RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "42385-933-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42385-933-60) ",
      "NDC11Code": "42385-0933-60",
      "ProductNDC": "42385-933",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lopinavir And Ritonavir",
      "NonProprietaryName": "Lopinavir And Ritonavir",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220322",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213857",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "LOPINAVIR; RITONAVIR",
      "StrengthNumber": "100; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220322",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lopinavir and ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV- 1 infection in adults and pediatric patients 14 days and older. Limitations of Use: 1 Genotypic or phenotypic testing and/or treatment history should guide the use of  lopinavir and ritonavir. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir [see Microbiology (12.4)].",
      "Description": "Lopinavir and ritonavir tablets, USP are a co-formulation of lopinavir USP and ritonavir USP. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir tablets, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir USP is chemically designated as [1S-[1R*,(R*),3R*,4R*]]-N-[4-[[(2,6- dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-α-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.8 g/mol. Lopinavir USP is a white to off-white color solid. It is freely soluble in methanol, soluble in isopropyl alcohol and practically insoluble in water. Lopinavir USP has the following structural formula. Ritonavir USP is chemically designated as 2,4,7,12-Tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-di-oxo-8,11-bis(phenylmethyl)-5-thiazolylmethylester[5S-(5R*,8R*,10R*,11R*)]-. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.94 g/mol. Ritonavir USP is a white or almost white solid. It is freely soluble in methanol and in dichloromethane; very slightly soluble in acetonitrile; practically insoluble in water. Ritonavir USP has the following structural formula. Lopinavir and ritonavir tablets, USP are available for oral administration in two strengths: : 1 Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP., 2 Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP."
    },
    {
      "NDCCode": "24689-933-06",
      "PackageDescription": "60 TABLET in 1 BOTTLE (24689-933-06) ",
      "NDC11Code": "24689-0933-06",
      "ProductNDC": "24689-933",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Buspirone Hydrochloride",
      "NonProprietaryName": "Buspirone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240617",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209696",
      "LabelerName": "APNAR PHARMA LP",
      "SubstanceName": "BUSPIRONE HYDROCHLORIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2024-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240617",
      "SamplePackage": "N",
      "IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorder or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long- term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.",
      "Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2  HCl is represented by the following structural formula:. Buspirone Hydrochloride Tablets are for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are functionally-scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are functionally-scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are functionally-scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one- third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
    },
    {
      "NDCCode": "37000-933-60",
      "PackageDescription": "1 KIT in 1 PACKAGE (37000-933-60)  *  8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK *  4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "37000-0933-60",
      "ProductNDC": "37000-933",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Vicks Dayquil And Vicks Nyquil",
      "ProprietaryNameSuffix": "Cold And Flu Multi-symptom Relief/cold And Flu Nighttime Relief",
      "NonProprietaryName": "Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, And Doxylamine Succinate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20190701",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "Status": "Deprecated",
      "LastUpdate": "2023-05-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200401",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "41250-933-02",
      "PackageDescription": "1 BOTTLE in 1 CARTON (41250-933-02)  > 60 SPRAY, METERED in 1 BOTTLE",
      "NDC11Code": "41250-0933-02",
      "ProductNDC": "41250-933",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "24 Hour Allergy Relief Nasal",
      "NonProprietaryName": "Fluticasone Propionate",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "NASAL",
      "StartMarketingDate": "20161117",
      "EndMarketingDate": "20230201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207957",
      "LabelerName": "Meijer Distribution Inc",
      "SubstanceName": "FLUTICASONE PROPIONATE",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20161117",
      "EndMarketingDatePackage": "20230101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52854-933-01",
      "PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (52854-933-01) ",
      "NDC11Code": "52854-0933-01",
      "ProductNDC": "52854-933",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Land Shark Spf 30",
      "NonProprietaryName": "Octocrylene, Octisalate, And Avobenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200214",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Tropical Seas, Inc.",
      "SubstanceName": "OCTOCRYLENE; OCTISALATE; AVOBENZONE",
      "StrengthNumber": "5; 3; 2.5",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL",
      "Status": "Active",
      "LastUpdate": "2025-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200629",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see  Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
    },
    {
      "NDCCode": "59651-933-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE (59651-933-60) ",
      "NDC11Code": "59651-0933-60",
      "ProductNDC": "59651-933",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Everolimus",
      "NonProprietaryName": "Everolimus",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260225",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219533",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "EVEROLIMUS",
      "StrengthNumber": ".75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260225",
      "SamplePackage": "N",
      "IndicationAndUsage": "Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: 1 Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1), 2 Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5).",
      "Description": "Everolimus is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone.The molecular formula is C53H83NO14 and the molecular weight is 958.22 g/mol. The structural formula is. Everolimus is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, anhydrous lactose, and magnesium stearate as inactive ingredients."
