{
"NDC": [
{
"NDCCode": "15631-0442-7",
"PackageDescription": "1000 PELLET in 1 PACKAGE (15631-0442-7) ",
"NDC11Code": "15631-0442-07",
"ProductNDC": "15631-0442",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thuja Occidentalis",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210823",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "50090-0442-7",
"PackageDescription": "200 TABLET in 1 BOTTLE (50090-0442-7) ",
"NDC11Code": "50090-0442-07",
"ProductNDC": "50090-0442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076900",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160629",
"SamplePackage": "N",
"IndicationAndUsage": "Atenolol is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 atenolol. 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 1 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. Atenolol may be administered with other antihypertensive agents.",
"Description": "Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are. Atenolol, USP has a molecular weight of 266. It is a white or almost white powder, sparingly soluble in water; soluble in absolute alcohol and practically insoluble in ether. Atenolol tablets, for oral administration, are available as 25 mg, 50 mg and 100 mg tablets. Inactive Ingredients: Citric acid (anhydrous), colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone."
},
{
"NDCCode": "51552-0442-7",
"PackageDescription": "3481 g in 1 CONTAINER (51552-0442-7) ",
"NDC11Code": "51552-0442-07",
"ProductNDC": "51552-0442",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sesame Oil",
"DosageFormName": "OIL",
"StartMarketingDate": "19980401",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "SESAME OIL",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "01-APR-98"
},
{
"NDCCode": "71335-0442-7",
"PackageDescription": "10 TABLET in 1 BOTTLE (71335-0442-7) ",
"NDC11Code": "71335-0442-07",
"ProductNDC": "71335-0442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090467",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20151125",
"SamplePackage": "N"
},
{
"NDCCode": "15631-0442-0",
"PackageDescription": "100 PELLET in 1 VIAL, SINGLE-DOSE (15631-0442-0) ",
"NDC11Code": "15631-0442-00",
"ProductNDC": "15631-0442",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thuja Occidentalis",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0442-1",
"PackageDescription": "200 PELLET in 1 PACKAGE (15631-0442-1) ",
"NDC11Code": "15631-0442-01",
"ProductNDC": "15631-0442",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thuja Occidentalis",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0442-2",
"PackageDescription": "400 PELLET in 1 PACKAGE (15631-0442-2) ",
"NDC11Code": "15631-0442-02",
"ProductNDC": "15631-0442",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thuja Occidentalis",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0442-3",
"PackageDescription": "750 PELLET in 1 PACKAGE (15631-0442-3) ",
"NDC11Code": "15631-0442-03",
"ProductNDC": "15631-0442",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thuja Occidentalis",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0442-4",
"PackageDescription": "2500 PELLET in 1 PACKAGE (15631-0442-4) ",
"NDC11Code": "15631-0442-04",
"ProductNDC": "15631-0442",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thuja Occidentalis",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0442-5",
"PackageDescription": "12500 PELLET in 1 PACKAGE (15631-0442-5) ",
"NDC11Code": "15631-0442-05",
"ProductNDC": "15631-0442",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thuja Occidentalis",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0442-6",
"PackageDescription": "500 PELLET in 1 PACKAGE (15631-0442-6) ",
"NDC11Code": "15631-0442-06",
"ProductNDC": "15631-0442",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thuja Occidentalis",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210823",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "0378-0442-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0442-01) ",
"NDC11Code": "00378-0442-01",
"ProductNDC": "0378-0442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perphenazine And Amitriptyline Hydrochloride",
"NonProprietaryName": "Perphenazine And Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19881110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071443",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PERPHENAZINE; AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "2; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS], Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19881110",
"SamplePackage": "N",
"IndicationAndUsage": "Perphenazine and amitriptyline hydrochloride tablets are recommended for treatment of (1) patients with moderate to severe anxiety and/or agitation and depressed mood, (2) patients with depression in whom anxiety and/or agitation are severe, and (3) patients with depression and anxiety in association with chronic physical disease. In many of these patients, anxiety masks the depressive state so that, although therapy with a tranquilizer appears to be indicated, the administration of a tranquilizer alone will not be adequate. Schizophrenic patients who have associated depressive symptoms should be considered for therapy with perphenazine and amitriptyline hydrochloride tablets.",
"Description": "Perphenazine and amitriptyline hydrochloride, a broad spectrum psychotherapeutic agent for the management of outpatients and hospitalized patients with psychoses or neuroses characterized by mixtures of anxiety or agitation with symptoms of depression, is a combination of perphenazine and amitriptyline hydrochloride. Since such mixed syndromes can occur in patients with various degrees of intensity of mental illness, perphenazine and amitriptyline hydrochloride tablets are provided in multiple combinations to afford dosage flexibility for optimum management. Perphenazine is a phenothiazine derivative. The formula is 4-[3-(2-chloro-10H-phenothiazin-10yl) propyl]-piperazineethanol. Perphenazine, USP is a white, odorless, bitter tasting powder that is insoluble in water. The molecular weight is 403.97. Its structural formula is. Amitriptyline is a dibenzocycloheptadiene derivative. The formula is 10,11-dihydro-N,N-dimethyl-5H-dibenzo[a,d]cycloheptene-∆5,γ -propylamine hydrochloride. Amitriptyline hydrochloride, USP is a white, odorless, crystalline compound which is freely soluble in water. The molecular weight is 313.87. Its structural formula is. Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide. The following additional product specific inactive ingredients are employed. 2 mg/10 mg - hydroxypropyl cellulose2 mg/25 mg - hydroxypropyl cellulose4 mg/10 mg - polysorbate 804 mg/25 mg - hydroxypropyl cellulose4 mg/50 mg - hydroxypropyl cellulose. The following product specific coloring agents are employed. 2 mg/10 mg - calcium sulfate, talc2 mg/25 mg - D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake4 mg/10 mg - FD&C Blue No. 1 Aluminum Lake4 mg/25 mg - FD&C Yellow No. 6 Aluminum Lake4 mg/50 mg - D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake."
