RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "60290-084-03",
      "PackageDescription": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-03) ",
      "NDC11Code": "60290-0084-03",
      "ProductNDC": "60290-084",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diclofenac Sodium",
      "NonProprietaryName": "Diclofenac Sodium",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219945",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
      "Description": "Diclofenac sodium delayed-release tablets, USP is a benzene-acetic acid derivative. Diclofenac sodium is a white to off-white, hygroscopic, crystalline powder, melts at about 284°C and freely soluble in. methanol; soluble in ethanol; sparingly soluble in water; practically insoluble in chloroform and in ether. The chemical name is Benzeneacetic acid, 2-[(2,6-dichlorophenyl)amino]-, monosodium salt. The molecular weight is 318.13 g/mol. Its molecular formula is C 14H 10Cl 2NNaO 2, and it has the following structural formula. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac. The inactive ingredients in diclofenac sodium delayed-release tablets, USP include: croscarmellose sodium, hypromellose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, methacrylic acid copolymer, polyethylene glycol, povidone, talc, triethyl citrate, Titanium dioxide, iron oxide red, iron oxide yellow (50 mg and 75 mg tablets) or D&C Yellow No. 10 Al. Lake (25 mg tablets)."
    },
    {
      "NDCCode": "60290-084-01",
      "PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-01) ",
      "NDC11Code": "60290-0084-01",
      "ProductNDC": "60290-084",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diclofenac Sodium",
      "NonProprietaryName": "Diclofenac Sodium",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219945",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
      "Description": "Diclofenac sodium delayed-release tablets, USP is a benzene-acetic acid derivative. Diclofenac sodium is a white to off-white, hygroscopic, crystalline powder, melts at about 284°C and freely soluble in. methanol; soluble in ethanol; sparingly soluble in water; practically insoluble in chloroform and in ether. The chemical name is Benzeneacetic acid, 2-[(2,6-dichlorophenyl)amino]-, monosodium salt. The molecular weight is 318.13 g/mol. Its molecular formula is C 14H 10Cl 2NNaO 2, and it has the following structural formula. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac. The inactive ingredients in diclofenac sodium delayed-release tablets, USP include: croscarmellose sodium, hypromellose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, methacrylic acid copolymer, polyethylene glycol, povidone, talc, triethyl citrate, Titanium dioxide, iron oxide red, iron oxide yellow (50 mg and 75 mg tablets) or D&C Yellow No. 10 Al. Lake (25 mg tablets)."
    },
    {
      "NDCCode": "60290-084-02",
      "PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-02) ",
      "NDC11Code": "60290-0084-02",
      "ProductNDC": "60290-084",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diclofenac Sodium",
      "NonProprietaryName": "Diclofenac Sodium",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219945",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
      "Description": "Diclofenac sodium delayed-release tablets, USP is a benzene-acetic acid derivative. Diclofenac sodium is a white to off-white, hygroscopic, crystalline powder, melts at about 284°C and freely soluble in. methanol; soluble in ethanol; sparingly soluble in water; practically insoluble in chloroform and in ether. The chemical name is Benzeneacetic acid, 2-[(2,6-dichlorophenyl)amino]-, monosodium salt. The molecular weight is 318.13 g/mol. Its molecular formula is C 14H 10Cl 2NNaO 2, and it has the following structural formula. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac. The inactive ingredients in diclofenac sodium delayed-release tablets, USP include: croscarmellose sodium, hypromellose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, methacrylic acid copolymer, polyethylene glycol, povidone, talc, triethyl citrate, Titanium dioxide, iron oxide red, iron oxide yellow (50 mg and 75 mg tablets) or D&C Yellow No. 10 Al. Lake (25 mg tablets)."
    },
    {
      "NDCCode": "60290-084-04",
      "PackageDescription": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-04) ",
      "NDC11Code": "60290-0084-04",
      "ProductNDC": "60290-084",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diclofenac Sodium",
      "NonProprietaryName": "Diclofenac Sodium",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219945",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
      "Description": "Diclofenac sodium delayed-release tablets, USP is a benzene-acetic acid derivative. Diclofenac sodium is a white to off-white, hygroscopic, crystalline powder, melts at about 284°C and freely soluble in. methanol; soluble in ethanol; sparingly soluble in water; practically insoluble in chloroform and in ether. The chemical name is Benzeneacetic acid, 2-[(2,6-dichlorophenyl)amino]-, monosodium salt. The molecular weight is 318.13 g/mol. Its molecular formula is C 14H 10Cl 2NNaO 2, and it has the following structural formula. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac. The inactive ingredients in diclofenac sodium delayed-release tablets, USP include: croscarmellose sodium, hypromellose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, methacrylic acid copolymer, polyethylene glycol, povidone, talc, triethyl citrate, Titanium dioxide, iron oxide red, iron oxide yellow (50 mg and 75 mg tablets) or D&C Yellow No. 10 Al. Lake (25 mg tablets)."
