{
"NDC": [
{
"NDCCode": "76331-900-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (76331-900-90) ",
"NDC11Code": "76331-0900-90",
"ProductNDC": "76331-900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hemetab",
"NonProprietaryName": "Folic Acid, Cyanocobalamin, Iron Sucrose, Heme Iron Polypeptide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "WH Nutritionals, LLC",
"SubstanceName": "FOLIC ACID; CYANOCOBALAMIN; IRON SUCROSE; HEME IRON POLYPEPTIDE",
"StrengthNumber": "1; 25; 22; 6",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin B 12 [CS],Vitamin B12 [EPC],Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20120501",
"SamplePackage": "N"
},
{
"NDCCode": "76331-901-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (76331-901-90)",
"NDC11Code": "76331-0901-90",
"ProductNDC": "76331-901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hemenatal Ob",
"NonProprietaryName": "Cholecalciferol, .alpha.-tocopherol Succinate, D-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Pantothenate, Iron Sucrose, Heme Iron Polypeptide, Potassium Iodide, Zinc Oxide, Sodium Selenate, Cupric Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120308",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "WH Nutritionals, LLC",
"SubstanceName": "CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; IRON SUCROSE; HEME IRON POLYPEPTIDE; POTASSIUM IODIDE; ZINC OXIDE; SODIUM SELENATE; CUPRIC SULFATE",
"StrengthNumber": "400; 10; 1.5; 1.6; 17; 50; 1; 12; 30; 10; 28; 6; 250; 4.5; 65; .8",
"StrengthUnit": "[iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1",
"Pharm_Classes": "Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "76331-905-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (76331-905-90)",
"NDC11Code": "76331-0905-90",
"ProductNDC": "76331-905",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nutri-tab Ob",
"NonProprietaryName": "Sodium Ascorbate, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Formate, Calcium Carbonate, Ferrous Bisglycinate, Potassium Iodide, Zinc Oxide, Choline Bitartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120503",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "WH Nutritionals, LLC",
"SubstanceName": "SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM FORMATE; CALCIUM CARBONATE; FERROUS BISGLYCINATE; POTASSIUM IODIDE; ZINC OXIDE; CHOLINE BITARTRATE",
"StrengthNumber": "120; 450; 30; 3; 3; 20; 50; 1000; 10; 155; 45; 32; 100; 10; 55",
"StrengthUnit": "mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "12784-454-90",
"PackageDescription": "900 kg in 1 DRUM (12784-454-90)",
"NDC11Code": "12784-0454-90",
"ProductNDC": "12784-454",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Magaldrate",
"DosageFormName": "GEL",
"StartMarketingDate": "20200521",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "SPI Pharma, Inc.",
"SubstanceName": "MAGALDRATE",
"StrengthNumber": "10",
"StrengthUnit": "kg/100kg",
"Status": "Unfinished",
"LastUpdate": "2020-05-23",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "23590-110-90",
"PackageDescription": "900 mL in 1 BOTTLE (23590-110-90) ",
"NDC11Code": "23590-0110-90",
"ProductNDC": "23590-110",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neptune 362 Antibacterial",
"NonProprietaryName": "Chloroxyenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210104",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "R.L. Williams Company",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": ".03",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210104",
"SamplePackage": "N"
},
{
"NDCCode": "23590-120-90",
"PackageDescription": "900 mL in 1 BOTTLE (23590-120-90) ",
"NDC11Code": "23590-0120-90",
"ProductNDC": "23590-120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neptune 367 Foaming Antibacterial",
"NonProprietaryName": "Chloroxyenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210104",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "R.L. Williams Company",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": ".03",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210104",
"SamplePackage": "N"
},
{
"NDCCode": "23590-130-90",
"PackageDescription": "900 mL in 1 BOTTLE (23590-130-90) ",
"NDC11Code": "23590-0130-90",
"ProductNDC": "23590-130",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neptune 375 Instant Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210104",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "R.L. Williams Company",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210104",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeted use."
},
{
"NDCCode": "23590-131-90",
"PackageDescription": "900 mL in 1 BOTTLE (23590-131-90) ",
"NDC11Code": "23590-0131-90",
"ProductNDC": "23590-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neptune 375 Instant Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210104",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "R.L. Williams Company",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210104",
"SamplePackage": "N"
},
{
"NDCCode": "23590-140-90",
"PackageDescription": "900 mL in 1 BOTTLE (23590-140-90) ",
"NDC11Code": "23590-0140-90",
"ProductNDC": "23590-140",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neptune 377 Foaming Instant Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210104",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "R.L. Williams Company",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210104",
"SamplePackage": "N"
},
{
"NDCCode": "35356-900-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (35356-900-90)",
"NDC11Code": "35356-0900-90",
"ProductNDC": "35356-900",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091103",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-10-17",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "51316-900-19",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (51316-900-19) / 90 CAPSULE in 1 BOTTLE, PLASTIC",
"NDC11Code": "51316-0900-19",
"ProductNDC": "51316-900",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hcl",
"NonProprietaryName": "Cetirizine Hcl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022429",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260824",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. ■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat."
},
{
"NDCCode": "52747-900-90",
"PackageDescription": "90 CAPSULE in 1 BLISTER PACK (52747-900-90)",
"NDC11Code": "52747-0900-90",
"ProductNDC": "52747-900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tandem",
"NonProprietaryName": "Ferrous Fumarate And Polysacchride Iron Complex",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060217",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "US Pharmaceutical Corporation",
"SubstanceName": "FERROUS FUMARATE; FERROUS ASPARTO GLYCINATE",
"StrengthNumber": "162; 115.2",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-02-27",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55700-900-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (55700-900-90) ",
"NDC11Code": "55700-0900-90",
"ProductNDC": "55700-900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril And Hydrochlorothiazide",
"NonProprietaryName": "Lisinopril And Hydrochlorothiazide Tablets",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204058",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "HYDROCHLOROTHIAZIDE; LISINOPRIL",
"StrengthNumber": "25; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210707",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril and hydrochlorothiazide tablets, USP are 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 lisinopril and hydrochlorothiazide. 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. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets, USP consideration should be given to the fact that an angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk (See WARNINGS). In considering the use of lisinopril and hydrochlorothiazide tablets, USP it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients (see WARNINGS, Lisinopril).",
"Description": "Lisinopril and hydrochlorothiazide tablets, USP combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5. 2H2O and its structural formula is. Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. 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, USP is a white, or practically white, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets, USP are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide, lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide and lisinopril and hydrochlorothiazide tablets 20 mg/25 mg, containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive ingredients are dibasic calcium phosphate anhydrous, mannitol, corn starch, pre-gelatinized starch and magnesium stearate. Lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg and 20 mg/25 mg also contain both yellow iron oxide and red iron oxide."