},
{
"NDCCode": "0378-0442-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0442-05) ",
"NDC11Code": "00378-0442-05",
"ProductNDC": "0378-0442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perphenazine And Amitriptyline Hydrochloride",
"NonProprietaryName": "Perphenazine And Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19881110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071443",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE",
"StrengthNumber": "25; 2",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS], Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19881110",
"EndMarketingDatePackage": "20221130",
"SamplePackage": "N",
"IndicationAndUsage": "Perphenazine and amitriptyline hydrochloride tablets are recommended for treatment of (1) patients with moderate to severe anxiety and/or agitation and depressed mood, (2) patients with depression in whom anxiety and/or agitation are severe, and (3) patients with depression and anxiety in association with chronic physical disease. In many of these patients, anxiety masks the depressive state so that, although therapy with a tranquilizer appears to be indicated, the administration of a tranquilizer alone will not be adequate. Schizophrenic patients who have associated depressive symptoms should be considered for therapy with perphenazine and amitriptyline hydrochloride tablets.",
"Description": "Perphenazine and amitriptyline hydrochloride, a broad spectrum psychotherapeutic agent for the management of outpatients and hospitalized patients with psychoses or neuroses characterized by mixtures of anxiety or agitation with symptoms of depression, is a combination of perphenazine and amitriptyline hydrochloride. Since such mixed syndromes can occur in patients with various degrees of intensity of mental illness, perphenazine and amitriptyline hydrochloride tablets are provided in multiple combinations to afford dosage flexibility for optimum management. Perphenazine is a phenothiazine derivative. The formula is 4-[3-(2-chloro-10H-phenothiazin-10yl) propyl]-piperazineethanol. Perphenazine, USP is a white, odorless, bitter tasting powder that is insoluble in water. The molecular weight is 403.97. Its structural formula is. Amitriptyline is a dibenzocycloheptadiene derivative. The formula is 10,11-dihydro-N,N-dimethyl-5H-dibenzo[a,d]cycloheptene-∆5,γ -propylamine hydrochloride. Amitriptyline hydrochloride, USP is a white, odorless, crystalline compound which is freely soluble in water. The molecular weight is 313.87. Its structural formula is. Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide. The following additional product specific inactive ingredients are employed. 2 mg/10 mg - hydroxypropyl cellulose2 mg/25 mg - hydroxypropyl cellulose4 mg/10 mg - polysorbate 804 mg/25 mg - hydroxypropyl cellulose4 mg/50 mg - hydroxypropyl cellulose. The following product specific coloring agents are employed. 2 mg/10 mg - calcium sulfate, talc2 mg/25 mg - D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake4 mg/10 mg - FD&C Blue No. 1 Aluminum Lake4 mg/25 mg - FD&C Yellow No. 6 Aluminum Lake4 mg/50 mg - D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake."
