{
"NDC": [
{
"NDCCode": "68382-536-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-536-05) ",
"NDC11Code": "68382-0536-05",
"ProductNDC": "68382-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203546",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "5",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140812",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium citrate extended-release tablet is a citrate salt of potassium indicated for the management of: : 1 Renal tubular acidosis (RTA) with calcium stones (1.1) , 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).",
"Description": "Potassium citrate is a citrate salt of potassium. Its molecular formula is K3C6H5O7 H2O, and it has the following chemical structure. Potassium citrate, USP is a transparent crystals or white, granular powder. It is freely soluble in water and slightly soluble in alcohol. Potassium citrate extended-release tablets, USP intended for oral administration, each contains 5 mEq (540 mg), 10 mEq (1,080 mg) or 15 mEq (1,620 mg) of potassium citrate, USP as monohydrate. In addition, each tablet contains the following inactive ingredients: carnauba wax and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "68382-536-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-536-01) ",
"NDC11Code": "68382-0536-01",
"ProductNDC": "68382-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203546",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "5",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140812",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium citrate extended-release tablet is a citrate salt of potassium indicated for the management of: : 1 Renal tubular acidosis (RTA) with calcium stones (1.1) , 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).",
"Description": "Potassium citrate is a citrate salt of potassium. Its molecular formula is K3C6H5O7 H2O, and it has the following chemical structure. Potassium citrate, USP is a transparent crystals or white, granular powder. It is freely soluble in water and slightly soluble in alcohol. Potassium citrate extended-release tablets, USP intended for oral administration, each contains 5 mEq (540 mg), 10 mEq (1,080 mg) or 15 mEq (1,620 mg) of potassium citrate, USP as monohydrate. In addition, each tablet contains the following inactive ingredients: carnauba wax and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "68382-536-06",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-536-06) ",
"NDC11Code": "68382-0536-06",
"ProductNDC": "68382-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203546",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "5",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140812",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium citrate extended-release tablet is a citrate salt of potassium indicated for the management of: : 1 Renal tubular acidosis (RTA) with calcium stones (1.1) , 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).",
"Description": "Potassium citrate is a citrate salt of potassium. Its molecular formula is K3C6H5O7 H2O, and it has the following chemical structure. Potassium citrate, USP is a transparent crystals or white, granular powder. It is freely soluble in water and slightly soluble in alcohol. Potassium citrate extended-release tablets, USP intended for oral administration, each contains 5 mEq (540 mg), 10 mEq (1,080 mg) or 15 mEq (1,620 mg) of potassium citrate, USP as monohydrate. In addition, each tablet contains the following inactive ingredients: carnauba wax and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "68382-536-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-536-10) ",
"NDC11Code": "68382-0536-10",
"ProductNDC": "68382-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203546",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "5",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140812",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium citrate extended-release tablet is a citrate salt of potassium indicated for the management of: : 1 Renal tubular acidosis (RTA) with calcium stones (1.1) , 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).",
"Description": "Potassium citrate is a citrate salt of potassium. Its molecular formula is K3C6H5O7 H2O, and it has the following chemical structure. Potassium citrate, USP is a transparent crystals or white, granular powder. It is freely soluble in water and slightly soluble in alcohol. Potassium citrate extended-release tablets, USP intended for oral administration, each contains 5 mEq (540 mg), 10 mEq (1,080 mg) or 15 mEq (1,620 mg) of potassium citrate, USP as monohydrate. In addition, each tablet contains the following inactive ingredients: carnauba wax and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "68382-536-16",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-536-16) ",
"NDC11Code": "68382-0536-16",
"ProductNDC": "68382-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203546",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "5",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140812",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium citrate extended-release tablet is a citrate salt of potassium indicated for the management of: : 1 Renal tubular acidosis (RTA) with calcium stones (1.1) , 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).",
"Description": "Potassium citrate is a citrate salt of potassium. Its molecular formula is K3C6H5O7 H2O, and it has the following chemical structure. Potassium citrate, USP is a transparent crystals or white, granular powder. It is freely soluble in water and slightly soluble in alcohol. Potassium citrate extended-release tablets, USP intended for oral administration, each contains 5 mEq (540 mg), 10 mEq (1,080 mg) or 15 mEq (1,620 mg) of potassium citrate, USP as monohydrate. In addition, each tablet contains the following inactive ingredients: carnauba wax and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "68382-536-30",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68382-536-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "68382-0536-30",
"ProductNDC": "68382-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203546",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "5",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140812",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium citrate extended-release tablet is a citrate salt of potassium indicated for the management of: : 1 Renal tubular acidosis (RTA) with calcium stones (1.1) , 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).",
"Description": "Potassium citrate is a citrate salt of potassium. Its molecular formula is K3C6H5O7 H2O, and it has the following chemical structure. Potassium citrate, USP is a transparent crystals or white, granular powder. It is freely soluble in water and slightly soluble in alcohol. Potassium citrate extended-release tablets, USP intended for oral administration, each contains 5 mEq (540 mg), 10 mEq (1,080 mg) or 15 mEq (1,620 mg) of potassium citrate, USP as monohydrate. In addition, each tablet contains the following inactive ingredients: carnauba wax and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "31722-536-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (31722-536-05) ",
"NDC11Code": "31722-0536-05",
"ProductNDC": "31722-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090515",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101008",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4."
