{
"NDC": [
{
"NDCCode": "42291-841-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (42291-841-10) ",
"NDC11Code": "42291-0841-10",
"ProductNDC": "42291-841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamterene And Hydrochlorothiazide",
"NonProprietaryName": "Triamterene And Hydrochlorothiazide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201407",
"LabelerName": "AvKARE",
"SubstanceName": "HYDROCHLOROTHIAZIDE; TRIAMTERENE",
"StrengthNumber": "25; 37.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120703",
"SamplePackage": "N"
},
{
"NDCCode": "17478-841-02",
"PackageDescription": "10 AMPULE in 1 CARTON (17478-841-02) > 2 mL in 1 AMPULE",
"NDC11Code": "17478-0841-02",
"ProductNDC": "17478-841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alfentanil",
"NonProprietaryName": "Alfentanil Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130719",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019353",
"LabelerName": "Akorn",
"SubstanceName": "ALFENTANIL HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2022-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20130719",
"SamplePackage": "N"
},
{
"NDCCode": "17478-841-05",
"PackageDescription": "10 AMPULE in 1 CARTON (17478-841-05) > 5 mL in 1 AMPULE",
"NDC11Code": "17478-0841-05",
"ProductNDC": "17478-841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alfentanil",
"NonProprietaryName": "Alfentanil Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130719",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019353",
"LabelerName": "Akorn",
"SubstanceName": "ALFENTANIL HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2022-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20130719",
"SamplePackage": "N"
},
{
"NDCCode": "17478-841-10",
"PackageDescription": "5 AMPULE in 1 CARTON (17478-841-10) > 10 mL in 1 AMPULE",
"NDC11Code": "17478-0841-10",
"ProductNDC": "17478-841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alfentanil",
"NonProprietaryName": "Alfentanil Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130719",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019353",
"LabelerName": "Akorn",
"SubstanceName": "ALFENTANIL HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2022-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20130719",
"SamplePackage": "N"
},
{
"NDCCode": "23155-841-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (23155-841-10) ",
"NDC11Code": "23155-0841-10",
"ProductNDC": "23155-841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230119",
"EndMarketingDate": "20270930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213320",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230830",
"EndMarketingDatePackage": "20270930",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients hypromellose, magnesium stearate, polyethylene glycol/macrogol, povidone and titanium dioxide. Metformin hydrochloride tablets dissolution USP Test-1 is used."
},
{
"NDCCode": "25021-841-10",
"PackageDescription": "5 AMPULE in 1 CARTON (25021-841-10) / 10 mL in 1 AMPULE",
"NDC11Code": "25021-0841-10",
"ProductNDC": "25021-841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zyogreen",
"NonProprietaryName": "Indocyanine Green",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTERSTITIAL; INTRAVENOUS",
"StartMarketingDate": "20260716",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218579",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "INDOCYANINE GREEN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260716",
"SamplePackage": "N",
"IndicationAndUsage": "ZYOGREEN is an optical imaging agent indicated for: : 1 Fluorescence imaging of vessels (micro- and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures, in adults and pediatric patients (1.1) , 2 Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age and older (1.2) , 3 Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer (1.3) , 4 Ophthalmic angiography in adults and pediatric patients (1.4) .",
"Description": "ZYOGREEN (indocyanine green injection) is an optical imaging agent for intravenous or interstitial use. The chemical name for indocyanine green is 1H-Benz[e]indolium, 2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2H-benz[e]indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-, hydroxide, inner salt, sodium salt. It has a molecular formula of C43H47N2NaO6S2 and a molecular mass of 774.96 g/mol. The structural formula is shown below. Indocyanine green has a peak spectral absorption at 805 nm in blood. ZYOGREEN is a sterile, ready-to-use solution. Each mL contains 2.5 mg of indocyanine green with not more than 0.125 mg sodium iodide and the following inactive ingredients: 1 mg sodium ascorbate and water for injection with a pH between 5.5 and 7.5."
