RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "49884-787-11",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (49884-787-11) ",
      "NDC11Code": "49884-0787-11",
      "ProductNDC": "49884-787",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161026",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206137",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "40; 5; 12.5",
      "StrengthUnit": "mg/1; 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], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-09-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20161026",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide 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 olmesartan medoxomil, amlodipine 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. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
      "Description": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets 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 amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets 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 C20H25CIN2O5C6H6O3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contains olmesartan medoxomil, a white to light yellowish-white powder or crystalline powder, amlodipine besylate, a white to off-white crystalline powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide tablets are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each 20/5/12.5 mg tablet contains 20 mg of olmesartan medoxomil, 5 mg of amlodipine besylate and 12.5 mg of hydrochlorothiazide. Each 40/5/12.5 mg tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine besylate and 12.5 mg of hydrochlorothiazide. Each 40/5/25 mg tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine besylate and 25 mg of hydrochlorothiazide. Each 40/10/12.5 mg tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine besylate and 12.5 mg of hydrochlorothiazide. Each 40/10/25 mg tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine besylate and 25 mg of hydrochlorothiazide. Each tablet of olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide also contains the following inactive ingredients: silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating for 20 /5 /12.5 mg, 40 /5 /25 mg tablets contains titanium dioxide, hypromellose, polyethylene glycol and polysorbate, the color coating for 40/10/25 mg and 40/5/12.5 mg tablets contains polyvinyl alcohol - part dehydrolyzed, titanium dioxide, polyethylene glycol, talc and iron oxide red and the color coating for 40 /10 /12.5 mg tablets polyvinyl alcohol - part dehydrolyzed, titanium dioxide, polyethylene glycol, talc iron oxide yellow and FD&C #6."
    },
    {
      "NDCCode": "49884-787-09",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (49884-787-09) ",
      "NDC11Code": "49884-0787-09",
      "ProductNDC": "49884-787",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161026",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206137",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "40; 5; 12.5",
      "StrengthUnit": "mg/1; 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], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-09-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20161026",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide 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 olmesartan medoxomil, amlodipine 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. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.",
      "Description": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets 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 amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets 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 C20H25CIN2O5C6H6O3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contains olmesartan medoxomil, a white to light yellowish-white powder or crystalline powder, amlodipine besylate, a white to off-white crystalline powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide tablets are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each 20/5/12.5 mg tablet contains 20 mg of olmesartan medoxomil, 5 mg of amlodipine besylate and 12.5 mg of hydrochlorothiazide. Each 40/5/12.5 mg tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine besylate and 12.5 mg of hydrochlorothiazide. Each 40/5/25 mg tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine besylate and 25 mg of hydrochlorothiazide. Each 40/10/12.5 mg tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine besylate and 12.5 mg of hydrochlorothiazide. Each 40/10/25 mg tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine besylate and 25 mg of hydrochlorothiazide. Each tablet of olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide also contains the following inactive ingredients: silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating for 20 /5 /12.5 mg, 40 /5 /25 mg tablets contains titanium dioxide, hypromellose, polyethylene glycol and polysorbate, the color coating for 40/10/25 mg and 40/5/12.5 mg tablets contains polyvinyl alcohol - part dehydrolyzed, titanium dioxide, polyethylene glycol, talc and iron oxide red and the color coating for 40 /10 /12.5 mg tablets polyvinyl alcohol - part dehydrolyzed, titanium dioxide, polyethylene glycol, talc iron oxide yellow and FD&C #6."
    },
    {
      "NDCCode": "50268-787-12",
      "PackageDescription": "20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-787-12)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-787-11) ",
      "NDC11Code": "50268-0787-12",
      "ProductNDC": "50268-787",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Valganciclovir",
      "NonProprietaryName": "Valganciclovir",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160727",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205166",
      "LabelerName": "AvPAK",
      "SubstanceName": "VALGANCICLOVIR HYDROCHLORIDE",
      "StrengthNumber": "450",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
      "Status": "Active",
      "LastUpdate": "2026-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160727",
      "SamplePackage": "N",
      "IndicationAndUsage": "Valganciclovir tablets, USP are a cytomegalovirus (CMV) nucleoside analogue DNA polymerase inhibitor indicated for:  Adult Patients (  1.1)   Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).   Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.  Pediatric Patients (  1.2)   Prevention of CMV disease in heart transplant patients at high risk.",
      "Description": "Valganciclovir tablets, USP contains valganciclovir hydrochloride, USP a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir tablets, USP are available as a 450 mg tablet for oral administration. Each film coated tablet contains 496.3 mg of valganciclovir hydrochloride, USP (corresponding to 450 mg of valganciclovir), and the inactive ingredients crospovidone, microcrystalline cellulose, povidone and stearic acid. The tablets are coated with Opadry Pink which contains hypromellose, iron oxide red, polyethylene glycol, polysorbate 80 and titanium dioxide. Valganciclovir hydrochloride, USP is a white to off-white powder, slightly hygroscopic with a molecular formula of C 14H 22N 6O 5HCl and a molecular weight of 390.82. The chemical name for valganciclovir hydrochloride, USP is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropylester, monohydrochloride. Valganciclovir hydrochloride, USP is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7 and an n-octanol/water partition coefficient of 0.0095 at pH 7. The pKa for valganciclovir hydrochloride, USP is 7.5. The chemical structure of valganciclovir hydrochloride, USP is:. All doses in this insert are specified in terms of valganciclovir."
