{
"NDC": [
{
"NDCCode": "68180-284-07",
"PackageDescription": "60 TABLET in 1 BOTTLE (68180-284-07) ",
"NDC11Code": "68180-0284-07",
"ProductNDC": "68180-284",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamivudine And Zidovudine",
"NonProprietaryName": "Lamivudine And Zidovudine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090246",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "LAMIVUDINE; ZIDOVUDINE",
"StrengthNumber": "150; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120516",
"SamplePackage": "N"
},
{
"NDCCode": "33342-284-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-284-07) ",
"NDC11Code": "33342-0284-07",
"ProductNDC": "33342-284",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine,valsartan And Hydrochlorothiazide",
"NonProprietaryName": "Amlodipine,valsartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207299",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "10; 160; 12.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250106",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine, valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine, valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 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 (e.g., 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. Limitation of Use Amlodipine, valsartan and hydrochlorothiazide tablet is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].",
"Description": "Amlodipine, valsartan and hydrochlorothiazide tablets, USP are a fixed combination of amlodipine, valsartan, and hydrochlorothiazide. Amlodipine, valsartan and hydrochlorothiazide tablets, USP contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]-4(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate ; its structural formula is. Its molecular formula is C20H25ClN2O5.C6H6O3S and its molecular weight is 567.1. Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2´-(1H-tetrazol-5-yl) [1,1´-biphenyl]-4yl]methyl]-L-valine; its structural formula is. Its molecular formula is C24H29N5O3 and its molecular weight is 435.5. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its molecular formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Amlodipine, valsartan and hydrochlorothiazide film-coated tablets, USP are formulated in 5 strengths for oral administration with a combination of amlodipine besylate, valsartan, and hydrochlorothiazide, providing for the following available combinations. 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg amlodipine besylate/valsartan/hydrochlorothiazide. The inactive ingredients for all strengths of the tablets include colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc. Additionally, the 5/160/12.5 mg strength contains titanium dioxide; the 10/160/12.5 mg strength contains titanium dioxide and yellow and red iron oxides; the 5/160/25 mg strength contains titanium dioxide and yellow iron oxide, and the 10/160/25 mg and 10/320/25 mg strengths both contain yellow iron oxide."
},
{
"NDCCode": "57297-284-07",
"PackageDescription": "60 TABLET in 1 BOTTLE (57297-284-07)",
"NDC11Code": "57297-0284-07",
"ProductNDC": "57297-284",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamivudine And Zidovudine",
"NonProprietaryName": "Lamivudine And Zidovudine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090246",
"LabelerName": "LUPIN LIMITED",
"SubstanceName": "LAMIVUDINE; ZIDOVUDINE",
"StrengthNumber": "150; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogue reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1).",
"Description": "Lamivudine and zidovudine tablets USP are combination tablets containing lamivudine and zidovudine. Lamivudine (EPIVIR®) and zidovudine (RETROVIR®, azidothymidine, AZT, or ZDV) are synthetic nucleoside analogues with activity against HIV-1. Lamivudine and zidovudine tablets USP are for oral administration. Each film-coated tablet contains 150 mg of lamivudine, 300 mg of zidovudine, and the inactive ingredients dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, and titanium dioxide. Lamivudine. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl) (1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S 0.2H2O and a molecular weight of 232.86. It has the following structural formula. Lamivudine is a white to off-white solid with a solubility of approximately 68 mg/mL in water at 20°C. Zidovudine. The chemical name of zidovudine is 3′-azido-3′-deoxythymidine. It has a molecular formula of C10H13N5O4 and a molecular weight of 267.24. It has the following structural formula. Zidovudine is a white to beige, odorless, crystalline solid with a solubility of 20.1 mg/mL in water at 25°C."
},
{
"NDCCode": "63539-284-03",
"PackageDescription": "3 DOSE PACK in 1 CARTON (63539-284-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (63539-284-07) ",
"NDC11Code": "63539-0284-03",
"ProductNDC": "63539-284",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibrance",
"NonProprietaryName": "Palbociclib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212436",
"LabelerName": "U.S. Pharmaceuticals",
"SubstanceName": "PALBOCICLIB",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "Y",
"Description": "IBRANCE tablets for oral administration contain 125 mg, 100 mg, or 75 mg of palbociclib, a kinase inhibitor. The molecular formula for palbociclib is C24H29N7O2. The molecular weight is 447.54 daltons. The chemical name is 6-acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one, and its structural formula is:. Palbociclib is a yellow to orange powder. At or below pH 4, palbociclib behaves as a high-solubility compound. Above pH 4, the solubility of the drug substance reduces significantly. Inactive Ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, succinic acid, HPMC 2910/hypromellose, titanium dioxide, triacetin, and FD&C Blue #2/Indigo Carmine Aluminum Lake. In addition, the 75 mg and 125 mg tablets contain red iron oxide and the 100 mg tablets contain yellow iron oxide."