    },
    {
      "NDCCode": "12714-084-03",
      "PackageDescription": ".3 mg in 1 VIAL, SINGLE-DOSE (12714-084-03) ",
      "NDC11Code": "12714-0084-03",
      "ProductNDC": "12714-084",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Interferon Beta-1b",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20110502",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Boehringer Ingelheim Pharma GmbH and Co. KG",
      "SubstanceName": "INTERFERON BETA-1B",
      "StrengthNumber": ".3",
      "StrengthUnit": "mg/.3mg",
      "Status": "Unfinished",
      "LastUpdate": "2024-07-27",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "02-MAY-11"
    },
    {
      "NDCCode": "16714-084-03",
      "PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (16714-084-03) ",
      "NDC11Code": "16714-0084-03",
      "ProductNDC": "16714-084",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Spironolactone",
      "NonProprietaryName": "Spironolactone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200423",
      "EndMarketingDate": "20250601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089424",
      "LabelerName": "NorthStar Rx LLC",
      "SubstanceName": "SPIRONOLACTONE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200423",
      "EndMarketingDatePackage": "20250601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Spironolactone tablets are an aldosterone antagonist indicated for: 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1). , 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.2). , 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response ( 1.3). , 4 Treatment of primary hyperaldosternism for: ( 1.4). Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia.",
      "Description": "Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17‑ hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Spironolactone tablets, 25 mg contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, docusate sodium 85%/sodium benzoate 15%, entrapped peppermint flavor, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Spironolactone tablets, 50 mg and 100 mg contain the following inactive ingredients: anhydrous lactose, carnauba wax, colloidal silicon dioxide, docusate sodium 85%/sodium benzoate 15%, entrapped peppermint flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, titanium dioxide, and triacetin."
    },
    {
      "NDCCode": "27241-084-03",
      "PackageDescription": "30 TABLET in 1 BOTTLE (27241-084-03) ",
      "NDC11Code": "27241-0084-03",
      "ProductNDC": "27241-084",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine Besylate And Olmesartan Medoxomil",
      "NonProprietaryName": "Amlodipine Besylate And Olmesartan Medoxomil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170206",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207216",
      "LabelerName": "Ajanta Pharma USA Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "5; 40",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170206",
      "SamplePackage": "N",
      "IndicationAndUsage": "Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. 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 amlodipine and 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. Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10/40 mg.",
      "Description": "Amlodipine besylate and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate, USP and the angiotensin II receptor blocker (ARB) olmesartan medoxomil, USP.The amlodipine besylate, USP component of amlodipine and olmesartan medoxomil tablets, USP is chemically described as 3-ethyl-5-methyl (±)-2-[(2- aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S.Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.The olmesartan medoxomil, USP component of amlodipine and olmesartan medoxomil tablets, USP is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl] imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6.The structural formula for amlodipine besylate, USP is:. The structural formula for olmesartan medoxomil, USP is. Amlodipine and olmesartan medoxomil tablets, USP contain amlodipine besylate, USP a white or almost white powder, and olmesartan medoxomil, USP white to off-white crystalline powder. The molecular weights of amlodipine besylate, USP and olmesartan medoxomil, USP are 567.1 and 558.59, respectively. Amlodipine besylate, USP is slightly soluble in water and 2-propanol, sparingly soluble in ethanol, freely soluble in methanol. Olmesartan medoxomil, USP is practically insoluble in water and sparingly soluble in methanol.Each tablet of amlodipine and olmesartan medoxomil also contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, croscarmellose sodium, and magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/polyethylene glycol, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (10/20 mg and 10/40 mg tablets), and iron oxide black (10/20 mg, 10/40 mg tablets)."
    },
    {
      "NDCCode": "49527-084-03",
      "PackageDescription": "1 TUBE in 1 CARTON (49527-084-03)  / 5 mL in 1 TUBE",
      "NDC11Code": "49527-0084-03",
      "ProductNDC": "49527-084",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Moisture Surge Spf",
      "NonProprietaryName": "Avobenzone,homosalate,octinoxate,octisalate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20221107",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "CLINIQUE LABORATORIES LLC",
      "SubstanceName": "HOMOSALATE; OCTINOXATE; OCTISALATE; AVOBENZONE",
      "StrengthNumber": "70; 70; 45; 30",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-08-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221130",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn."