},
{
"NDCCode": "42627-442-01",
"PackageDescription": "1 TUBE in 1 CARTON (42627-442-01) / 50 mL in 1 TUBE",
"NDC11Code": "42627-0442-01",
"ProductNDC": "42627-442",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Illusion Hyaluronic Skin Tint Oil Free Sunscreen Broad Spectrum Light Beige",
"ProprietaryNameSuffix": "Spf 15",
"NonProprietaryName": "Octonoxate, Octisalate, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210630",
"EndMarketingDate": "20231104",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "Kingdon Animalia, LLC DBA Hourglass Cosmetics",
"SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "7; 4; 4",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210630",
"EndMarketingDatePackage": "20231104",
"SamplePackage": "N"
},
{
"NDCCode": "43547-442-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (43547-442-03) ",
"NDC11Code": "43547-0442-03",
"ProductNDC": "43547-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan And Hydrochlorothiazide",
"NonProprietaryName": "Telmisartan And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209028",
"LabelerName": "Solco Healthcare LLC",
"SubstanceName": "TELMISARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "80; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180205",
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"IndicationAndUsage": "Telmisartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan 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 [see Clinical Studies (14)]. Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy for the treatment of hypertension [see Dosage and Administration (2.1)]. Telmisartan and hydrochlorothiazide tablets may be used alone or in combination with other antihypertensive agents.",
"Description": "Telmisartan and hydrochlorothiazide tablets are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic. Telmisartan, a non-peptide molecule, is chemically described as 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets USP, are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan, USP, and hydrochlorothiazide, USP, respectively. The tablets contain the following inactive ingredients: crospovidone (Type B), hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, microcrystalline cellulose, povidone, sodium hydroxide, sodium starch glycolate, and sodium stearyl fumarate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. Telmisartan and hydrochlorothiazide tablets are hygroscopic and require protection from moisture."
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"IndicationAndUsage": "Telmisartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan 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 [see Clinical Studies (14)]. Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy for the treatment of hypertension [see Dosage and Administration (2.1)]. Telmisartan and hydrochlorothiazide tablets may be used alone or in combination with other antihypertensive agents.",
"Description": "Telmisartan and hydrochlorothiazide tablets are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic. Telmisartan, a non-peptide molecule, is chemically described as 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets USP, are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan, USP, and hydrochlorothiazide, USP, respectively. The tablets contain the following inactive ingredients: crospovidone (Type B), hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, microcrystalline cellulose, povidone, sodium hydroxide, sodium starch glycolate, and sodium stearyl fumarate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. Telmisartan and hydrochlorothiazide tablets are hygroscopic and require protection from moisture."
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"IndicationAndUsage": "Irbesartan and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension. Irbesartan and Hydrochlorothiazide Tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and Hydrochlorothiazide Tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Irbesartan and Hydrochlorothiazide Tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 (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 may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with mono therapy. Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with Irbesartan and Hydrochlorothiazide Tablets compared to irbesartan or HCTZ monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with Irbesartan and Hydrochlorothiazide Tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b. *For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to- treat analysis).The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone).The likelihood of achieving these goals on Irbesartan and Hydrochlorothiazide Tablets rises to about 40% (systolic) or 70% (diastolic).",
"Description": "Irbesartan and Hydrochlorothiazide Tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro [4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is. Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1- dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7 Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and Hydrochlorothiazide Tablets USP are available for oral administration in tablets containing 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide or 300 mg of irbesartan combined with 25 mg hydrochlorothiazide. Inactive ingredients include: lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, iron oxide red and iron oxide yellow. In addition, the 300/25 mg pinkish brown film-coated tablet contains titanium dioxide, hypromellose, iron oxide black and polyethylene glycol."
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"IndicationAndUsage": "Irbesartan and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension. Irbesartan and Hydrochlorothiazide Tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and Hydrochlorothiazide Tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Irbesartan and Hydrochlorothiazide Tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 (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 may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with mono therapy. Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with Irbesartan and Hydrochlorothiazide Tablets compared to irbesartan or HCTZ monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with Irbesartan and Hydrochlorothiazide Tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b. *For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to- treat analysis).The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone).The likelihood of achieving these goals on Irbesartan and Hydrochlorothiazide Tablets rises to about 40% (systolic) or 70% (diastolic).",
"Description": "Irbesartan and Hydrochlorothiazide Tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro [4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is. Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1- dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7 Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and Hydrochlorothiazide Tablets USP are available for oral administration in tablets containing 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide or 300 mg of irbesartan combined with 25 mg hydrochlorothiazide. Inactive ingredients include: lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, iron oxide red and iron oxide yellow. In addition, the 300/25 mg pinkish brown film-coated tablet contains titanium dioxide, hypromellose, iron oxide black and polyethylene glycol."
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"IndicationAndUsage": "Irbesartan and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension. Irbesartan and Hydrochlorothiazide Tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and Hydrochlorothiazide Tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Irbesartan and Hydrochlorothiazide Tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 (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 may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with mono therapy. Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with Irbesartan and Hydrochlorothiazide Tablets compared to irbesartan or HCTZ monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with Irbesartan and Hydrochlorothiazide Tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b. *For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to- treat analysis).The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone).The likelihood of achieving these goals on Irbesartan and Hydrochlorothiazide Tablets rises to about 40% (systolic) or 70% (diastolic).",
"Description": "Irbesartan and Hydrochlorothiazide Tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro [4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is. Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1- dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7 Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and Hydrochlorothiazide Tablets USP are available for oral administration in tablets containing 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide or 300 mg of irbesartan combined with 25 mg hydrochlorothiazide. Inactive ingredients include: lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, iron oxide red and iron oxide yellow. In addition, the 300/25 mg pinkish brown film-coated tablet contains titanium dioxide, hypromellose, iron oxide black and polyethylene glycol."