},
{
"NDCCode": "71919-284-07",
"PackageDescription": "15 mL in 1 VIAL, GLASS (71919-284-07) ",
"NDC11Code": "71919-0284-07",
"ProductNDC": "71919-284",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fagus Sylvatica",
"NonProprietaryName": "Fagus Sylvatica Nut",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131212",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FAGUS SYLVATICA NUT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20131212",
"SamplePackage": "N"
},
{
"NDCCode": "73377-284-07",
"PackageDescription": "25000 g in 1 JAR (73377-284-07) ",
"NDC11Code": "73377-0284-07",
"ProductNDC": "73377-284",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ketoprofen",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240823",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "AX Pharmaceutical Corp.",
"SubstanceName": "KETOPROFEN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-02-17",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "07-FEB-25"
},
{
"NDCCode": "68180-115-07",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (68180-115-07) ",
"NDC11Code": "68180-0115-07",
"ProductNDC": "68180-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090025",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090115",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets USP are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam tablets USP are indicated for adjunctive therapy for treatment of: 1 Partial onset seizures in patients one month of age and older with epilepsy (1.1), 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam USP 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)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and 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 (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets USP contain the labeled amount of levetiracetam. For 250 mg, 500 mg and 750 mg strengths. Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue No. 2/indigo carmine Aluminum Lake. 500 mg tablets: Yellow Iron Oxide. 750 mg tablets: FD&C Blue No. 2/indigo carmine Aluminum Lake, FD&C Yellow No. 6/sunset yellow FCF Aluminum Lake, iron oxide red. For 1000 mg strength. Inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide."
},
{
"NDCCode": "68180-117-07",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-117-07) ",
"NDC11Code": "68180-0117-07",
"ProductNDC": "68180-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091399",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110912",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam extended-release tablet is indicated for the treatment of partial-onset seizures in patients 12 years of age and older (1).",
"Description": "Levetiracetam extended-release tablet USP is an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, lactose anhydrous, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide. The imprinting ink contains shellac, iron oxide black and propylene glycol. The medication is combined with a drug release controlling agent that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass."
},
{
"NDCCode": "68180-118-07",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-118-07) ",
"NDC11Code": "68180-0118-07",
"ProductNDC": "68180-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091399",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110912",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam extended-release tablet is indicated for the treatment of partial-onset seizures in patients 12 years of age and older (1).",
"Description": "Levetiracetam extended-release tablet USP is an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, lactose anhydrous, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide. The imprinting ink contains shellac, iron oxide black and propylene glycol. The medication is combined with a drug release controlling agent that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass."
},
{
"NDCCode": "68180-157-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (68180-157-07) / 60 TABLET in 1 BOTTLE",
"NDC11Code": "68180-0157-07",
"ProductNDC": "68180-157",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobazam",
"NonProprietaryName": "Clobazam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210545",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "CLOBAZAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190508",
"SamplePackage": "N"
},
{
"NDCCode": "68180-158-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (68180-158-07) / 60 TABLET in 1 BOTTLE",
"NDC11Code": "68180-0158-07",
"ProductNDC": "68180-158",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobazam",
"NonProprietaryName": "Clobazam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210545",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "CLOBAZAM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190508",
"SamplePackage": "N"
},
{
"NDCCode": "68180-169-07",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-169-07) ",
"NDC11Code": "68180-0169-07",
"ProductNDC": "68180-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zileuton",
"NonProprietaryName": "Zileuton",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211972",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ZILEUTON",
"StrengthNumber": "600",
"StrengthUnit": "1/1",
"Pharm_Classes": "5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200810",
"SamplePackage": "N",
"IndicationAndUsage": "Zileuton extended-release tabletis indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton extended-release tabletis not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with zileuton extended-release tablet can be continued during acute exacerbations of asthma.",
"Description": "Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid. Zileuton has the chemical name (±)-1-(1-Benzo[b]thien-2-ylethyl)-1-hydroxyurea and the following chemical structure. Zileuton has the molecular formula C11H12N2O2S and a molecular weight of 236.29. It is a racemic mixture (50:50) of R(+) and S(-) enantiomers. Zileuton is white to off-white powder that is soluble in methanol, slightly soluble in acetonitrile, and practically insoluble in water. The melting point ranges from 145.29°C to 150.50°C. Zileuton extended-release tablets for oral administration are bi-layer tablets comprised of an immediate-release layer, and a extended-release layer. Zileuton extended-release tablets are white colored, oval shaped, film coated tablets, debossed with 'LU' on one side and 'R21' on other side. Each tablet contains 600 mg of zileuton and the following inactive ingredients: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, polyethylene glycol, pregelatinised starch."