},
{
"NDCCode": "63187-900-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (63187-900-90) ",
"NDC11Code": "63187-0900-90",
"ProductNDC": "63187-900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Mononitrate",
"NonProprietaryName": "Isosorbide Mononitrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930630",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020215",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ISOSORBIDE MONONITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2019-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170901",
"SamplePackage": "N",
"IndicationAndUsage": "Isosorbide Mononitrate Tablets are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide mononitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The empirical formula is C6H9NO6 and the molecular weight is 191.14. The chemical name for isosorbide mononitrate is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound has the following structural formula. Isosorbide Mononitrate Tablets, USP are available as 10 mg and 20 mg tablets. Each tablet also contains as inactive ingredients: lactose, talc, colloidal silicon dioxide, starch, microcrystalline cellulose and aluminum stearate."
},
{
"NDCCode": "63304-900-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (63304-900-90) ",
"NDC11Code": "63304-0900-90",
"ProductNDC": "63304-900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076635",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "54",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200918",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1)., 2 For treatment of adult patients with severe hypertriglyceridemia (1.2).",
"Description": "Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79-82°C. Fenofibrate, USP is a white or almost white crystalline powder. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, crospovidone, microcrystalline cellulose, polyvinyl alcohol (part-hydrolyzed), polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium stearyl fumarate, talc and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "67253-900-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (67253-900-09) ",
"NDC11Code": "67253-0900-09",
"ProductNDC": "67253-900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070328",
"EndMarketingDate": "20220731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074174",
"LabelerName": "Par Pharmaceutical",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2022-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070328",
"EndMarketingDatePackage": "20220331",
"SamplePackage": "N"
},
{
"NDCCode": "67877-900-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (67877-900-90) ",
"NDC11Code": "67877-0900-90",
"ProductNDC": "67877-900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078925",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251206",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: * Hypertension (1.1) ○ Amlodipine besylate tablets is 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. * Coronary Artery Disease (1.2) ○ Chronic Stable Angina ○ Vasospastic Angina (Prinzmetal's or Variant Angina) ○ Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.Amlodipine besylate is chemically described as 3-Ethyl-5-methyl(±)-2- [(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6- methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate."
},
{
"NDCCode": "68387-900-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (68387-900-90)",
"NDC11Code": "68387-0900-90",
"ProductNDC": "68387-900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076003",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tramadol hydrochloride is indicated for the management of moderate to moderately severe pain in adults.",
"Description": "Tramadol hydrochloride tablets is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular formula of tramadol hydrochloride is C16H25NO2HCl and its molecular weight is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Each tramadol hydrochloride tablet intended for oral administration contains 50 mg of tramadol hydrochloride. In addition, it also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "71205-900-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-900-90) ",
"NDC11Code": "71205-0900-90",
"ProductNDC": "71205-900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Darifenacin 7.5 Mg",
"NonProprietaryName": "Darifenacin Hydrobromide",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209571",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DARIFENACIN HYDROBROMIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210721",
"SamplePackage": "N",
"IndicationAndUsage": "Darifenacin extended-release tablets are muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.",
"Description": "Darifenacin extended-release tablets are an extended-release tablet for oral administration which contains 7.5 mg or 15 mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist. Chemically, darifenacin hydrobromide is (S)-2-{1-[2-(2,3-dihydrobenzofuran-5-yl)ethyl]-3-pyrrolidinyl}-2,2-diphenylacetamide hydrobromide. The molecular formula of darifenacin hydrobromide is C28H30N2O2HBr. The structural formula is. Darifenacin hydrobromide is a white to off-white, crystalline powder, with a molecular weight of 507.5. Darifenacin extended-release tablets are a once-a-day extended-release tablet and contains the following inactive ingredients: hypromellose, lactose monohydrate, anhydrous dibasic calcium phosphate, magnesium stearate, titanium dioxide, polydextrose, talc, maltodextrin, medium chain triglycerides (vegetable).The 15 mg tablet also contains red iron oxide non-irradiated, yellow iron oxide non-irradiated and black iron oxide non-irradiated."
},
{
"NDCCode": "76420-900-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (76420-900-90) ",
"NDC11Code": "76420-0900-90",
"ProductNDC": "76420-900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine Hydrochloride",
"NonProprietaryName": "Tizanidine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212196",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250128",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine hydrochloride is indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration ( 2.1)].",
"Description": "Tizanidine hydrochloride is a central alpha 2-adrenergic agonist. Tizanidine hydrochloride is almost a white to slightly yellow crystalline powder. Tizanidine is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2- imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. Tizanidine’s molecular formula is C 9H 8ClN 5S-HCl, its molecular weight is 290.2 and its structural formula is:. Tizanidine hydrochloride capsules are supplied as 2, 4, and 6 mg capsules for oral administration. Tizanidine hydrochloride capsules contain the active ingredient, tizanidine hydrochloride (2.29 mg equivalent to 2 mg tizanidine base, 4.58 mg equivalent to 4 mg tizanidine base, and 6.87 mg equivalent to 6 mg tizanidine base). In addition each capsule contains the following inactive ingredients: sugar spheres, hypromellose and silicon dioxide. Each capsule shell contains FD and C Blue1, FD and C Red 3, titanium dioxide and gelatin. The 2 mg and 6 mg capsule is printed with white pharmaceutical ink which contains shellac, propylene glycol, potassium hydroxide and titanium dioxide; 4 mg capsule is printed with black pharmaceutical ink which contains shellac, propylene glycol, black iron oxide, potassium hydroxide and titanium dioxide."
