<Pharm_Classes>Antiprotozoal [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pentamidine Isethionate is indicated for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients defined by one or both of the following criteria:. i. a history of one or more episodes of PJP. ii. a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm 3. These indications are based on the results of an 18-month randomized, dose-response trial in high risk HIV-infected patients and on existing epidemiological data from natural history studies. The patient population of the controlled trial consisted of 408 patients, 237 of whom had a history of one or more episodes of PJP. The remaining patients without a history of PJP included 55 patients with Kaposi’s sarcoma and 116 patients with other AIDS diagnoses, ARC or asymptomatic HIV infection. Patients were randomly assigned to receive Pentamidine isethionate via the Respirgard ® II nebulizer at one of the following three doses: 30 mg every two weeks (n=135), 150 mg every two weeks (n=134) or 300 mg every four weeks (n=139). The results of the trial demonstrated a significant protective effect (p<0.01) against PJP with the 300 mg every four week dosage regimen compared to the 30 mg every two week dosage regimen. The 300 mg dose regimen reduced the risk of developing PJP by 50 to 70% compared to the 30 mg regimen. A total of 293 patients (72% of all patients) also received zidovudine at sometime during the trial. The analysis of the data demonstrated the efficacy of the 300 mg dose even after adjusting for the effect of zidovudine. The results of the trial further demonstrate that the dose and frequency of dosing are important to the efficacy of Pentamidine Isethionate prophylaxis in that multiple analyses consistently demonstrated a trend toward greater efficacy with 300 mg every four weeks as compared to 150 mg every two weeks. No dose-response was observed for reduction in overall mortality; however, mortality from PJP was low in all three dosage groups.</IndicationAndUsage>
<Description>Pentamidine Isethionate for inhalation, an antifungal agent, is a nonpyrogenic lyophilized product. After reconstitution with Sterile Water for Injection, USP, Pentamidine Isethionate is administered by inhalation via the Respirgard ® II nebulizer [Marquest, Englewood, CO] (see DOSAGE AND ADMINISTRATION). Pentamidine isethionate, 4,4’-[1,5-pentane-diylbis(oxy)]bis-benzenecarboximidamid, is a white crystalline powder soluble in water and glycerin and insoluble in ether, acetone, and chloroform. C 19H 24N 4O 22C 2H 6O 4S 592.68. Each vial contains 300 mg pentamidine isethionate.</Description>
</NDC>
<NDC>
<NDCCode>39822-3030-3</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (39822-3030-3) / 6 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>39822-3030-03</NDC11Code>
<ProductNDC>39822-3030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pentamidine Isethionate</ProprietaryName>
<NonProprietaryName>Pentamidine Isethionate</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20230404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206983</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>PENTAMIDINE ISETHIONATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/6mL</StrengthUnit>
<Pharm_Classes>Antiprotozoal [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>39822-4050-6</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (39822-4050-6) > 10 mL in 1 VIAL, SINGLE-DOSE (39822-4050-5)</PackageDescription>
<NDC11Code>39822-4050-06</NDC11Code>
<ProductNDC>39822-4050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenytoin Sodium</ProprietaryName>
<NonProprietaryName>Phenytoin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20110502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040573</ApplicationNumber>
<LabelerName>X-GEN Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>39822-4200-6</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (39822-4200-6) > 10 mL in 1 VIAL (39822-4200-5) </PackageDescription>
<NDC11Code>39822-4200-06</NDC11Code>
<ProductNDC>39822-4200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rocuronium Bromide</ProprietaryName>
<NonProprietaryName>Rocuronium Bromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20121201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091115</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>ROCURONIUM BROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rocuronium bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium bromide. The structural formula is. The chemical formula is C 32H 53BrN 2O 4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>39822-5500-6</NDCCode>
<PackageDescription>25 AMPULE in 1 CARTON (39822-5500-6) > 2 mL in 1 AMPULE (39822-5500-5)</PackageDescription>
<NDC11Code>39822-5500-06</NDC11Code>
<ProductNDC>39822-5500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20110502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040737</ApplicationNumber>
<LabelerName>X-GEN Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>39822-5550-6</NDCCode>
<PackageDescription>25 AMPULE in 1 CARTON (39822-5550-6) / 1 mL in 1 AMPULE (39822-5550-5) </PackageDescription>