    },
    {
      "NDCCode": "58159-084-03",
      "PackageDescription": "15 kg in 1 DRUM (58159-084-03) ",
      "NDC11Code": "58159-0084-03",
      "ProductNDC": "58159-084",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Pitolisant Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20210610",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
      "SubstanceName": "PITOLISANT HYDROCHLORIDE",
      "StrengthNumber": "35",
      "StrengthUnit": "kg/35kg",
      "Status": "Unfinished",
      "LastUpdate": "2021-06-23",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "10-JUN-21"
    },
    {
      "NDCCode": "63545-084-03",
      "PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (63545-084-03) ",
      "NDC11Code": "63545-0084-03",
      "ProductNDC": "63545-084",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aralia Racemosa",
      "NonProprietaryName": "Aralia Racemosa",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210224",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, Inc.",
      "SubstanceName": "ARALIA RACEMOSA ROOT",
      "StrengthNumber": "200",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2021-02-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210224",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71085-084-03",
      "PackageDescription": "1 TUBE in 1 CARTON (71085-084-03)  / 110 g in 1 TUBE",
      "NDC11Code": "71085-0084-03",
      "ProductNDC": "71085-084",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Diclofenac Sodium",
      "NonProprietaryName": "Diclofenac Sodium Topical Gel, 1%",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260906",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210986",
      "LabelerName": "IPG Pharmaceuticals, inc.",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-09-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260906",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of arthritis pain ONLY inthe following areas: hand, wrist, elbow (upper body areas)foot, ankle, knee (lower body areas). this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use."
    },
    {
      "NDCCode": "71209-084-03",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71209-084-03) ",
      "NDC11Code": "71209-0084-03",
      "ProductNDC": "71209-084",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Labetalol Hydrochloride",
      "NonProprietaryName": "Labetalol Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180305",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211325",
      "LabelerName": "Cadila Pharmaceuticals Limited",
      "SubstanceName": "LABETALOL HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Labetalol hydrochloride tablets, are indicated in the management of hypertension. Labetalol hydrochloride tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
      "Description": "Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride, USP has the molecular formula C19H24N2O3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white to off-white powder, soluble in water and in alcohol. Insoluble in ether and in chloroform. Labetalol hydrochloride tablets, USP for oral administration, contains 100 mg, 200 mg or 300 mg of labetalol hydrochloride USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, opadry white, polysorbate, and sodium starch glycolate (potato). Opadry white contains hypromellose, polyethylene glycol, titanium dioxide, and talc."
    },
    {
      "NDCCode": "72578-084-03",
      "PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (72578-084-03)  / 60 mL in 1 BOTTLE, WITH APPLICATOR",
      "NDC11Code": "72578-0084-03",
      "ProductNDC": "72578-084",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin Phosphate",
      "NonProprietaryName": "Clindamycin Phosphate",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200615",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208767",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200615",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin phosphate topical solution USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).",
      "Description": "Clindamycin phosphate topical solution USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1  methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto octopyranoside 2-(dihydrogen phosphate). Clindamycin phosphate topical solution USP, 1% contains isopropyl alcohol, 50% v/v; propylene glycol and purified water. Sodium hydroxide or hydrochloric acid may be added to adjust pH between 4.0 to 7.0."
    },
    {
      "NDCCode": "73377-084-03",
      "PackageDescription": "10 g in 1 JAR (73377-084-03) ",
      "NDC11Code": "73377-0084-03",
      "ProductNDC": "73377-084",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Tofacitinib Citrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20201103",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "AX Pharmaceutical Corp",
      "SubstanceName": "TOFACITINIB CITRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2026-05-06",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "03-NOV-20"
    },
    {
      "NDCCode": "83703-084-03",
      "PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (83703-084-03)  / .5 mL in 1 SYRINGE, GLASS (83703-084-04) ",
      "NDC11Code": "83703-0084-03",
      "ProductNDC": "83703-084",
      "ProductTypeName": "VACCINE",
      "ProprietaryName": "Flucelvax",
      "NonProprietaryName": "Influenza A Virus A/georgia/12/2022 Cvr-167 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/victoria/800/2024 Cvr-289 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/wuh4618/2021 Antigen (mdck Cell Derived, Propiolactone Inactivated)",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20250701",
      "EndMarketingDate": "20260731",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125408",
      "LabelerName": "Bamboo US BidCo LLC",
      "SubstanceName": "INFLUENZA A VIRUS A/GEORGIA/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/800/2024 CVR-289 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)",
      "StrengthNumber": "15; 15; 15",
      "StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20250701",
      "EndMarketingDatePackage": "20260731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "84386-084-03",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (84386-084-03)  / 10 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "84386-0084-03",
      "ProductNDC": "84386-084",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Perampanel",
      "NonProprietaryName": "Perampanel",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20261002",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA220492",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "PERAMPANEL",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
      "DEASchedule": "CIII",
      "Status": "Active",
      "LastUpdate": "2026-10-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20261002",
      "SamplePackage": "N",
      "IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .",
      "Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3).  The molecular formula is C23H15N3O  ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2  aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg)."