    },
    {
      "NDCCode": "60760-933-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE (60760-933-60) ",
      "NDC11Code": "60760-0933-60",
      "ProductNDC": "60760-933",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone Hydrochloride, Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040545",
      "LabelerName": "St Marys Medical Park Pharmacy",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "7.5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20101222",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63187-933-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (63187-933-60) ",
      "NDC11Code": "63187-0933-60",
      "ProductNDC": "63187-933",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
      "NonProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120913",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200243",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
      "StrengthNumber": "50; 325; 40",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
      "DEASchedule": "CIII",
      "Status": "Active",
      "LastUpdate": "2022-02-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20171101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Butalbital, acetaminophen, and caffeine tablets, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
      "Description": "Butalbital, Acetaminophen, and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients. Butalbital, USP                      50 mgAcetaminophen, USP         325 mgCaffeine, USP                      40 mg. Inactive Ingredients: microcrystalline cellulose, crospovidone, croscarmellose sodium, corn starch, stearic acid, colloidal silicon dioxide, magnesium stearate, and FD&C Blue No. 1. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula."
    },
    {
      "NDCCode": "71205-933-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71205-933-60) ",
      "NDC11Code": "71205-0933-60",
      "ProductNDC": "71205-933",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Solifenacin Succinate",
      "NonProprietaryName": "Solifenacin Succiate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201122",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210281",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "SOLIFENACIN SUCCINATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20210319",
      "SamplePackage": "N",
      "IndicationAndUsage": "Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
      "Description": "Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each Solifenacin Succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each Solifenacin Succinate tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, hypromellose 2910, magnesium stearate, triacetin, polyethylene glycol 3350 and titanium dioxide with yellow ferric oxide and red ferric oxide."
    },
    {
      "NDCCode": "42385-902-06",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42385-902-06) ",
      "NDC11Code": "42385-0902-06",
      "ProductNDC": "42385-902",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209882",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190115",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "42385-920-60",
      "PackageDescription": "60 CAPSULE in 1 BOTTLE (42385-920-60) ",
      "NDC11Code": "42385-0920-60",
      "ProductNDC": "42385-920",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atazanavir",
      "NonProprietaryName": "Atazanavir",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212579",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "ATAZANAVIR SULFATE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210430",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years of age and older weighing at least 15 kg. Limitations of Use: 1 Atazanavir is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of atazanavir with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].",
      "Description": "The active ingredient in atazanavir capsules is atazanavir sulfate USP, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-­ pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H54N6O11S, which corresponds to a molecular weight of 802.93 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula. Atazanavir sulfate USP is a white to pale yellow crystalline powder. It is freely soluble in methanol and practically insoluble in water. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate USP, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue No. 2, FD & C Yellow 6, iron oxide yellow, and titanium dioxide. The capsules are printed with ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, and titanium dioxide."
    },
    {
      "NDCCode": "42385-921-60",
      "PackageDescription": "60 CAPSULE in 1 BOTTLE (42385-921-60) ",
      "NDC11Code": "42385-0921-60",
      "ProductNDC": "42385-921",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atazanavir",
      "NonProprietaryName": "Atazanavir",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212579",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "ATAZANAVIR SULFATE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210430",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years of age and older weighing at least 15 kg. Limitations of Use: 1 Atazanavir is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of atazanavir with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].",
      "Description": "The active ingredient in atazanavir capsules is atazanavir sulfate USP, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-­ pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H54N6O11S, which corresponds to a molecular weight of 802.93 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula. Atazanavir sulfate USP is a white to pale yellow crystalline powder. It is freely soluble in methanol and practically insoluble in water. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate USP, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue No. 2, FD & C Yellow 6, iron oxide yellow, and titanium dioxide. The capsules are printed with ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, and titanium dioxide."
