RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "70756-830-16",
      "PackageDescription": "16000 TABLET, EXTENDED RELEASE in 1 BOX (70756-830-16) ",
      "NDC11Code": "70756-0830-16",
      "ProductNDC": "70756-830",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupropion Hcl Er (xl)",
      "NonProprietaryName": "Bupropion Hcl Er",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260501",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022497",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "BUPROPION HYDROCHLORIDE",
      "StrengthNumber": "450",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14)]. The physician who elects to use bupropion hydrochloride extended-release tablets (XL) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
      "Description": "Bupropion hydrochloride extended-release tablets (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-2-(tert-Butylamino)-3'-chloropropiophenone hydrochloride. The molecular weight is 276.2. The empirical formula is C13H18ClNO.HCl. Bupropion hydrochloride powder is white or almost white, crystalline, and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration of 450 mg of bupropion hydrochloride, USP as white to off-white extended-release tablets. Each film-coated tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: carboxymethyl cellulose sodium, colloidal silicon dioxide, hydrochloric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 8000, polyethylene oxide, polyvinyl pyrrolidone and polyvinyl acetate blend, stearic acid, talc, titanium dioxide and triacetin. \"LS 830\" is printed on one side of the tablet with edible black ink."
    },
    {
      "NDCCode": "65841-830-16",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (65841-830-16) ",
      "NDC11Code": "65841-0830-16",
      "ProductNDC": "65841-830",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Voriconazole",
      "NonProprietaryName": "Voriconazole",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160525",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206747",
      "LabelerName": "Zydus Lifesciences Limited",
      "SubstanceName": "VORICONAZOLE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160525",
      "SamplePackage": "N",
      "IndicationAndUsage": "Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients aged 2 years of age and older with: 1 Invasive aspergillosis (1.1), 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2), 3 Esophageal candidiasis (1.3), 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy (1.4).",
      "Description": "Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to almost white powder. Each voriconazole tablet intended for oral administration contains 50 mg or 200 mg of voriconazole. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and pregelatinized starch. Additionally, each voriconazole tablets contain opadry II white 33F28398 which contains hypromellose, lactose monohydrate, polyethylene glycol, talc and titanium dioxide."
    },
    {
      "NDCCode": "70756-830-30",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70756-830-30) ",
      "NDC11Code": "70756-0830-30",
      "ProductNDC": "70756-830",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupropion Hcl Er (xl)",
      "NonProprietaryName": "Bupropion Hcl Er",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260501",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022497",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "BUPROPION HYDROCHLORIDE",
      "StrengthNumber": "450",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-05-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14)]. The physician who elects to use bupropion hydrochloride extended-release tablets (XL) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
      "Description": "Bupropion hydrochloride extended-release tablets (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-2-(tert-Butylamino)-3'-chloropropiophenone hydrochloride. The molecular weight is 276.2. The empirical formula is C13H18ClNO.HCl. Bupropion hydrochloride powder is white or almost white, crystalline, and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration of 450 mg of bupropion hydrochloride, USP as white to off-white extended-release tablets. Each film-coated tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: carboxymethyl cellulose sodium, colloidal silicon dioxide, hydrochloric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 8000, polyethylene oxide, polyvinyl pyrrolidone and polyvinyl acetate blend, stearic acid, talc, titanium dioxide and triacetin. \"LS 830\" is printed on one side of the tablet with edible black ink."
    },
    {
      "NDCCode": "24208-830-60",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (24208-830-60)  / 5 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "24208-0830-60",
      "ProductNDC": "24208-830",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Neomycin Polymyxin B Sulfates And Dexamethasone",
      "NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19950913",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA064135",
      "LabelerName": "Bausch & Lomb Incorporated",
      "SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE",
      "StrengthNumber": "3.5; 10000; 1",
      "StrengthUnit": "mg/mL; [USP'U]/mL; mg/mL",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
      "Status": "Active",
      "LastUpdate": "2024-09-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19950913",
      "SamplePackage": "N",
      "IndicationAndUsage": "For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacterspecies, Neisseriaspecies, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescensand streptococci, including Streptococcus pneumoniae.",
      "Description": "Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension, USP is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is. Established name:dexamethasone. Chemical name:pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β,16α)-. The other active ingredients are neomycin sulfate and polymyxin B sulfate. The structural formula for neomycin sulfate is. The structural formula for polymyxin B sulfate is. Each mL contains:Actives:neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Inactives:hypromellose 2910 0.5%, sodium chloride, polysorbate 20, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water, benzalkonium chloride 0.004% (preservative)."