    },
    {
      "NDCCode": "60687-787-01",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (60687-787-01)  / 1 CAPSULE in 1 BLISTER PACK (60687-787-11) ",
      "NDC11Code": "60687-0787-01",
      "ProductNDC": "60687-787",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amoxicillin",
      "NonProprietaryName": "Amoxicillin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250303",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065271",
      "LabelerName": "American Health Packaging",
      "SubstanceName": "AMOXICILLIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250303",
      "SamplePackage": "N",
      "IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. , 4 Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae. .",
      "Description": "Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "49884-104-11",
      "PackageDescription": "1 BOTTLE in 1 CARTON (49884-104-11)  > 30 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "49884-0104-11",
      "ProductNDC": "49884-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Entecavir",
      "NonProprietaryName": "Entecavir",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140818",
      "EndMarketingDate": "20170831",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA021797",
      "LabelerName": "Par Pharmaceutical Inc.",
      "SubstanceName": "ENTECAVIR",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-09-01"
    },
    {
      "NDCCode": "49884-105-11",
      "PackageDescription": "1 BOTTLE in 1 CARTON (49884-105-11)  > 30 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "49884-0105-11",
      "ProductNDC": "49884-105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Entecavir",
      "NonProprietaryName": "Entecavir",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140818",
      "EndMarketingDate": "20170831",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA021797",
      "LabelerName": "Par Pharmaceutical Inc.",
      "SubstanceName": "ENTECAVIR",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-09-01"
    },
    {
      "NDCCode": "49884-147-11",
      "PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-147-11) ",
      "NDC11Code": "49884-0147-11",
      "ProductNDC": "49884-147",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexlansoprazole",
      "NonProprietaryName": "Dexlansoprazole",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230610",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202294",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "DEXLANSOPRAZOLE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-05-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230610",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dexlansoprazole is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: 1 Healing of all grades of erosive esophagitis (EE). (1.1) , 2 Maintenance of healed EE and relief of heartburn. (1.2) , 3 Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). (1.3) .",
      "Description": "The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R-enantiomer of lansoprazole (a racemic mixture of the R- and S-enantiomers). Its molecular formula is: C16H14F3N3O2S, with a molecular weight of 369.36. Dexlansoprazole has the following chemical structure. Dexlansoprazole is a white to off white crystalline powder which melts with decomposition at 143° to 144°C. Dexlansoprazole is practically insoluble in water, freely soluble in dimethylformamide, soluble in methanol, slightly soluble in ethyl acetate and acetonitrile, practically insoluble in hexane. Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3)]. Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: calcium hydroxide, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer, methacrylic acid copolymer type B, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc and triethyl citrate. The black imprinting ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze in ethanol. The capsule shells contain hypromellose and titanium dioxide. In addition, 60 mg contain FD&C Blue #1, FD&C Yellow #5*, and FD&C Yellow #6. *60 mg capsule contains FD&C Yellow No. 5 (tartrazine) [see Warnings and Precautions (5)]."