},
{
"NDCCode": "46672-841-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (46672-841-10)",
"NDC11Code": "46672-0841-10",
"ProductNDC": "46672-841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111025",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090533",
"LabelerName": "Mikart, Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-11-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "54864-841-15",
"PackageDescription": "10 kg in 1 DRUM (54864-841-15)",
"NDC11Code": "54864-0841-15",
"ProductNDC": "54864-841",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Olaparib",
"DosageFormName": "POWDER",
"StartMarketingDate": "20170818",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "DOTTIKON EXCLUSIVE SYNTHESIS AG",
"SubstanceName": "OLAPARIB",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "54864-841-62",
"PackageDescription": "10 kg in 1 DRUM (54864-841-62)",
"NDC11Code": "54864-0841-62",
"ProductNDC": "54864-841",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Olaparib",
"DosageFormName": "POWDER",
"StartMarketingDate": "20170818",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "DOTTIKON EXCLUSIVE SYNTHESIS AG",
"SubstanceName": "OLAPARIB",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "62559-841-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (62559-841-10) ",
"NDC11Code": "62559-0841-10",
"ProductNDC": "62559-841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211227",
"EndMarketingDate": "20241031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084657",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211227",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.",
"Description": "Meclizine hydrochloride USP, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. It has the following structural formula. Chemically, meclizine hydrochloride USP is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Meclizine Hydrochloride Tablets USP contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, hydrogenated vegetable oil, sodium starch glycolate, and magnesium stearate. The 12.5 mg tablets also contain: FD&C Blue # 1 aluminum lake. The 25 mg tablets also contain: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base."
},
{
"NDCCode": "65601-841-10",
"PackageDescription": "1100 mL in 1 BAG (65601-841-10) ",
"NDC11Code": "65601-0841-10",
"ProductNDC": "65601-841",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Lotions Skin Cleanser",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121112",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Betco Corporation, Ltd.",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160201",
"SamplePackage": "N",
"IndicationAndUsage": "Antibacterial hand cleaner. . Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics."
},
{
"NDCCode": "68462-841-13",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68462-841-13) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "68462-0841-13",
"ProductNDC": "68462-841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan And Hydrochlorothiazide",
"NonProprietaryName": "Telmisartan And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202544",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "TELMISARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "80; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190304",
"SamplePackage": "N",
"IndicationAndUsage": "Telmisartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy [see Clinical Studies (14)]. Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy for the treatment of hypertension [see Dosage and Administration (2.1)]. Telmisartan and hydrochlorothiazide tablets may be used alone or in combination with other antihypertensive agents.",
"Description": "Telmisartan and Hydrochlorothiazide Tablets, USP are a combination of telmisartan, USP an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, USP a thiazide diuretic. Telmisartan, USP a non-peptide molecule, is chemically described as 4’-[[4-methyl- 6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl] methyl]-2-biphenylcarboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.62, and its structural formula is. Telmisartan, USP is a white or slightly yellowish crystalline powder. It is practically insoluble in water, slightly soluble in methanol, sparingly soluble in methylene chloride and it dissolves in 1M sodium hydroxide. Hydrochlorothiazide, USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is very slightly soluble in water, and freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide, sparingly soluble in methanol; insoluble in ether, in chloroform and dilute mineral acids. Hydrochlorothiazide, USP is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and Hydrochlorothiazide Tablets, USP are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan, USP and hydrochlorothiazide, USP respectively. The tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, povidone K-25, sodium hydroxide, sodium stearyl fumarate and talc. As coloring agents, the 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg tablets contain ferric oxide red, the 80 mg/25 mg tablets also contain ferric oxide yellow. Telmisartan and Hydrochlorothiazide Tablets, USP are hygroscopic and require protection from moisture. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "68999-841-24",
"PackageDescription": "2 TRAY in 1 BOX (68999-841-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-841-45) ",
"NDC11Code": "68999-0841-24",
"ProductNDC": "68999-841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20210921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212428",
"LabelerName": "Chartwell Governmental & Specialty RX, LLC.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251219",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine oral suspension is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.",
"Description": "Oxcarbazepine, USP is an AED available as a 300 mg/5 mL (60 mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo-5 H-dibenz[b, f]azepine-5-carboxamide, and its structural formula is:. Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27 g/mol. Oxcarbazepine Oral Suspension, USP contains the following inactive ingredients: ascorbic acid, artificial yellow plum flavor, macrogol stearate, methylparaben, microcrystalline cellulose/sodium carboxymethyl cellulose, natural and artificial lemon cream flavor, propylene glycol, propylparaben, purified water, sodium saccharin dihydrate, sorbic acid, and sorbitol."
