{
"NDC": [
{
"NDCCode": "47781-536-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-536-05) ",
"NDC11Code": "47781-0536-05",
"ProductNDC": "47781-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204984",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170130",
"SamplePackage": "N"
},
{
"NDCCode": "47781-536-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (47781-536-01) ",
"NDC11Code": "47781-0536-01",
"ProductNDC": "47781-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204984",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170130",
"SamplePackage": "N"
},
{
"NDCCode": "31722-536-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (31722-536-05) ",
"NDC11Code": "31722-0536-05",
"ProductNDC": "31722-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090515",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101008",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4."
},
{
"NDCCode": "43598-536-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-536-05) ",
"NDC11Code": "43598-0536-05",
"ProductNDC": "43598-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Sr",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205794",
"LabelerName": "Dr. Reddy�s Laboratories Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-12-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160801",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].",
"Description": "Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, powder, soluble in 0.1N HCl, alcohol 96% and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: copovidone, cysteine hydrochloride,hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,polysorbate 80 and titanium dioxide.In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP Dissolution Test 2."
},
{
"NDCCode": "53489-536-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (53489-536-05)",
"NDC11Code": "53489-0536-05",
"ProductNDC": "53489-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074499",
"LabelerName": "Mutual Pharmaceutical Company, Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Atenolol is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol may be administered with other antihypertensive agents.",
"Description": "Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol is available as 25 mg, 50 mg, and 100 mg tablets for oral administration. Inactive ingredients are: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."
},
{
"NDCCode": "63304-536-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (63304-536-05)",
"NDC11Code": "63304-0536-05",
"ProductNDC": "63304-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril And Hydrochlorothiazide",
"NonProprietaryName": "Lisinopril And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076007",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "LISINOPRIL; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "10; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Lisinopril and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets, USP, consideration should be given to the fact that an angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk (See WARNINGS). In considering the use of lisinopril and hydrochlorothiazide tablets, USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients (see WARNINGS, Lisinopril).",
"Description": "Lisinopril and hydrochlorothiazide tablets, USP combine an angiotensin converting enzyme inhibitor, lisinopril, USP, and a diuretic, hydrochlorothiazide, USP. Lisinopril, USP, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its molecular formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril, USP is a white crystalline powder, with a molecular weight of 441.52. It is soluble in water and sparingly soluble in methanol and practically insoluble in alcohol, in acetone, in acetonitrile and in chloroform. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Lisinopril and hydrochlorothiazide is available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 containing 10 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; lisinopril and hydrochlorothiazide tablets, USP 20-12.5 containing 20 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; and, lisinopril and hydrochlorothiazide tablets, USP 20-25 containing 20 mg lisinopril, USP and 25 mg hydrochlorothiazide, USP. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch, and starch (corn). Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 mg also contain FD&C blue #2 aluminum lake. Lisinopril and hydrochlorothiazide tablets, USP 20-12.5 mg contain yellow iron oxide. Lisinopril and hydrochlorothiazide tablets, USP 20-25 mg contain yellow and red iron oxide."