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"Description": "Irbesartan and Hydrochlorothiazide Tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro [4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is. Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1- dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7 Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and Hydrochlorothiazide Tablets USP are available for oral administration in tablets containing 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide or 300 mg of irbesartan combined with 25 mg hydrochlorothiazide. Inactive ingredients include: lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, iron oxide red and iron oxide yellow. In addition, the 300/25 mg pinkish brown film-coated tablet contains titanium dioxide, hypromellose, iron oxide black and polyethylene glycol."
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"SubstanceName": "BETULA LENTA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
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"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
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"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49643-442-10) ",
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"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Cherry Birch Pollen",
"NonProprietaryName": "Betula Lenta",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
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"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "BETULA LENTA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
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"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49643-442-30) ",
"NDC11Code": "49643-0442-30",
"ProductNDC": "49643-442",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Cherry Birch Pollen",
"NonProprietaryName": "Betula Lenta",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "BETULA LENTA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-442-50",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49643-442-50) ",
"NDC11Code": "49643-0442-50",
"ProductNDC": "49643-442",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Cherry Birch Pollen",
"NonProprietaryName": "Betula Lenta",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "BETULA LENTA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "19740312",
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"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
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{
"NDCCode": "50268-442-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-442-15) / 1 TABLET in 1 BLISTER PACK (50268-442-11) ",
"NDC11Code": "50268-0442-15",
"ProductNDC": "50268-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irbesartan",
"NonProprietaryName": "Irbesartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230808",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202910",
"LabelerName": "AvPAK",
"SubstanceName": "IRBESARTAN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20230808",
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"IndicationAndUsage": "1.1 Hypertension Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. 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 1 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. Irbesartan tablets may be used alone or in combination with other antihypertensive agents. 1.2 Nephropathy in Type 2 Diabetic Patients Irbesartan tablets are indicated for the treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension, an elevated serum creatinine, and proteinuria (>300 mg/day). In this population, irbesartan reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.2)].",
"Description": "Irbesartan USP is an angiotensin II receptor (AT1 subtype) antagonist. Irbesartan USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C 25H 28N 6O, and the structural formula: Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Irbesartan is available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of Irbesartan USP. Inactive ingredients include: calcium stearate, carboxy methyl cellulose calcium, colloidal silicon dioxide, microcrystalline cellulose and povidone."
},
{
"NDCCode": "59735-442-01",
"PackageDescription": "1 TUBE in 1 CARTON (59735-442-01) / 14 g in 1 TUBE",
"NDC11Code": "59735-0442-01",
"ProductNDC": "59735-442",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stick Foundation Spf Honey Beige",
"NonProprietaryName": "Stick Foundation",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131212",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "MANA PRODUCTS, INC.",
"SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "7.5; 5; 2",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20131212",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
},
{
"NDCCode": "64058-442-64",
"PackageDescription": "118 mL in 1 BOTTLE (64058-442-64)",
"NDC11Code": "64058-0442-64",
"ProductNDC": "64058-442",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nanofreeze",
"NonProprietaryName": "Menthol And Camphor (synthetic)",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110310",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Concept Laboratories, Inc.",
"SubstanceName": "MENTHOL; CAMPHOR (SYNTHETIC)",
"StrengthNumber": "14.16; 7.08",
"StrengthUnit": "g/118mL; g/118mL",
"Status": "Deprecated",
"LastUpdate": "2017-02-20"
},
{
"NDCCode": "64380-442-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (64380-442-01) ",
"NDC11Code": "64380-0442-01",
"ProductNDC": "64380-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202935",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5 α -Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains. Hydrocodone Bitartrate …..... 5 mg. Acetaminophen ................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ..................... 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen ..................... 325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 1."
},
{
"NDCCode": "64380-442-02",
"PackageDescription": "500 TABLET in 1 BOTTLE (64380-442-02) ",
"NDC11Code": "64380-0442-02",
"ProductNDC": "64380-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202935",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "325; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5 α -Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains. Hydrocodone Bitartrate …..... 5 mg. Acetaminophen ................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ..................... 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen ..................... 325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 1."
},
{
"NDCCode": "64380-442-03",
"PackageDescription": "1000 TABLET in 1 BOTTLE (64380-442-03) ",
"NDC11Code": "64380-0442-03",
"ProductNDC": "64380-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202935",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "325; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5 α -Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains. Hydrocodone Bitartrate …..... 5 mg. Acetaminophen ................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ..................... 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen ..................... 325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 1."