},
{
"NDCCode": "68180-170-07",
"PackageDescription": "60 TABLET in 1 BOTTLE (68180-170-07) ",
"NDC11Code": "68180-0170-07",
"ProductNDC": "68180-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078410",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20131109",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate tablet is indicated for: 1 Epilepsy: initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (1.2), 2 Prophylaxis 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 tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. 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. Topiramate tablets USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium starch glycolate and titanium dioxide. The 50 mg tablets contain yellow iron oxide. The 100 mg and 200 mg tablets contain yellow iron oxide and red iron oxide. The imprinting ink contains black iron oxide, propylene glycol and shellac."
},
{
"NDCCode": "68180-171-07",
"PackageDescription": "60 TABLET in 1 BOTTLE (68180-171-07) ",
"NDC11Code": "68180-0171-07",
"ProductNDC": "68180-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078410",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20131109",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate tablet is indicated for: 1 Epilepsy: initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (1.2), 2 Prophylaxis 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 tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. 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. Topiramate tablets USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium starch glycolate and titanium dioxide. The 50 mg tablets contain yellow iron oxide. The 100 mg and 200 mg tablets contain yellow iron oxide and red iron oxide. The imprinting ink contains black iron oxide, propylene glycol and shellac."
},
{
"NDCCode": "68180-172-07",
"PackageDescription": "60 TABLET in 1 BOTTLE (68180-172-07) ",
"NDC11Code": "68180-0172-07",
"ProductNDC": "68180-172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078410",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20131109",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate tablet is indicated for: 1 Epilepsy: initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (1.2), 2 Prophylaxis 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 tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. 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. Topiramate tablets USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium starch glycolate and titanium dioxide. The 50 mg tablets contain yellow iron oxide. The 100 mg and 200 mg tablets contain yellow iron oxide and red iron oxide. The imprinting ink contains black iron oxide, propylene glycol and shellac."
},
{
"NDCCode": "68180-173-07",
"PackageDescription": "60 TABLET in 1 BOTTLE (68180-173-07) ",
"NDC11Code": "68180-0173-07",
"ProductNDC": "68180-173",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078410",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20131109",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate tablet is indicated for: 1 Epilepsy: initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (1.2), 2 Prophylaxis 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 tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. 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. Topiramate tablets USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium starch glycolate and titanium dioxide. The 50 mg tablets contain yellow iron oxide. The 100 mg and 200 mg tablets contain yellow iron oxide and red iron oxide. The imprinting ink contains black iron oxide, propylene glycol and shellac."
},
{
"NDCCode": "68180-197-07",
"PackageDescription": "90 TABLET in 1 BOTTLE (68180-197-07)",
"NDC11Code": "68180-0197-07",
"ProductNDC": "68180-197",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan And Amlodipine",
"NonProprietaryName": "Telmisartan And Amlodipine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201586",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "TELMISARTAN; AMLODIPINE BESYLATE",
"StrengthNumber": "40; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-02-26"
},
{
"NDCCode": "68180-229-07",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (68180-229-07) ",
"NDC11Code": "68180-0229-07",
"ProductNDC": "68180-229",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090051",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150713",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride Tablets are available for oral administration as capsule-shaped, biconvex, film-coated tablets, containing memantine hydrochloride 5 mg and 10 mg. The tablets also contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, silicified microcrystalline cellulose and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol, FD&C Yellow No. 6/Sunset Yellow FCF Aluminium Lake and FD&C Blue No. 2/Indigo Carmine Aluminium Lake (5 mg tablets), and hypromellose, titanium dioxide, polyethylene glycol and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "68180-230-07",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (68180-230-07) ",
"NDC11Code": "68180-0230-07",
"ProductNDC": "68180-230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090051",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150713",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride Tablets are available for oral administration as capsule-shaped, biconvex, film-coated tablets, containing memantine hydrochloride 5 mg and 10 mg. The tablets also contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, silicified microcrystalline cellulose and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol, FD&C Yellow No. 6/Sunset Yellow FCF Aluminium Lake and FD&C Blue No. 2/Indigo Carmine Aluminium Lake (5 mg tablets), and hypromellose, titanium dioxide, polyethylene glycol and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "68180-252-07",
"PackageDescription": "60 TABLET in 1 BOTTLE (68180-252-07) ",
"NDC11Code": "68180-0252-07",
"ProductNDC": "68180-252",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078691",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110120",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine tablet is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic 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 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:. Lamotrigine tablets are supplied for oral administration as 25 mg (white), 100 mg (peach), 150 mg (yellow), and 200 mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose and povidone, FD&C Yellow No. 6 (100 mg tablet only), yellow iron oxide (150 mg tablet only), and FD&C Blue o. 1 (200 mg tablet only)."