    },
    {
      "NDCCode": "42385-930-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42385-930-60) ",
      "NDC11Code": "42385-0930-60",
      "ProductNDC": "42385-930",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sacubitril And Valsartan",
      "NonProprietaryName": "Sacubitril And Valsartan",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213676",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "SACUBITRIL; VALSARTAN",
      "StrengthNumber": "24; 26",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241111",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and are expected to improve cardiovascular outcomes. (1.2).",
      "Description": "Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain a complex comprised of anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3’-methyl-2’-(pentanoyl{2”-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate]. Its molecular formula is C48H55N6O8●3Na. Its molecular mass is 912.95 and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film-coat inactive ingredients are hypromellose, titanium dioxide, Macrogol 4000, talc, and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow."
    },
    {
      "NDCCode": "42385-931-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42385-931-60) ",
      "NDC11Code": "42385-0931-60",
      "ProductNDC": "42385-931",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sacubitril And Valsartan",
      "NonProprietaryName": "Sacubitril And Valsartan",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213676",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "SACUBITRIL; VALSARTAN",
      "StrengthNumber": "49; 51",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241111",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and are expected to improve cardiovascular outcomes. (1.2).",
      "Description": "Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain a complex comprised of anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3’-methyl-2’-(pentanoyl{2”-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate]. Its molecular formula is C48H55N6O8●3Na. Its molecular mass is 912.95 and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film-coat inactive ingredients are hypromellose, titanium dioxide, Macrogol 4000, talc, and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow."
    },
    {
      "NDCCode": "42385-932-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42385-932-60) ",
      "NDC11Code": "42385-0932-60",
      "ProductNDC": "42385-932",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sacubitril And Valsartan",
      "NonProprietaryName": "Sacubitril And Valsartan",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213676",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "SACUBITRIL; VALSARTAN",
      "StrengthNumber": "97; 103",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241111",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and are expected to improve cardiovascular outcomes. (1.2).",
      "Description": "Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain a complex comprised of anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3’-methyl-2’-(pentanoyl{2”-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate]. Its molecular formula is C48H55N6O8●3Na. Its molecular mass is 912.95 and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film-coat inactive ingredients are hypromellose, titanium dioxide, Macrogol 4000, talc, and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow."
    },
    {
      "NDCCode": "42385-949-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42385-949-60) ",
      "NDC11Code": "42385-0949-60",
      "ProductNDC": "42385-949",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210517",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209882",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-09-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210517",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride tablets/Metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to or almost white crystals with a molecular formula of C4H11N5HCl and a molecular weight of 165.62. It is freely soluble in water, slightly soluble in 96% ethanol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg contain the inactive ingredients carboxymethylcellulose sodium, hypromellose, and magnesium stearate. Metformin Hydrochloride Extended-Release Tablets, USP meets USP Dissolution Test 11."
    },
    {
      "NDCCode": "42385-957-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE (42385-957-60) ",
      "NDC11Code": "42385-0957-60",
      "ProductNDC": "42385-957",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210322",
      "EndMarketingDate": "20250531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090767",
      "LabelerName": "Laurus Generics Inc.",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210322",
      "EndMarketingDatePackage": "20250531",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial- onset seizures in patients 1 month of age and older (1.1). Levetiracetam tablets are indicated for adjunctive therapy for the treatment of:.",
      "Description": "Levetiracetam, USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (dark pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue #2/Indigo Carmine Aluminum Lake. 500 mg tablets: Iron Oxide Yellow. 750 mg tablets: FD&C Red #40/Allura Red A C Aluminum Lake."
    },
    {
      "NDCCode": "42385-963-60",
      "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42385-963-60) ",
      "NDC11Code": "42385-0963-60",
      "ProductNDC": "42385-963",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ranolazine",
      "NonProprietaryName": "Ranolazine",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220119",
      "EndMarketingDate": "20250531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214035",
      "LabelerName": "Laurus Generics Inc.",
      "SubstanceName": "RANOLAZINE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20220301",
      "EndMarketingDatePackage": "20250531",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ranolazine extended-release tablets is indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
      "Description": "Ranolazine extended-release tablets (ranolazine) is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N- (2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, ethanol, acetonitrile, and acetone; slightly soluble in ethyl acetate, isopropanol, toluene, and ethyl ether; and very slightly soluble in water. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer, hydroxy propyl methyl cellulose, sodium hydroxide, magnesium stearate. Additional inactive ingredients used in film coating for the 500 mg tablet polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol, iron oxide yellow and iron oxide red; additional inactive ingredients used in film coating for the 1000 mg tablet include lactose monohydrate, polyethylene glycol, hypromellose, titanium dioxide, triacetin and iron oxide yellow."