},
{
"NDCCode": "65841-536-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-536-05) ",
"NDC11Code": "65841-0536-05",
"ProductNDC": "65841-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203546",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "5",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140812",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium citrate extended-release tablet is a citrate salt of potassium indicated for the management of: : 1 Renal tubular acidosis (RTA) with calcium stones (1.1) , 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).",
"Description": "Potassium citrate is a citrate salt of potassium. Its molecular formula is K3C6H5O7 H2O, and it has the following chemical structure. Potassium citrate, USP is a transparent crystals or white, granular powder. It is freely soluble in water and slightly soluble in alcohol. Potassium citrate extended-release tablets, USP intended for oral administration, each contains 5 mEq (540 mg), 10 mEq (1,080 mg) or 15 mEq (1,620 mg) of potassium citrate, USP as monohydrate. In addition, each tablet contains the following inactive ingredients: carnauba wax and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "68382-536-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-536-05) ",
"NDC11Code": "68382-0536-05",
"ProductNDC": "68382-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203546",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "5",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140812",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium citrate extended-release tablet is a citrate salt of potassium indicated for the management of: : 1 Renal tubular acidosis (RTA) with calcium stones (1.1) , 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).",
"Description": "Potassium citrate is a citrate salt of potassium. Its molecular formula is K3C6H5O7 H2O, and it has the following chemical structure. Potassium citrate, USP is a transparent crystals or white, granular powder. It is freely soluble in water and slightly soluble in alcohol. Potassium citrate extended-release tablets, USP intended for oral administration, each contains 5 mEq (540 mg), 10 mEq (1,080 mg) or 15 mEq (1,620 mg) of potassium citrate, USP as monohydrate. In addition, each tablet contains the following inactive ingredients: carnauba wax and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "68428-536-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-536-05) ",
"NDC11Code": "68428-0536-05",
"ProductNDC": "68428-536",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nux Moschata",
"NonProprietaryName": "Nutmeg",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "NUTMEG",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "84756-536-05",
"PackageDescription": "100 mL in 1 BOTTLE (84756-536-05) ",
"NDC11Code": "84756-0536-05",
"ProductNDC": "84756-536",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "100% Pure Natural Jojoba Oil",
"NonProprietaryName": "100% Pure Natural Jojoba Oil",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Yucheng E Commerce Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84827-536-05",
"PackageDescription": "100 mL in 1 BOTTLE (84827-536-05) ",
"NDC11Code": "84827-0536-05",
"ProductNDC": "84827-536",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Crocodile Repair Serum",
"NonProprietaryName": "Trstay Crocodile Repair Serum",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Luoxin E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "47781-174-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-174-05)",
"NDC11Code": "47781-0174-05",
"ProductNDC": "47781-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 5 Mg,cll",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207388",
"LabelerName": "Alvogen inc.",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "1.25; 1.25; 1.25; 1.25",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-09-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "47781-175-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-175-05)",
"NDC11Code": "47781-0175-05",
"ProductNDC": "47781-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 7.5 Mg,cll",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207388",
"LabelerName": "Alvogen inc.",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "1.875; 1.875; 1.875; 1.875",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-09-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "47781-176-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-176-05)",
"NDC11Code": "47781-0176-05",
"ProductNDC": "47781-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 10 Mg,cll",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207388",
"LabelerName": "Alvogen inc.",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "2.5; 2.5; 2.5; 2.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-09-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "47781-177-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-177-05)",
"NDC11Code": "47781-0177-05",
"ProductNDC": "47781-177",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 12.5 Mg,cll",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207388",
"LabelerName": "Alvogen inc.",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "3.125; 3.125; 3.125; 3.125",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-09-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "47781-178-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-178-05)",
"NDC11Code": "47781-0178-05",
"ProductNDC": "47781-178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 15 Mg,cll",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207388",
"LabelerName": "Alvogen inc.",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "3.75; 3.75; 3.75; 3.75",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-09-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "47781-179-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-179-05)",
"NDC11Code": "47781-0179-05",
"ProductNDC": "47781-179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 20 Mg,cll",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207388",
"LabelerName": "Alvogen inc.",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "5; 5; 5; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-09-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "47781-180-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-180-05)",
"NDC11Code": "47781-0180-05",
"ProductNDC": "47781-180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 30 Mg,cll",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207388",
"LabelerName": "Alvogen inc.",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "7.5; 7.5; 7.5; 7.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-09-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "47781-196-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-196-05) ",
"NDC11Code": "47781-0196-05",
"ProductNDC": "47781-196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202677",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160309",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients forwhom alternative treatmentoptions are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride, USP.................................... 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Inactive Ingredients. All strengths of Oxycodone and Acetaminophen Tablets, USP contain the inactive ingredients crospovidone, lactose monohydrate, povidone, pregelatinized corn starch, and stearic acid. The 5 mg/325 mg tablets contain FD&C Blue No. 1 Aluminum Lake as a colorant. The 7.5 mg/325 mg tablets contain FD&C Yellow No. 6 Aluminum Lake as a colorant. The 10 mg/325 mg tablets contain D&C Yellow No. 10 Aluminum Lake as a colorant. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