}
]
}
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<StartMarketingDatePackage>20160629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atenolol is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 atenolol. 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 1 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. Atenolol may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are. Atenolol, USP has a molecular weight of 266. It is a white or almost white powder, sparingly soluble in water; soluble in absolute alcohol and practically insoluble in ether. Atenolol tablets, for oral administration, are available as 25 mg, 50 mg and 100 mg tablets. Inactive Ingredients: Citric acid (anhydrous), colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone.</Description>
</NDC>
<NDC>
<NDCCode>51552-0442-7</NDCCode>
<PackageDescription>3481 g in 1 CONTAINER (51552-0442-7) </PackageDescription>
<NDC11Code>51552-0442-07</NDC11Code>
<ProductNDC>51552-0442</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sesame Oil</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<StartMarketingDate>19980401</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>SESAME OIL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-APR-98</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>71335-0442-7</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (71335-0442-7) </PackageDescription>
<NDC11Code>71335-0442-07</NDC11Code>
<ProductNDC>71335-0442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090467</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>15631-0442-0</NDCCode>
<PackageDescription>100 PELLET in 1 VIAL, SINGLE-DOSE (15631-0442-0) </PackageDescription>
<NDC11Code>15631-0442-00</NDC11Code>
<ProductNDC>15631-0442</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thuja Occidentalis</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151031</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-0442-1</NDCCode>
<PackageDescription>200 PELLET in 1 PACKAGE (15631-0442-1) </PackageDescription>
<NDC11Code>15631-0442-01</NDC11Code>
<ProductNDC>15631-0442</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thuja Occidentalis</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151031</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-0442-2</NDCCode>
<PackageDescription>400 PELLET in 1 PACKAGE (15631-0442-2) </PackageDescription>
<NDC11Code>15631-0442-02</NDC11Code>
<ProductNDC>15631-0442</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thuja Occidentalis</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151031</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-0442-3</NDCCode>
<PackageDescription>750 PELLET in 1 PACKAGE (15631-0442-3) </PackageDescription>
<NDC11Code>15631-0442-03</NDC11Code>
<ProductNDC>15631-0442</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thuja Occidentalis</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151031</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-0442-4</NDCCode>
<PackageDescription>2500 PELLET in 1 PACKAGE (15631-0442-4) </PackageDescription>
<NDC11Code>15631-0442-04</NDC11Code>
<ProductNDC>15631-0442</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thuja Occidentalis</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151031</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-0442-5</NDCCode>
<PackageDescription>12500 PELLET in 1 PACKAGE (15631-0442-5) </PackageDescription>
<NDC11Code>15631-0442-05</NDC11Code>
<ProductNDC>15631-0442</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thuja Occidentalis</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151031</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-0442-6</NDCCode>
<PackageDescription>500 PELLET in 1 PACKAGE (15631-0442-6) </PackageDescription>
<NDC11Code>15631-0442-06</NDC11Code>
<ProductNDC>15631-0442</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thuja Occidentalis</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151031</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0378-0442-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0442-01) </PackageDescription>
<NDC11Code>00378-0442-01</NDC11Code>
<ProductNDC>0378-0442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine And Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Perphenazine And Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071443</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PERPHENAZINE; AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS], Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19881110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perphenazine and amitriptyline hydrochloride tablets are recommended for treatment of (1) patients with moderate to severe anxiety and/or agitation and depressed mood, (2) patients with depression in whom anxiety and/or agitation are severe, and (3) patients with depression and anxiety in association with chronic physical disease. In many of these patients, anxiety masks the depressive state so that, although therapy with a tranquilizer appears to be indicated, the administration of a tranquilizer alone will not be adequate. Schizophrenic patients who have associated depressive symptoms should be considered for therapy with perphenazine and amitriptyline hydrochloride tablets.</IndicationAndUsage>
<Description>Perphenazine and amitriptyline hydrochloride, a broad spectrum psychotherapeutic agent for the management of outpatients and hospitalized patients with psychoses or neuroses characterized by mixtures of anxiety or agitation with symptoms of depression, is a combination of perphenazine and amitriptyline hydrochloride. Since such mixed syndromes can occur in patients with various degrees of intensity of mental illness, perphenazine and amitriptyline hydrochloride tablets are provided in multiple combinations to afford dosage flexibility for optimum management. Perphenazine is a phenothiazine derivative. The formula is 4-[3-(2-chloro-10H-phenothiazin-10yl) propyl]-piperazineethanol. Perphenazine, USP is a white, odorless, bitter tasting powder that is insoluble in water. The molecular weight is 403.97. Its structural formula is. Amitriptyline is a dibenzocycloheptadiene derivative. The formula is 10,11-dihydro-N,N-dimethyl-5H-dibenzo[a,d]cycloheptene-∆5,γ -propylamine hydrochloride. Amitriptyline hydrochloride, USP is a white, odorless, crystalline compound which is freely soluble in water. The molecular weight is 313.87. Its structural formula is. Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide. The following additional product specific inactive ingredients are employed. 2 mg/10 mg - hydroxypropyl cellulose2 mg/25 mg - hydroxypropyl cellulose4 mg/10 mg - polysorbate 804 mg/25 mg - hydroxypropyl cellulose4 mg/50 mg - hydroxypropyl cellulose. The following product specific coloring agents are employed. 2 mg/10 mg - calcium sulfate, talc2 mg/25 mg - D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake4 mg/10 mg - FD&C Blue No. 1 Aluminum Lake4 mg/25 mg - FD&C Yellow No. 6 Aluminum Lake4 mg/50 mg - D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0378-0442-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0442-05) </PackageDescription>