    },
    {
      "NDCCode": "42385-964-60",
      "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42385-964-60) ",
      "NDC11Code": "42385-0964-60",
      "ProductNDC": "42385-964",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ranolazine",
      "NonProprietaryName": "Ranolazine",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220119",
      "EndMarketingDate": "20250531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214035",
      "LabelerName": "Laurus Generics Inc.",
      "SubstanceName": "RANOLAZINE",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20220301",
      "EndMarketingDatePackage": "20250531",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ranolazine extended-release tablets is indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
      "Description": "Ranolazine extended-release tablets (ranolazine) is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N- (2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, ethanol, acetonitrile, and acetone; slightly soluble in ethyl acetate, isopropanol, toluene, and ethyl ether; and very slightly soluble in water. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer, hydroxy propyl methyl cellulose, sodium hydroxide, magnesium stearate. Additional inactive ingredients used in film coating for the 500 mg tablet polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol, iron oxide yellow and iron oxide red; additional inactive ingredients used in film coating for the 1000 mg tablet include lactose monohydrate, polyethylene glycol, hypromellose, titanium dioxide, triacetin and iron oxide yellow."
    },
    {
      "NDCCode": "42385-971-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42385-971-60) ",
      "NDC11Code": "42385-0971-60",
      "ProductNDC": "42385-971",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydroxychloroquine Sulfate",
      "NonProprietaryName": "Hydroxychloroquine Sulfate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230306",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210959",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-01-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230306",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydroxychloroquine sulfate tablets are an antimalarial and antirheumatic indicated for the:  Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1)  Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1)  Treatment of rheumatoid arthritis in adults. (1.2)  Treatment of systemic lupus erythematosus in adults. (1.3)  Treatment of chronic discoid lupus erythematosus in adults. (1.4)Limitations of Use (1.1): Hydroxychloroquine sulfate tablets are not recommended for the:  Treatment of complicated malaria.   Treatment of chloroquine or hydroxychloroquine-resistant strains ofPlasmodium species.  Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified.  Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.  Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.",
      "Description": "Hydroxychloroquine is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is:. Hydroxychloroquine sulfate USP is a white or off-white to slightly yellowish color powder, freely soluble in water and practically insoluble in ethanol. Hydroxychloroquine sulfate tablets, USP for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: lactose monohydrate, magnesium stearate, maize starch and povidone. The film coating contains polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "42385-993-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE (42385-993-60) ",
      "NDC11Code": "42385-0993-60",
      "ProductNDC": "42385-993",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ticagrelor",
      "NonProprietaryName": "Ticagrelor",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260820",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218869",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "TICAGRELOR",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260820",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ticagrelor is a P2Y12 platelet inhibitor indicated.  to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1)  to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes mellitus (T2DM). (1.2)  to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3).",
      "Description": "Ticagrelor contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S, 2S, 3R, 5S)-3-(7-(((1R, 2S)-2-(3, 4-difluorophenyl) cyclopropyl) amino)-5-(propylthio)-3H-[1, 2, 3] triazolo [4, 5-d] pyrimidin-3-yl)-5-(2-hydroxyethoxy) cyclopentane-1, 2-diol. The molecular formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is. Ticagrelor is a white or off-white to pale pink powder, freely soluble in methanol with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl methylcellulose, iron oxide yellow, magnesium stearate, mannitol, polyethylene glycol 3350, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide. Ticagrelor 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: dibasic calcium phosphate dihydrate, ferrosoferric oxide, hydroxypropyl methylcellulose, iron oxide red, magnesium stearate, mannitol, polyethylene glycol 3350, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide."