},
{
"NDCCode": "43598-536-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-536-05) ",
"NDC11Code": "43598-0536-05",
"ProductNDC": "43598-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Sr",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205794",
"LabelerName": "Dr. Reddy�s Laboratories Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-12-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160801",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].",
"Description": "Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, powder, soluble in 0.1N HCl, alcohol 96% and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: copovidone, cysteine hydrochloride,hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,polysorbate 80 and titanium dioxide.In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP Dissolution Test 2."
},
{
"NDCCode": "47781-536-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-536-05) ",
"NDC11Code": "47781-0536-05",
"ProductNDC": "47781-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204984",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170130",
"SamplePackage": "N"
},
{
"NDCCode": "53489-536-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (53489-536-05)",
"NDC11Code": "53489-0536-05",
"ProductNDC": "53489-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074499",
"LabelerName": "Mutual Pharmaceutical Company, Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Atenolol is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol may be administered with other antihypertensive agents.",
"Description": "Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol is available as 25 mg, 50 mg, and 100 mg tablets for oral administration. Inactive ingredients are: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."
},
{
"NDCCode": "63304-536-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (63304-536-05)",
"NDC11Code": "63304-0536-05",
"ProductNDC": "63304-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril And Hydrochlorothiazide",
"NonProprietaryName": "Lisinopril And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076007",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "LISINOPRIL; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "10; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Lisinopril and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets, USP, consideration should be given to the fact that an angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk (See WARNINGS). In considering the use of lisinopril and hydrochlorothiazide tablets, USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients (see WARNINGS, Lisinopril).",
"Description": "Lisinopril and hydrochlorothiazide tablets, USP combine an angiotensin converting enzyme inhibitor, lisinopril, USP, and a diuretic, hydrochlorothiazide, USP. Lisinopril, USP, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its molecular formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril, USP is a white crystalline powder, with a molecular weight of 441.52. It is soluble in water and sparingly soluble in methanol and practically insoluble in alcohol, in acetone, in acetonitrile and in chloroform. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Lisinopril and hydrochlorothiazide is available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 containing 10 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; lisinopril and hydrochlorothiazide tablets, USP 20-12.5 containing 20 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; and, lisinopril and hydrochlorothiazide tablets, USP 20-25 containing 20 mg lisinopril, USP and 25 mg hydrochlorothiazide, USP. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch, and starch (corn). Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 mg also contain FD&C blue #2 aluminum lake. Lisinopril and hydrochlorothiazide tablets, USP 20-12.5 mg contain yellow iron oxide. Lisinopril and hydrochlorothiazide tablets, USP 20-25 mg contain yellow and red iron oxide."