},
{
"NDCCode": "68180-253-07",
"PackageDescription": "60 TABLET in 1 BOTTLE (68180-253-07) ",
"NDC11Code": "68180-0253-07",
"ProductNDC": "68180-253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078691",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110120",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine tablet is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic 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 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:. Lamotrigine tablets are supplied for oral administration as 25 mg (white), 100 mg (peach), 150 mg (yellow), and 200 mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose and povidone, FD&C Yellow No. 6 (100 mg tablet only), yellow iron oxide (150 mg tablet only), and FD&C Blue o. 1 (200 mg tablet only)."
},
{
"NDCCode": "68180-285-07",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (68180-285-07) ",
"NDC11Code": "68180-0285-07",
"ProductNDC": "68180-285",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifabutin",
"NonProprietaryName": "Rifabutin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090033",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "RIFABUTIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antimycobacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140326",
"SamplePackage": "N"
},
{
"NDCCode": "68180-286-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (68180-286-07) / 60 TABLET in 1 BOTTLE",
"NDC11Code": "68180-0286-07",
"ProductNDC": "68180-286",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abacavir, Lamivudine And Zidovudine",
"NonProprietaryName": "Abacavir , Lamivudine And Zidovudine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202912",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE",
"StrengthNumber": "300; 150; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 1A1 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20131217",
"SamplePackage": "N"
},
{
"NDCCode": "68180-292-07",
"PackageDescription": "60 TABLET in 1 BOTTLE (68180-292-07) ",
"NDC11Code": "68180-0292-07",
"ProductNDC": "68180-292",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eslicarbazepine Acetate",
"NonProprietaryName": "Eslicarbazepine Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211246",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "600",
"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": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250506",
"SamplePackage": "N",
"IndicationAndUsage": "Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of eslicarbazepine acetate is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]-azepine-5-carboxamide. Eslicarbazepine acetate is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is. Eslicarbazepine acetate is a white to off-white powder. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, low substituted hydroxypropyl cellulose and magnesium stearate."
},
{
"NDCCode": "68180-294-07",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-294-07) ",
"NDC11Code": "68180-0294-07",
"ProductNDC": "68180-294",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090694",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-08",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsule is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 1 Major depressive disorder (MDD) in adults (1), 2 Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1), 3 Diabetic peripheral neuropathic Pain (DPNP) in adults (1), 4 Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older (1), 5 Chronic musculoskeletal pain in adults (1).",
"Description": "Duloxetine delayed-release capsules, USP are selective serotonin and norepinephrine reuptake inhibitor SNRI for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to cream colored powder, which is soluble in methanol. Each capsule contains enteric-coated mini tablets of 20, 30, 40, or 60 mg of duloxetine (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated mini tablets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonia solution, black iron oxide, croscarmellose sodium, FD & C Blue 2, gelatin, hypromellose, hypromellose phthalate, lactose monohydrate, magnesium stearate, polysorbate 80, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziprasidone Hydrochloride",
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"ApplicationNumber": "ANDA077560",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
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"Pharm_Classes": "Atypical Antipsychotic [EPC]",
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"StartMarketingDate": "20120302",
"MarketingCategoryName": "ANDA",
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"LabelerName": "Lupin Pharmaceuticals, Inc.",
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"StrengthUnit": "mg/1",
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"PackageNdcExcludeFlag": "N",
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{
"NDCCode": "68180-333-07",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (68180-333-07) ",
"NDC11Code": "68180-0333-07",
"ProductNDC": "68180-333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziprasidone Hydrochloride",
"NonProprietaryName": "Ziprasidone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120302",
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"ApplicationNumber": "ANDA077560",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziprasidone Hydrochloride",
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"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-12-29",
"PackageNdcExcludeFlag": "N",
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},
{
"NDCCode": "68180-336-07",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-336-07) ",
"NDC11Code": "68180-0336-07",
"ProductNDC": "68180-336",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090692",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20110930",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride extended-release tablets, USP contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is:. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ammonio methacrylate copolymer type A, ammonio methacrylate copolymer type B, colloidal silicone dioxide, crospovidone, dibutyl sebacate, hypromellose, magnesium stearate, microcrystalline cellulose and povidone. Metformin hydrochloride extended-release tablets USP meets USP Dissolution Test 12."