<NDC11Code>39822-5550-06</NDC11Code>
<ProductNDC>39822-5550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20150130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040737</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride injection is indicated for the following conditions: 1 Amelioration of allergic reactions to blood or plasma., 2 In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled., 3 For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated., 4 For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused., 5 Active treatment of motion sickness., 6 Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery., 7 As an adjunct to analgesics for the control of postoperative pain., 8 Preoperative, postoperative, and obstetric (during labor) sedation., 9 Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.</IndicationAndUsage>
<Description>Promethazine hydrochloride injection, USP is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine hydrochloride (10H-phenothiazine-10-ethanamine, N, N, α-trimethyl-, monohydrochloride, (±)-) is a racemic compound and has the following structural formula. Each mL contains promethazine hydrochloride, either 25 mg or 50 mg, edetate disodium 0.1 mg, calcium chloride 0.04 mg, sodium metabisulfite 0.25 mg and phenol 5 mg in Water for Injection, USP. pH 4.0 to 5.5; buffered with acetic acid-sodium acetate. Sealed under nitrogen. Promethazine hydrochloride injection is a clear, colorless solution. The product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.</Description>
</NDC>
<NDC>
<NDCCode>39822-9994-6</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 BOX (39822-9994-6) > 50 mL in 1 VIAL, SINGLE-USE (39822-9994-5)</PackageDescription>
<NDC11Code>39822-9994-06</NDC11Code>
<ProductNDC>39822-9994</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin, Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin, Tazobactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170214</StartMarketingDate>
<EndMarketingDate>20171130</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</MarketingCategoryName>
<LabelerName>X-GEN Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>4; .5</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>0228-1410-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-1410-03) </PackageDescription>
<NDC11Code>00228-1410-03</NDC11Code>
<ProductNDC>0228-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<EndMarketingDate>20260831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200672</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<EndMarketingDatePackage>20260831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine extended-release tablets are indicated for: 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). (1.2).</IndicationAndUsage>
<Description>Lamotrigine extended-release tablets, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 100 mg (gray, round), 200 mg (white to off-white, round), 250 mg (yellow, capsule-shaped), and 300 mg (gray, capsule-shaped) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: hypromellose, lactose monohydrate; magnesium stearate; methacrylic acid copolymer, silicon dioxide, talc, titanium dioxide, and triethyl citrate. In addition, the 100 mg and 300 mg tablets also contain FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake (Sunset Yellow Lake) and triacetin. The 200 mg tablets also contain polyethylene glycol 400. The 250 mg tablets also contain black iron oxide, medium chain triglycerides, copovidone, polydextrose, polyethylene glycol 3350, red iron oxide, and yellow iron oxide. Lamotrigine extended-release tablets, USP contain a modified-release formulation as the core. The tablets are coated with an enteric coat, dry coat and color coat, to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of time. Meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>0456-1410-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0456-1410-01) </PackageDescription>
<NDC11Code>00456-1410-01</NDC11Code>
<ProductNDC>0456-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bystolic</ProprietaryName>
<NonProprietaryName>Nebivolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080122</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021742</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>0456-1410-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0456-1410-30) </PackageDescription>
<NDC11Code>00456-1410-30</NDC11Code>
<ProductNDC>0456-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bystolic</ProprietaryName>
<NonProprietaryName>Nebivolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080122</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021742</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>0456-1410-63</NDCCode>
<PackageDescription>100 TABLET in 1 BOX, UNIT-DOSE (0456-1410-63) </PackageDescription>
<NDC11Code>00456-1410-63</NDC11Code>
<ProductNDC>0456-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bystolic</ProprietaryName>
<NonProprietaryName>Nebivolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080122</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021742</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>0456-1410-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (0456-1410-90) </PackageDescription>