},
{
"NDCCode": "65841-536-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-536-05) ",
"NDC11Code": "65841-0536-05",
"ProductNDC": "65841-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203546",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "5",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140812",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium citrate extended-release tablet is a citrate salt of potassium indicated for the management of: : 1 Renal tubular acidosis (RTA) with calcium stones (1.1) , 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).",
"Description": "Potassium citrate is a citrate salt of potassium. Its molecular formula is K3C6H5O7 H2O, and it has the following chemical structure. Potassium citrate, USP is a transparent crystals or white, granular powder. It is freely soluble in water and slightly soluble in alcohol. Potassium citrate extended-release tablets, USP intended for oral administration, each contains 5 mEq (540 mg), 10 mEq (1,080 mg) or 15 mEq (1,620 mg) of potassium citrate, USP as monohydrate. In addition, each tablet contains the following inactive ingredients: carnauba wax and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "68428-536-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-536-05) ",
"NDC11Code": "68428-0536-05",
"ProductNDC": "68428-536",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nux Moschata",
"NonProprietaryName": "Nutmeg",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "NUTMEG",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "84756-536-05",
"PackageDescription": "100 mL in 1 BOTTLE (84756-536-05) ",
"NDC11Code": "84756-0536-05",
"ProductNDC": "84756-536",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "100% Pure Natural Jojoba Oil",
"NonProprietaryName": "100% Pure Natural Jojoba Oil",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Yucheng E Commerce Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84827-536-05",
"PackageDescription": "100 mL in 1 BOTTLE (84827-536-05) ",
"NDC11Code": "84827-0536-05",
"ProductNDC": "84827-536",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Crocodile Repair Serum",
"NonProprietaryName": "Trstay Crocodile Repair Serum",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Luoxin E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "68382-001-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68382-001-05) ",
"NDC11Code": "68382-0001-05",
"ProductNDC": "68382-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077584",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070413",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine tablets, USP contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120°C to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water. Paroxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "68382-003-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (68382-003-05) ",
"NDC11Code": "68382-0003-05",
"ProductNDC": "68382-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azathioprine",
"NonProprietaryName": "Azathioprine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077621",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "AZATHIOPRINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleosides [CS], Purine Antimetabolite [EPC], Purines [CS]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070711",
"SamplePackage": "N",
"IndicationAndUsage": "Azathioprine tablets, USP are indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms.",
"Description": "Azathioprine is an immunosuppressive antimetabolite. Each uncoated azathioprine tablet intended for oral administration contains 25 mg or 50 mg or 75 mg or 100 mg of azathioprine. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and starch. Azathioprine is chemically 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine. The structural formula of azathioprine is. It is an imidazolyl derivative of 6-mercaptopurine and many of its biological effects are similar to those of the parent compound. Azathioprine, USP is a pale yellow, odorless powder. It is insoluble in water, soluble in dilute solutions of alkali hydroxides, sparingly soluble in dilute mineral acids, very slightly soluble in alcohol and in chloroform. The sodium salt of azathioprine is sufficiently soluble to make a 10 mg/mL water solution which is stable for 24 hours at 59° to 77°F (15° to 25°C). Azathioprine is stable in solution at neutral or acid pH but hydrolysis to mercaptopurine occurs in excess sodium hydroxide (0.1N), especially on warming. Conversion to mercaptopurine also occurs in the presence of sulfhydryl compounds such as cysteine, glutathione, and hydrogen sulfide."
},
{
"NDCCode": "68382-004-05",
"PackageDescription": "500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-05) ",
"NDC11Code": "68382-0004-05",
"ProductNDC": "68382-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20091014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078877",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091014",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white crystalline powder with bitter taste. It is freely soluble in dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Each topiramate tablet,USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 200 mg of topiramate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Each topiramate capsule, USP intended for oral administration contains 15 mg or 25 mg or 50 mg of topiramate. In addition, each capsule contains the following inactive ingredients: cellulose acetate, gelatin, hypromellose, povidone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and water. Each capsule is printed with black pharmaceutical ink and contains the following inactive ingredients: shellac, propylene glycol, black iron oxide and potassium hydroxide. Topiramate Capsules, USP meet USP dissolution test 2."