},
{
"NDCCode": "69584-841-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (69584-841-10) ",
"NDC11Code": "69584-0841-10",
"ProductNDC": "69584-841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sotalol Hydrochloride",
"NonProprietaryName": "Sotalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200724",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075563",
"LabelerName": "Oxford Pharmaceuticals, LLC",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Active",
"LastUpdate": "2023-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200724",
"SamplePackage": "N",
"IndicationAndUsage": "Sotalol hydrochloride tablets are an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1) , 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).",
"Description": "Sotalol hydrochloride tablets, USP contain sotalol hydrochloride USP, an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol hydrochloride tablets, USP are supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3S●HCl and is represented by the following structural formula. Sotalol hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, FD&C blue color #2 (aluminum lake, conc.), lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "70512-841-11",
"PackageDescription": "70 BAG in 1 CARTON (70512-841-11) / 100 mL in 1 BAG (70512-841-10) ",
"NDC11Code": "70512-0841-11",
"ProductNDC": "70512-841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207956",
"LabelerName": "SOLA Pharmaceuticals, LLC",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "9",
"StrengthUnit": "g/1000mL",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231220",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.",
"Description": "Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The pH ranges from 4.5 to 7.0. Composition, osmolarity, and ionic concentration are shown below. 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The FLEBOFLEX and FLEBOFLEX LUER plastic containers are fabricated from latex-free polyolefins or polypropylene plastic materials. The solution contact materials do not contain PVC, DEHP, or other plasticizers. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. The suitability of the container materials has been established through biological evaluations, which have shown the containers pass Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container systems."
},
{
"NDCCode": "70512-841-61",
"PackageDescription": "10 BAG in 1 CARTON (70512-841-61) / 1000 mL in 1 BAG (70512-841-60) ",
"NDC11Code": "70512-0841-61",
"ProductNDC": "70512-841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207956",
"LabelerName": "SOLA Pharmaceuticals, LLC",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "9",
"StrengthUnit": "g/1000mL",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231220",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.",
"Description": "Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The pH ranges from 4.5 to 7.0. Composition, osmolarity, and ionic concentration are shown below. 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The FLEBOFLEX and FLEBOFLEX LUER plastic containers are fabricated from latex-free polyolefins or polypropylene plastic materials. The solution contact materials do not contain PVC, DEHP, or other plasticizers. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. The suitability of the container materials has been established through biological evaluations, which have shown the containers pass Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container systems."
},
{
"NDCCode": "76420-841-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (76420-841-10) ",
"NDC11Code": "76420-0841-10",
"ProductNDC": "76420-841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200706",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213324",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240816",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless, crystalline powder with the molecular formula C 20H 21NHCl and a molecular weight of 311.85. It has a melting point between 215°C to 219°C and a pKa of 8.47. It is freely soluble in water, in alcohol, and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-Hexane. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H-Dibenzo[a,d] cyclohepten-5 ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 7.5 mg is supplied as a 7.5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets, USP 5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Cyclobenzaprine hydrochloride tablets, USP 7.5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. Cyclobenzaprine hydrochloride tablets, USP 10 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. FDA approved organic impurities test acceptance criterion differs from the USP organic impurities test acceptance criterion in Cyclobenzaprine Hydrochloride Tablets."