<NDC11Code>00378-0442-05</NDC11Code>
<ProductNDC>0378-0442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine And Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Perphenazine And Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071443</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE</SubstanceName>
<StrengthNumber>25; 2</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS], Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19881110</StartMarketingDatePackage>
<EndMarketingDatePackage>20221130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perphenazine and amitriptyline hydrochloride tablets are recommended for treatment of (1) patients with moderate to severe anxiety and/or agitation and depressed mood, (2) patients with depression in whom anxiety and/or agitation are severe, and (3) patients with depression and anxiety in association with chronic physical disease. In many of these patients, anxiety masks the depressive state so that, although therapy with a tranquilizer appears to be indicated, the administration of a tranquilizer alone will not be adequate. Schizophrenic patients who have associated depressive symptoms should be considered for therapy with perphenazine and amitriptyline hydrochloride tablets.</IndicationAndUsage>
<Description>Perphenazine and amitriptyline hydrochloride, a broad spectrum psychotherapeutic agent for the management of outpatients and hospitalized patients with psychoses or neuroses characterized by mixtures of anxiety or agitation with symptoms of depression, is a combination of perphenazine and amitriptyline hydrochloride. Since such mixed syndromes can occur in patients with various degrees of intensity of mental illness, perphenazine and amitriptyline hydrochloride tablets are provided in multiple combinations to afford dosage flexibility for optimum management. Perphenazine is a phenothiazine derivative. The formula is 4-[3-(2-chloro-10H-phenothiazin-10yl) propyl]-piperazineethanol. Perphenazine, USP is a white, odorless, bitter tasting powder that is insoluble in water. The molecular weight is 403.97. Its structural formula is. Amitriptyline is a dibenzocycloheptadiene derivative. The formula is 10,11-dihydro-N,N-dimethyl-5H-dibenzo[a,d]cycloheptene-∆5,γ -propylamine hydrochloride. Amitriptyline hydrochloride, USP is a white, odorless, crystalline compound which is freely soluble in water. The molecular weight is 313.87. Its structural formula is. Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide. The following additional product specific inactive ingredients are employed. 2 mg/10 mg - hydroxypropyl cellulose2 mg/25 mg - hydroxypropyl cellulose4 mg/10 mg - polysorbate 804 mg/25 mg - hydroxypropyl cellulose4 mg/50 mg - hydroxypropyl cellulose. The following product specific coloring agents are employed. 2 mg/10 mg - calcium sulfate, talc2 mg/25 mg - D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake4 mg/10 mg - FD&C Blue No. 1 Aluminum Lake4 mg/25 mg - FD&C Yellow No. 6 Aluminum Lake4 mg/50 mg - D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>42627-442-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42627-442-01) / 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>42627-0442-01</NDC11Code>
<ProductNDC>42627-442</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Illusion Hyaluronic Skin Tint Oil Free Sunscreen Broad Spectrum Light Beige</ProprietaryName>
<ProprietaryNameSuffix>Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Octonoxate, Octisalate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210630</StartMarketingDate>
<EndMarketingDate>20231104</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Kingdon Animalia, LLC DBA Hourglass Cosmetics</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>7; 4; 4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210630</StartMarketingDatePackage>
<EndMarketingDatePackage>20231104</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43547-442-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43547-442-03) </PackageDescription>
<NDC11Code>43547-0442-03</NDC11Code>
<ProductNDC>43547-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209028</ApplicationNumber>
<LabelerName>Solco Healthcare LLC</LabelerName>
<SubstanceName>TELMISARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>80; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Telmisartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan 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 [see Clinical Studies (14)]. Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy for the treatment of hypertension [see Dosage and Administration (2.1)]. Telmisartan and hydrochlorothiazide tablets may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Telmisartan and hydrochlorothiazide tablets are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic. Telmisartan, a non-peptide molecule, is chemically described as 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets USP, are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan, USP, and hydrochlorothiazide, USP, respectively. The tablets contain the following inactive ingredients: crospovidone (Type B), hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, microcrystalline cellulose, povidone, sodium hydroxide, sodium starch glycolate, and sodium stearyl fumarate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. Telmisartan and hydrochlorothiazide tablets are hygroscopic and require protection from moisture.</Description>
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<IndicationAndUsage>Telmisartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan 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 [see Clinical Studies (14)]. Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy for the treatment of hypertension [see Dosage and Administration (2.1)]. Telmisartan and hydrochlorothiazide tablets may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Telmisartan and hydrochlorothiazide tablets are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic. Telmisartan, a non-peptide molecule, is chemically described as 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is. Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets USP, are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan, USP, and hydrochlorothiazide, USP, respectively. The tablets contain the following inactive ingredients: crospovidone (Type B), hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, microcrystalline cellulose, povidone, sodium hydroxide, sodium starch glycolate, and sodium stearyl fumarate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. Telmisartan and hydrochlorothiazide tablets are hygroscopic and require protection from moisture.</Description>