    },
    {
      "NDCCode": "56062-830-28",
      "PackageDescription": "1 TUBE in 1 CARTON (56062-830-28)  / 28 g in 1 TUBE",
      "NDC11Code": "56062-0830-28",
      "ProductNDC": "56062-830",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Publix Triple Antibiotic",
      "NonProprietaryName": "Bacitracin Zinc 400 U, Polymxyin B Sulfate 5,000 U, Neomycin Sulfate 3.5mg/g",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240715",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M004",
      "LabelerName": "PUBLIX SUPER MARKETS, INC.",
      "SubstanceName": "BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE",
      "StrengthNumber": "400; 5000; 3.5",
      "StrengthUnit": "[USP'U]/g; [USP'U]/g; mg/g",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
      "Status": "Active",
      "LastUpdate": "2024-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240715",
      "SamplePackage": "N",
      "IndicationAndUsage": "First aid to help prevent infection in minor;: 1 cuts , 2 scrapes, 3 burns."
    },
    {
      "NDCCode": "58160-830-34",
      "PackageDescription": "1 SYRINGE in 1 CARTON (58160-830-34)  > .5 mL in 1 SYRINGE (58160-830-05)",
      "NDC11Code": "58160-0830-34",
      "ProductNDC": "58160-830",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Cervarix",
      "NonProprietaryName": "Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20091016",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125259",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN RESIDUES 2-471 ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN RESIDUES 2-472 ANTIGEN",
      "StrengthNumber": "20; 20",
      "StrengthUnit": "ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "58160-830-52",
      "PackageDescription": "10 SYRINGE in 1 CARTON (58160-830-52)  > .5 mL in 1 SYRINGE (58160-830-43)",
      "NDC11Code": "58160-0830-52",
      "ProductNDC": "58160-830",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Cervarix",
      "NonProprietaryName": "Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20091016",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125259",
      "LabelerName": "GlaxoSmithKline Biologicals SA",
      "SubstanceName": "HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN RESIDUES 2-471 ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN RESIDUES 2-472 ANTIGEN",
      "StrengthNumber": "20; 20",
      "StrengthUnit": "ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "61919-830-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (61919-830-60) ",
      "NDC11Code": "61919-0830-60",
      "ProductNDC": "61919-830",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levertiracetam",
      "NonProprietaryName": "Levertiracetam",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190603",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078993",
      "LabelerName": "Direct_Rx",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20190603",
      "SamplePackage": "N",
      "IndicationAndUsage": "1.1 Partial Onset Seizures. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.",
      "Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white to off-white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. [Chemical Structure]. 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 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. Inactive ingredients: corn starch, colloidal silicon dioxide, povidone, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water. In addition 250 mg contains FD&C Blue #2/indigo carmine aluminum lake, 500 mg contains iron oxide yellow, and 750 mg contains FD&C Yellow #6/sunset yellow FCF aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, and iron oxide red. Meets USP dissolution test 2."
    },
    {
      "NDCCode": "66721-830-60",
      "PackageDescription": "20 kg in 1 DRUM (66721-830-60) ",
      "NDC11Code": "66721-0830-60",
      "ProductNDC": "66721-830",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Lenacapavir",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20220817",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Yuhan Chemical Inc",
      "SubstanceName": "LENACAPAVIR",
      "StrengthNumber": "20",
      "StrengthUnit": "kg/20kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-12-16",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "17-AUG-22"
    },
    {
      "NDCCode": "70069-830-01",
      "PackageDescription": "1 VIAL in 1 CARTON (70069-830-01)  / 25 mL in 1 VIAL",
      "NDC11Code": "70069-0830-01",
      "ProductNDC": "70069-830",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dalbavancin",
      "NonProprietaryName": "Dalbavancin",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260727",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219604",
      "LabelerName": "Somerset Therapeutics, LLC",
      "SubstanceName": "DALBAVANCIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/25mL",
      "Pharm_Classes": "Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260727",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dalbavancin for injection is a lipoglycopeptide antibacterial indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of dalbavancin for injection and other antibacterial drugs, dalbavancin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.2).",
      "Description": "Dalbavancin for injection is a lipoglycopeptide antibacterial synthesized from a fermentation product of Nonomuraea species. Dalbavancin is a mixture of five closely related active homologs (A0, A1, B0, B1, and B2); the component B0 is the major component of dalbavancin. The homologs share the same core structure and differ in the fatty acid side chain of the N-acylaminoglucuronic acid moiety (R1) structure and/or the presence of an additional methyl group (R2) on the terminal amino group (shown in the Figure 1 and Table 3 below). Figure 1. Dalbavancin Structural Formula. Table 3. Substitution Patterns for Dalbavancin API Homologs. *Anhydrous free base. The B0 INN chemical name is: 5,31-dichloro-38-de(methoxycarbonyl)-7-demethyl-19-deoxy-56. -O-[2-deoxy-2-[(10-methylundecanoyl)amino]-β-D-glucopyranuronosyl]-38-[[3-(dimethylamino).  propyl]carbamoyl]-42-O-α-D-mannopyranosyl-15-N-methyl(ristomycin A aglycone) hydrochloride. Dalbavancin for injection is supplied in clear glass vials as a sterile, lyophilized, preservative-free, white to off-white to pale yellow solid. Each vial contains dalbavancin HCl equivalent to 500 mg of dalbavancin as the free base, plus lactose monohydrate (129 mg) and mannitol (129 mg) as excipients. Sodium hydroxide or hydrochloric acid may be added to adjust the pH at the time of manufacture. The powder is to be reconstituted and further diluted for IV infusion [see Dosage and Administration (2.4), How Supplied/Storage and Handling (16)]."