}
]
}
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<NDCList>
<NDC>
<NDCCode>68180-284-07</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68180-284-07) </PackageDescription>
<NDC11Code>68180-0284-07</NDC11Code>
<ProductNDC>68180-284</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamivudine And Zidovudine</ProprietaryName>
<NonProprietaryName>Lamivudine And Zidovudine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090246</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LAMIVUDINE; ZIDOVUDINE</SubstanceName>
<StrengthNumber>150; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>33342-284-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-284-07) </PackageDescription>
<NDC11Code>33342-0284-07</NDC11Code>
<ProductNDC>33342-284</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine,valsartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Amlodipine,valsartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207299</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>10; 160; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine, valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine, valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 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 (e.g., 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. Limitation of Use Amlodipine, valsartan and hydrochlorothiazide tablet is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Amlodipine, valsartan and hydrochlorothiazide tablets, USP are a fixed combination of amlodipine, valsartan, and hydrochlorothiazide. Amlodipine, valsartan and hydrochlorothiazide tablets, USP contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]-4(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate ; its structural formula is. Its molecular formula is C20H25ClN2O5.C6H6O3S and its molecular weight is 567.1. Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2´-(1H-tetrazol-5-yl) [1,1´-biphenyl]-4yl]methyl]-L-valine; its structural formula is. Its molecular formula is C24H29N5O3 and its molecular weight is 435.5. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its molecular formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Amlodipine, valsartan and hydrochlorothiazide film-coated tablets, USP are formulated in 5 strengths for oral administration with a combination of amlodipine besylate, valsartan, and hydrochlorothiazide, providing for the following available combinations. 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg amlodipine besylate/valsartan/hydrochlorothiazide. The inactive ingredients for all strengths of the tablets include colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc. Additionally, the 5/160/12.5 mg strength contains titanium dioxide; the 10/160/12.5 mg strength contains titanium dioxide and yellow and red iron oxides; the 5/160/25 mg strength contains titanium dioxide and yellow iron oxide, and the 10/160/25 mg and 10/320/25 mg strengths both contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>57297-284-07</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (57297-284-07)</PackageDescription>
<NDC11Code>57297-0284-07</NDC11Code>
<ProductNDC>57297-284</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamivudine And Zidovudine</ProprietaryName>
<NonProprietaryName>Lamivudine And Zidovudine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090246</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<SubstanceName>LAMIVUDINE; ZIDOVUDINE</SubstanceName>
<StrengthNumber>150; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogue reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1).</IndicationAndUsage>
<Description>Lamivudine and zidovudine tablets USP are combination tablets containing lamivudine and zidovudine. Lamivudine (EPIVIR®) and zidovudine (RETROVIR®, azidothymidine, AZT, or ZDV) are synthetic nucleoside analogues with activity against HIV-1. Lamivudine and zidovudine tablets USP are for oral administration. Each film-coated tablet contains 150 mg of lamivudine, 300 mg of zidovudine, and the inactive ingredients dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, and titanium dioxide. Lamivudine. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl) (1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S 0.2H2O and a molecular weight of 232.86. It has the following structural formula. Lamivudine is a white to off-white solid with a solubility of approximately 68 mg/mL in water at 20°C. Zidovudine. The chemical name of zidovudine is 3′-azido-3′-deoxythymidine. It has a molecular formula of C10H13N5O4 and a molecular weight of 267.24. It has the following structural formula. Zidovudine is a white to beige, odorless, crystalline solid with a solubility of 20.1 mg/mL in water at 25°C.</Description>
</NDC>
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<NDCCode>63539-284-03</NDCCode>
<PackageDescription>3 DOSE PACK in 1 CARTON (63539-284-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (63539-284-07) </PackageDescription>
<NDC11Code>63539-0284-03</NDC11Code>
<ProductNDC>63539-284</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibrance</ProprietaryName>
<NonProprietaryName>Palbociclib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212436</ApplicationNumber>
<LabelerName>U.S. Pharmaceuticals</LabelerName>
<SubstanceName>PALBOCICLIB</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<Description>IBRANCE tablets for oral administration contain 125 mg, 100 mg, or 75 mg of palbociclib, a kinase inhibitor. The molecular formula for palbociclib is C24H29N7O2. The molecular weight is 447.54 daltons. The chemical name is 6-acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one, and its structural formula is:. Palbociclib is a yellow to orange powder. At or below pH 4, palbociclib behaves as a high-solubility compound. Above pH 4, the solubility of the drug substance reduces significantly. Inactive Ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, succinic acid, HPMC 2910/hypromellose, titanium dioxide, triacetin, and FD&C Blue #2/Indigo Carmine Aluminum Lake. In addition, the 75 mg and 125 mg tablets contain red iron oxide and the 100 mg tablets contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>71919-284-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-284-07) </PackageDescription>
<NDC11Code>71919-0284-07</NDC11Code>
<ProductNDC>71919-284</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fagus Sylvatica</ProprietaryName>