<NDC11Code>00456-1410-90</NDC11Code>
<ProductNDC>0456-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bystolic</ProprietaryName>
<NonProprietaryName>Nebivolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080122</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021742</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>0574-1410-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (0574-1410-28) </PackageDescription>
<NDC11Code>00574-1410-28</NDC11Code>
<ProductNDC>0574-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lenalidomide</ProprietaryName>
<NonProprietaryName>Lenalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217265</ApplicationNumber>
<LabelerName>Padagis US LLC</LabelerName>
<SubstanceName>LENALIDOMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lenalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients with. Multiple myeloma (MM), in combination with dexamethasone (1.1). MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1). Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2). Limitations of Use. Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials (1.6).</IndicationAndUsage>
<Description>Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H- isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is a white to slight yellow crystalline powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide capsules are available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 2.5 mg capsule shell contains gelatin, FD&C blue #1, yellow iron oxide, titanium dioxide and black ink. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 10 mg capsule shell contains gelatin, FD&C blue #1, FD&C yellow #6, red iron oxide, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #1, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #1, yellow iron oxide, titanium dioxide and black ink. The black ink contains dewaxed shellac, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0641-1410-35</NDCCode>
<PackageDescription>25 AMPULE in 1 CARTON (0641-1410-35) / 2 mL in 1 AMPULE (0641-1410-31) </PackageDescription>
<NDC11Code>00641-1410-35</NDC11Code>
<ProductNDC>0641-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digoxin</ProprietaryName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19751024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083391</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC], Cardiac Glycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19751024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Digoxin is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1) , 2 Control of resting ventricular rate in adults with chronic atrial fibrillation. (1.3) .</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin has the chemical name: 3β-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide, and the following structural formula. C41H64O14 MW 780.94. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Injection, USP is a sterile solution for slow intravenous or deep intramuscular injection. Each mL contains digoxin 250 mcg (0.25 mg), alcohol 0.1 mL, propylene glycol 0.4 mL, dibasic sodium phosphate, anhydrous 3 mg and citric acid, anhydrous 0.8 mg in Water for Injection. pH 6.7-7.3; citric acid and/or sodium phosphate added, if necessary, for pH adjustment. Dilution is not required.</Description>
</NDC>
<NDC>
<NDCCode>0832-1410-03</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0832-1410-03) / 3 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00832-1410-03</NDC11Code>
<ProductNDC>0832-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Moxifloxacin Hydrochloride</ProprietaryName>
<NonProprietaryName>Moxifloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20210210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212616</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms. Corynebacterium speciesEfficacy for this organism was studied in fewer than 10 infections.Micrococcus luteusStaphylococcus aureusStaphylococcus epidermidisStaphylococcus haemolyticusStaphylococcus hominisStaphylococcus warneriStreptococcus pneumoniaeStreptococcus viridans groupAcinetobacter lwoffiiHaemophilus influenzaHaemophilus parainfluenzaeChlamydia trachomatis.</IndicationAndUsage>
<Description>Moxifloxacin ophthalmic solution, USP 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. Chemical Name: 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4b]pyridin6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride. The molecular formula for moxifloxacin hydrochloride, USP is C21H24FN3O4∙HCl and its molecular weight is 437.9 g/mol. The chemical structure is presented below. Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. Each mL of moxifloxacin ophthalmic solution contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base. Moxifloxacin ophthalmic solution contains: Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, purified water and sodium chloride. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8. Moxifloxacin ophthalmic solution, USP is an isotonic solution with an osmolality of approximately 290 mOsm/kg.</Description>