},
{
"NDCCode": "68382-005-05",
"PackageDescription": "500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-005-05) ",
"NDC11Code": "68382-0005-05",
"ProductNDC": "68382-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20091014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078877",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091014",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white crystalline powder with bitter taste. It is freely soluble in dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Each topiramate tablet,USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 200 mg of topiramate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Each topiramate capsule, USP intended for oral administration contains 15 mg or 25 mg or 50 mg of topiramate. In addition, each capsule contains the following inactive ingredients: cellulose acetate, gelatin, hypromellose, povidone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and water. Each capsule is printed with black pharmaceutical ink and contains the following inactive ingredients: shellac, propylene glycol, black iron oxide and potassium hydroxide. Topiramate Capsules, USP meet USP dissolution test 2."
},
{
"NDCCode": "68382-006-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (68382-006-05) ",
"NDC11Code": "68382-0006-05",
"ProductNDC": "68382-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077633",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090127",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Each lamotrigine tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 150 mg or 200 mg or 250 mg of lamotrigine. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Each lamotrigine tablets for oral suspension, USP intended for oral administration contains 5 mg or 25 mg of amotrigine. In addition, each tablet contains the following inactive ingredients: aspartame, croscarmellose sodium, flavour black currant, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide and tribasic calcium phosphate. Lamotrigine tablets, USP comply with USP Dissolution Test 3. Lamotrigine Tablets for Oral Suspension, USP comply with Organic Impurities Procedure 2."
},
{
"NDCCode": "68382-007-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (68382-007-05) ",
"NDC11Code": "68382-0007-05",
"ProductNDC": "68382-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077633",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090127",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Each lamotrigine tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 150 mg or 200 mg or 250 mg of lamotrigine. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Each lamotrigine tablets for oral suspension, USP intended for oral administration contains 5 mg or 25 mg of amotrigine. In addition, each tablet contains the following inactive ingredients: aspartame, croscarmellose sodium, flavour black currant, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide and tribasic calcium phosphate. Lamotrigine tablets, USP comply with USP Dissolution Test 3. Lamotrigine Tablets for Oral Suspension, USP comply with Organic Impurities Procedure 2."
},
{
"NDCCode": "68382-008-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (68382-008-05) ",
"NDC11Code": "68382-0008-05",
"ProductNDC": "68382-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077633",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090127",
"SamplePackage": "N",
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"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Each lamotrigine tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 150 mg or 200 mg or 250 mg of lamotrigine. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Each lamotrigine tablets for oral suspension, USP intended for oral administration contains 5 mg or 25 mg of amotrigine. In addition, each tablet contains the following inactive ingredients: aspartame, croscarmellose sodium, flavour black currant, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide and tribasic calcium phosphate. Lamotrigine tablets, USP comply with USP Dissolution Test 3. Lamotrigine Tablets for Oral Suspension, USP comply with Organic Impurities Procedure 2."
},
{
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"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Each lamotrigine tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 150 mg or 200 mg or 250 mg of lamotrigine. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Each lamotrigine tablets for oral suspension, USP intended for oral administration contains 5 mg or 25 mg of amotrigine. In addition, each tablet contains the following inactive ingredients: aspartame, croscarmellose sodium, flavour black currant, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide and tribasic calcium phosphate. Lamotrigine tablets, USP comply with USP Dissolution Test 3. Lamotrigine Tablets for Oral Suspension, USP comply with Organic Impurities Procedure 2."
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"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Each lamotrigine tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 150 mg or 200 mg or 250 mg of lamotrigine. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Each lamotrigine tablets for oral suspension, USP intended for oral administration contains 5 mg or 25 mg of amotrigine. In addition, each tablet contains the following inactive ingredients: aspartame, croscarmellose sodium, flavour black currant, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide and tribasic calcium phosphate. Lamotrigine tablets, USP comply with USP Dissolution Test 3. Lamotrigine Tablets for Oral Suspension, USP comply with Organic Impurities Procedure 2."
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{
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"PackageDescription": "500 TABLET in 1 BOTTLE (68382-011-05) ",
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"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Each lamotrigine tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 150 mg or 200 mg or 250 mg of lamotrigine. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Each lamotrigine tablets for oral suspension, USP intended for oral administration contains 5 mg or 25 mg of amotrigine. In addition, each tablet contains the following inactive ingredients: aspartame, croscarmellose sodium, flavour black currant, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide and tribasic calcium phosphate. Lamotrigine tablets, USP comply with USP Dissolution Test 3. Lamotrigine Tablets for Oral Suspension, USP comply with Organic Impurities Procedure 2."