},
{
"NDCCode": "76426-020-90",
"PackageDescription": "900 mL in 1 BOTTLE (76426-020-90) ",
"NDC11Code": "76426-0020-90",
"ProductNDC": "76426-020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gfs Bioprotect Alcohol Free Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160628",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GFS-US",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160628",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "76441-900-90",
"PackageDescription": "200 mL in 1 BOTTLE, PUMP (76441-900-90) ",
"NDC11Code": "76441-0900-90",
"ProductNDC": "76441-900",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wow Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200630",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "SUJANIL CHEMO INDUSTRIES",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200630",
"SamplePackage": "N",
"IndicationAndUsage": "Wow Hand Sanitizer Gel to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "0037-6830-15",
"PackageDescription": "1 CANISTER in 1 CARTON (0037-6830-15) / 15 g in 1 CANISTER",
"NDC11Code": "00037-6830-15",
"ProductNDC": "0037-6830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cortifoam",
"NonProprietaryName": "Hydrocortisone Acetate",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150615",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017351",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "HYDROCORTISONE ACETATE",
"StrengthNumber": "1500",
"StrengthUnit": "mg/15g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150615",
"SamplePackage": "N",
"IndicationAndUsage": "Cortifoam® is indicated as adjunctive therapy in the topical treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas.",
"Description": "Cortifoam® (hydrocortisone acetate rectal aerosol) 10% Rectal Foam contains hydrocortisone acetate 10% in a base containing propylene glycol, emulsifying wax, polyoxyethylene-10-stearyl ether, cetyl alcohol, methylparaben, propylparaben, trolamine, purified water and inert propellants: isobutane and propane. Each application delivers approximately 900 mg of foam containing 80 mg of hydrocortisone (90 mg of hydrocortisone acetate). The molecular weight of hydrocortisone acetate is 404.50. It is designated chemically as pregn-4-ene-3,20-dione,21-(acetyloxy)-11,17-dihydroxy-,(11β)-. The empirical formula is C23H32O6 and the structural formula is. Hydrocortisone acetate, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is insoluble in water (1 mg/100 mL) and slightly soluble in alcohol and chloroform."
},
{
"NDCCode": "0264-4050-90",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-4050-90) / 50 mL in 1 CONTAINER",
"NDC11Code": "00264-4050-90",
"ProductNDC": "0264-4050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231010",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204957",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231010",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen Injection is indicated for: 1 the management of mild to moderate pain in adult and pediatric patients 2 years and older, 2 the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, 3 the reduction of fever in adult and pediatric patients.",
"Description": "Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16. Its structural formula is. Acetaminophen Injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.0 and an osmolality of approximately 290 mOsm/kg. Each 50 mL contains 500 mg Acetaminophen, USP, 1,900 mg Mannitol, USP, 15 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. pH is adjusted with glacial acetic acid. Not made with natural rubber latex, PVC or DEHP."
},
{
"NDCCode": "0264-4100-90",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-4100-90) / 100 mL in 1 CONTAINER",
"NDC11Code": "00264-4100-90",
"ProductNDC": "0264-4100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204957",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2023-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210218",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen Injection is indicated for: 1 the management of mild to moderate pain in adult and pediatric patients 2 years and older, 2 the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, 3 the reduction of fever in adult and pediatric patients.",
"Description": "Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16. Its structural formula is:. Acetaminophen Injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.0 and an osmolality of approximately 290 mOsm/kg. Each 100 mL contains 1,000 mg Acetaminophen, USP, 3,800 mg Mannitol, USP, 30 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. Each 50 mL contains 500 mg Acetaminophen, USP, 1,900 mg Mannitol, USP, 15 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. pH is adjusted with glacial acetic acid. Not made with natural rubber latex, PVC or DEHP."
},
{
"NDCCode": "0338-9644-12",
"PackageDescription": "12 BAG in 1 CARTON (0338-9644-12) / 100 mL in 1 BAG (0338-9644-01) ",
"NDC11Code": "00338-9644-12",
"ProductNDC": "0338-9644",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium In 0.9% Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217512",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240214",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following: : 1 Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1) , 2 Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2).",
"Description": "The active ingredient in pantoprazole sodium in 0.9% sodium chloride injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The thawed solution of pantoprazole sodium in 0.9% sodium chloride injection is in the pH range 9.0 to 10.5. Pantoprazole sodium in 0.9% sodium chloride injection is supplied for intravenous administration as a frozen, premixed, iso-osmotic, sterile, nonpyrogenic 50 mL or 100 mL single-dose GALAXY container in following presentations:. 40 mg/100 mL (0.4 mg/mL): containing 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP;. 40 mg/50 mL (0.8 mg/mL): containing 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 77.5 mg histidine, USP; 450 mg sodium chloride, USP;. 80 mg/100 mL (0.8 mg/mL): containing 80 mg of pantoprazole (equivalent to 90.2 mg of pantoprazole sodium USP); 2 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP;. Sodium hydroxide and/or hydrochloric acid may be used to adjust pH. The solution is intended for intravenous use after thawing to room temperature. Thawed solution is expected to range from colorless to yellow over time."