    },
    {
      "NDCCode": "72578-012-16",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (72578-012-16) ",
      "NDC11Code": "72578-0012-16",
      "ProductNDC": "72578-012",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clopidogrel",
      "NonProprietaryName": "Clopidogrel",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190808",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201686",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "CLOPIDOGREL BISULFATE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20190808",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clopidogrel tablet is a P2Y12 platelet inhibitor indicated for: 1 Acute coronary syndrome .",
      "Description": "Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1).  The molecular formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate, USP is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Each clopidogrel tablet intended for oral administration is provided as pink-colored, biconvex, round-shaped, film-coated tablets contains 97.830 mg of clopidogrel bisulfate, which is molar equivalent to 75 mg of clopidogrel base. In addition, each tablet contains the following inactive ingredients: citric acid, colloidal silicon dioxide, corn starch, crospovidone, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose anhydrous, lactose monohydrate, magnesium stearate, polyethylene glycol and titanium dioxide."
    },
    {
      "NDCCode": "80725-830-60",
      "PackageDescription": "60 CAPSULE in 1 BOTTLE (80725-830-60) ",
      "NDC11Code": "80725-0830-60",
      "ProductNDC": "80725-830",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Droxia",
      "NonProprietaryName": "Hydroxyurea",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250911",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016295",
      "LabelerName": "Waylis Therapeutics LLC",
      "SubstanceName": "HYDROXYUREA",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimetabolite [EPC], Urea [CS]",
      "Status": "Active",
      "LastUpdate": "2025-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250911",
      "SamplePackage": "N",
      "IndicationAndUsage": "DROXIA is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises.",
      "Description": "DROXIA® (hydroxyurea capsules, USP) is available for oral use as capsules containing 200 mg, 300 mg, and 400 mg hydroxyurea. Inactive ingredients include citric acid, gelatin, lactose, magnesium stearate, sodium phosphate, titanium dioxide, and capsule colorants: FD&C Blue No. 1 and FD&C Green No. 3 (200 mg capsules); D&C Red No. 28, D&C Red No. 33, and FD&C Blue No. 1 (300 mg capsules); D&C Red No. 28, D&C Red No. 33, and D&C Yellow No. 10 (400 mg capsules). Hydroxyurea is a white to off-white crystalline powder. It is hygroscopic and freely soluble in water, but practically insoluble in alcohol. The empirical formula is CH4N2O2 and it has a molecular weight of 76.05. Its structural formula is."
    },
    {
      "NDCCode": "70756-018-51",
      "PackageDescription": "500 TABLET in 1 BOTTLE (70756-018-51) ",
      "NDC11Code": "70756-0018-51",
      "ProductNDC": "70756-018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pantoprazole Sodium Delayed-release",
      "NonProprietaryName": "Pantoprazole Sodium Delayed-release",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240425",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215880",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "PANTOPRAZOLE SODIUM",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240425",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
      "Description": "The active ingredient in pantoprazole sodium delayed-release tablets, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.37. The structural formula is. Pantoprazole sodium is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP is freely soluble in water, in methanol, and in dehydrated alcohol; practically insoluble in hexane and dichloromethane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole Sodium Delayed-Release Tablets, USP contains the following inactive ingredients: calcium stearate, crospovidone, hypromellose, ferric oxide red, ferrosoferric oxide black, mannitol, methacrylic acid- ethyl acrylate copolymer, polyethylene glycol, silicon dioxide, sodium carbonate, sucrose, talc, and triethyl citrate. Imprinting ink contains ammonium hydroxide, ferrosoferric oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "70756-018-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (70756-018-90) ",
      "NDC11Code": "70756-0018-90",
      "ProductNDC": "70756-018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pantoprazole Sodium Delayed-release",
      "NonProprietaryName": "Pantoprazole Sodium Delayed-release",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240425",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215880",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "PANTOPRAZOLE SODIUM",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240425",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
      "Description": "The active ingredient in pantoprazole sodium delayed-release tablets, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.37. The structural formula is. Pantoprazole sodium is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP is freely soluble in water, in methanol, and in dehydrated alcohol; practically insoluble in hexane and dichloromethane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole Sodium Delayed-Release Tablets, USP contains the following inactive ingredients: calcium stearate, crospovidone, hypromellose, ferric oxide red, ferrosoferric oxide black, mannitol, methacrylic acid- ethyl acrylate copolymer, polyethylene glycol, silicon dioxide, sodium carbonate, sucrose, talc, and triethyl citrate. Imprinting ink contains ammonium hydroxide, ferrosoferric oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "70756-019-12",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (70756-019-12) ",
      "NDC11Code": "70756-0019-12",
      "ProductNDC": "70756-019",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pantoprazole Sodium Delayed-release",
      "NonProprietaryName": "Pantoprazole Sodium Delayed-release",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220727",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215880",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "PANTOPRAZOLE SODIUM",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220727",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
      "Description": "The active ingredient in pantoprazole sodium delayed-release tablets, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.37. The structural formula is. Pantoprazole sodium is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP is freely soluble in water, in methanol, and in dehydrated alcohol; practically insoluble in hexane and dichloromethane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole Sodium Delayed-Release Tablets, USP contains the following inactive ingredients: calcium stearate, crospovidone, hypromellose, ferric oxide red, ferrosoferric oxide black, mannitol, methacrylic acid- ethyl acrylate copolymer, polyethylene glycol, silicon dioxide, sodium carbonate, sucrose, talc, and triethyl citrate. Imprinting ink contains ammonium hydroxide, ferrosoferric oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "70756-019-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (70756-019-90) ",