    },
    {
      "NDCCode": "84778-084-03",
      "PackageDescription": "4 PATCH in 1 BOX (84778-084-03)  / 40 mg in 1 PATCH",
      "NDC11Code": "84778-0084-03",
      "ProductNDC": "84778-084",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Esokalli Testosterone Booster Oral Dissolving Film",
      "NonProprietaryName": "Esokalli Testosterone Booster Oral Dissolving Film",
      "DosageFormName": "FILM, SOLUBLE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250824",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Guangzhou Yixin Cross-border E-commerce Co., Ltd.",
      "SubstanceName": "TADALAFIL; VARDENAFIL",
      "StrengthNumber": "20; 20",
      "StrengthUnit": "mg/100mg; mg/100mg",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-07-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250824",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the treatment of erectile dysfunction (ED)."
    },
    {
      "NDCCode": "60290-002-03",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (60290-002-03) ",
      "NDC11Code": "60290-0002-03",
      "ProductNDC": "60290-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sildenafil Citrate",
      "NonProprietaryName": "Sildenafil Citrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209302",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "SILDENAFIL CITRATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-05-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
      "Description": "Sildenafil tablets, USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets USP are formulated as pale blue to blue film-coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. Sildenafil tablets 50 mg and 100 mg are caplet shaped whereas sildenafil tablets 25 mg are round shaped. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, FD&C Blue # 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "60290-003-03",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (60290-003-03) ",
      "NDC11Code": "60290-0003-03",
      "ProductNDC": "60290-003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sildenafil Citrate",
      "NonProprietaryName": "Sildenafil Citrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209302",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "SILDENAFIL CITRATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-05-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
      "Description": "Sildenafil tablets, USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets USP are formulated as pale blue to blue film-coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. Sildenafil tablets 50 mg and 100 mg are caplet shaped whereas sildenafil tablets 25 mg are round shaped. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, FD&C Blue # 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "60290-009-03",
      "PackageDescription": "10 TABLET in 1 BLISTER PACK (60290-009-03) ",
      "NDC11Code": "60290-0009-03",
      "ProductNDC": "60290-009",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207135",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "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 1 H-Imidazole-5-Carboxylic Acid, 4-(1-Hydroxy-1-Methylethyl)-2-Propyl-1-[[2'-1 H-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, USP 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. Practically insoluble in water. 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. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "60290-010-03",
      "PackageDescription": "10 TABLET in 1 BLISTER PACK (60290-010-03) ",
      "NDC11Code": "60290-0010-03",
      "ProductNDC": "60290-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207135",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "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 1 H-Imidazole-5-Carboxylic Acid, 4-(1-Hydroxy-1-Methylethyl)-2-Propyl-1-[[2'-1 H-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, USP 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. Practically insoluble in water. 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. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "60290-011-03",
      "PackageDescription": "10 TABLET in 1 BLISTER PACK (60290-011-03) ",
      "NDC11Code": "60290-0011-03",
      "ProductNDC": "60290-011",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil",
      "NonProprietaryName": "Olmesartan Medoxomil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207135",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "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 1 H-Imidazole-5-Carboxylic Acid, 4-(1-Hydroxy-1-Methylethyl)-2-Propyl-1-[[2'-1 H-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, USP 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. Practically insoluble in water. 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. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "60290-016-03",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (60290-016-03) ",
      "NDC11Code": "60290-0016-03",
      "ProductNDC": "60290-016",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Celecoxib",
      "NonProprietaryName": "Celecoxib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210628",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "CELECOXIB",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Celecoxib capsules are indicated.",
      "Description": "Celecoxib capsule are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white or almost white, crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: lactose monohydrate, croscarmellose sodium, povidone, sodium lauryl sulphate and magnesium stearate. The content of empty hard gelatin capsules: titanium dioxide, gelatin, sodium lauryl sulphate. The content of edible ink: shellac, propylene glycol, black iron oxide, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution."