<NonProprietaryName>Fagus Sylvatica Nut</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131212</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>FAGUS SYLVATICA NUT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73377-284-07</NDCCode>
<PackageDescription>25000 g in 1 JAR (73377-284-07) </PackageDescription>
<NDC11Code>73377-0284-07</NDC11Code>
<ProductNDC>73377-284</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ketoprofen</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240823</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>AX Pharmaceutical Corp.</LabelerName>
<SubstanceName>KETOPROFEN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-02-17</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>07-FEB-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68180-115-07</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (68180-115-07) </PackageDescription>
<NDC11Code>68180-0115-07</NDC11Code>
<ProductNDC>68180-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090025</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets USP are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam tablets USP are indicated for adjunctive therapy for treatment of: 1 Partial onset seizures in patients one month of age and older with epilepsy (1.1), 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam USP 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)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and 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 (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets USP contain the labeled amount of levetiracetam. For 250 mg, 500 mg and 750 mg strengths. Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue No. 2/indigo carmine Aluminum Lake. 500 mg tablets: Yellow Iron Oxide. 750 mg tablets: FD&C Blue No. 2/indigo carmine Aluminum Lake, FD&C Yellow No. 6/sunset yellow FCF Aluminum Lake, iron oxide red. For 1000 mg strength. Inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68180-117-07</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-117-07) </PackageDescription>
<NDC11Code>68180-0117-07</NDC11Code>
<ProductNDC>68180-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091399</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam extended-release tablet is indicated for the treatment of partial-onset seizures in patients 12 years of age and older (1).</IndicationAndUsage>
<Description>Levetiracetam extended-release tablet USP is an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, lactose anhydrous, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide. The imprinting ink contains shellac, iron oxide black and propylene glycol. The medication is combined with a drug release controlling agent that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.</Description>
</NDC>
<NDC>
<NDCCode>68180-118-07</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-118-07) </PackageDescription>
<NDC11Code>68180-0118-07</NDC11Code>
<ProductNDC>68180-118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091399</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam extended-release tablet is indicated for the treatment of partial-onset seizures in patients 12 years of age and older (1).</IndicationAndUsage>
<Description>Levetiracetam extended-release tablet USP is an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam extended-release tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, lactose anhydrous, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide. The imprinting ink contains shellac, iron oxide black and propylene glycol. The medication is combined with a drug release controlling agent that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.</Description>
</NDC>
<NDC>
<NDCCode>68180-157-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68180-157-07) / 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>68180-0157-07</NDC11Code>
<ProductNDC>68180-157</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobazam</ProprietaryName>
<NonProprietaryName>Clobazam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210545</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CLOBAZAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-158-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68180-158-07) / 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>68180-0158-07</NDC11Code>
<ProductNDC>68180-158</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobazam</ProprietaryName>
<NonProprietaryName>Clobazam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210545</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CLOBAZAM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-169-07</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-169-07) </PackageDescription>
<NDC11Code>68180-0169-07</NDC11Code>
<ProductNDC>68180-169</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zileuton</ProprietaryName>
<NonProprietaryName>Zileuton</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211972</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ZILEUTON</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>1/1</StrengthUnit>
<Pharm_Classes>5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zileuton extended-release tabletis indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton extended-release tabletis not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with zileuton extended-release tablet can be continued during acute exacerbations of asthma.</IndicationAndUsage>
<Description>Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid. Zileuton has the chemical name (±)-1-(1-Benzo[b]thien-2-ylethyl)-1-hydroxyurea and the following chemical structure. Zileuton has the molecular formula C11H12N2O2S and a molecular weight of 236.29. It is a racemic mixture (50:50) of R(+) and S(-) enantiomers. Zileuton is white to off-white powder that is soluble in methanol, slightly soluble in acetonitrile, and practically insoluble in water. The melting point ranges from 145.29°C to 150.50°C. Zileuton extended-release tablets for oral administration are bi-layer tablets comprised of an immediate-release layer, and a extended-release layer. Zileuton extended-release tablets are white colored, oval shaped, film coated tablets, debossed with 'LU' on one side and 'R21' on other side. Each tablet contains 600 mg of zileuton and the following inactive ingredients: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, polyethylene glycol, pregelatinised starch.</Description>
</NDC>
<NDC>