},
{
"NDCCode": "0338-9646-24",
"PackageDescription": "24 BAG in 1 CARTON (0338-9646-24) / 50 mL in 1 BAG (0338-9646-01) ",
"NDC11Code": "00338-9646-24",
"ProductNDC": "0338-9646",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium In 0.9% Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217512",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240214",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following: : 1 Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1) , 2 Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2).",
"Description": "The active ingredient in pantoprazole sodium in 0.9% sodium chloride injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The thawed solution of pantoprazole sodium in 0.9% sodium chloride injection is in the pH range 9.0 to 10.5. Pantoprazole sodium in 0.9% sodium chloride injection is supplied for intravenous administration as a frozen, premixed, iso-osmotic, sterile, nonpyrogenic 50 mL or 100 mL single-dose GALAXY container in following presentations:. 40 mg/100 mL (0.4 mg/mL): containing 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP;. 40 mg/50 mL (0.8 mg/mL): containing 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 77.5 mg histidine, USP; 450 mg sodium chloride, USP;. 80 mg/100 mL (0.8 mg/mL): containing 80 mg of pantoprazole (equivalent to 90.2 mg of pantoprazole sodium USP); 2 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP;. Sodium hydroxide and/or hydrochloric acid may be used to adjust pH. The solution is intended for intravenous use after thawing to room temperature. Thawed solution is expected to range from colorless to yellow over time."
},
{
"NDCCode": "0338-9648-12",
"PackageDescription": "12 BAG in 1 CARTON (0338-9648-12) / 100 mL in 1 BAG (0338-9648-01) ",
"NDC11Code": "00338-9648-12",
"ProductNDC": "0338-9648",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium In 0.9% Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217512",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "80",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240214",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following: : 1 Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1) , 2 Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2).",
"Description": "The active ingredient in pantoprazole sodium in 0.9% sodium chloride injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The thawed solution of pantoprazole sodium in 0.9% sodium chloride injection is in the pH range 9.0 to 10.5. Pantoprazole sodium in 0.9% sodium chloride injection is supplied for intravenous administration as a frozen, premixed, iso-osmotic, sterile, nonpyrogenic 50 mL or 100 mL single-dose GALAXY container in following presentations:. 40 mg/100 mL (0.4 mg/mL): containing 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP;. 40 mg/50 mL (0.8 mg/mL): containing 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 77.5 mg histidine, USP; 450 mg sodium chloride, USP;. 80 mg/100 mL (0.8 mg/mL): containing 80 mg of pantoprazole (equivalent to 90.2 mg of pantoprazole sodium USP); 2 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP;. Sodium hydroxide and/or hydrochloric acid may be used to adjust pH. The solution is intended for intravenous use after thawing to room temperature. Thawed solution is expected to range from colorless to yellow over time."
},
{
"NDCCode": "0642-0207-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (0642-0207-90) ",
"NDC11Code": "00642-0207-90",
"ProductNDC": "0642-0207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strovite One",
"ProprietaryNameSuffix": "Caplets",
"NonProprietaryName": "Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Manganese, Chromium, .alpha.-lipoic Acid, And Lutein",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010504",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exeltis USA, Inc.",
"SubstanceName": "MANGANESE; VITAMIN A; CALCIUM PANTOTHENATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN; SELENIUM; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC SULFATE; CHROMIUM; ALPHA LIPOIC ACID; LUTEIN",
"StrengthNumber": "1.5; 900; 7.5; 300; 25; 45; 20; 5; 25; 25; 1700; 100; 50; 100; 50; 25; 1.5; 50; 15; 5",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Standardized Chemical Allergen [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010504",
"SamplePackage": "N",
"IndicationAndUsage": "STROVITE ® ONE is indicated to provide nutritional supplementation to support optimum vitamin and mineral levels.",
"Description": "Other ingredients: Microcrystalline cellulose, dicalcium phosphate, hydroxypropyl methylcellulose, croscarmellose sodium, polyethylene glycol, titanium dioxide, talc, maltodextrin, modified food starch, sucrose, polyvinyl alcohol, stearic acid, silica, magnesium stearate, corn oil, starch, vitamin E alcohol, sodium ascorbate, mannitol."
},
{
"NDCCode": "52427-803-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (52427-803-90) ",
"NDC11Code": "52427-0803-90",
"ProductNDC": "52427-803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gralise",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022544",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "GRALISE is indicated for the management of postherpetic neuralgia. GRALISE is not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.",
"Description": "GRALISE contains gabapentin, a gamma-aminobutyric acid (GABA) analogue, as the active pharmaceutical ingredient. Gabapentin's chemical name is 1-(aminomethyl)cyclohexaneacetic acid; with a molecular formula of C9H17NO2 and a molecular weight of 171.24 g/mol. Gabapentin chemical structural formula is:. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and acidic and basic solutions. The log of the partition coefficient (n-octanol/ 0.05M phosphate buffer) at pH 7.4 is -1.25. GRALISE is intended for oral administration and is supplied as tablets containing 300 mg, 450 mg, 600 mg, 750 mg, or 900 mg of gabapentin USP. Each 300 mg tablet contains the inactive ingredients Copovidone NF, Hypromellose USP, Magnesium Stearate NF, Microcrystalline Cellulose NF, Polyethylene Oxide NF, and white film coating (Polyvinyl Alcohol USP, Talc USP, Titanium Oxide USP, Polyethylene Glycol 3350 USP, and Lecithin NF (soya)). Each 450 mg tablet contains the inactive ingredients Copovidone NF, Hypromellose USP, Magnesium Stearate NF, Polyethylene Oxide NF, and red film coating (Polyethylene glycol 3350 USP, Polyvinyl Alcohol USP, Talc USP, Titanium Oxide USP, and Iron Oxide Red NF). Each 600 mg tablet contains the inactive ingredients Copovidone NF, Hypromellose USP, Magnesium Stearate NF, Polyethylene Oxide NF, and beige film coating (Polyethylene Glycol 3350 USP, Polyvinyl Alcohol USP, Talc USP, Titanium Oxide USP, Iron Oxide Yellow NF, and Iron Oxide Red NF). Each 750 mg tablet contains the inactive ingredients Copovidone NF, Hypromellose USP, Magnesium Stearate NF, Polyethylene Oxide NF, and yellow film coating (Polyethylene Glycol 3350 USP, Polyvinyl Alcohol USP, Talc USP, Titanium oxide USP, and Iron Oxide Yellow NF). Each 900 mg tablet contains the inactive ingredients Copovidone NF, Hypromellose USP, Magnesium Stearate NF, Polyethylene Oxide NF, and pink film coating (Polyethylene Glycol 3350 USP, Polyvinyl Alcohol USP, Talc USP, Titanium oxide USP, and Iron Oxide Red NF)."