    },
    {
      "NDCCode": "60290-017-03",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (60290-017-03) ",
      "NDC11Code": "60290-0017-03",
      "ProductNDC": "60290-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Celecoxib",
      "NonProprietaryName": "Celecoxib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210628",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "CELECOXIB",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Celecoxib capsules are indicated.",
      "Description": "Celecoxib capsule are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white or almost white, crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: lactose monohydrate, croscarmellose sodium, povidone, sodium lauryl sulphate and magnesium stearate. The content of empty hard gelatin capsules: titanium dioxide, gelatin, sodium lauryl sulphate. The content of edible ink: shellac, propylene glycol, black iron oxide, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution."
    },
    {
      "NDCCode": "60290-018-03",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (60290-018-03) ",
      "NDC11Code": "60290-0018-03",
      "ProductNDC": "60290-018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Celecoxib",
      "NonProprietaryName": "Celecoxib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210628",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "CELECOXIB",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Celecoxib capsules are indicated.",
      "Description": "Celecoxib capsule are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white or almost white, crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: lactose monohydrate, croscarmellose sodium, povidone, sodium lauryl sulphate and magnesium stearate. The content of empty hard gelatin capsules: titanium dioxide, gelatin, sodium lauryl sulphate. The content of edible ink: shellac, propylene glycol, black iron oxide, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution."
    },
    {
      "NDCCode": "60290-019-03",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (60290-019-03) ",
      "NDC11Code": "60290-0019-03",
      "ProductNDC": "60290-019",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Celecoxib",
      "NonProprietaryName": "Celecoxib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210628",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "CELECOXIB",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Celecoxib capsules are indicated.",
      "Description": "Celecoxib capsule are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white or almost white, crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: lactose monohydrate, croscarmellose sodium, povidone, sodium lauryl sulphate and magnesium stearate. The content of empty hard gelatin capsules: titanium dioxide, gelatin, sodium lauryl sulphate. The content of edible ink: shellac, propylene glycol, black iron oxide, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution."
    },
    {
      "NDCCode": "60290-024-03",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (60290-024-03) ",
      "NDC11Code": "60290-0024-03",
      "ProductNDC": "60290-024",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200312",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208847",
      "LabelerName": "UMEDICA LABORATORIES PRIVATE LIMITED",
      "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": "Deprecated",
      "LastUpdate": "2020-03-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20200312",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "60290-025-03",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (60290-025-03) ",
      "NDC11Code": "60290-0025-03",
      "ProductNDC": "60290-025",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208847",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "40; 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": "2026-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "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": "60290-026-03",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (60290-026-03) ",
      "NDC11Code": "60290-0026-03",
      "ProductNDC": "60290-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208847",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "40; 25",
      "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": "2026-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "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": "60290-027-03",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (60290-027-03) ",
      "NDC11Code": "60290-0027-03",
      "ProductNDC": "60290-027",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tadalafil",
      "NonProprietaryName": "Tadalafil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211298",
      "LabelerName": "Umedica Laboratories USA Inc.",
      "SubstanceName": "TADALAFIL",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-04-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tadalafil tablet is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH)  ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
      "Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41 The structural formula is:. The chemical designation Pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R-12aR)-.It is a white or almost white powder, freely soluble in dimethylsulphoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hypromellose, yellow iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin."