<NDCCode>68180-170-07</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68180-170-07) </PackageDescription>
<NDC11Code>68180-0170-07</NDC11Code>
<ProductNDC>68180-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078410</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablet is indicated for: 1 Epilepsy: initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (1.2), 2 Prophylaxis 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 tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. 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. Topiramate tablets USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium starch glycolate and titanium dioxide. The 50 mg tablets contain yellow iron oxide. The 100 mg and 200 mg tablets contain yellow iron oxide and red iron oxide. The imprinting ink contains black iron oxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>68180-171-07</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68180-171-07) </PackageDescription>
<NDC11Code>68180-0171-07</NDC11Code>
<ProductNDC>68180-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078410</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablet is indicated for: 1 Epilepsy: initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (1.2), 2 Prophylaxis 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 tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. 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. Topiramate tablets USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium starch glycolate and titanium dioxide. The 50 mg tablets contain yellow iron oxide. The 100 mg and 200 mg tablets contain yellow iron oxide and red iron oxide. The imprinting ink contains black iron oxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>68180-172-07</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68180-172-07) </PackageDescription>
<NDC11Code>68180-0172-07</NDC11Code>
<ProductNDC>68180-172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078410</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablet is indicated for: 1 Epilepsy: initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (1.2), 2 Prophylaxis 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 tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. 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. Topiramate tablets USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium starch glycolate and titanium dioxide. The 50 mg tablets contain yellow iron oxide. The 100 mg and 200 mg tablets contain yellow iron oxide and red iron oxide. The imprinting ink contains black iron oxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>68180-173-07</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68180-173-07) </PackageDescription>
<NDC11Code>68180-0173-07</NDC11Code>
<ProductNDC>68180-173</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078410</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablet is indicated for: 1 Epilepsy: initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (1.2), 2 Prophylaxis 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 tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. 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. Topiramate tablets USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium starch glycolate and titanium dioxide. The 50 mg tablets contain yellow iron oxide. The 100 mg and 200 mg tablets contain yellow iron oxide and red iron oxide. The imprinting ink contains black iron oxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>68180-197-07</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68180-197-07)</PackageDescription>
<NDC11Code>68180-0197-07</NDC11Code>
<ProductNDC>68180-197</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan And Amlodipine</ProprietaryName>
<NonProprietaryName>Telmisartan And Amlodipine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201586</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TELMISARTAN; AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>40; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-02-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>68180-229-07</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (68180-229-07) </PackageDescription>
<NDC11Code>68180-0229-07</NDC11Code>
<ProductNDC>68180-229</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090051</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride Tablets are available for oral administration as capsule-shaped, biconvex, film-coated tablets, containing memantine hydrochloride 5 mg and 10 mg. The tablets also contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, silicified microcrystalline cellulose and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol, FD&C Yellow No. 6/Sunset Yellow FCF Aluminium Lake and FD&C Blue No. 2/Indigo Carmine Aluminium Lake (5 mg tablets), and hypromellose, titanium dioxide, polyethylene glycol and iron oxide black (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>68180-230-07</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (68180-230-07) </PackageDescription>
<NDC11Code>68180-0230-07</NDC11Code>
<ProductNDC>68180-230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090051</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride Tablets are available for oral administration as capsule-shaped, biconvex, film-coated tablets, containing memantine hydrochloride 5 mg and 10 mg. The tablets also contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, silicified microcrystalline cellulose and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol, FD&C Yellow No. 6/Sunset Yellow FCF Aluminium Lake and FD&C Blue No. 2/Indigo Carmine Aluminium Lake (5 mg tablets), and hypromellose, titanium dioxide, polyethylene glycol and iron oxide black (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>68180-252-07</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68180-252-07) </PackageDescription>
<NDC11Code>68180-0252-07</NDC11Code>
<ProductNDC>68180-252</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078691</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, 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],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine tablet is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic 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 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:. Lamotrigine tablets are supplied for oral administration as 25 mg (white), 100 mg (peach), 150 mg (yellow), and 200 mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose and povidone, FD&C Yellow No. 6 (100 mg tablet only), yellow iron oxide (150 mg tablet only), and FD&C Blue o. 1 (200 mg tablet only).</Description>