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<IndicationAndUsage>Irbesartan and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension. Irbesartan and Hydrochlorothiazide Tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and Hydrochlorothiazide Tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Irbesartan and Hydrochlorothiazide Tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 (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 may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with mono therapy. Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with Irbesartan and Hydrochlorothiazide Tablets compared to irbesartan or HCTZ monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with Irbesartan and Hydrochlorothiazide Tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b. *For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to- treat analysis).The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone).The likelihood of achieving these goals on Irbesartan and Hydrochlorothiazide Tablets rises to about 40% (systolic) or 70% (diastolic).</IndicationAndUsage>
<Description>Irbesartan and Hydrochlorothiazide Tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro [4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is. Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1- dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7 Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and Hydrochlorothiazide Tablets USP are available for oral administration in tablets containing 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide or 300 mg of irbesartan combined with 25 mg hydrochlorothiazide. Inactive ingredients include: lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, iron oxide red and iron oxide yellow. In addition, the 300/25 mg pinkish brown film-coated tablet contains titanium dioxide, hypromellose, iron oxide black and polyethylene glycol.</Description>
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<IndicationAndUsage>Irbesartan and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension. Irbesartan and Hydrochlorothiazide Tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and Hydrochlorothiazide Tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Irbesartan and Hydrochlorothiazide Tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 (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 may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with mono therapy. Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with Irbesartan and Hydrochlorothiazide Tablets compared to irbesartan or HCTZ monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with Irbesartan and Hydrochlorothiazide Tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b. *For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to- treat analysis).The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone).The likelihood of achieving these goals on Irbesartan and Hydrochlorothiazide Tablets rises to about 40% (systolic) or 70% (diastolic).</IndicationAndUsage>
<Description>Irbesartan and Hydrochlorothiazide Tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro [4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is. Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1- dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7 Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and Hydrochlorothiazide Tablets USP are available for oral administration in tablets containing 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide or 300 mg of irbesartan combined with 25 mg hydrochlorothiazide. Inactive ingredients include: lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, iron oxide red and iron oxide yellow. In addition, the 300/25 mg pinkish brown film-coated tablet contains titanium dioxide, hypromellose, iron oxide black and polyethylene glycol.</Description>
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<IndicationAndUsage>Irbesartan and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension. Irbesartan and Hydrochlorothiazide Tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and Hydrochlorothiazide Tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Irbesartan and Hydrochlorothiazide Tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 (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 may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with mono therapy. Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with Irbesartan and Hydrochlorothiazide Tablets compared to irbesartan or HCTZ monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with Irbesartan and Hydrochlorothiazide Tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b. *For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to- treat analysis).The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone).The likelihood of achieving these goals on Irbesartan and Hydrochlorothiazide Tablets rises to about 40% (systolic) or 70% (diastolic).</IndicationAndUsage>
<Description>Irbesartan and Hydrochlorothiazide Tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro [4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is. Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1- dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7 Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and Hydrochlorothiazide Tablets USP are available for oral administration in tablets containing 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide or 300 mg of irbesartan combined with 25 mg hydrochlorothiazide. Inactive ingredients include: lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, iron oxide red and iron oxide yellow. In addition, the 300/25 mg pinkish brown film-coated tablet contains titanium dioxide, hypromellose, iron oxide black and polyethylene glycol.</Description>
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<IndicationAndUsage>Irbesartan and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension. Irbesartan and Hydrochlorothiazide Tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and Hydrochlorothiazide Tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Irbesartan and Hydrochlorothiazide Tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 (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 may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with mono therapy. Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with Irbesartan and Hydrochlorothiazide Tablets compared to irbesartan or HCTZ monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with Irbesartan and Hydrochlorothiazide Tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b. *For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to- treat analysis).The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone).The likelihood of achieving these goals on Irbesartan and Hydrochlorothiazide Tablets rises to about 40% (systolic) or 70% (diastolic).</IndicationAndUsage>