},
{
"NDCCode": "42291-025-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42291-025-10) ",
"NDC11Code": "42291-0025-10",
"ProductNDC": "42291-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076846",
"LabelerName": "AvKARE",
"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": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230622",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension ( 1.1) .",
"Description": "Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its structural formula is. C 20H 25ClN 2O 5C 6H 6O 3S M.W. 567.1. Amlodipine besylate, USP is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as white to off-white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: calcium phosphate dibasic anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "42291-026-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42291-026-10) ",
"NDC11Code": "42291-0026-10",
"ProductNDC": "42291-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076846",
"LabelerName": "AvKARE",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "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": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230622",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension ( 1.1) .",
"Description": "Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its structural formula is. C 20H 25ClN 2O 5C 6H 6O 3S M.W. 567.1. Amlodipine besylate, USP is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as white to off-white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: calcium phosphate dibasic anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "42291-027-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42291-027-10) ",
"NDC11Code": "42291-0027-10",
"ProductNDC": "42291-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076846",
"LabelerName": "AvKARE",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"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": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230622",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension ( 1.1) .",
"Description": "Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its structural formula is. C 20H 25ClN 2O 5C 6H 6O 3S M.W. 567.1. Amlodipine besylate, USP is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as white to off-white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: calcium phosphate dibasic anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "42291-078-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42291-078-10) ",
"NDC11Code": "42291-0078-10",
"ProductNDC": "42291-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe And Simvastatin",
"NonProprietaryName": "Ezetimibe And Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208831",
"LabelerName": "AvKARE",
"SubstanceName": "EZETIMIBE; SIMVASTATIN",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20221004",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.",
"Description": "Ezetimibe and simvastatin tablets contains ezetimibe USP, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C 24H 21F 2NO 3 and its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate."
},
{
"NDCCode": "42291-079-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42291-079-10) ",
"NDC11Code": "42291-0079-10",
"ProductNDC": "42291-079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe And Simvastatin",
"NonProprietaryName": "Ezetimibe And Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221004",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208831",
"LabelerName": "AvKARE",
"SubstanceName": "EZETIMIBE; SIMVASTATIN",
"StrengthNumber": "10; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221004",
"EndMarketingDatePackage": "20260331",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.",
"Description": "Ezetimibe and simvastatin tablets contains ezetimibe USP, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C 24H 21F 2NO 3 and its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate."
},
{
"NDCCode": "42291-080-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42291-080-10) ",
"NDC11Code": "42291-0080-10",
"ProductNDC": "42291-080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe And Simvastatin",
"NonProprietaryName": "Ezetimibe And Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221004",
"EndMarketingDate": "20260430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208831",
"LabelerName": "AvKARE",
"SubstanceName": "EZETIMIBE; SIMVASTATIN",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221004",
"EndMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.",
"Description": "Ezetimibe and simvastatin tablets contains ezetimibe USP, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C 24H 21F 2NO 3 and its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate."