}
]
}
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<NDCList>
<NDC>
<NDCCode>76331-900-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (76331-900-90) </PackageDescription>
<NDC11Code>76331-0900-90</NDC11Code>
<ProductNDC>76331-900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hemetab</ProprietaryName>
<NonProprietaryName>Folic Acid, Cyanocobalamin, Iron Sucrose, Heme Iron Polypeptide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>WH Nutritionals, LLC</LabelerName>
<SubstanceName>FOLIC ACID; CYANOCOBALAMIN; IRON SUCROSE; HEME IRON POLYPEPTIDE</SubstanceName>
<StrengthNumber>1; 25; 22; 6</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin B 12 [CS],Vitamin B12 [EPC],Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76331-901-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (76331-901-90)</PackageDescription>
<NDC11Code>76331-0901-90</NDC11Code>
<ProductNDC>76331-901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hemenatal Ob</ProprietaryName>
<NonProprietaryName>Cholecalciferol, .alpha.-tocopherol Succinate, D-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Pantothenate, Iron Sucrose, Heme Iron Polypeptide, Potassium Iodide, Zinc Oxide, Sodium Selenate, Cupric Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120308</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>WH Nutritionals, LLC</LabelerName>
<SubstanceName>CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; IRON SUCROSE; HEME IRON POLYPEPTIDE; POTASSIUM IODIDE; ZINC OXIDE; SODIUM SELENATE; CUPRIC SULFATE</SubstanceName>
<StrengthNumber>400; 10; 1.5; 1.6; 17; 50; 1; 12; 30; 10; 28; 6; 250; 4.5; 65; .8</StrengthNumber>
<StrengthUnit>[iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>76331-905-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (76331-905-90)</PackageDescription>
<NDC11Code>76331-0905-90</NDC11Code>
<ProductNDC>76331-905</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nutri-tab Ob</ProprietaryName>
<NonProprietaryName>Sodium Ascorbate, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Formate, Calcium Carbonate, Ferrous Bisglycinate, Potassium Iodide, Zinc Oxide, Choline Bitartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120503</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>WH Nutritionals, LLC</LabelerName>
<SubstanceName>SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM FORMATE; CALCIUM CARBONATE; FERROUS BISGLYCINATE; POTASSIUM IODIDE; ZINC OXIDE; CHOLINE BITARTRATE</SubstanceName>
<StrengthNumber>120; 450; 30; 3; 3; 20; 50; 1000; 10; 155; 45; 32; 100; 10; 55</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>12784-454-90</NDCCode>
<PackageDescription>900 kg in 1 DRUM (12784-454-90)</PackageDescription>
<NDC11Code>12784-0454-90</NDC11Code>
<ProductNDC>12784-454</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Magaldrate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<StartMarketingDate>20200521</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>SPI Pharma, Inc.</LabelerName>
<SubstanceName>MAGALDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2020-05-23</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>23590-110-90</NDCCode>
<PackageDescription>900 mL in 1 BOTTLE (23590-110-90) </PackageDescription>
<NDC11Code>23590-0110-90</NDC11Code>
<ProductNDC>23590-110</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neptune 362 Antibacterial</ProprietaryName>
<NonProprietaryName>Chloroxyenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>R.L. Williams Company</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>.03</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>23590-120-90</NDCCode>
<PackageDescription>900 mL in 1 BOTTLE (23590-120-90) </PackageDescription>
<NDC11Code>23590-0120-90</NDC11Code>
<ProductNDC>23590-120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neptune 367 Foaming Antibacterial</ProprietaryName>
<NonProprietaryName>Chloroxyenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>R.L. Williams Company</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>.03</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>23590-130-90</NDCCode>
<PackageDescription>900 mL in 1 BOTTLE (23590-130-90) </PackageDescription>
<NDC11Code>23590-0130-90</NDC11Code>
<ProductNDC>23590-130</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neptune 375 Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>R.L. Williams Company</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeted use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23590-131-90</NDCCode>
<PackageDescription>900 mL in 1 BOTTLE (23590-131-90) </PackageDescription>
<NDC11Code>23590-0131-90</NDC11Code>
<ProductNDC>23590-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neptune 375 Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>R.L. Williams Company</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>23590-140-90</NDCCode>
<PackageDescription>900 mL in 1 BOTTLE (23590-140-90) </PackageDescription>
<NDC11Code>23590-0140-90</NDC11Code>
<ProductNDC>23590-140</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neptune 377 Foaming Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>R.L. Williams Company</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>35356-900-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (35356-900-90)</PackageDescription>
<NDC11Code>35356-0900-90</NDC11Code>
<ProductNDC>35356-900</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091103</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-17</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51316-900-19</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (51316-900-19) / 90 CAPSULE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>51316-0900-19</NDC11Code>
<ProductNDC>51316-900</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hcl</ProprietaryName>
<NonProprietaryName>Cetirizine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022429</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. ■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52747-900-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BLISTER PACK (52747-900-90)</PackageDescription>
<NDC11Code>52747-0900-90</NDC11Code>
<ProductNDC>52747-900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tandem</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate And Polysacchride Iron Complex</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060217</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>US Pharmaceutical Corporation</LabelerName>
<SubstanceName>FERROUS FUMARATE; FERROUS ASPARTO GLYCINATE</SubstanceName>
<StrengthNumber>162; 115.2</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-02-27</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55700-900-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (55700-900-90) </PackageDescription>
<NDC11Code>55700-0900-90</NDC11Code>
<ProductNDC>55700-900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Lisinopril And Hydrochlorothiazide Tablets</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204058</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; LISINOPRIL</SubstanceName>