      "NDC11Code": "70756-0019-90",
      "ProductNDC": "70756-019",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pantoprazole Sodium Delayed-release",
      "NonProprietaryName": "Pantoprazole Sodium Delayed-release",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220727",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215880",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "PANTOPRAZOLE SODIUM",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220727",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
      "Description": "The active ingredient in pantoprazole sodium delayed-release tablets, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.37. The structural formula is. Pantoprazole sodium is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP is freely soluble in water, in methanol, and in dehydrated alcohol; practically insoluble in hexane and dichloromethane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole Sodium Delayed-Release Tablets, USP contains the following inactive ingredients: calcium stearate, crospovidone, hypromellose, ferric oxide red, ferrosoferric oxide black, mannitol, methacrylic acid- ethyl acrylate copolymer, polyethylene glycol, silicon dioxide, sodium carbonate, sucrose, talc, and triethyl citrate. Imprinting ink contains ammonium hydroxide, ferrosoferric oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "70756-404-11",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (70756-404-11) ",
      "NDC11Code": "70756-0404-11",
      "ProductNDC": "70756-404",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrofurantoin (monohydrate/macrocrystals)",
      "NonProprietaryName": "Nitrofurantoin (monohydrate/macrocrystals)",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230914",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217357",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN",
      "StrengthNumber": "75; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]",
      "Status": "Active",
      "LastUpdate": "2026-10-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230914",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nitrofurantoin capsules (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (monohydrate/macrocrystals) 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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES.) Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
      "Description": "Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsule, USP (monohydrate/macrocrystals) is hard gelatin capsule. Each capsule contains 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals, USP and 75 mg of nitrofurantoin monohydrate, USP. The chemical name of nitrofurantoin macrocrystals, USP is 2,4-Imidazolidinedione, 1-[[(5-nitro-2-furanyl)methylene]-amino]. The chemical structure is the following. Molecular Weight: 238.16. Molecular formula: C8H6N4O5. The chemical name of nitrofurantoin monohydrate, USP is 2,4-Imidazolidinedione, 1-[[(5-nitro-2-furanyl)methylene]-amino]-monohydrate. The chemical structure is the following. Molecular Weight: 256.18. Molecular formula: C8H6N4O5 · H2O. Inactive Ingredients: Each capsule contains carbomer homopolymer type B, corn starch, D&C Yellow No. 10, FD&C Blue No.1, FD&C Red No. 40, FD&C Red No. 3, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, povidone K 30, povidone K 90, shellac, sucrose, talc, and titanium dioxide. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "70756-404-51",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (70756-404-51) ",
      "NDC11Code": "70756-0404-51",
      "ProductNDC": "70756-404",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrofurantoin (monohydrate/macrocrystals)",
      "NonProprietaryName": "Nitrofurantoin (monohydrate/macrocrystals)",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230914",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217357",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN",
      "StrengthNumber": "75; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]",
      "Status": "Active",
      "LastUpdate": "2026-10-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230914",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nitrofurantoin capsules (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (monohydrate/macrocrystals) 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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES.) Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
      "Description": "Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsule, USP (monohydrate/macrocrystals) is hard gelatin capsule. Each capsule contains 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals, USP and 75 mg of nitrofurantoin monohydrate, USP. The chemical name of nitrofurantoin macrocrystals, USP is 2,4-Imidazolidinedione, 1-[[(5-nitro-2-furanyl)methylene]-amino]. The chemical structure is the following. Molecular Weight: 238.16. Molecular formula: C8H6N4O5. The chemical name of nitrofurantoin monohydrate, USP is 2,4-Imidazolidinedione, 1-[[(5-nitro-2-furanyl)methylene]-amino]-monohydrate. The chemical structure is the following. Molecular Weight: 256.18. Molecular formula: C8H6N4O5 · H2O. Inactive Ingredients: Each capsule contains carbomer homopolymer type B, corn starch, D&C Yellow No. 10, FD&C Blue No.1, FD&C Red No. 40, FD&C Red No. 3, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, povidone K 30, povidone K 90, shellac, sucrose, talc, and titanium dioxide. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "70756-410-11",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (70756-410-11) ",
      "NDC11Code": "70756-0410-11",
      "ProductNDC": "70756-410",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrofurantoin Macrocrystals",
      "NonProprietaryName": "Nitrofurantoin Macrocrystals",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230321",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217272",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "NITROFURANTOIN",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofurans [CS]",
      "Status": "Active",
      "LastUpdate": "2026-10-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230321",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) 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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
      "Description": "Nitrofurantoin capsules, USP (macrocrystals) are a synthetic chemical of controlled crystal size. It is a stable, lemon yellow, crystalline compound. Nitrofurantoin capsules, USP (macrocrystals) are an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin, USP (macrocrystals). Molecular Formula: C8H6N4O5        Molecular Weight: 238.16 g/mole. 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione. Inactive Ingredients: Each capsule contains: corn starch, gelatin, lactose monohydrate, talc and titanium dioxide.  Additionally, each 50 mg and 100 mg capsule shell contains FD&C Blue no. 1 and FD&C Red no. 3. The capsule is printed with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, and shellac."