</NDC>
<NDC>
<NDCCode>68180-253-07</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68180-253-07) </PackageDescription>
<NDC11Code>68180-0253-07</NDC11Code>
<ProductNDC>68180-253</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078691</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, 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],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine tablet is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic 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 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:. Lamotrigine tablets are supplied for oral administration as 25 mg (white), 100 mg (peach), 150 mg (yellow), and 200 mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose and povidone, FD&C Yellow No. 6 (100 mg tablet only), yellow iron oxide (150 mg tablet only), and FD&C Blue o. 1 (200 mg tablet only).</Description>
</NDC>
<NDC>
<NDCCode>68180-285-07</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (68180-285-07) </PackageDescription>
<NDC11Code>68180-0285-07</NDC11Code>
<ProductNDC>68180-285</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifabutin</ProprietaryName>
<NonProprietaryName>Rifabutin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090033</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>RIFABUTIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antimycobacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-286-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68180-286-07) / 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>68180-0286-07</NDC11Code>
<ProductNDC>68180-286</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abacavir, Lamivudine And Zidovudine</ProprietaryName>
<NonProprietaryName>Abacavir , Lamivudine And Zidovudine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202912</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE</SubstanceName>
<StrengthNumber>300; 150; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A1 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-292-07</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68180-292-07) </PackageDescription>
<NDC11Code>68180-0292-07</NDC11Code>
<ProductNDC>68180-292</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eslicarbazepine Acetate</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211246</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
<StrengthNumber>600</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>2025-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of eslicarbazepine acetate is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]-azepine-5-carboxamide. Eslicarbazepine acetate is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is. Eslicarbazepine acetate is a white to off-white powder. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, low substituted hydroxypropyl cellulose and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>68180-294-07</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-294-07) </PackageDescription>
<NDC11Code>68180-0294-07</NDC11Code>
<ProductNDC>68180-294</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090694</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsule is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 1 Major depressive disorder (MDD) in adults (1), 2 Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1), 3 Diabetic peripheral neuropathic Pain (DPNP) in adults (1), 4 Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older (1), 5 Chronic musculoskeletal pain in adults (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP are selective serotonin and norepinephrine reuptake inhibitor SNRI for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to cream colored powder, which is soluble in methanol. Each capsule contains enteric-coated mini tablets of 20, 30, 40, or 60 mg of duloxetine (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated mini tablets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonia solution, black iron oxide, croscarmellose sodium, FD & C Blue 2, gelatin, hypromellose, hypromellose phthalate, lactose monohydrate, magnesium stearate, polysorbate 80, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>68180-331-07</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (68180-331-07) </PackageDescription>
<NDC11Code>68180-0331-07</NDC11Code>
<ProductNDC>68180-331</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziprasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077560</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-332-07</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (68180-332-07) </PackageDescription>
<NDC11Code>68180-0332-07</NDC11Code>
<ProductNDC>68180-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziprasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077560</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-333-07</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (68180-333-07) </PackageDescription>
<NDC11Code>68180-0333-07</NDC11Code>
<ProductNDC>68180-333</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziprasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077560</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-334-07</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (68180-334-07) </PackageDescription>
<NDC11Code>68180-0334-07</NDC11Code>
<ProductNDC>68180-334</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziprasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077560</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-336-07</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-336-07) </PackageDescription>
<NDC11Code>68180-0336-07</NDC11Code>
<ProductNDC>68180-336</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090692</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets, USP contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is:. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ammonio methacrylate copolymer type A, ammonio methacrylate copolymer type B, colloidal silicone dioxide, crospovidone, dibutyl sebacate, hypromellose, magnesium stearate, microcrystalline cellulose and povidone. Metformin hydrochloride extended-release tablets USP meets USP Dissolution Test 12.</Description>
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