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{
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{
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{
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{
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<ProductNDC>68382-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Citrate</ProprietaryName>
<NonProprietaryName>Potassium Citrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140812</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203546</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>POTASSIUM CITRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium citrate extended-release tablet is a citrate salt of potassium indicated for the management of: : 1 Renal tubular acidosis (RTA) with calcium stones (1.1) , 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).</IndicationAndUsage>
<Description>Potassium citrate is a citrate salt of potassium. Its molecular formula is K3C6H5O7 H2O, and it has the following chemical structure. Potassium citrate, USP is a transparent crystals or white, granular powder. It is freely soluble in water and slightly soluble in alcohol. Potassium citrate extended-release tablets, USP intended for oral administration, each contains 5 mEq (540 mg), 10 mEq (1,080 mg) or 15 mEq (1,620 mg) of potassium citrate, USP as monohydrate. In addition, each tablet contains the following inactive ingredients: carnauba wax and magnesium stearate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68382-536-30</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68382-536-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68382-0536-30</NDC11Code>
<ProductNDC>68382-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Citrate</ProprietaryName>
<NonProprietaryName>Potassium Citrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140812</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203546</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>POTASSIUM CITRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium citrate extended-release tablet is a citrate salt of potassium indicated for the management of: : 1 Renal tubular acidosis (RTA) with calcium stones (1.1) , 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).</IndicationAndUsage>
<Description>Potassium citrate is a citrate salt of potassium. Its molecular formula is K3C6H5O7 H2O, and it has the following chemical structure. Potassium citrate, USP is a transparent crystals or white, granular powder. It is freely soluble in water and slightly soluble in alcohol. Potassium citrate extended-release tablets, USP intended for oral administration, each contains 5 mEq (540 mg), 10 mEq (1,080 mg) or 15 mEq (1,620 mg) of potassium citrate, USP as monohydrate. In addition, each tablet contains the following inactive ingredients: carnauba wax and magnesium stearate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>31722-536-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (31722-536-05) </PackageDescription>
<NDC11Code>31722-0536-05</NDC11Code>
<ProductNDC>31722-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090515</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4.</Description>
</NDC>
<NDC>
<NDCCode>43598-536-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-536-05) </PackageDescription>
<NDC11Code>43598-0536-05</NDC11Code>
<ProductNDC>43598-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Sr</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205794</ApplicationNumber>
<LabelerName>Dr. Reddy�s Laboratories Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, powder, soluble in 0.1N HCl, alcohol 96% and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: copovidone, cysteine hydrochloride,hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,polysorbate 80 and titanium dioxide.In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>47781-536-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-536-05) </PackageDescription>
<NDC11Code>47781-0536-05</NDC11Code>
<ProductNDC>47781-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen, And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen, And Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204984</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53489-536-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (53489-536-05)</PackageDescription>
<NDC11Code>53489-0536-05</NDC11Code>
<ProductNDC>53489-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074499</ApplicationNumber>
<LabelerName>Mutual Pharmaceutical Company, 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>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atenolol is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol is available as 25 mg, 50 mg, and 100 mg tablets for oral administration. Inactive ingredients are: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>63304-536-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (63304-536-05)</PackageDescription>
<NDC11Code>63304-0536-05</NDC11Code>
<ProductNDC>63304-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076007</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LISINOPRIL; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>10; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lisinopril and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets, USP, consideration should be given to the fact that an angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk (See WARNINGS). In considering the use of lisinopril and hydrochlorothiazide tablets, USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients (see WARNINGS, Lisinopril).</IndicationAndUsage>