},
{
"NDCCode": "42291-103-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42291-103-10) ",
"NDC11Code": "42291-0103-10",
"ProductNDC": "42291-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetazolamide",
"NonProprietaryName": "Acetazolamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084840",
"LabelerName": "AvKARE",
"SubstanceName": "ACETAZOLAMIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20130910",
"SamplePackage": "N"
},
{
"NDCCode": "42291-110-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-110-10) ",
"NDC11Code": "42291-0110-10",
"ProductNDC": "42291-110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alfuzosin Hydrochloride",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Alfuzosin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120313",
"EndMarketingDate": "20190430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079013",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ALFUZOSIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120313",
"EndMarketingDatePackage": "20190430",
"SamplePackage": "N"
},
{
"NDCCode": "42291-130-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42291-130-10)",
"NDC11Code": "42291-0130-10",
"ProductNDC": "42291-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acarbose",
"NonProprietaryName": "Acarbose",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091343",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ACARBOSE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-01-22"
},
{
"NDCCode": "42291-131-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42291-131-10)",
"NDC11Code": "42291-0131-10",
"ProductNDC": "42291-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acarbose",
"NonProprietaryName": "Acarbose",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091343",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ACARBOSE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-01-22"
},
{
"NDCCode": "42291-132-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42291-132-10)",
"NDC11Code": "42291-0132-10",
"ProductNDC": "42291-132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acarbose",
"NonProprietaryName": "Acarbose",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091343",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ACARBOSE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-01-22"
},
{
"NDCCode": "42291-140-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42291-140-10) ",
"NDC11Code": "42291-0140-10",
"ProductNDC": "42291-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074056",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130617",
"SamplePackage": "N"
},
{
"NDCCode": "42291-141-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42291-141-10) ",
"NDC11Code": "42291-0141-10",
"ProductNDC": "42291-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074056",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130617",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>42291-841-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (42291-841-10) </PackageDescription>
<NDC11Code>42291-0841-10</NDC11Code>
<ProductNDC>42291-841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamterene And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201407</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; TRIAMTERENE</SubstanceName>
<StrengthNumber>25; 37.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17478-841-02</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (17478-841-02) > 2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>17478-0841-02</NDC11Code>
<ProductNDC>17478-841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alfentanil</ProprietaryName>
<NonProprietaryName>Alfentanil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130719</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019353</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>ALFENTANIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17478-841-05</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (17478-841-05) > 5 mL in 1 AMPULE</PackageDescription>
<NDC11Code>17478-0841-05</NDC11Code>
<ProductNDC>17478-841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alfentanil</ProprietaryName>
<NonProprietaryName>Alfentanil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130719</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019353</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>ALFENTANIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17478-841-10</NDCCode>
<PackageDescription>5 AMPULE in 1 CARTON (17478-841-10) > 10 mL in 1 AMPULE</PackageDescription>
<NDC11Code>17478-0841-10</NDC11Code>
<ProductNDC>17478-841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alfentanil</ProprietaryName>
<NonProprietaryName>Alfentanil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130719</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019353</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>ALFENTANIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>23155-841-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (23155-841-10) </PackageDescription>
<NDC11Code>23155-0841-10</NDC11Code>
<ProductNDC>23155-841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230119</StartMarketingDate>
<EndMarketingDate>20270930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213320</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230830</StartMarketingDatePackage>
<EndMarketingDatePackage>20270930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients hypromellose, magnesium stearate, polyethylene glycol/macrogol, povidone and titanium dioxide. Metformin hydrochloride tablets dissolution USP Test-1 is used.</Description>
</NDC>
<NDC>
<NDCCode>25021-841-10</NDCCode>
<PackageDescription>5 AMPULE in 1 CARTON (25021-841-10) / 10 mL in 1 AMPULE</PackageDescription>
<NDC11Code>25021-0841-10</NDC11Code>
<ProductNDC>25021-841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zyogreen</ProprietaryName>
<NonProprietaryName>Indocyanine Green</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTERSTITIAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20260716</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218579</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>INDOCYANINE GREEN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZYOGREEN is an optical imaging agent indicated for: : 1 Fluorescence imaging of vessels (micro- and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures, in adults and pediatric patients (1.1) , 2 Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age and older (1.2) , 3 Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer (1.3) , 4 Ophthalmic angiography in adults and pediatric patients (1.4) .</IndicationAndUsage>