    },
    {
      "NDCCode": "70756-411-11",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (70756-411-11) ",
      "NDC11Code": "70756-0411-11",
      "ProductNDC": "70756-411",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrofurantoin Macrocrystals",
      "NonProprietaryName": "Nitrofurantoin Macrocrystals",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230321",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217272",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "NITROFURANTOIN",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofurans [CS]",
      "Status": "Active",
      "LastUpdate": "2026-10-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230321",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) 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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
      "Description": "Nitrofurantoin capsules, USP (macrocrystals) are a synthetic chemical of controlled crystal size. It is a stable, lemon yellow, crystalline compound. Nitrofurantoin capsules, USP (macrocrystals) are an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin, USP (macrocrystals). Molecular Formula: C8H6N4O5        Molecular Weight: 238.16 g/mole. 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione. Inactive Ingredients: Each capsule contains: corn starch, gelatin, lactose monohydrate, talc and titanium dioxide.  Additionally, each 50 mg and 100 mg capsule shell contains FD&C Blue no. 1 and FD&C Red no. 3. The capsule is printed with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, and shellac."
    },
    {
      "NDCCode": "70756-412-11",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (70756-412-11) ",
      "NDC11Code": "70756-0412-11",
      "ProductNDC": "70756-412",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrofurantoin Macrocrystals",
      "NonProprietaryName": "Nitrofurantoin Macrocrystals",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230321",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217272",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "NITROFURANTOIN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofurans [CS]",
      "Status": "Active",
      "LastUpdate": "2026-10-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230321",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) 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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
      "Description": "Nitrofurantoin capsules, USP (macrocrystals) are a synthetic chemical of controlled crystal size. It is a stable, lemon yellow, crystalline compound. Nitrofurantoin capsules, USP (macrocrystals) are an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin, USP (macrocrystals). Molecular Formula: C8H6N4O5        Molecular Weight: 238.16 g/mole. 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione. Inactive Ingredients: Each capsule contains: corn starch, gelatin, lactose monohydrate, talc and titanium dioxide.  Additionally, each 50 mg and 100 mg capsule shell contains FD&C Blue no. 1 and FD&C Red no. 3. The capsule is printed with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, and shellac."
    },
    {
      "NDCCode": "70756-423-22",
      "PackageDescription": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (70756-423-22) ",
      "NDC11Code": "70756-0423-22",
      "ProductNDC": "70756-423",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Omega-3-acid Ethyl Esters",
      "NonProprietaryName": "Omega-3-acid Ethyl Esters",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211116",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215458",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "OMEGA-3-ACID ETHYL ESTERS",
      "StrengthNumber": "1",
      "StrengthUnit": "g/1",
      "Pharm_Classes": "Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211116",
      "SamplePackage": "N",
      "IndicationAndUsage": "Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients,  and control  of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of TG-lowering drug therapy. Limitations of Use. The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined.",
      "Description": "Omega-3-acid ethyl esters, USP a lipid-regulating agent, are supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of omega-3-acid ethyl esters, USP contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA — approximately 465 mg) and docosahexaenoic acid (DHA — approximately 375 mg). The empirical formula of EPA ethyl ester is C22H34O2, and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is. The empirical formula of DHA ethyl ester is C24H36O2, and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is. Omega-3-acid ethyl esters capsules, USP also contain the following inactive ingredients: 4 mg a-tocopherol, gelatin, glycerol, and purified water (components of the capsule shell)."
    },
    {
      "NDCCode": "70756-808-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (70756-808-30) ",
      "NDC11Code": "70756-0808-30",
      "ProductNDC": "70756-808",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207135",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
      "Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 2,3-dihydroxy-2-butenyl 4-­(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low substituted hydroxyl propyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide.  FDA approved dissolution test specification differs from the USP."