    },
    {
      "NDCCode": "49884-148-11",
      "PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-11) ",
      "NDC11Code": "49884-0148-11",
      "ProductNDC": "49884-148",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexlansoprazole",
      "NonProprietaryName": "Dexlansoprazole",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221122",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202294",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "DEXLANSOPRAZOLE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-05-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20221122",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dexlansoprazole is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: 1 Healing of all grades of erosive esophagitis (EE). (1.1) , 2 Maintenance of healed EE and relief of heartburn. (1.2) , 3 Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). (1.3) .",
      "Description": "The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R-enantiomer of lansoprazole (a racemic mixture of the R- and S-enantiomers). Its molecular formula is: C16H14F3N3O2S, with a molecular weight of 369.36. Dexlansoprazole has the following chemical structure. Dexlansoprazole is a white to off white crystalline powder which melts with decomposition at 143° to 144°C. Dexlansoprazole is practically insoluble in water, freely soluble in dimethylformamide, soluble in methanol, slightly soluble in ethyl acetate and acetonitrile, practically insoluble in hexane. Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3)]. Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: calcium hydroxide, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer, methacrylic acid copolymer type B, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc and triethyl citrate. The black imprinting ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze in ethanol. The capsule shells contain hypromellose and titanium dioxide. In addition, 60 mg contain FD&C Blue #1, FD&C Yellow #5*, and FD&C Yellow #6. *60 mg capsule contains FD&C Yellow No. 5 (tartrazine) [see Warnings and Precautions (5)]."
    },
    {
      "NDCCode": "49884-161-11",
      "PackageDescription": "3.7 mL in 1 BOTTLE, GLASS (49884-161-11) ",
      "NDC11Code": "49884-0161-11",
      "ProductNDC": "49884-161",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Calcitonin Salmon",
      "NonProprietaryName": "Calcitonin Salmon",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "NASAL",
      "StartMarketingDate": "20090608",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076979",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "CALCITONIN SALMON",
      "StrengthNumber": "200",
      "StrengthUnit": "[iU]/.09mL",
      "Pharm_Classes": "Calcitonin [CS], Calcitonin [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20090608",
      "SamplePackage": "N",
      "IndicationAndUsage": "Calcitonin Salmon Nasal Solution is a calcitonin, indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated. (1.1). Limitations of Use: 1 Due to the possible association between malignancy and calcitonin-salmon use, the need for continued therapy should be re-evaluated on a periodic basis. (1.2, 5.4), 2 Calcitonin Salmon Nasal Solution has not been shown to increase bone mineral density in early postmenopausal women (1.2).",
      "Description": "Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. Calcitonin Salmon Nasal Solution is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula. It is provided in a 3.7 mL fill glass bottle as a solution for nasal administration. This is sufficient medication for 30 doses. Active Ingredient: calcitonin-salmon, 2200 International Units per mL (corresponding to 200 International Units per 0.09 mL actuation). Inactive Ingredients: sodium chloride, chlorobutanol (possesses a characteristic odor), hydrochloric acid (added as necessary to adjust pH), purified water and nitrogen. The activity of Calcitonin Salmon Nasal Solution is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin-salmon for Bioassay, distributed by the National Institute of Biological Standards and Control, Holly Hill, London."
    },
    {
      "NDCCode": "49884-171-11",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (49884-171-11) ",
      "NDC11Code": "49884-0171-11",
      "ProductNDC": "49884-171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Colchicine",
      "NonProprietaryName": "Colchicine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220927",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203976",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "COLCHICINE",
      "StrengthNumber": ".6",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS]",
      "Status": "Active",
      "LastUpdate": "2026-06-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220927",
      "SamplePackage": "N",
      "IndicationAndUsage": "Colchicine tablets, USP are an alkaloid indicated for: 1 Prophylaxis and treatment of gout flares in adults (1.1)., 2 Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).",
      "Description": "Colchicine, USP is an alkaloid chemically described as (S)N- (5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo [alpha] heptalen-7-yl) acetamide with a molecular formula of C22H25NO6 and a molecular weight of 399.4. The structural formula of colchicine is given below. Colchicine, USP occurs as a pale yellow powder that is soluble in water. Colchicine Tablets, USP are supplied for oral administration as purple, film coated, modified capsule-shaped tablets (0.1575” × 0.3030”), debossed with “p171” on one side and bisect on the other, containing 0.6 mg of the active ingredient colchicine USP. Inactive ingredients: FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (botanical source: corn starch), sodium starch glycolate, titanium dioxide, and triacetin."