    },
    {
      "NDCCode": "42385-994-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE (42385-994-60) ",
      "NDC11Code": "42385-0994-60",
      "ProductNDC": "42385-994",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ticagrelor",
      "NonProprietaryName": "Ticagrelor",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260820",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218869",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "TICAGRELOR",
      "StrengthNumber": "90",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260820",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ticagrelor is a P2Y12 platelet inhibitor indicated.  to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1)  to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes mellitus (T2DM). (1.2)  to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3).",
      "Description": "Ticagrelor contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S, 2S, 3R, 5S)-3-(7-(((1R, 2S)-2-(3, 4-difluorophenyl) cyclopropyl) amino)-5-(propylthio)-3H-[1, 2, 3] triazolo [4, 5-d] pyrimidin-3-yl)-5-(2-hydroxyethoxy) cyclopentane-1, 2-diol. The molecular formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is. Ticagrelor is a white or off-white to pale pink powder, freely soluble in methanol with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl methylcellulose, iron oxide yellow, magnesium stearate, mannitol, polyethylene glycol 3350, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide. Ticagrelor 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: dibasic calcium phosphate dihydrate, ferrosoferric oxide, hydroxypropyl methylcellulose, iron oxide red, magnesium stearate, mannitol, polyethylene glycol 3350, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide."
    },
    {
      "NDCCode": "21695-933-20",
      "PackageDescription": "20 g in 1 TUBE, WITH APPLICATOR (21695-933-20)",
      "NDC11Code": "21695-0933-20",
      "ProductNDC": "21695-933",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Terconazole",
      "NonProprietaryName": "Terconazole",
      "DosageFormName": "CREAM",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20040401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019964",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "TERCONAZOLE",
      "StrengthNumber": "8",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Azole Antifungal [EPC],Azoles [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Terconazole Vaginal Cream is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As this product is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.",
      "Description": "Terconazole Vaginal Cream 0.4% is a white to off-white, water washable cream for intravaginal administration containing 0.4% of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water. Terconazole Vaginal Cream 0.8% is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water. The structural formula of terconazole is as follows. Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol."
    },
    {
      "NDCCode": "47335-933-45",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (47335-933-45)  / 1 mL in 1 VIAL, SINGLE-DOSE (47335-933-40) ",
      "NDC11Code": "47335-0933-45",
      "ProductNDC": "47335-933",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ketorolac Tromethamine",
      "NonProprietaryName": "Ketorolac Tromethamine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20221225",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078737",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "KETOROLAC TROMETHAMINE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221225",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients. Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.",
      "Description": "Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. FIGURE 1. Ketorolac tromethamine, USP is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac tromethamine injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The sterile solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.7 mg respectively, of sodium chloride, USP. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide NF and/or hydrochloric acid NF. The sterile solutions are clear,  yellowish to pale yellow in color."
    },
    {
      "NDCCode": "49281-933-50",
      "PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-933-50)  / .7 mL in 1 SYRINGE, GLASS (49281-933-88) ",
      "NDC11Code": "49281-0933-50",
      "ProductNDC": "49281-933",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Fluzone High-dose Quadrivalent Southern Hemisphere",
      "NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/california/122/2022 (a/thailand/8/2022-like Virus (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated), And Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20240326",
      "EndMarketingDate": "20241231",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103914",
      "LabelerName": "Sanofi Pasteur Inc.",
      "SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/122/2022 SAN-022 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
      "StrengthNumber": "60; 60; 60; 60",
      "StrengthUnit": "ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240326",
      "EndMarketingDatePackage": "20241231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluzone® High-Dose Quadrivalent Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone High-Dose Quadrivalent Southern Hemisphere is indicated for use in persons 65 years of age and older.",
      "Description": "Fluzone High-Dose Quadrivalent Southern Hemisphere for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus.\" The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose Quadrivalent Southern Hemisphere process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Fluzone High-Dose Quadrivalent Southern Hemisphere is an injectable suspension and is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose Quadrivalent Southern Hemisphere. The Fluzone High-Dose Quadrivalent Southern Hemisphere prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose Quadrivalent Southern Hemisphere is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2024 Southern Hemisphere influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/California/122/2022 SAN-022 (A/Thailand/8/2022-like virus) (H3N2), B/Phuket/3073/2013 (B Yamagata lineage) and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2."