<Description>ZYOGREEN (indocyanine green injection) is an optical imaging agent for intravenous or interstitial use. The chemical name for indocyanine green is 1H-Benz[e]indolium, 2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2H-benz[e]indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-, hydroxide, inner salt, sodium salt. It has a molecular formula of C43H47N2NaO6S2 and a molecular mass of 774.96 g/mol. The structural formula is shown below. Indocyanine green has a peak spectral absorption at 805 nm in blood. ZYOGREEN is a sterile, ready-to-use solution. Each mL contains 2.5 mg of indocyanine green with not more than 0.125 mg sodium iodide and the following inactive ingredients: 1 mg sodium ascorbate and water for injection with a pH between 5.5 and 7.5.</Description>
</NDC>
<NDC>
<NDCCode>46672-841-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (46672-841-10)</PackageDescription>
<NDC11Code>46672-0841-10</NDC11Code>
<ProductNDC>46672-841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111025</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090533</ApplicationNumber>
<LabelerName>Mikart, Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-11-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54864-841-15</NDCCode>
<PackageDescription>10 kg in 1 DRUM (54864-841-15)</PackageDescription>
<NDC11Code>54864-0841-15</NDC11Code>
<ProductNDC>54864-841</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Olaparib</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20170818</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>DOTTIKON EXCLUSIVE SYNTHESIS AG</LabelerName>
<SubstanceName>OLAPARIB</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54864-841-62</NDCCode>
<PackageDescription>10 kg in 1 DRUM (54864-841-62)</PackageDescription>
<NDC11Code>54864-0841-62</NDC11Code>
<ProductNDC>54864-841</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Olaparib</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20170818</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>DOTTIKON EXCLUSIVE SYNTHESIS AG</LabelerName>
<SubstanceName>OLAPARIB</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62559-841-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (62559-841-10) </PackageDescription>
<NDC11Code>62559-0841-10</NDC11Code>
<ProductNDC>62559-841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211227</StartMarketingDate>
<EndMarketingDate>20241031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084657</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211227</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.</IndicationAndUsage>
<Description>Meclizine hydrochloride USP, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. It has the following structural formula. Chemically, meclizine hydrochloride USP is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Meclizine Hydrochloride Tablets USP contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, hydrogenated vegetable oil, sodium starch glycolate, and magnesium stearate. The 12.5 mg tablets also contain: FD&C Blue # 1 aluminum lake. The 25 mg tablets also contain: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base.</Description>
</NDC>
<NDC>
<NDCCode>65601-841-10</NDCCode>
<PackageDescription>1100 mL in 1 BAG (65601-841-10) </PackageDescription>
<NDC11Code>65601-0841-10</NDC11Code>
<ProductNDC>65601-841</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Lotions Skin Cleanser</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Betco Corporation, Ltd.</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Antibacterial hand cleaner. . Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68462-841-13</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68462-841-13) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68462-0841-13</NDC11Code>
<ProductNDC>68462-841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202544</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>TELMISARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>80; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Telmisartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy [see Clinical Studies (14)]. Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy for the treatment of hypertension [see Dosage and Administration (2.1)]. Telmisartan and hydrochlorothiazide tablets may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Telmisartan and Hydrochlorothiazide Tablets, USP are a combination of telmisartan, USP an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, USP a thiazide diuretic. Telmisartan, USP a non-peptide molecule, is chemically described as 4’-[[4-methyl- 6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl] methyl]-2-biphenylcarboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.62, and its structural formula is. Telmisartan, USP is a white or slightly yellowish crystalline powder. It is practically insoluble in water, slightly soluble in methanol, sparingly soluble in methylene chloride and it dissolves in 1M sodium hydroxide. Hydrochlorothiazide, USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is very slightly soluble in water, and freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide, sparingly soluble in methanol; insoluble in ether, in chloroform and dilute mineral acids. Hydrochlorothiazide, USP is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and Hydrochlorothiazide Tablets, USP are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan, USP and hydrochlorothiazide, USP respectively. The tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, povidone K-25, sodium hydroxide, sodium stearyl fumarate and talc. As coloring agents, the 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg tablets contain ferric oxide red, the 80 mg/25 mg tablets also contain ferric oxide yellow. Telmisartan and Hydrochlorothiazide Tablets, USP are hygroscopic and require protection from moisture. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>68999-841-24</NDCCode>
<PackageDescription>2 TRAY in 1 BOX (68999-841-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-841-45) </PackageDescription>
<NDC11Code>68999-0841-24</NDC11Code>
<ProductNDC>68999-841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212428</ApplicationNumber>