<StrengthNumber>25; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril and hydrochlorothiazide tablets, USP are 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 lisinopril and hydrochlorothiazide. 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. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets, USP consideration should be given to the fact that an angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk (See WARNINGS). In considering the use of lisinopril and hydrochlorothiazide tablets, USP it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients (see WARNINGS, Lisinopril).</IndicationAndUsage>
<Description>Lisinopril and hydrochlorothiazide tablets, USP combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5. 2H2O and its structural formula is. Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. 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, USP is a white, or practically white, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets, USP are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide, lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide and lisinopril and hydrochlorothiazide tablets 20 mg/25 mg, containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive ingredients are dibasic calcium phosphate anhydrous, mannitol, corn starch, pre-gelatinized starch and magnesium stearate. Lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg and 20 mg/25 mg also contain both yellow iron oxide and red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>63187-900-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (63187-900-90) </PackageDescription>
<NDC11Code>63187-0900-90</NDC11Code>
<ProductNDC>63187-900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930630</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020215</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosorbide Mononitrate Tablets are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide mononitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The empirical formula is C6H9NO6 and the molecular weight is 191.14. The chemical name for isosorbide mononitrate is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound has the following structural formula. Isosorbide Mononitrate Tablets, USP are available as 10 mg and 20 mg tablets. Each tablet also contains as inactive ingredients: lactose, talc, colloidal silicon dioxide, starch, microcrystalline cellulose and aluminum stearate.</Description>
</NDC>
<NDC>
<NDCCode>63304-900-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (63304-900-90) </PackageDescription>
<NDC11Code>63304-0900-90</NDC11Code>
<ProductNDC>63304-900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200918</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076635</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>54</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1)., 2 For treatment of adult patients with severe hypertriglyceridemia (1.2).</IndicationAndUsage>
<Description>Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79-82°C. Fenofibrate, USP is a white or almost white crystalline powder. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, crospovidone, microcrystalline cellulose, polyvinyl alcohol (part-hydrolyzed), polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium stearyl fumarate, talc and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>67253-900-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (67253-900-09) </PackageDescription>
<NDC11Code>67253-0900-09</NDC11Code>
<ProductNDC>67253-900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070328</StartMarketingDate>
<EndMarketingDate>20220731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074174</ApplicationNumber>
<LabelerName>Par Pharmaceutical</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070328</StartMarketingDatePackage>
<EndMarketingDatePackage>20220331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67877-900-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (67877-900-90) </PackageDescription>
<NDC11Code>67877-0900-90</NDC11Code>
<ProductNDC>67877-900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078925</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: * Hypertension (1.1) ○ Amlodipine besylate tablets is 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. * Coronary Artery Disease (1.2) ○ Chronic Stable Angina ○ Vasospastic Angina (Prinzmetal's or Variant Angina) ○ Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.Amlodipine besylate is chemically described as 3-Ethyl-5-methyl(±)-2- [(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6- methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>68387-900-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (68387-900-90)</PackageDescription>
<NDC11Code>68387-0900-90</NDC11Code>
<ProductNDC>68387-900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076003</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tramadol hydrochloride is indicated for the management of moderate to moderately severe pain in adults.</IndicationAndUsage>
<Description>Tramadol hydrochloride tablets is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular formula of tramadol hydrochloride is C16H25NO2HCl and its molecular weight is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Each tramadol hydrochloride tablet intended for oral administration contains 50 mg of tramadol hydrochloride. In addition, it also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71205-900-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-900-90) </PackageDescription>
<NDC11Code>71205-0900-90</NDC11Code>
<ProductNDC>71205-900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Darifenacin 7.5 Mg</ProprietaryName>
<NonProprietaryName>Darifenacin Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209571</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DARIFENACIN HYDROBROMIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Darifenacin extended-release tablets are muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.</IndicationAndUsage>
<Description>Darifenacin extended-release tablets are an extended-release tablet for oral administration which contains 7.5 mg or 15 mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist. Chemically, darifenacin hydrobromide is (S)-2-{1-[2-(2,3-dihydrobenzofuran-5-yl)ethyl]-3-pyrrolidinyl}-2,2-diphenylacetamide hydrobromide. The molecular formula of darifenacin hydrobromide is C28H30N2O2HBr. The structural formula is. Darifenacin hydrobromide is a white to off-white, crystalline powder, with a molecular weight of 507.5. Darifenacin extended-release tablets are a once-a-day extended-release tablet and contains the following inactive ingredients: hypromellose, lactose monohydrate, anhydrous dibasic calcium phosphate, magnesium stearate, titanium dioxide, polydextrose, talc, maltodextrin, medium chain triglycerides (vegetable).The 15 mg tablet also contains red iron oxide non-irradiated, yellow iron oxide non-irradiated and black iron oxide non-irradiated.</Description>
</NDC>
<NDC>
<NDCCode>76420-900-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (76420-900-90) </PackageDescription>
<NDC11Code>76420-0900-90</NDC11Code>
<ProductNDC>76420-900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tizanidine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212196</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine hydrochloride is indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration ( 2.1)].</IndicationAndUsage>