<Description>Lisinopril and hydrochlorothiazide tablets, USP combine an angiotensin converting enzyme inhibitor, lisinopril, USP, and a diuretic, hydrochlorothiazide, USP. Lisinopril, USP, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its molecular formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril, USP is a white crystalline powder, with a molecular weight of 441.52. It is soluble in water and sparingly soluble in methanol and practically insoluble in alcohol, in acetone, in acetonitrile and in chloroform. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Lisinopril and hydrochlorothiazide is available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 containing 10 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; lisinopril and hydrochlorothiazide tablets, USP 20-12.5 containing 20 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; and, lisinopril and hydrochlorothiazide tablets, USP 20-25 containing 20 mg lisinopril, USP and 25 mg hydrochlorothiazide, USP. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch, and starch (corn). Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 mg also contain FD&C blue #2 aluminum lake. Lisinopril and hydrochlorothiazide tablets, USP 20-12.5 mg contain yellow iron oxide. Lisinopril and hydrochlorothiazide tablets, USP 20-25 mg contain yellow and red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>65841-536-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-536-05) </PackageDescription>
<NDC11Code>65841-0536-05</NDC11Code>
<ProductNDC>65841-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Citrate</ProprietaryName>
<NonProprietaryName>Potassium Citrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140812</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203546</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>POTASSIUM CITRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium citrate extended-release tablet is a citrate salt of potassium indicated for the management of: : 1 Renal tubular acidosis (RTA) with calcium stones (1.1) , 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).</IndicationAndUsage>
<Description>Potassium citrate is a citrate salt of potassium. Its molecular formula is K3C6H5O7 H2O, and it has the following chemical structure. Potassium citrate, USP is a transparent crystals or white, granular powder. It is freely soluble in water and slightly soluble in alcohol. Potassium citrate extended-release tablets, USP intended for oral administration, each contains 5 mEq (540 mg), 10 mEq (1,080 mg) or 15 mEq (1,620 mg) of potassium citrate, USP as monohydrate. In addition, each tablet contains the following inactive ingredients: carnauba wax and magnesium stearate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68428-536-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-536-05) </PackageDescription>
<NDC11Code>68428-0536-05</NDC11Code>
<ProductNDC>68428-536</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nux Moschata</ProprietaryName>
<NonProprietaryName>Nutmeg</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>NUTMEG</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84756-536-05</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (84756-536-05) </PackageDescription>
<NDC11Code>84756-0536-05</NDC11Code>
<ProductNDC>84756-536</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>100% Pure Natural Jojoba Oil</ProprietaryName>
<NonProprietaryName>100% Pure Natural Jojoba Oil</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yiwu Yucheng E Commerce Co Ltd</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84827-536-05</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (84827-536-05) </PackageDescription>
<NDC11Code>84827-0536-05</NDC11Code>
<ProductNDC>84827-536</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Crocodile Repair Serum</ProprietaryName>
<NonProprietaryName>Trstay Crocodile Repair Serum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Luoxin E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68382-001-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68382-001-05) </PackageDescription>
<NDC11Code>68382-0001-05</NDC11Code>
<ProductNDC>68382-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077584</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine tablets, USP contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120°C to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water. Paroxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68382-003-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (68382-003-05) </PackageDescription>
<NDC11Code>68382-0003-05</NDC11Code>
<ProductNDC>68382-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azathioprine</ProprietaryName>
<NonProprietaryName>Azathioprine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077621</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>AZATHIOPRINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleosides [CS], Purine Antimetabolite [EPC], Purines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azathioprine tablets, USP are indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms.</IndicationAndUsage>
<Description>Azathioprine is an immunosuppressive antimetabolite. Each uncoated azathioprine tablet intended for oral administration contains 25 mg or 50 mg or 75 mg or 100 mg of azathioprine. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and starch. Azathioprine is chemically 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine. The structural formula of azathioprine is. It is an imidazolyl derivative of 6-mercaptopurine and many of its biological effects are similar to those of the parent compound. Azathioprine, USP is a pale yellow, odorless powder. It is insoluble in water, soluble in dilute solutions of alkali hydroxides, sparingly soluble in dilute mineral acids, very slightly soluble in alcohol and in chloroform. The sodium salt of azathioprine is sufficiently soluble to make a 10 mg/mL water solution which is stable for 24 hours at 59° to 77°F (15° to 25°C). Azathioprine is stable in solution at neutral or acid pH but hydrolysis to mercaptopurine occurs in excess sodium hydroxide (0.1N), especially on warming. Conversion to mercaptopurine also occurs in the presence of sulfhydryl compounds such as cysteine, glutathione, and hydrogen sulfide.</Description>