    },
    {
      "NDCCode": "66267-933-80",
      "PackageDescription": "80 g in 1 BOX (66267-933-80) ",
      "NDC11Code": "66267-0933-80",
      "ProductNDC": "66267-933",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Triamcinolone Acetonide",
      "NonProprietaryName": "Triamcinolone Acetonide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20060928",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA086414",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "TRIAMCINOLONE ACETONIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170713",
      "SamplePackage": "N",
      "IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis (oxy)]-,(11ß,16α)-. C 24H 31FO 6, and M.W. of 434.51; CAS Reg. No. 76-25-5. Each gram of 0.025%, 0.1% and 0.5% Triamcinolone Acetonide Cream USP contains 0.25 mg, 1 mg, or 5 mg triamcinolone acetonide respectively, in a washable cream base of cetyl alcohol, cetyl esters wax, glycerin, glyceryl monostearate, isopropyl palmitate, polysorbate-60, propylene glycol, purified water, sorbic acid, and sorbitan monostearate."
    },
    {
      "NDCCode": "83034-003-60",
      "PackageDescription": "60 POUCH in 1 CARTON (83034-003-60)  / 1 AMPULE in 1 POUCH (83034-003-01)  / 2.5 mL in 1 AMPULE",
      "NDC11Code": "83034-0003-60",
      "ProductNDC": "83034-003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ohtuvayre",
      "NonProprietaryName": "Ensifentrine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20240626",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA217389",
      "LabelerName": "MERCK SHARP & DOHME LLC",
      "SubstanceName": "ENSIFENTRINE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/2.5mL",
      "Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA], Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-05-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240626",
      "SamplePackage": "N",
      "IndicationAndUsage": "OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.",
      "Description": "OHTUVAYRE (ensifentrine) is a sterile, yellow to pale yellow aqueous inhalation suspension of ensifentrine for oral inhalation. Ensifentrine, the active component of OHTUVAYRE, is an inhibitor of phosphodiesterases 3 and 4 (PDE3 and PDE4). The chemical name for ensifentrine is N-(2-{(2E)-9,10-dimethoxy-4-oxo-2-[(2,4,6-trimethylphenyl)imino]-6,7-dihydro-2H-pyrimido[6,1-a]isoquinolin-3(4H)-yl}ethyl)urea; its structural formula is. Ensifentrine has a molecular weight of 477.56 and its empirical formula is C26H31N5O4. Ensifentrine is a yellow to pale yellow crystalline powder which is practically insoluble in water. OHTUVAYRE is supplied as 2.5 mL of sterile ensifentrine (1.2 mg/mL) suspension packaged in a unit-dose low-density polyethylene ampule overwrapped in a sealed foil pouch. Each unit-dose ampule contains 3 mg ensifentrine suspended in a pH 6.7 aqueous solution containing dibasic sodium phosphate, monobasic sodium phosphate, polysorbate 20, sodium chloride, sorbitan monolaurate and water for injection. The ampule containing OHTUVAYRE should be shaken vigorously to ensure complete resuspension of the active ingredient immediately prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the nebulization system used, and compressor performance. Using the PARI LC Sprint® jet nebulizer attached to a PARI Vios Pro® compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 933 micrograms (31% of label claim) at a mean flow rate of approximately 5 liters per minute. The mean nebulization time was approximately 7 minutes. The mass median aerodynamic diameter (MMAD) of the nebulized particles/droplets using the PARI LC Sprint® jet nebulizer attached to a PARI Vios Pro® compressor (flow rate approximately 15 L per minute, nebulization time approximately 10 minutes) is 5.82 microns (geometric standard deviation = 1.97) with a typical fine particle dose (mass of aerosolized drug < 5 microns) of approximately 614 micrograms, as determined using the Next Generation Impactor (NGI) method, based on USP <601>. OHTUVAYRE should only be administered via a standard jet nebulizer connected to an air compressor with an adequate airflow and equipped with a mouthpiece."