    },
    {
      "NDCCode": "49884-172-11",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (49884-172-11) ",
      "NDC11Code": "49884-0172-11",
      "ProductNDC": "49884-172",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine, Valsartan, Hydrochlorothiazide",
      "NonProprietaryName": "Amlodipine Besylate Valsartan Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150601",
      "EndMarketingDate": "20220531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201087",
      "LabelerName": "Par Pharmaceutical, Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
      "StrengthNumber": "5; 12.5; 160",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150601",
      "EndMarketingDatePackage": "20220531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49884-173-11",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (49884-173-11) ",
      "NDC11Code": "49884-0173-11",
      "ProductNDC": "49884-173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine, Valsartan, Hydrochlorothiazide",
      "NonProprietaryName": "Amlodipine Besylate Valsartan Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150601",
      "EndMarketingDate": "20220531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201087",
      "LabelerName": "Par Pharmaceutical, Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
      "StrengthNumber": "5; 25; 160",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150601",
      "EndMarketingDatePackage": "20220531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49884-174-11",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (49884-174-11) ",
      "NDC11Code": "49884-0174-11",
      "ProductNDC": "49884-174",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine, Valsartan, Hydrochlorothiazide",
      "NonProprietaryName": "Amlodipine Besylate Valsartan Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150601",
      "EndMarketingDate": "20220531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201087",
      "LabelerName": "Par Pharmaceutical, Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
      "StrengthNumber": "10; 12.5; 160",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150601",
      "EndMarketingDatePackage": "20220531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49884-175-11",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (49884-175-11) ",
      "NDC11Code": "49884-0175-11",
      "ProductNDC": "49884-175",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine, Valsartan, Hydrochlorothiazide",
      "NonProprietaryName": "Amlodipine Besylate Valsartan Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150601",
      "EndMarketingDate": "20220531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201087",
      "LabelerName": "Par Pharmaceutical, Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
      "StrengthNumber": "10; 25; 320",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150601",
      "EndMarketingDatePackage": "20220531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49884-185-11",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (49884-185-11) ",
      "NDC11Code": "49884-0185-11",
      "ProductNDC": "49884-185",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine, Valsartan, Hydrochlorothiazide",
      "NonProprietaryName": "Amlodipine Besylate Valsartan Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150601",
      "EndMarketingDate": "20220531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201087",
      "LabelerName": "Par Pharmaceutical, Inc.",
      "SubstanceName": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
      "StrengthNumber": "10; 25; 160",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-06-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150601",
      "EndMarketingDatePackage": "20220531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49884-228-11",
      "PackageDescription": "30 TABLET in 1 BOTTLE (49884-228-11) ",
      "NDC11Code": "49884-0228-11",
      "ProductNDC": "49884-228",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ezetimibe",
      "NonProprietaryName": "Ezetimibe",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161212",
      "EndMarketingDate": "20200331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078560",
      "LabelerName": "Par Pharmaceutical Inc",
      "SubstanceName": "EZETIMIBE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20161212",
      "EndMarketingDatePackage": "20200331",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49884-232-11",
      "PackageDescription": "30 TABLET in 1 BOTTLE (49884-232-11) ",
      "NDC11Code": "49884-0232-11",
      "ProductNDC": "49884-232",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Donepezil Hydrochloride",
      "NonProprietaryName": "Donepezil Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130915",
      "EndMarketingDate": "20200731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202542",
      "LabelerName": "Par Pharmaceutical, Inc.",
      "SubstanceName": "DONEPEZIL HYDROCHLORIDE",
      "StrengthNumber": "23",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-08-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20130915",
      "EndMarketingDatePackage": "20200731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49884-236-11",
      "PackageDescription": "30 TABLET in 1 BOTTLE (49884-236-11) ",
      "NDC11Code": "49884-0236-11",
      "ProductNDC": "49884-236",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline",
      "NonProprietaryName": "Doxycycline",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20001215",
      "EndMarketingDate": "20200630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065070",
      "LabelerName": "Par Pharmaceutical, Inc.",
      "SubstanceName": "DOXYCYCLINE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20001215",
      "EndMarketingDatePackage": "20200630",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49884-239-11",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (49884-239-11) ",
      "NDC11Code": "49884-0239-11",
      "ProductNDC": "49884-239",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Itraconazole",
      "NonProprietaryName": "Itraconazole",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160701",
      "EndMarketingDate": "20250731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205724",
      "LabelerName": "Par Pharmaceutical, Inc.",
      "SubstanceName": "ITRACONAZOLE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160701",
      "EndMarketingDatePackage": "20250731",
      "SamplePackage": "N",
      "IndicationAndUsage": "Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients. 1. Blastomycosis, pulmonary and extrapulmonary. 2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and. 3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. Itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised patients. 1. Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and. 2. Onychomycosis of the fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS: Post-marketing Experience for more information.).",
      "Description": "Itraconazole is an azole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2R*,4S*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1­ ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-one mixture with (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2S*,4R*)-2-(2,4-dichlorophenyl)-2-(1H­1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4­triazolin-5-one. or. (±)-1-[(RS)-sec-butyl]-4-[p-[4-[p-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1­ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-one. Itraconazole has a molecular formula of C35H38Cl2N8O4 and a molecular weight of 705.64. It is a white to almost white powder. It is insoluble in water, very slightly soluble in alcohols, and freely soluble in dichloromethane. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules contain 100 mg of itraconazole coated on sugar spheres. Inactive ingredients are gelatin capsule, hypromellose, Polyethylene Glycol and Sugar spheres (composed of sucrose, corn starch, and purified water). Gelatin capsules include gelatin and titanium dioxide. Black ink contains Propylene Glycol and Iron Oxide Black."