</NDC>
<NDC>
<NDCCode>51662-1410-1</NDCCode>
<PackageDescription>1 mL in 1 VIAL (51662-1410-1) </PackageDescription>
<NDC11Code>51662-1410-01</NDC11Code>
<ProductNDC>51662-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyridoxine Hci</ProprietaryName>
<NonProprietaryName>Pyridoxine Hci</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20191008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080618</ApplicationNumber>
<LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
<SubstanceName>PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pyridoxine Hydrochloride Injection is effective for the treatment of pyridoxine deficiency as seen in the following. Inadequate dietary intake. Drug-induced deficiency, as from isoniazid (INH) or oral contraceptives. Inborn errors of metabolism, e.g., vitamin B6 dependent convulsions or vitamin B6 responsive anemia. The parenteral route is indicated when oral administration is not feasible as in anorexia, nausea and vomiting, and preoperative and postoperative conditions. It is also indicated when gastrointestinal absorption is impaired.</IndicationAndUsage>
<Description>Pyridoxine Hydrochloride Injection, USP is a sterile solution of pyridoxine hydrochloride in Water for Injection. Each mL contains 100 mg pyridoxine hydrochloride and 0.5% chlorobutanol anhydrous (chloral deriv.). pH adjusted with sodium hydroxide if necessary (2.0 to 3.8). Pyridoxine hydrochloride is a colorless or white crystal or a white crystalline powder. One gram dissolves in 5 mL of water. It is stable in air and is slowly affected by sunlight. The chemical name is 2-methyl-3-hydroxy-4,5-bis (hydroxymethyl) pyridine hydrochloride. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>51662-1410-3</NDCCode>
<PackageDescription>25 POUCH in 1 CASE (51662-1410-3) / 1 VIAL in 1 POUCH (51662-1410-2) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>51662-1410-03</NDC11Code>
<ProductNDC>51662-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyridoxine Hci</ProprietaryName>
<NonProprietaryName>Pyridoxine Hci</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20191008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080618</ApplicationNumber>
<LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
<SubstanceName>PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pyridoxine Hydrochloride Injection is effective for the treatment of pyridoxine deficiency as seen in the following. Inadequate dietary intake. Drug-induced deficiency, as from isoniazid (INH) or oral contraceptives. Inborn errors of metabolism, e.g., vitamin B6 dependent convulsions or vitamin B6 responsive anemia. The parenteral route is indicated when oral administration is not feasible as in anorexia, nausea and vomiting, and preoperative and postoperative conditions. It is also indicated when gastrointestinal absorption is impaired.</IndicationAndUsage>
<Description>Pyridoxine Hydrochloride Injection, USP is a sterile solution of pyridoxine hydrochloride in Water for Injection. Each mL contains 100 mg pyridoxine hydrochloride and 0.5% chlorobutanol anhydrous (chloral deriv.). pH adjusted with sodium hydroxide if necessary (2.0 to 3.8). Pyridoxine hydrochloride is a colorless or white crystal or a white crystalline powder. One gram dissolves in 5 mL of water. It is stable in air and is slowly affected by sunlight. The chemical name is 2-methyl-3-hydroxy-4,5-bis (hydroxymethyl) pyridine hydrochloride. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>63479-1410-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (63479-1410-1) </PackageDescription>
<NDC11Code>63479-1410-01</NDC11Code>
<ProductNDC>63479-1410</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>N10</ProprietaryName>
<ProprietaryNameSuffix>Paraklenz</ProprietaryNameSuffix>
<NonProprietaryName>Allium Cepa, Allium Sativum, Baryta Iodata, Berberis Vulgaris, Carduus Marianus, Chenopodium Anthelminticum, Chininum Arsenicosum, Cina, Cinchona Officinalis, Croton Tiglium, Echinacea Angustifolia, Hydrastis Canadensis, Illicium Anisatum, Lycopodium Clavatum, Natrum Phosphoricum, Rhamnus Purshiana, Santoninum, Scrophularia Nodosa, Senna, Sulphur, Tanacetum Vulgare, Teucrium Marum</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>19941215</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Apex Energetics Inc.</LabelerName>
<SubstanceName>TEUCRIUM MARUM; ONION; GARLIC; SCROPHULARIA NODOSA; TANACETUM VULGARE TOP; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; STAR ANISE; FRANGULA PURSHIANA BARK; SANTONIN; ARTEMISIA CINA FLOWER; MILK THISTLE; CHENOPODIUM AMBROSIOIDES; QUININE ARSENITE; CINCHONA OFFICINALIS BARK; CROTON TIGLIUM SEED; SENNA LEAF; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SULFUR; BARIUM IODIDE; BERBERIS VULGARIS ROOT BARK; LYCOPODIUM CLAVATUM SPORE</SubstanceName>
<StrengthNumber>8; 1; 1; 3; 8; 1; 1; 2; 1; 8; 6; 1; 1; 9; 9; 3; 1; 12; 9; 10; 1; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19941215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of minor. digestive discomfort* diarrhea*. skin rash*. gas*. fatigue*. abdominal pain*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
</NDCList>