</NDC>
<NDC>
<NDCCode>68382-004-05</NDCCode>
<PackageDescription>500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-004-05) </PackageDescription>
<NDC11Code>68382-0004-05</NDC11Code>
<ProductNDC>68382-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078877</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white crystalline powder with bitter taste. It is freely soluble in dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Each topiramate tablet,USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 200 mg of topiramate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Each topiramate capsule, USP intended for oral administration contains 15 mg or 25 mg or 50 mg of topiramate. In addition, each capsule contains the following inactive ingredients: cellulose acetate, gelatin, hypromellose, povidone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and water. Each capsule is printed with black pharmaceutical ink and contains the following inactive ingredients: shellac, propylene glycol, black iron oxide and potassium hydroxide. Topiramate Capsules, USP meet USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>68382-005-05</NDCCode>
<PackageDescription>500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-005-05) </PackageDescription>
<NDC11Code>68382-0005-05</NDC11Code>
<ProductNDC>68382-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078877</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white crystalline powder with bitter taste. It is freely soluble in dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Each topiramate tablet,USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 200 mg of topiramate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Each topiramate capsule, USP intended for oral administration contains 15 mg or 25 mg or 50 mg of topiramate. In addition, each capsule contains the following inactive ingredients: cellulose acetate, gelatin, hypromellose, povidone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and water. Each capsule is printed with black pharmaceutical ink and contains the following inactive ingredients: shellac, propylene glycol, black iron oxide and potassium hydroxide. Topiramate Capsules, USP meet USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>68382-006-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (68382-006-05) </PackageDescription>
<NDC11Code>68382-0006-05</NDC11Code>
<ProductNDC>68382-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077633</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Each lamotrigine tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 150 mg or 200 mg or 250 mg of lamotrigine. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Each lamotrigine tablets for oral suspension, USP intended for oral administration contains 5 mg or 25 mg of amotrigine. In addition, each tablet contains the following inactive ingredients: aspartame, croscarmellose sodium, flavour black currant, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide and tribasic calcium phosphate. Lamotrigine tablets, USP comply with USP Dissolution Test 3. Lamotrigine Tablets for Oral Suspension, USP comply with Organic Impurities Procedure 2.</Description>
</NDC>
<NDC>
<NDCCode>68382-007-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (68382-007-05) </PackageDescription>
<NDC11Code>68382-0007-05</NDC11Code>
<ProductNDC>68382-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077633</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Each lamotrigine tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 150 mg or 200 mg or 250 mg of lamotrigine. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Each lamotrigine tablets for oral suspension, USP intended for oral administration contains 5 mg or 25 mg of amotrigine. In addition, each tablet contains the following inactive ingredients: aspartame, croscarmellose sodium, flavour black currant, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide and tribasic calcium phosphate. Lamotrigine tablets, USP comply with USP Dissolution Test 3. Lamotrigine Tablets for Oral Suspension, USP comply with Organic Impurities Procedure 2.</Description>
</NDC>
<NDC>
<NDCCode>68382-008-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (68382-008-05) </PackageDescription>
<NDC11Code>68382-0008-05</NDC11Code>
<ProductNDC>68382-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077633</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Each lamotrigine tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 150 mg or 200 mg or 250 mg of lamotrigine. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Each lamotrigine tablets for oral suspension, USP intended for oral administration contains 5 mg or 25 mg of amotrigine. In addition, each tablet contains the following inactive ingredients: aspartame, croscarmellose sodium, flavour black currant, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide and tribasic calcium phosphate. Lamotrigine tablets, USP comply with USP Dissolution Test 3. Lamotrigine Tablets for Oral Suspension, USP comply with Organic Impurities Procedure 2.</Description>
</NDC>
<NDC>
<NDCCode>68382-009-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (68382-009-05) </PackageDescription>
<NDC11Code>68382-0009-05</NDC11Code>