    },
    {
      "NDCCode": "49884-250-11",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (49884-250-11) ",
      "NDC11Code": "49884-0250-11",
      "ProductNDC": "49884-250",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine And Fluoxetine",
      "NonProprietaryName": "Olanzapine And Fuoxetine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121126",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077742",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "OLANZAPINE; FLUOXETINE HYDROCHLORIDE",
      "StrengthNumber": "6; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-09-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20121126",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]. , 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].",
      "Description": "Olanzapine and Fluoxetine Capsules, USP combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac and Sarafem). Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H- thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-­[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The molecular formula is C17H18F3NOHCl, which corresponds to a molecular weight of 345.79. The chemical structures are:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule consists of gelatin, magnesium stearate, partially pregelatinized starch, titanium dioxide, and yellow iron oxide. In addition, the 3 mg/25 mg capsule also contains red iron oxide; the 6 mg/50 mg capsule also contains FD&C blue No. 2, FD&C red No. 3, and FD&C yellow No. 6; the 12 mg/25 mg capsule also contains D&C red No. 28, FD&C blue No. 1, FD&C red No. 40, and red iron oxide; and the 12 mg/50 mg capsule also contains D&C red No. 28, FD&C blue No. 1 FD&C blue No. 2, FD&C red No. 3, FD&C red No. 40, and FD&C yellow No. 6. The capsules also have printing in edible black ink which contains the following ingredients: D&C yellow No. 10, ethanol, FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40, iron oxide black, methanol, n-Butyl alcohol, propylene glycol, and shellac glaze in alcohol."
    },
    {
      "NDCCode": "49884-251-11",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (49884-251-11) ",
      "NDC11Code": "49884-0251-11",
      "ProductNDC": "49884-251",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine And Fluoxetine",
      "NonProprietaryName": "Olanzapine And Fuoxetine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121126",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077742",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "OLANZAPINE; FLUOXETINE HYDROCHLORIDE",
      "StrengthNumber": "6; 50",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-09-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20121126",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]. , 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].",
      "Description": "Olanzapine and Fluoxetine Capsules, USP combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac and Sarafem). Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H- thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-­[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The molecular formula is C17H18F3NOHCl, which corresponds to a molecular weight of 345.79. The chemical structures are:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule consists of gelatin, magnesium stearate, partially pregelatinized starch, titanium dioxide, and yellow iron oxide. In addition, the 3 mg/25 mg capsule also contains red iron oxide; the 6 mg/50 mg capsule also contains FD&C blue No. 2, FD&C red No. 3, and FD&C yellow No. 6; the 12 mg/25 mg capsule also contains D&C red No. 28, FD&C blue No. 1, FD&C red No. 40, and red iron oxide; and the 12 mg/50 mg capsule also contains D&C red No. 28, FD&C blue No. 1 FD&C blue No. 2, FD&C red No. 3, FD&C red No. 40, and FD&C yellow No. 6. The capsules also have printing in edible black ink which contains the following ingredients: D&C yellow No. 10, ethanol, FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40, iron oxide black, methanol, n-Butyl alcohol, propylene glycol, and shellac glaze in alcohol."
    },
    {
      "NDCCode": "49884-252-11",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (49884-252-11) ",
      "NDC11Code": "49884-0252-11",
      "ProductNDC": "49884-252",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine And Fluoxetine",
      "NonProprietaryName": "Olanzapine And Fuoxetine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121126",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077742",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "OLANZAPINE; FLUOXETINE HYDROCHLORIDE",
      "StrengthNumber": "12; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-09-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20121126",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]. , 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].",
      "Description": "Olanzapine and Fluoxetine Capsules, USP combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac and Sarafem). Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H- thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-­[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The molecular formula is C17H18F3NOHCl, which corresponds to a molecular weight of 345.79. The chemical structures are:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule consists of gelatin, magnesium stearate, partially pregelatinized starch, titanium dioxide, and yellow iron oxide. In addition, the 3 mg/25 mg capsule also contains red iron oxide; the 6 mg/50 mg capsule also contains FD&C blue No. 2, FD&C red No. 3, and FD&C yellow No. 6; the 12 mg/25 mg capsule also contains D&C red No. 28, FD&C blue No. 1, FD&C red No. 40, and red iron oxide; and the 12 mg/50 mg capsule also contains D&C red No. 28, FD&C blue No. 1 FD&C blue No. 2, FD&C red No. 3, FD&C red No. 40, and FD&C yellow No. 6. The capsules also have printing in edible black ink which contains the following ingredients: D&C yellow No. 10, ethanol, FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40, iron oxide black, methanol, n-Butyl alcohol, propylene glycol, and shellac glaze in alcohol."