<Description>Irbesartan and Hydrochlorothiazide Tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro [4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is. Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1- dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7 Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and Hydrochlorothiazide Tablets USP are available for oral administration in tablets containing 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide or 300 mg of irbesartan combined with 25 mg hydrochlorothiazide. Inactive ingredients include: lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, iron oxide red and iron oxide yellow. In addition, the 300/25 mg pinkish brown film-coated tablet contains titanium dioxide, hypromellose, iron oxide black and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>49643-442-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49643-442-05) </PackageDescription>
<NDC11Code>49643-0442-05</NDC11Code>
<ProductNDC>49643-442</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Cherry Birch Pollen</ProprietaryName>
<NonProprietaryName>Betula Lenta</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>BETULA LENTA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>49643-442-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49643-442-10) </PackageDescription>
<NDC11Code>49643-0442-10</NDC11Code>
<ProductNDC>49643-442</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Cherry Birch Pollen</ProprietaryName>
<NonProprietaryName>Betula Lenta</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>BETULA LENTA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>49643-442-30</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49643-442-30) </PackageDescription>
<NDC11Code>49643-0442-30</NDC11Code>
<ProductNDC>49643-442</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Cherry Birch Pollen</ProprietaryName>
<NonProprietaryName>Betula Lenta</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>BETULA LENTA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>49643-442-50</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49643-442-50) </PackageDescription>
<NDC11Code>49643-0442-50</NDC11Code>
<ProductNDC>49643-442</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Cherry Birch Pollen</ProprietaryName>
<NonProprietaryName>Betula Lenta</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>BETULA LENTA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>50268-442-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-442-15) / 1 TABLET in 1 BLISTER PACK (50268-442-11) </PackageDescription>
<NDC11Code>50268-0442-15</NDC11Code>
<ProductNDC>50268-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Irbesartan</ProprietaryName>
<NonProprietaryName>Irbesartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230808</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202910</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>IRBESARTAN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hypertension Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. 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 1 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. Irbesartan tablets may be used alone or in combination with other antihypertensive agents. 1.2 Nephropathy in Type 2 Diabetic Patients Irbesartan tablets are indicated for the treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension, an elevated serum creatinine, and proteinuria (>300 mg/day). In this population, irbesartan reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Irbesartan USP is an angiotensin II receptor (AT1 subtype) antagonist. Irbesartan USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C 25H 28N 6O, and the structural formula: Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Irbesartan is available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of Irbesartan USP. Inactive ingredients include: calcium stearate, carboxy methyl cellulose calcium, colloidal silicon dioxide, microcrystalline cellulose and povidone.</Description>
</NDC>
<NDC>
<NDCCode>59735-442-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (59735-442-01) / 14 g in 1 TUBE</PackageDescription>
<NDC11Code>59735-0442-01</NDC11Code>
<ProductNDC>59735-442</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stick Foundation Spf Honey Beige</ProprietaryName>
<NonProprietaryName>Stick Foundation</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131212</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>MANA PRODUCTS, INC.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>7.5; 5; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64058-442-64</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (64058-442-64)</PackageDescription>
<NDC11Code>64058-0442-64</NDC11Code>
<ProductNDC>64058-442</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nanofreeze</ProprietaryName>
<NonProprietaryName>Menthol And Camphor (synthetic)</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110310</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Concept Laboratories, Inc.</LabelerName>
<SubstanceName>MENTHOL; CAMPHOR (SYNTHETIC)</SubstanceName>
<StrengthNumber>14.16; 7.08</StrengthNumber>
<StrengthUnit>g/118mL; g/118mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-02-20</LastUpdate>
</NDC>
<NDC>
<NDCCode>64380-442-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (64380-442-01) </PackageDescription>
<NDC11Code>64380-0442-01</NDC11Code>
<ProductNDC>64380-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202935</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5 α -Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains. Hydrocodone Bitartrate …..... 5 mg. Acetaminophen ................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ..................... 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen ..................... 325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>64380-442-02</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (64380-442-02) </PackageDescription>
<NDC11Code>64380-0442-02</NDC11Code>
<ProductNDC>64380-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202935</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>325; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5 α -Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains. Hydrocodone Bitartrate …..... 5 mg. Acetaminophen ................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ..................... 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen ..................... 325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>64380-442-03</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (64380-442-03) </PackageDescription>
<NDC11Code>64380-0442-03</NDC11Code>
<ProductNDC>64380-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202935</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>325; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5 α -Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains. Hydrocodone Bitartrate …..... 5 mg. Acetaminophen ................. 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains. Hydrocodone Bitartrate ......... 7.5 mg. Acetaminophen ..................... 325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains. Hydrocodone Bitartrate .......... 10 mg. Acetaminophen ..................... 325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 1.</Description>
</NDC>
</NDCList>