    },
    {
      "NDCCode": "70756-808-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (70756-808-90) ",
      "NDC11Code": "70756-0808-90",
      "ProductNDC": "70756-808",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207135",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
      "Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 2,3-dihydroxy-2-butenyl 4-­(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low substituted hydroxyl propyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide.  FDA approved dissolution test specification differs from the USP."
    },
    {
      "NDCCode": "70756-809-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (70756-809-30) ",
      "NDC11Code": "70756-0809-30",
      "ProductNDC": "70756-809",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207135",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
      "Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 2,3-dihydroxy-2-butenyl 4-­(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low substituted hydroxyl propyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide.  FDA approved dissolution test specification differs from the USP."
    },
    {
      "NDCCode": "70756-809-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (70756-809-90) ",
      "NDC11Code": "70756-0809-90",
      "ProductNDC": "70756-809",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207135",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
      "Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 2,3-dihydroxy-2-butenyl 4-­(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low substituted hydroxyl propyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide.  FDA approved dissolution test specification differs from the USP."
    },
    {
      "NDCCode": "70756-810-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (70756-810-30) ",
      "NDC11Code": "70756-0810-30",
      "ProductNDC": "70756-810",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207135",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
      "Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 2,3-dihydroxy-2-butenyl 4-­(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low substituted hydroxyl propyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide.  FDA approved dissolution test specification differs from the USP."
    },
    {
      "NDCCode": "70756-810-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (70756-810-90) ",
      "NDC11Code": "70756-0810-90",
      "ProductNDC": "70756-810",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207135",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
      "Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 2,3-dihydroxy-2-butenyl 4-­(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low substituted hydroxyl propyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide.  FDA approved dissolution test specification differs from the USP."
    },
    {
      "NDCCode": "70756-812-12",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (70756-812-12) ",
      "NDC11Code": "70756-0812-12",
      "ProductNDC": "70756-812",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208847",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "20; 12.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure [see Dosage and Administration ( 2)] . Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs. Limitations of Use. Olmesartan medoxomil and hydrochlorothiazide tablets is not indicated for the initial therapy of hypertension.",
      "Description": "Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT 1subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 1H-Imidazole-5-Carboxylic Acid, 4-(1-Hydroxy-1-Methylethyl)-2-Propyl-1-[[2’-1H-Tetrazol-5yl)[1, 1’-Biphenyl]-4-yl]Methyl]-, (5-Methyl-2-Oxo-1, 3-Dioxol-4-yl) Methyl Ester. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil is a white to off white powder with a molecular weight of 558.59. It is slightly soluble in acetone and methanol, very slightly soluble in ethanol and practically insoluble in water. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8ClN 3O 4S 2and its structural formula is:. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. Hydrochlorothiazide is freely soluble in sodium hydroxide solution, in n-butyl amine and in dimethylformamide; very slightly soluble in water, sparingly soluble in methanol, insoluble in ether, in chloroform and in dilute mineral acids. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxy propyl cellulose, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide."
    },
    {
      "NDCCode": "70756-812-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (70756-812-30) ",
      "NDC11Code": "70756-0812-30",
      "ProductNDC": "70756-812",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208847",