    },
    {
      "NDCCode": "49884-253-11",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (49884-253-11) ",
      "NDC11Code": "49884-0253-11",
      "ProductNDC": "49884-253",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine And Fluoxetine",
      "NonProprietaryName": "Olanzapine And Fuoxetine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121126",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077742",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "OLANZAPINE; FLUOXETINE HYDROCHLORIDE",
      "StrengthNumber": "12; 50",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-09-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20121126",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]. , 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].",
      "Description": "Olanzapine and Fluoxetine Capsules, USP combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac and Sarafem). Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H- thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-­[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The molecular formula is C17H18F3NOHCl, which corresponds to a molecular weight of 345.79. The chemical structures are:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule consists of gelatin, magnesium stearate, partially pregelatinized starch, titanium dioxide, and yellow iron oxide. In addition, the 3 mg/25 mg capsule also contains red iron oxide; the 6 mg/50 mg capsule also contains FD&C blue No. 2, FD&C red No. 3, and FD&C yellow No. 6; the 12 mg/25 mg capsule also contains D&C red No. 28, FD&C blue No. 1, FD&C red No. 40, and red iron oxide; and the 12 mg/50 mg capsule also contains D&C red No. 28, FD&C blue No. 1 FD&C blue No. 2, FD&C red No. 3, FD&C red No. 40, and FD&C yellow No. 6. The capsules also have printing in edible black ink which contains the following ingredients: D&C yellow No. 10, ethanol, FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40, iron oxide black, methanol, n-Butyl alcohol, propylene glycol, and shellac glaze in alcohol."
    },
    {
      "NDCCode": "49884-263-11",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (49884-263-11) ",
      "NDC11Code": "49884-0263-11",
      "ProductNDC": "49884-263",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rosuvastatin Calcium",
      "NonProprietaryName": "Rosuvastatin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160719",
      "EndMarketingDate": "20200630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079168",
      "LabelerName": "Par Pharmaceutical, Inc.",
      "SubstanceName": "ROSUVASTATIN CALCIUM",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160719",
      "EndMarketingDatePackage": "20200630",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49884-268-11",
      "PackageDescription": "30 PACKET in 1 CARTON (49884-268-11)  / 1 POWDER, FOR SUSPENSION in 1 PACKET (49884-268-52) ",
      "NDC11Code": "49884-0268-11",
      "ProductNDC": "49884-268",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Omeprazole/sodium Bicarbonate",
      "NonProprietaryName": "Omeprazole And Sodium Bicarbonate",
      "DosageFormName": "POWDER, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160718",
      "EndMarketingDate": "20231231",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079182",
      "LabelerName": "Par Pharmaceutical, Inc.",
      "SubstanceName": "OMEPRAZOLE; SODIUM BICARBONATE",
      "StrengthNumber": "20; 1680",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Alkalinizing Activity [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160718",
      "EndMarketingDatePackage": "20231231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Omeprazole and sodium bicarbonate for oral suspension is indicated in adults for the: 1 short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. .",
      "Description": "Omeprazole and sodium bicarbonate for oral suspension is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole and sodium bicarbonate is supplied as unit dose packets for oral suspension. Packets of powder for oral suspension contain either 40 mg or 20 mg of omeprazole and 1680 mg of sodium bicarbonate with the following excipients: xylitol, xanthan gum, sucralose powder, peach powder, sucrose and peppermint flavor. Omeprazole and sodium bicarbonate for oral suspension is immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation."