<Description>Tizanidine hydrochloride is a central alpha 2-adrenergic agonist. Tizanidine hydrochloride is almost a white to slightly yellow crystalline powder. Tizanidine is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2- imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. Tizanidine’s molecular formula is C 9H 8ClN 5S-HCl, its molecular weight is 290.2 and its structural formula is:. Tizanidine hydrochloride capsules are supplied as 2, 4, and 6 mg capsules for oral administration. Tizanidine hydrochloride capsules contain the active ingredient, tizanidine hydrochloride (2.29 mg equivalent to 2 mg tizanidine base, 4.58 mg equivalent to 4 mg tizanidine base, and 6.87 mg equivalent to 6 mg tizanidine base). In addition each capsule contains the following inactive ingredients: sugar spheres, hypromellose and silicon dioxide. Each capsule shell contains FD and C Blue1, FD and C Red 3, titanium dioxide and gelatin. The 2 mg and 6 mg capsule is printed with white pharmaceutical ink which contains shellac, propylene glycol, potassium hydroxide and titanium dioxide; 4 mg capsule is printed with black pharmaceutical ink which contains shellac, propylene glycol, black iron oxide, potassium hydroxide and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76426-020-90</NDCCode>
<PackageDescription>900 mL in 1 BOTTLE (76426-020-90) </PackageDescription>
<NDC11Code>76426-0020-90</NDC11Code>
<ProductNDC>76426-020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gfs Bioprotect Alcohol Free Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160628</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GFS-US</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160628</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76441-900-90</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE, PUMP (76441-900-90) </PackageDescription>
<NDC11Code>76441-0900-90</NDC11Code>
<ProductNDC>76441-900</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wow Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>SUJANIL CHEMO INDUSTRIES</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Wow Hand Sanitizer Gel to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0037-6830-15</NDCCode>
<PackageDescription>1 CANISTER in 1 CARTON (0037-6830-15) / 15 g in 1 CANISTER</PackageDescription>
<NDC11Code>00037-6830-15</NDC11Code>
<ProductNDC>0037-6830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cortifoam</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150615</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017351</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>1500</StrengthNumber>
<StrengthUnit>mg/15g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cortifoam® is indicated as adjunctive therapy in the topical treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas.</IndicationAndUsage>
<Description>Cortifoam® (hydrocortisone acetate rectal aerosol) 10% Rectal Foam contains hydrocortisone acetate 10% in a base containing propylene glycol, emulsifying wax, polyoxyethylene-10-stearyl ether, cetyl alcohol, methylparaben, propylparaben, trolamine, purified water and inert propellants: isobutane and propane. Each application delivers approximately 900 mg of foam containing 80 mg of hydrocortisone (90 mg of hydrocortisone acetate). The molecular weight of hydrocortisone acetate is 404.50. It is designated chemically as pregn-4-ene-3,20-dione,21-(acetyloxy)-11,17-dihydroxy-,(11β)-. The empirical formula is C23H32O6 and the structural formula is. Hydrocortisone acetate, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is insoluble in water (1 mg/100 mL) and slightly soluble in alcohol and chloroform.</Description>
</NDC>
<NDC>
<NDCCode>0264-4050-90</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-4050-90) / 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-4050-90</NDC11Code>
<ProductNDC>0264-4050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231010</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204957</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen Injection is indicated for: 1 the management of mild to moderate pain in adult and pediatric patients 2 years and older, 2 the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, 3 the reduction of fever in adult and pediatric patients.</IndicationAndUsage>
<Description>Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16. Its structural formula is. Acetaminophen Injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.0 and an osmolality of approximately 290 mOsm/kg. Each 50 mL contains 500 mg Acetaminophen, USP, 1,900 mg Mannitol, USP, 15 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. pH is adjusted with glacial acetic acid. Not made with natural rubber latex, PVC or DEHP.</Description>
</NDC>
<NDC>
<NDCCode>0264-4100-90</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-4100-90) / 100 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-4100-90</NDC11Code>
<ProductNDC>0264-4100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204957</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen Injection is indicated for: 1 the management of mild to moderate pain in adult and pediatric patients 2 years and older, 2 the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, 3 the reduction of fever in adult and pediatric patients.</IndicationAndUsage>
<Description>Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16. Its structural formula is:. Acetaminophen Injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.0 and an osmolality of approximately 290 mOsm/kg. Each 100 mL contains 1,000 mg Acetaminophen, USP, 3,800 mg Mannitol, USP, 30 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. Each 50 mL contains 500 mg Acetaminophen, USP, 1,900 mg Mannitol, USP, 15 mg Sodium Citrate Dihydrate USP, and Water for Injection, USP qs. pH is adjusted with glacial acetic acid. Not made with natural rubber latex, PVC or DEHP.</Description>
</NDC>
<NDC>
<NDCCode>0338-9644-12</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (0338-9644-12) / 100 mL in 1 BAG (0338-9644-01) </PackageDescription>
<NDC11Code>00338-9644-12</NDC11Code>
<ProductNDC>0338-9644</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium In 0.9% Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217512</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following: : 1 Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1) , 2 Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2).</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium in 0.9% sodium chloride injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The thawed solution of pantoprazole sodium in 0.9% sodium chloride injection is in the pH range 9.0 to 10.5. Pantoprazole sodium in 0.9% sodium chloride injection is supplied for intravenous administration as a frozen, premixed, iso-osmotic, sterile, nonpyrogenic 50 mL or 100 mL single-dose GALAXY container in following presentations:. 40 mg/100 mL (0.4 mg/mL): containing 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP;. 40 mg/50 mL (0.8 mg/mL): containing 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 77.5 mg histidine, USP; 450 mg sodium chloride, USP;. 80 mg/100 mL (0.8 mg/mL): containing 80 mg of pantoprazole (equivalent to 90.2 mg of pantoprazole sodium USP); 2 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP;. Sodium hydroxide and/or hydrochloric acid may be used to adjust pH. The solution is intended for intravenous use after thawing to room temperature. Thawed solution is expected to range from colorless to yellow over time.</Description>