<LabelerName>Chartwell Governmental & Specialty RX, LLC.</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxcarbazepine oral suspension is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.</IndicationAndUsage>
<Description>Oxcarbazepine, USP is an AED available as a 300 mg/5 mL (60 mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo-5 H-dibenz[b, f]azepine-5-carboxamide, and its structural formula is:. Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27 g/mol. Oxcarbazepine Oral Suspension, USP contains the following inactive ingredients: ascorbic acid, artificial yellow plum flavor, macrogol stearate, methylparaben, microcrystalline cellulose/sodium carboxymethyl cellulose, natural and artificial lemon cream flavor, propylene glycol, propylparaben, purified water, sodium saccharin dihydrate, sorbic acid, and sorbitol.</Description>
</NDC>
<NDC>
<NDCCode>69584-841-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (69584-841-10) </PackageDescription>
<NDC11Code>69584-0841-10</NDC11Code>
<ProductNDC>69584-841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sotalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200724</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075563</ApplicationNumber>
<LabelerName>Oxford Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sotalol hydrochloride tablets are an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1) , 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).</IndicationAndUsage>
<Description>Sotalol hydrochloride tablets, USP contain sotalol hydrochloride USP, an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol hydrochloride tablets, USP are supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3S●HCl and is represented by the following structural formula. Sotalol hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, FD&C blue color #2 (aluminum lake, conc.), lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>70512-841-11</NDCCode>
<PackageDescription>70 BAG in 1 CARTON (70512-841-11) / 100 mL in 1 BAG (70512-841-10) </PackageDescription>
<NDC11Code>70512-0841-11</NDC11Code>
<ProductNDC>70512-841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207956</ApplicationNumber>
<LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>g/1000mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.</IndicationAndUsage>
<Description>Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The pH ranges from 4.5 to 7.0. Composition, osmolarity, and ionic concentration are shown below. 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The FLEBOFLEX and FLEBOFLEX LUER plastic containers are fabricated from latex-free polyolefins or polypropylene plastic materials. The solution contact materials do not contain PVC, DEHP, or other plasticizers. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. The suitability of the container materials has been established through biological evaluations, which have shown the containers pass Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container systems.</Description>
</NDC>
<NDC>
<NDCCode>70512-841-61</NDCCode>
<PackageDescription>10 BAG in 1 CARTON (70512-841-61) / 1000 mL in 1 BAG (70512-841-60) </PackageDescription>
<NDC11Code>70512-0841-61</NDC11Code>
<ProductNDC>70512-841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207956</ApplicationNumber>
<LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>g/1000mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.</IndicationAndUsage>
<Description>Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The pH ranges from 4.5 to 7.0. Composition, osmolarity, and ionic concentration are shown below. 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The FLEBOFLEX and FLEBOFLEX LUER plastic containers are fabricated from latex-free polyolefins or polypropylene plastic materials. The solution contact materials do not contain PVC, DEHP, or other plasticizers. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. The suitability of the container materials has been established through biological evaluations, which have shown the containers pass Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container systems.</Description>
</NDC>
<NDC>
<NDCCode>76420-841-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (76420-841-10) </PackageDescription>
<NDC11Code>76420-0841-10</NDC11Code>
<ProductNDC>76420-841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200706</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213324</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless, crystalline powder with the molecular formula C 20H 21NHCl and a molecular weight of 311.85. It has a melting point between 215°C to 219°C and a pKa of 8.47. It is freely soluble in water, in alcohol, and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-Hexane. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H-Dibenzo[a,d] cyclohepten-5 ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 7.5 mg is supplied as a 7.5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets, USP 5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Cyclobenzaprine hydrochloride tablets, USP 7.5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. Cyclobenzaprine hydrochloride tablets, USP 10 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. FDA approved organic impurities test acceptance criterion differs from the USP organic impurities test acceptance criterion in Cyclobenzaprine Hydrochloride Tablets.</Description>
</NDC>
<NDC>
<NDCCode>42291-025-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42291-025-10) </PackageDescription>
<NDC11Code>42291-0025-10</NDC11Code>
<ProductNDC>42291-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076846</ApplicationNumber>
<LabelerName>AvKARE</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>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension ( 1.1) .</IndicationAndUsage>
<Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its structural formula is. C 20H 25ClN 2O 5C 6H 6O 3S M.W. 567.1. Amlodipine besylate, USP is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as white to off-white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: calcium phosphate dibasic anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>42291-026-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42291-026-10) </PackageDescription>
<NDC11Code>42291-0026-10</NDC11Code>
<ProductNDC>42291-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076846</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>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>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension ( 1.1) .</IndicationAndUsage>
<Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its structural formula is. C 20H 25ClN 2O 5C 6H 6O 3S M.W. 567.1. Amlodipine besylate, USP is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as white to off-white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: calcium phosphate dibasic anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>42291-027-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42291-027-10) </PackageDescription>
<NDC11Code>42291-0027-10</NDC11Code>
<ProductNDC>42291-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076846</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</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>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension ( 1.1) .</IndicationAndUsage>
<Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its structural formula is. C 20H 25ClN 2O 5C 6H 6O 3S M.W. 567.1. Amlodipine besylate, USP is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as white to off-white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: calcium phosphate dibasic anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>42291-078-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42291-078-10) </PackageDescription>
<NDC11Code>42291-0078-10</NDC11Code>
<ProductNDC>42291-078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
<NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208831</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>Ezetimibe and simvastatin tablets contains ezetimibe USP, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C 24H 21F 2NO 3 and its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
</NDC>
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<NDCCode>42291-079-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42291-079-10) </PackageDescription>
<NDC11Code>42291-0079-10</NDC11Code>
<ProductNDC>42291-079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
<NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
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<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208831</ApplicationNumber>
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<SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
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<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-01</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>Ezetimibe and simvastatin tablets contains ezetimibe USP, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C 24H 21F 2NO 3 and its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
</NDC>
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<PackageDescription>1000 TABLET in 1 BOTTLE (42291-080-10) </PackageDescription>
<NDC11Code>42291-0080-10</NDC11Code>
<ProductNDC>42291-080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
<NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221004</StartMarketingDate>
<EndMarketingDate>20260430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208831</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221004</StartMarketingDatePackage>
<EndMarketingDatePackage>20260430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>Ezetimibe and simvastatin tablets contains ezetimibe USP, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C 24H 21F 2NO 3 and its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
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<NDC>
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<NDC11Code>42291-0103-10</NDC11Code>
<ProductNDC>42291-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetazolamide</ProprietaryName>
<NonProprietaryName>Acetazolamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084840</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ACETAZOLAMIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>42291-110-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-110-10) </PackageDescription>
<NDC11Code>42291-0110-10</NDC11Code>
<ProductNDC>42291-110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alfuzosin Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Alfuzosin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120313</StartMarketingDate>
<EndMarketingDate>20190430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079013</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ALFUZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120313</StartMarketingDatePackage>
<EndMarketingDatePackage>20190430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>42291-130-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42291-130-10)</PackageDescription>
<NDC11Code>42291-0130-10</NDC11Code>
<ProductNDC>42291-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acarbose</ProprietaryName>
<NonProprietaryName>Acarbose</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091343</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ACARBOSE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>42291-131-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42291-131-10)</PackageDescription>
<NDC11Code>42291-0131-10</NDC11Code>
<ProductNDC>42291-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acarbose</ProprietaryName>
<NonProprietaryName>Acarbose</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091343</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ACARBOSE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>42291-132-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42291-132-10)</PackageDescription>
<NDC11Code>42291-0132-10</NDC11Code>
<ProductNDC>42291-132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acarbose</ProprietaryName>
<NonProprietaryName>Acarbose</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091343</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ACARBOSE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>42291-140-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42291-140-10) </PackageDescription>
<NDC11Code>42291-0140-10</NDC11Code>
<ProductNDC>42291-140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074056</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>1000 TABLET in 1 BOTTLE (42291-141-10) </PackageDescription>
<NDC11Code>42291-0141-10</NDC11Code>
<ProductNDC>42291-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074056</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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