    },
    {
      "NDCCode": "49884-269-11",
      "PackageDescription": "30 PACKET in 1 CARTON (49884-269-11)  / 1 POWDER, FOR SUSPENSION in 1 PACKET (49884-269-52) ",
      "NDC11Code": "49884-0269-11",
      "ProductNDC": "49884-269",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Omeprazole/sodium Bicarbonate",
      "NonProprietaryName": "Omeprazole And Sodium Bicarbonate",
      "DosageFormName": "POWDER, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160718",
      "EndMarketingDate": "20241130",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079182",
      "LabelerName": "Par Pharmaceutical, Inc.",
      "SubstanceName": "OMEPRAZOLE; SODIUM BICARBONATE",
      "StrengthNumber": "40; 1680",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Alkalinizing Activity [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160718",
      "EndMarketingDatePackage": "20241130",
      "SamplePackage": "N",
      "IndicationAndUsage": "Omeprazole and sodium bicarbonate for oral suspension is indicated in adults for the: 1 short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. .",
      "Description": "Omeprazole and sodium bicarbonate for oral suspension is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole and sodium bicarbonate is supplied as unit dose packets for oral suspension. Packets of powder for oral suspension contain either 40 mg or 20 mg of omeprazole and 1680 mg of sodium bicarbonate with the following excipients: xylitol, xanthan gum, sucralose powder, peach powder, sucrose and peppermint flavor. Omeprazole and sodium bicarbonate for oral suspension is immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation."
    },
    {
      "NDCCode": "49884-277-11",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (49884-277-11) ",
      "NDC11Code": "49884-0277-11",
      "ProductNDC": "49884-277",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olanzapine And Fluoxetine",
      "NonProprietaryName": "Olanzapine And Fuoxetine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121126",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077742",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "OLANZAPINE; FLUOXETINE HYDROCHLORIDE",
      "StrengthNumber": "3; 25",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-09-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20121126",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]. , 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].",
      "Description": "Olanzapine and Fluoxetine Capsules, USP combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac and Sarafem). Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H- thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-­[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The molecular formula is C17H18F3NOHCl, which corresponds to a molecular weight of 345.79. The chemical structures are:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule consists of gelatin, magnesium stearate, partially pregelatinized starch, titanium dioxide, and yellow iron oxide. In addition, the 3 mg/25 mg capsule also contains red iron oxide; the 6 mg/50 mg capsule also contains FD&C blue No. 2, FD&C red No. 3, and FD&C yellow No. 6; the 12 mg/25 mg capsule also contains D&C red No. 28, FD&C blue No. 1, FD&C red No. 40, and red iron oxide; and the 12 mg/50 mg capsule also contains D&C red No. 28, FD&C blue No. 1 FD&C blue No. 2, FD&C red No. 3, FD&C red No. 40, and FD&C yellow No. 6. The capsules also have printing in edible black ink which contains the following ingredients: D&C yellow No. 10, ethanol, FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40, iron oxide black, methanol, n-Butyl alcohol, propylene glycol, and shellac glaze in alcohol."
    },
    {
      "NDCCode": "49884-335-11",
      "PackageDescription": "30 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-11) ",
      "NDC11Code": "49884-0335-11",
      "ProductNDC": "49884-335",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluoxetine Hydrochloride",
      "NonProprietaryName": "Fluoxetine Hydrochloride",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160822",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203836",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "FLUOXETINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160822",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluoxetine is a selective serotonin reuptake inhibitor indicated for: 1 Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1), 2 Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years (1.2), 3 Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3), 4 Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4).",
      "Description": "Fluoxetine tablets, USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NO∙HCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each tablet contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol) or 20 mg (64.7 µmol) of fluoxetine. In addition, each tablet also contains the following inactive ingredients: microcrystalline cellulose, crospovidone, magnesium stearate, corn starch, colloidal silicon dioxide, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
    },
    {
      "NDCCode": "49884-336-11",
      "PackageDescription": "30 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-336-11) ",
      "NDC11Code": "49884-0336-11",
      "ProductNDC": "49884-336",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluoxetine Hydrochloride",
      "NonProprietaryName": "Fluoxetine Hydrochloride",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160822",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203836",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "FLUOXETINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160822",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluoxetine is a selective serotonin reuptake inhibitor indicated for: 1 Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1), 2 Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years (1.2), 3 Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3), 4 Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4).",