      "LabelerName": "Lifestar Pharma LLC",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "20; 12.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure [see Dosage and Administration ( 2)] . Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs. Limitations of Use. Olmesartan medoxomil and hydrochlorothiazide tablets is not indicated for the initial therapy of hypertension.",
      "Description": "Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT 1subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 1H-Imidazole-5-Carboxylic Acid, 4-(1-Hydroxy-1-Methylethyl)-2-Propyl-1-[[2’-1H-Tetrazol-5yl)[1, 1’-Biphenyl]-4-yl]Methyl]-, (5-Methyl-2-Oxo-1, 3-Dioxol-4-yl) Methyl Ester. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil is a white to off white powder with a molecular weight of 558.59. It is slightly soluble in acetone and methanol, very slightly soluble in ethanol and practically insoluble in water. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8ClN 3O 4S 2and its structural formula is:. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. Hydrochlorothiazide is freely soluble in sodium hydroxide solution, in n-butyl amine and in dimethylformamide; very slightly soluble in water, sparingly soluble in methanol, insoluble in ether, in chloroform and in dilute mineral acids. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxy propyl cellulose, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"70756-830-16","ProprietaryName":"Bupropion Hcl Er (xl)","NonProprietaryName":"Bupropion Hcl Er"},{"NDCCode":"65841-830-16","ProprietaryName":"Voriconazole","NonProprietaryName":"Voriconazole"},{"NDCCode":"70756-830-30","ProprietaryName":"Bupropion Hcl Er (xl)","NonProprietaryName":"Bupropion Hcl Er"},{"NDCCode":"24208-830-60","ProprietaryName":"Neomycin Polymyxin B Sulfates And Dexamethasone","NonProprietaryName":"Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone"},{"NDCCode":"56062-830-28","ProprietaryName":"Publix Triple Antibiotic","NonProprietaryName":"Bacitracin Zinc 400 U, Polymxyin B Sulfate 5,000 U, Neomycin Sulfate 3.5mg/g"},{"NDCCode":"58160-830-34","ProprietaryName":"Cervarix","NonProprietaryName":"Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant"},{"NDCCode":"58160-830-52","ProprietaryName":"Cervarix","NonProprietaryName":"Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant"},{"NDCCode":"61919-830-60","ProprietaryName":"Levertiracetam","NonProprietaryName":"Levertiracetam"},{"NDCCode":"66721-830-60","NonProprietaryName":"Lenacapavir"},{"NDCCode":"70069-830-01","ProprietaryName":"Dalbavancin","NonProprietaryName":"Dalbavancin"},{"NDCCode":"72578-012-16","ProprietaryName":"Clopidogrel","NonProprietaryName":"Clopidogrel"},{"NDCCode":"80725-830-60","ProprietaryName":"Droxia","NonProprietaryName":"Hydroxyurea"},{"NDCCode":"70756-018-51","ProprietaryName":"Pantoprazole Sodium Delayed-release","NonProprietaryName":"Pantoprazole Sodium Delayed-release"},{"NDCCode":"70756-018-90","ProprietaryName":"Pantoprazole Sodium Delayed-release","NonProprietaryName":"Pantoprazole Sodium Delayed-release"},{"NDCCode":"70756-019-12","ProprietaryName":"Pantoprazole Sodium Delayed-release","NonProprietaryName":"Pantoprazole Sodium Delayed-release"},{"NDCCode":"70756-019-90","ProprietaryName":"Pantoprazole Sodium Delayed-release","NonProprietaryName":"Pantoprazole Sodium Delayed-release"},{"NDCCode":"70756-404-11","ProprietaryName":"Nitrofurantoin (monohydrate/macrocrystals)","NonProprietaryName":"Nitrofurantoin (monohydrate/macrocrystals)"},{"NDCCode":"70756-404-51","ProprietaryName":"Nitrofurantoin (monohydrate/macrocrystals)","NonProprietaryName":"Nitrofurantoin (monohydrate/macrocrystals)"},{"NDCCode":"70756-410-11","ProprietaryName":"Nitrofurantoin Macrocrystals","NonProprietaryName":"Nitrofurantoin Macrocrystals"},{"NDCCode":"70756-411-11","ProprietaryName":"Nitrofurantoin Macrocrystals","NonProprietaryName":"Nitrofurantoin Macrocrystals"},{"NDCCode":"70756-412-11","ProprietaryName":"Nitrofurantoin Macrocrystals","NonProprietaryName":"Nitrofurantoin Macrocrystals"},{"NDCCode":"70756-423-22","ProprietaryName":"Omega-3-acid Ethyl Esters","NonProprietaryName":"Omega-3-acid Ethyl Esters"},{"NDCCode":"70756-808-30","ProprietaryName":"Olmesartan Medoxomil","NonProprietaryName":"Olmesartan Medoxomil"},{"NDCCode":"70756-808-90","ProprietaryName":"Olmesartan Medoxomil","NonProprietaryName":"Olmesartan Medoxomil"},{"NDCCode":"70756-809-30","ProprietaryName":"Olmesartan Medoxomil","NonProprietaryName":"Olmesartan Medoxomil"},{"NDCCode":"70756-809-90","ProprietaryName":"Olmesartan Medoxomil","NonProprietaryName":"Olmesartan Medoxomil"},{"NDCCode":"70756-810-30","ProprietaryName":"Olmesartan Medoxomil","NonProprietaryName":"Olmesartan Medoxomil"},{"NDCCode":"70756-810-90","ProprietaryName":"Olmesartan Medoxomil","NonProprietaryName":"Olmesartan Medoxomil"},{"NDCCode":"70756-812-12","ProprietaryName":"Olmesartan Medoxomil And Hydrochlorothiazide","NonProprietaryName":"Olmesartan Medoxomil And Hydrochlorothiazide"},{"NDCCode":"70756-812-30","ProprietaryName":"Olmesartan Medoxomil And Hydrochlorothiazide","NonProprietaryName":"Olmesartan Medoxomil And Hydrochlorothiazide"}]}
                    