<ProductNDC>68382-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077633</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Each lamotrigine tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 150 mg or 200 mg or 250 mg of lamotrigine. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Each lamotrigine tablets for oral suspension, USP intended for oral administration contains 5 mg or 25 mg of amotrigine. In addition, each tablet contains the following inactive ingredients: aspartame, croscarmellose sodium, flavour black currant, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide and tribasic calcium phosphate. Lamotrigine tablets, USP comply with USP Dissolution Test 3. Lamotrigine Tablets for Oral Suspension, USP comply with Organic Impurities Procedure 2.</Description>
</NDC>
<NDC>
<NDCCode>68382-010-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (68382-010-05) </PackageDescription>
<NDC11Code>68382-0010-05</NDC11Code>
<ProductNDC>68382-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077633</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Each lamotrigine tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 150 mg or 200 mg or 250 mg of lamotrigine. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Each lamotrigine tablets for oral suspension, USP intended for oral administration contains 5 mg or 25 mg of amotrigine. In addition, each tablet contains the following inactive ingredients: aspartame, croscarmellose sodium, flavour black currant, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide and tribasic calcium phosphate. Lamotrigine tablets, USP comply with USP Dissolution Test 3. Lamotrigine Tablets for Oral Suspension, USP comply with Organic Impurities Procedure 2.</Description>
</NDC>
<NDC>
<NDCCode>68382-011-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (68382-011-05) </PackageDescription>
<NDC11Code>68382-0011-05</NDC11Code>
<ProductNDC>68382-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077633</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Each lamotrigine tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 150 mg or 200 mg or 250 mg of lamotrigine. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Each lamotrigine tablets for oral suspension, USP intended for oral administration contains 5 mg or 25 mg of amotrigine. In addition, each tablet contains the following inactive ingredients: aspartame, croscarmellose sodium, flavour black currant, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide and tribasic calcium phosphate. Lamotrigine tablets, USP comply with USP Dissolution Test 3. Lamotrigine Tablets for Oral Suspension, USP comply with Organic Impurities Procedure 2.</Description>
</NDC>
<NDC>
<NDCCode>68382-013-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (68382-013-05) </PackageDescription>
<NDC11Code>68382-0013-05</NDC11Code>
<ProductNDC>68382-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078620</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>375</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080919</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Naproxen tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.</IndicationAndUsage>
<Description>Naproxen tablets are nonsteroidal anti-inflammatory drugs available as follows:. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen has the following structure. Naproxen, USP is white to off-white, practically odorless, crystalline powder. It is soluble in chloroform, in dehydrated alcohol, and in alcohol; sparingly soluble in ether; practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Each naproxen tablet intended for oral administration contains 250 mg or 375 mg or 500 mg of naproxen. In addition, each tablet contains following inactive ingredients: croscarmellose sodium, ferric oxide (yellow), magnesium stearate and povidone.</Description>
</NDC>
<NDC>
<NDCCode>68382-014-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (68382-014-05) </PackageDescription>
<NDC11Code>68382-0014-05</NDC11Code>
<ProductNDC>68382-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078620</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080919</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Naproxen tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.</IndicationAndUsage>
<Description>Naproxen tablets are nonsteroidal anti-inflammatory drugs available as follows:. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen has the following structure. Naproxen, USP is white to off-white, practically odorless, crystalline powder. It is soluble in chloroform, in dehydrated alcohol, and in alcohol; sparingly soluble in ether; practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Each naproxen tablet intended for oral administration contains 250 mg or 375 mg or 500 mg of naproxen. In addition, each tablet contains following inactive ingredients: croscarmellose sodium, ferric oxide (yellow), magnesium stearate and povidone.</Description>
</NDC>
<NDC>
<NDCCode>68382-015-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68382-015-05) </PackageDescription>
<NDC11Code>68382-0015-05</NDC11Code>
<ProductNDC>68382-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077652</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-016-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68382-016-05) </PackageDescription>
<NDC11Code>68382-0016-05</NDC11Code>
<ProductNDC>68382-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077652</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-017-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68382-017-05) </PackageDescription>
<NDC11Code>68382-0017-05</NDC11Code>
<ProductNDC>68382-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077652</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>