      "Description": "Fluoxetine tablets, USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NO∙HCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each tablet contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µmol) or 20 mg (64.7 µmol) of fluoxetine. In addition, each tablet also contains the following inactive ingredients: microcrystalline cellulose, crospovidone, magnesium stearate, corn starch, colloidal silicon dioxide, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
    },
    {
      "NDCCode": "49884-353-11",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (49884-353-11) ",
      "NDC11Code": "49884-0353-11",
      "ProductNDC": "49884-353",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ambrisentan",
      "NonProprietaryName": "Ambrisentan",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190416",
      "EndMarketingDate": "20230131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209509",
      "LabelerName": "Par Pharmaceutical, Inc.",
      "SubstanceName": "AMBRISENTAN",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-02-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190416",
      "EndMarketingDatePackage": "20230131",
      "SamplePackage": "N"
    }
  ]
}
                    

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Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>50268-787-12</NDCCode><ProprietaryName>Valganciclovir</ProprietaryName><NonProprietaryName>Valganciclovir</NonProprietaryName></NDC><NDC><NDCCode>60687-787-01</NDCCode><ProprietaryName>Amoxicillin</ProprietaryName><NonProprietaryName>Amoxicillin</NonProprietaryName></NDC><NDC><NDCCode>49884-104-11</NDCCode><ProprietaryName>Entecavir</ProprietaryName><NonProprietaryName>Entecavir</NonProprietaryName></NDC><NDC><NDCCode>49884-105-11</NDCCode><ProprietaryName>Entecavir</ProprietaryName><NonProprietaryName>Entecavir</NonProprietaryName></NDC><NDC><NDCCode>49884-147-11</NDCCode><ProprietaryName>Dexlansoprazole</ProprietaryName><NonProprietaryName>Dexlansoprazole</NonProprietaryName></NDC><NDC><NDCCode>49884-148-11</NDCCode><ProprietaryName>Dexlansoprazole</ProprietaryName><NonProprietaryName>Dexlansoprazole</NonProprietaryName></NDC><NDC><NDCCode>49884-161-11</NDCCode><ProprietaryName>Calcitonin Salmon</ProprietaryName><NonProprietaryName>Calcitonin Salmon</NonProprietaryName></NDC><NDC><NDCCode>49884-171-11</NDCCode><ProprietaryName>Colchicine</ProprietaryName><NonProprietaryName>Colchicine</NonProprietaryName></NDC><NDC><NDCCode>49884-172-11</NDCCode><ProprietaryName>Amlodipine, Valsartan, Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Amlodipine Besylate Valsartan Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>49884-173-11</NDCCode><ProprietaryName>Amlodipine, Valsartan, Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Amlodipine Besylate Valsartan Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>49884-174-11</NDCCode><ProprietaryName>Amlodipine, Valsartan, Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Amlodipine Besylate Valsartan Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>49884-175-11</NDCCode><ProprietaryName>Amlodipine, Valsartan, Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Amlodipine Besylate Valsartan Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>49884-185-11</NDCCode><ProprietaryName>Amlodipine, Valsartan, Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Amlodipine Besylate Valsartan Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>49884-228-11</NDCCode><ProprietaryName>Ezetimibe</ProprietaryName><NonProprietaryName>Ezetimibe</NonProprietaryName></NDC><NDC><NDCCode>49884-232-11</NDCCode><ProprietaryName>Donepezil Hydrochloride</ProprietaryName><NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>49884-236-11</NDCCode><ProprietaryName>Doxycycline</ProprietaryName><NonProprietaryName>Doxycycline</NonProprietaryName></NDC><NDC><NDCCode>49884-239-11</NDCCode><ProprietaryName>Itraconazole</ProprietaryName><NonProprietaryName>Itraconazole</NonProprietaryName></NDC><NDC><NDCCode>49884-250-11</NDCCode><ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName><NonProprietaryName>Olanzapine And Fuoxetine</NonProprietaryName></NDC><NDC><NDCCode>49884-251-11</NDCCode><ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName><NonProprietaryName>Olanzapine And Fuoxetine</NonProprietaryName></NDC><NDC><NDCCode>49884-252-11</NDCCode><ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName><NonProprietaryName>Olanzapine And Fuoxetine</NonProprietaryName></NDC><NDC><NDCCode>49884-253-11</NDCCode><ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName><NonProprietaryName>Olanzapine And Fuoxetine</NonProprietaryName></NDC><NDC><NDCCode>49884-263-11</NDCCode><ProprietaryName>Rosuvastatin Calcium</ProprietaryName><NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName></NDC><NDC><NDCCode>49884-268-11</NDCCode><ProprietaryName>Omeprazole/sodium Bicarbonate</ProprietaryName><NonProprietaryName>Omeprazole And Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>49884-269-11</NDCCode><ProprietaryName>Omeprazole/sodium Bicarbonate</ProprietaryName><NonProprietaryName>Omeprazole And Sodium Bicarbonate</NonProprietaryName></NDC><NDC><NDCCode>49884-277-11</NDCCode><ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName><NonProprietaryName>Olanzapine And Fuoxetine</NonProprietaryName></NDC><NDC><NDCCode>49884-335-11</NDCCode><ProprietaryName>Fluoxetine Hydrochloride</ProprietaryName><NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>49884-336-11</NDCCode><ProprietaryName>Fluoxetine Hydrochloride</ProprietaryName><NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>49884-353-11</NDCCode><ProprietaryName>Ambrisentan</ProprietaryName><NonProprietaryName>Ambrisentan</NonProprietaryName></NDC></NDCList>