    },
    {
      "NDCCode": "83034-003-65",
      "PackageDescription": "60 POUCH in 1 CARTON (83034-003-65)  / 5 AMPULE in 1 POUCH (83034-003-05)  / 2.5 mL in 1 AMPULE",
      "NDC11Code": "83034-0003-65",
      "ProductNDC": "83034-003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ohtuvayre",
      "NonProprietaryName": "Ensifentrine",
      "DosageFormName": "SUSPENSION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20240626",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA217389",
      "LabelerName": "MERCK SHARP & DOHME LLC",
      "SubstanceName": "ENSIFENTRINE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/2.5mL",
      "Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA], Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-05-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240626",
      "SamplePackage": "N",
      "IndicationAndUsage": "OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.",
      "Description": "OHTUVAYRE (ensifentrine) is a sterile, yellow to pale yellow aqueous inhalation suspension of ensifentrine for oral inhalation. Ensifentrine, the active component of OHTUVAYRE, is an inhibitor of phosphodiesterases 3 and 4 (PDE3 and PDE4). The chemical name for ensifentrine is N-(2-{(2E)-9,10-dimethoxy-4-oxo-2-[(2,4,6-trimethylphenyl)imino]-6,7-dihydro-2H-pyrimido[6,1-a]isoquinolin-3(4H)-yl}ethyl)urea; its structural formula is. Ensifentrine has a molecular weight of 477.56 and its empirical formula is C26H31N5O4. Ensifentrine is a yellow to pale yellow crystalline powder which is practically insoluble in water. OHTUVAYRE is supplied as 2.5 mL of sterile ensifentrine (1.2 mg/mL) suspension packaged in a unit-dose low-density polyethylene ampule overwrapped in a sealed foil pouch. Each unit-dose ampule contains 3 mg ensifentrine suspended in a pH 6.7 aqueous solution containing dibasic sodium phosphate, monobasic sodium phosphate, polysorbate 20, sodium chloride, sorbitan monolaurate and water for injection. The ampule containing OHTUVAYRE should be shaken vigorously to ensure complete resuspension of the active ingredient immediately prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the nebulization system used, and compressor performance. Using the PARI LC Sprint® jet nebulizer attached to a PARI Vios Pro® compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 933 micrograms (31% of label claim) at a mean flow rate of approximately 5 liters per minute. The mean nebulization time was approximately 7 minutes. The mass median aerodynamic diameter (MMAD) of the nebulized particles/droplets using the PARI LC Sprint® jet nebulizer attached to a PARI Vios Pro® compressor (flow rate approximately 15 L per minute, nebulization time approximately 10 minutes) is 5.82 microns (geometric standard deviation = 1.97) with a typical fine particle dose (mass of aerosolized drug < 5 microns) of approximately 614 micrograms, as determined using the Next Generation Impactor (NGI) method, based on USP <601>. OHTUVAYRE should only be administered via a standard jet nebulizer connected to an air compressor with an adequate airflow and equipped with a mouthpiece."
    },
    {
      "NDCCode": "42385-993-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (42385-993-01) ",
      "NDC11Code": "42385-0993-01",
      "ProductNDC": "42385-993",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ticagrelor",
      "NonProprietaryName": "Ticagrelor",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260820",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218869",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "TICAGRELOR",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260820",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ticagrelor is a P2Y12 platelet inhibitor indicated.  to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1)  to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes mellitus (T2DM). (1.2)  to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3).",
      "Description": "Ticagrelor contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S, 2S, 3R, 5S)-3-(7-(((1R, 2S)-2-(3, 4-difluorophenyl) cyclopropyl) amino)-5-(propylthio)-3H-[1, 2, 3] triazolo [4, 5-d] pyrimidin-3-yl)-5-(2-hydroxyethoxy) cyclopentane-1, 2-diol. The molecular formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is. Ticagrelor is a white or off-white to pale pink powder, freely soluble in methanol with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl methylcellulose, iron oxide yellow, magnesium stearate, mannitol, polyethylene glycol 3350, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide. Ticagrelor 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: dibasic calcium phosphate dihydrate, ferrosoferric oxide, hydroxypropyl methylcellulose, iron oxide red, magnesium stearate, mannitol, polyethylene glycol 3350, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide."
    },
    {
      "NDCCode": "42385-993-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (42385-993-05) ",
      "NDC11Code": "42385-0993-05",
      "ProductNDC": "42385-993",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ticagrelor",
      "NonProprietaryName": "Ticagrelor",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260820",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218869",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "TICAGRELOR",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260820",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ticagrelor is a P2Y12 platelet inhibitor indicated.  to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1)  to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes mellitus (T2DM). (1.2)  to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3).",
      "Description": "Ticagrelor contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S, 2S, 3R, 5S)-3-(7-(((1R, 2S)-2-(3, 4-difluorophenyl) cyclopropyl) amino)-5-(propylthio)-3H-[1, 2, 3] triazolo [4, 5-d] pyrimidin-3-yl)-5-(2-hydroxyethoxy) cyclopentane-1, 2-diol. The molecular formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is. Ticagrelor is a white or off-white to pale pink powder, freely soluble in methanol with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl methylcellulose, iron oxide yellow, magnesium stearate, mannitol, polyethylene glycol 3350, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide. Ticagrelor 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: dibasic calcium phosphate dihydrate, ferrosoferric oxide, hydroxypropyl methylcellulose, iron oxide red, magnesium stearate, mannitol, polyethylene glycol 3350, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide."