</NDC>
<NDC>
<NDCCode>0338-9646-24</NDCCode>
<PackageDescription>24 BAG in 1 CARTON (0338-9646-24) / 50 mL in 1 BAG (0338-9646-01) </PackageDescription>
<NDC11Code>00338-9646-24</NDC11Code>
<ProductNDC>0338-9646</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium In 0.9% Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217512</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following: : 1 Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1) , 2 Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2).</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium in 0.9% sodium chloride injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The thawed solution of pantoprazole sodium in 0.9% sodium chloride injection is in the pH range 9.0 to 10.5. Pantoprazole sodium in 0.9% sodium chloride injection is supplied for intravenous administration as a frozen, premixed, iso-osmotic, sterile, nonpyrogenic 50 mL or 100 mL single-dose GALAXY container in following presentations:. 40 mg/100 mL (0.4 mg/mL): containing 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP;. 40 mg/50 mL (0.8 mg/mL): containing 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 77.5 mg histidine, USP; 450 mg sodium chloride, USP;. 80 mg/100 mL (0.8 mg/mL): containing 80 mg of pantoprazole (equivalent to 90.2 mg of pantoprazole sodium USP); 2 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP;. Sodium hydroxide and/or hydrochloric acid may be used to adjust pH. The solution is intended for intravenous use after thawing to room temperature. Thawed solution is expected to range from colorless to yellow over time.</Description>
</NDC>
<NDC>
<NDCCode>0338-9648-12</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (0338-9648-12) / 100 mL in 1 BAG (0338-9648-01) </PackageDescription>
<NDC11Code>00338-9648-12</NDC11Code>
<ProductNDC>0338-9648</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium In 0.9% Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217512</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following: : 1 Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1) , 2 Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2).</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium in 0.9% sodium chloride injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The thawed solution of pantoprazole sodium in 0.9% sodium chloride injection is in the pH range 9.0 to 10.5. Pantoprazole sodium in 0.9% sodium chloride injection is supplied for intravenous administration as a frozen, premixed, iso-osmotic, sterile, nonpyrogenic 50 mL or 100 mL single-dose GALAXY container in following presentations:. 40 mg/100 mL (0.4 mg/mL): containing 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP;. 40 mg/50 mL (0.8 mg/mL): containing 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 77.5 mg histidine, USP; 450 mg sodium chloride, USP;. 80 mg/100 mL (0.8 mg/mL): containing 80 mg of pantoprazole (equivalent to 90.2 mg of pantoprazole sodium USP); 2 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP;. Sodium hydroxide and/or hydrochloric acid may be used to adjust pH. The solution is intended for intravenous use after thawing to room temperature. Thawed solution is expected to range from colorless to yellow over time.</Description>
</NDC>
<NDC>
<NDCCode>0642-0207-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (0642-0207-90) </PackageDescription>
<NDC11Code>00642-0207-90</NDC11Code>
<ProductNDC>0642-0207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strovite One</ProprietaryName>
<ProprietaryNameSuffix>Caplets</ProprietaryNameSuffix>
<NonProprietaryName>Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Manganese, Chromium, .alpha.-lipoic Acid, And Lutein</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010504</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exeltis USA, Inc.</LabelerName>
<SubstanceName>MANGANESE; VITAMIN A; CALCIUM PANTOTHENATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN; SELENIUM; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC SULFATE; CHROMIUM; ALPHA LIPOIC ACID; LUTEIN</SubstanceName>
<StrengthNumber>1.5; 900; 7.5; 300; 25; 45; 20; 5; 25; 25; 1700; 100; 50; 100; 50; 25; 1.5; 50; 15; 5</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Standardized Chemical Allergen [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STROVITE ® ONE is indicated to provide nutritional supplementation to support optimum vitamin and mineral levels.</IndicationAndUsage>
<Description>Other ingredients: Microcrystalline cellulose, dicalcium phosphate, hydroxypropyl methylcellulose, croscarmellose sodium, polyethylene glycol, titanium dioxide, talc, maltodextrin, modified food starch, sucrose, polyvinyl alcohol, stearic acid, silica, magnesium stearate, corn oil, starch, vitamin E alcohol, sodium ascorbate, mannitol.</Description>
</NDC>
<NDC>
<NDCCode>52427-803-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (52427-803-90) </PackageDescription>
<NDC11Code>52427-0803-90</NDC11Code>
<ProductNDC>52427-803</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gralise</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022544</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GRALISE is indicated for the management of postherpetic neuralgia. GRALISE is not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.</IndicationAndUsage>
<Description>GRALISE contains gabapentin, a gamma-aminobutyric acid (GABA) analogue, as the active pharmaceutical ingredient. Gabapentin's chemical name is 1-(aminomethyl)cyclohexaneacetic acid; with a molecular formula of C9H17NO2 and a molecular weight of 171.24 g/mol. Gabapentin chemical structural formula is:. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and acidic and basic solutions. The log of the partition coefficient (n-octanol/ 0.05M phosphate buffer) at pH 7.4 is -1.25. GRALISE is intended for oral administration and is supplied as tablets containing 300 mg, 450 mg, 600 mg, 750 mg, or 900 mg of gabapentin USP. Each 300 mg tablet contains the inactive ingredients Copovidone NF, Hypromellose USP, Magnesium Stearate NF, Microcrystalline Cellulose NF, Polyethylene Oxide NF, and white film coating (Polyvinyl Alcohol USP, Talc USP, Titanium Oxide USP, Polyethylene Glycol 3350 USP, and Lecithin NF (soya)). Each 450 mg tablet contains the inactive ingredients Copovidone NF, Hypromellose USP, Magnesium Stearate NF, Polyethylene Oxide NF, and red film coating (Polyethylene glycol 3350 USP, Polyvinyl Alcohol USP, Talc USP, Titanium Oxide USP, and Iron Oxide Red NF). Each 600 mg tablet contains the inactive ingredients Copovidone NF, Hypromellose USP, Magnesium Stearate NF, Polyethylene Oxide NF, and beige film coating (Polyethylene Glycol 3350 USP, Polyvinyl Alcohol USP, Talc USP, Titanium Oxide USP, Iron Oxide Yellow NF, and Iron Oxide Red NF). Each 750 mg tablet contains the inactive ingredients Copovidone NF, Hypromellose USP, Magnesium Stearate NF, Polyethylene Oxide NF, and yellow film coating (Polyethylene Glycol 3350 USP, Polyvinyl Alcohol USP, Talc USP, Titanium oxide USP, and Iron Oxide Yellow NF). Each 900 mg tablet contains the inactive ingredients Copovidone NF, Hypromellose USP, Magnesium Stearate NF, Polyethylene Oxide NF, and pink film coating (Polyethylene Glycol 3350 USP, Polyvinyl Alcohol USP, Talc USP, Titanium oxide USP, and Iron Oxide Red NF).</Description>
</NDC>
</NDCList>