    }
  ]
}
                    

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<NDCList><NDC><NDCCode>60290-084-03</NDCCode><ProprietaryName>Diclofenac Sodium</ProprietaryName><NonProprietaryName>Diclofenac Sodium</NonProprietaryName></NDC><NDC><NDCCode>60290-084-01</NDCCode><ProprietaryName>Diclofenac Sodium</ProprietaryName><NonProprietaryName>Diclofenac Sodium</NonProprietaryName></NDC><NDC><NDCCode>60290-084-02</NDCCode><ProprietaryName>Diclofenac Sodium</ProprietaryName><NonProprietaryName>Diclofenac Sodium</NonProprietaryName></NDC><NDC><NDCCode>60290-084-04</NDCCode><ProprietaryName>Diclofenac Sodium</ProprietaryName><NonProprietaryName>Diclofenac Sodium</NonProprietaryName></NDC><NDC><NDCCode>12714-084-03</NDCCode><NonProprietaryName>Interferon Beta-1b</NonProprietaryName></NDC><NDC><NDCCode>16714-084-03</NDCCode><ProprietaryName>Spironolactone</ProprietaryName><NonProprietaryName>Spironolactone</NonProprietaryName></NDC><NDC><NDCCode>27241-084-03</NDCCode><ProprietaryName>Amlodipine Besylate And Olmesartan Medoxomil</ProprietaryName><NonProprietaryName>Amlodipine Besylate And Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>49527-084-03</NDCCode><ProprietaryName>Moisture Surge Spf</ProprietaryName><NonProprietaryName>Avobenzone,homosalate,octinoxate,octisalate</NonProprietaryName></NDC><NDC><NDCCode>58159-084-03</NDCCode><NonProprietaryName>Pitolisant Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>63545-084-03</NDCCode><ProprietaryName>Aralia Racemosa</ProprietaryName><NonProprietaryName>Aralia Racemosa</NonProprietaryName></NDC><NDC><NDCCode>71085-084-03</NDCCode><ProprietaryName>Diclofenac Sodium</ProprietaryName><NonProprietaryName>Diclofenac Sodium Topical Gel, 1%</NonProprietaryName></NDC><NDC><NDCCode>71209-084-03</NDCCode><ProprietaryName>Labetalol Hydrochloride</ProprietaryName><NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>72578-084-03</NDCCode><ProprietaryName>Clindamycin Phosphate</ProprietaryName><NonProprietaryName>Clindamycin Phosphate</NonProprietaryName></NDC><NDC><NDCCode>73377-084-03</NDCCode><NonProprietaryName>Tofacitinib Citrate</NonProprietaryName></NDC><NDC><NDCCode>83703-084-03</NDCCode><ProprietaryName>Flucelvax</ProprietaryName><NonProprietaryName>Influenza A Virus A/georgia/12/2022 Cvr-167 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/victoria/800/2024 Cvr-289 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/wuh4618/2021 Antigen (mdck Cell Derived, Propiolactone Inactivated)</NonProprietaryName></NDC><NDC><NDCCode>84386-084-03</NDCCode><ProprietaryName>Perampanel</ProprietaryName><NonProprietaryName>Perampanel</NonProprietaryName></NDC><NDC><NDCCode>84778-084-03</NDCCode><ProprietaryName>Esokalli Testosterone Booster Oral Dissolving Film</ProprietaryName><NonProprietaryName>Esokalli Testosterone Booster Oral Dissolving Film</NonProprietaryName></NDC><NDC><NDCCode>60290-002-03</NDCCode><ProprietaryName>Sildenafil Citrate</ProprietaryName><NonProprietaryName>Sildenafil Citrate</NonProprietaryName></NDC><NDC><NDCCode>60290-003-03</NDCCode><ProprietaryName>Sildenafil Citrate</ProprietaryName><NonProprietaryName>Sildenafil Citrate</NonProprietaryName></NDC><NDC><NDCCode>60290-009-03</NDCCode><ProprietaryName>Olmesartan Medoxomil</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>60290-010-03</NDCCode><ProprietaryName>Olmesartan Medoxomil</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>60290-011-03</NDCCode><ProprietaryName>Olmesartan Medoxomil</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName></NDC><NDC><NDCCode>60290-016-03</NDCCode><ProprietaryName>Celecoxib</ProprietaryName><NonProprietaryName>Celecoxib</NonProprietaryName></NDC><NDC><NDCCode>60290-017-03</NDCCode><ProprietaryName>Celecoxib</ProprietaryName><NonProprietaryName>Celecoxib</NonProprietaryName></NDC><NDC><NDCCode>60290-018-03</NDCCode><ProprietaryName>Celecoxib</ProprietaryName><NonProprietaryName>Celecoxib</NonProprietaryName></NDC><NDC><NDCCode>60290-019-03</NDCCode><ProprietaryName>Celecoxib</ProprietaryName><NonProprietaryName>Celecoxib</NonProprietaryName></NDC><NDC><NDCCode>60290-024-03</NDCCode><ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>60290-025-03</NDCCode><ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>60290-026-03</NDCCode><ProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>60290-027-03</NDCCode><ProprietaryName>Tadalafil</ProprietaryName><NonProprietaryName>Tadalafil</NonProprietaryName></NDC></NDCList>