<NDCList><NDC><NDCCode>70756-830-16</NDCCode><ProprietaryName>Bupropion Hcl Er (xl)</ProprietaryName><NonProprietaryName>Bupropion Hcl Er</NonProprietaryName></NDC><NDC><NDCCode>65841-830-16</NDCCode><ProprietaryName>Voriconazole</ProprietaryName><NonProprietaryName>Voriconazole</NonProprietaryName></NDC><NDC><NDCCode>70756-830-30</NDCCode><ProprietaryName>Bupropion Hcl Er (xl)</ProprietaryName><NonProprietaryName>Bupropion Hcl Er</NonProprietaryName></NDC><NDC><NDCCode>24208-830-60</NDCCode><ProprietaryName>Neomycin Polymyxin B Sulfates And Dexamethasone</ProprietaryName><NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone</NonProprietaryName></NDC><NDC><NDCCode>56062-830-28</NDCCode><ProprietaryName>Publix Triple Antibiotic</ProprietaryName><NonProprietaryName>Bacitracin Zinc 400 U, Polymxyin B Sulfate 5,000 U, Neomycin Sulfate 3.5mg/g</NonProprietaryName></NDC><NDC><NDCCode>58160-830-34</NDCCode><ProprietaryName>Cervarix</ProprietaryName><NonProprietaryName>Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant</NonProprietaryName></NDC><NDC><NDCCode>58160-830-52</NDCCode><ProprietaryName>Cervarix</ProprietaryName><NonProprietaryName>Human Papillomavirus Bivalent (types 16 And 18) Vaccine, Recombinant</NonProprietaryName></NDC><NDC><NDCCode>61919-830-60</NDCCode><ProprietaryName>Levertiracetam</ProprietaryName><NonProprietaryName>Levertiracetam</NonProprietaryName></NDC><NDC><NDCCode>66721-830-60</NDCCode><NonProprietaryName>Lenacapavir</NonProprietaryName></NDC><NDC><NDCCode>70069-830-01</NDCCode><ProprietaryName>Dalbavancin</ProprietaryName><NonProprietaryName>Dalbavancin</NonProprietaryName></NDC><NDC><NDCCode>72578-012-16</NDCCode><ProprietaryName>Clopidogrel</ProprietaryName><NonProprietaryName>Clopidogrel</NonProprietaryName></NDC><NDC><NDCCode>80725-830-60</NDCCode><ProprietaryName>Droxia</ProprietaryName><NonProprietaryName>Hydroxyurea</NonProprietaryName></NDC><NDC><NDCCode>70756-018-51</NDCCode><ProprietaryName>Pantoprazole Sodium Delayed-release</ProprietaryName><NonProprietaryName>Pantoprazole Sodium Delayed-release</NonProprietaryName></NDC><NDC><NDCCode>70756-018-90</NDCCode><ProprietaryName>Pantoprazole Sodium Delayed-release</ProprietaryName><NonProprietaryName>Pantoprazole Sodium Delayed-release</NonProprietaryName></NDC><NDC><NDCCode>70756-019-12</NDCCode><ProprietaryName>Pantoprazole Sodium Delayed-release</ProprietaryName><NonProprietaryName>Pantoprazole Sodium Delayed-release</NonProprietaryName></NDC><NDC><NDCCode>70756-019-90</NDCCode><ProprietaryName>Pantoprazole Sodium Delayed-release</ProprietaryName><NonProprietaryName>Pantoprazole Sodium Delayed-release</NonProprietaryName></NDC><NDC><NDCCode>70756-404-11</NDCCode><ProprietaryName>Nitrofurantoin (monohydrate/macrocrystals)</ProprietaryName><NonProprietaryName>Nitrofurantoin (monohydrate/macrocrystals)</NonProprietaryName></NDC><NDC><NDCCode>70756-404-51</NDCCode><ProprietaryName>Nitrofurantoin (monohydrate/macrocrystals)</ProprietaryName><NonProprietaryName>Nitrofurantoin (monohydrate/macrocrystals)</NonProprietaryName></NDC><NDC><NDCCode>70756-410-11</NDCCode><ProprietaryName>Nitrofurantoin Macrocrystals</ProprietaryName><NonProprietaryName>Nitrofurantoin Macrocrystals</NonProprietaryName></NDC><NDC><NDCCode>70756-411-11</NDCCode><ProprietaryName>Nitrofurantoin Macrocrystals</ProprietaryName><NonProprietaryName>Nitrofurantoin Macrocrystals</NonProprietaryName></NDC><NDC><NDCCode>70756-412-11</NDCCode><ProprietaryName>Nitrofurantoin Macrocrystals</ProprietaryName><NonProprietaryName>Nitrofurantoin Macrocrystals</NonProprietaryName></NDC><NDC><NDCCode>70756-423-22</NDCCode><ProprietaryName>Omega-3-acid Ethyl Esters</ProprietaryName><NonProprietaryName>Omega-3-acid Ethyl Esters</NonProprietaryName></NDC><NDC><NDCCode>70756-808-30</NDCCode><ProprietaryName>Olmesartan Medoxomil</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>70756-808-90</NDCCode><ProprietaryName>Olmesartan Medoxomil</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>70756-809-30</NDCCode><ProprietaryName>Olmesartan Medoxomil</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>70756-809-90</NDCCode><ProprietaryName>Olmesartan Medoxomil</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>70756-810-30</NDCCode><ProprietaryName>Olmesartan Medoxomil</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>70756-810-90</NDCCode><ProprietaryName>Olmesartan Medoxomil</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>70756-812-12</NDCCode><ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>70756-812-30</NDCCode><ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</NonProprietaryName></NDC></NDCList>