    }
  ]
}
                    

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Avobenzone</NonProprietaryName></NDC><NDC><NDCCode>59651-933-60</NDCCode><ProprietaryName>Everolimus</ProprietaryName><NonProprietaryName>Everolimus</NonProprietaryName></NDC><NDC><NDCCode>60760-933-60</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone Hydrochloride, Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>63187-933-60</NDCCode><ProprietaryName>Butalbital, Acetaminophen, And Caffeine</ProprietaryName><NonProprietaryName>Butalbital, Acetaminophen, And Caffeine</NonProprietaryName></NDC><NDC><NDCCode>71205-933-60</NDCCode><ProprietaryName>Solifenacin Succinate</ProprietaryName><NonProprietaryName>Solifenacin Succiate</NonProprietaryName></NDC><NDC><NDCCode>42385-902-06</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42385-920-60</NDCCode><ProprietaryName>Atazanavir</ProprietaryName><NonProprietaryName>Atazanavir</NonProprietaryName></NDC><NDC><NDCCode>42385-921-60</NDCCode><ProprietaryName>Atazanavir</ProprietaryName><NonProprietaryName>Atazanavir</NonProprietaryName></NDC><NDC><NDCCode>42385-930-60</NDCCode><ProprietaryName>Sacubitril And Valsartan</ProprietaryName><NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName></NDC><NDC><NDCCode>42385-931-60</NDCCode><ProprietaryName>Sacubitril And Valsartan</ProprietaryName><NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName></NDC><NDC><NDCCode>42385-932-60</NDCCode><ProprietaryName>Sacubitril And Valsartan</ProprietaryName><NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName></NDC><NDC><NDCCode>42385-949-60</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42385-957-60</NDCCode><ProprietaryName>Levetiracetam</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>42385-963-60</NDCCode><ProprietaryName>Ranolazine</ProprietaryName><NonProprietaryName>Ranolazine</NonProprietaryName></NDC><NDC><NDCCode>42385-964-60</NDCCode><ProprietaryName>Ranolazine</ProprietaryName><NonProprietaryName>Ranolazine</NonProprietaryName></NDC><NDC><NDCCode>42385-971-60</NDCCode><ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName><NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>42385-993-60</NDCCode><ProprietaryName>Ticagrelor</ProprietaryName><NonProprietaryName>Ticagrelor</NonProprietaryName></NDC><NDC><NDCCode>42385-994-60</NDCCode><ProprietaryName>Ticagrelor</ProprietaryName><NonProprietaryName>Ticagrelor</NonProprietaryName></NDC><NDC><NDCCode>21695-933-20</NDCCode><ProprietaryName>Terconazole</ProprietaryName><NonProprietaryName>Terconazole</NonProprietaryName></NDC><NDC><NDCCode>47335-933-45</NDCCode><ProprietaryName>Ketorolac Tromethamine</ProprietaryName><NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName></NDC><NDC><NDCCode>49281-933-50</NDCCode><ProprietaryName>Fluzone High-dose Quadrivalent Southern Hemisphere</ProprietaryName><NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/california/122/2022 (a/thailand/8/2022-like Virus (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated), And Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>66267-933-80</NDCCode><ProprietaryName>Triamcinolone Acetonide</ProprietaryName><NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName></NDC><NDC><NDCCode>83034-003-60</NDCCode><ProprietaryName>Ohtuvayre</ProprietaryName><NonProprietaryName>Ensifentrine</NonProprietaryName></NDC><NDC><NDCCode>83034-003-65</NDCCode><ProprietaryName>Ohtuvayre</ProprietaryName><NonProprietaryName>Ensifentrine</NonProprietaryName></NDC><NDC><NDCCode>42385-993-01</NDCCode><ProprietaryName>Ticagrelor</ProprietaryName><NonProprietaryName>Ticagrelor</NonProprietaryName></NDC><NDC><NDCCode>42385-993-05</NDCCode><ProprietaryName>Ticagrelor</ProprietaryName><NonProprietaryName>Ticagrelor</NonProprietaryName></NDC></NDCList>