},
{
"NDCCode": "47781-216-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (47781-216-05)",
"NDC11Code": "47781-0216-05",
"ProductNDC": "47781-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202114",
"LabelerName": "ALVOGEN",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-09-05"
},
{
"NDCCode": "47781-217-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (47781-217-05)",
"NDC11Code": "47781-0217-05",
"ProductNDC": "47781-217",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202114",
"LabelerName": "ALVOGEN",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-09-05"
},
{
"NDCCode": "47781-219-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-219-05)",
"NDC11Code": "47781-0219-05",
"ProductNDC": "47781-219",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202076",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "325; 37.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-09-26"
},
{
"NDCCode": "47781-229-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-229-05) ",
"NDC11Code": "47781-0229-05",
"ProductNDC": "47781-229",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202677",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120117",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients forwhom alternative treatmentoptions are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride, USP.................................... 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Inactive Ingredients. All strengths of Oxycodone and Acetaminophen Tablets, USP contain the inactive ingredients crospovidone, lactose monohydrate, povidone, pregelatinized corn starch, and stearic acid. The 5 mg/325 mg tablets contain FD&C Blue No. 1 Aluminum Lake as a colorant. The 7.5 mg/325 mg tablets contain FD&C Yellow No. 6 Aluminum Lake as a colorant. The 10 mg/325 mg tablets contain D&C Yellow No. 10 Aluminum Lake as a colorant. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
},
{
"NDCCode": "47781-230-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-230-05) ",
"NDC11Code": "47781-0230-05",
"ProductNDC": "47781-230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202677",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120117",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients forwhom alternative treatmentoptions are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride, USP.................................... 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Inactive Ingredients. All strengths of Oxycodone and Acetaminophen Tablets, USP contain the inactive ingredients crospovidone, lactose monohydrate, povidone, pregelatinized corn starch, and stearic acid. The 5 mg/325 mg tablets contain FD&C Blue No. 1 Aluminum Lake as a colorant. The 7.5 mg/325 mg tablets contain FD&C Yellow No. 6 Aluminum Lake as a colorant. The 10 mg/325 mg tablets contain D&C Yellow No. 10 Aluminum Lake as a colorant. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
},
{
"NDCCode": "47781-263-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-263-05) ",
"NDC11Code": "47781-0263-05",
"ProductNDC": "47781-263",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202116",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20111230",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Oxycodone hydrochloride tablets contain the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized corn starch, stearic acid, D&C Yellow No. 10 (15 mg tablet) and FD&C Blue No. 2 (15 mg and 30 mg tablet). The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27.0 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "47781-264-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-264-05) ",
"NDC11Code": "47781-0264-05",
"ProductNDC": "47781-264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202116",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20111230",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Oxycodone hydrochloride tablets contain the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized corn starch, stearic acid, D&C Yellow No. 10 (15 mg tablet) and FD&C Blue No. 2 (15 mg and 30 mg tablet). The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27.0 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "47781-265-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-265-05) ",
"NDC11Code": "47781-0265-05",
"ProductNDC": "47781-265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202116",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20111230",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Oxycodone hydrochloride tablets contain the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized corn starch, stearic acid, D&C Yellow No. 10 (15 mg tablet) and FD&C Blue No. 2 (15 mg and 30 mg tablet). The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27.0 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "47781-275-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-275-05)",
"NDC11Code": "47781-0275-05",
"ProductNDC": "47781-275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Mononitrate",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Isosorbide Mononitrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075522",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "ISOSORBIDE MONONITRATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-09-05"
},
{
"NDCCode": "47781-332-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (47781-332-05) ",
"NDC11Code": "47781-0332-05",
"ProductNDC": "47781-332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa Tablets, 25 Mg",
"NonProprietaryName": "Carbidopa Tablets, 25 Mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204291",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "CARBIDOPA",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "47781-490-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (47781-490-05) ",
"NDC11Code": "47781-0490-05",
"ProductNDC": "47781-490",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160627",
"EndMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062500",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160628",
"EndMarketingDatePackage": "20201101",
"SamplePackage": "N"
}
]
}
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<NDCList>
<NDC>
<NDCCode>47781-536-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-536-05) </PackageDescription>
<NDC11Code>47781-0536-05</NDC11Code>
<ProductNDC>47781-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen, And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen, And Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204984</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>47781-536-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (47781-536-01) </PackageDescription>
<NDC11Code>47781-0536-01</NDC11Code>
<ProductNDC>47781-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen, And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen, And Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204984</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>31722-536-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (31722-536-05) </PackageDescription>
<NDC11Code>31722-0536-05</NDC11Code>
<ProductNDC>31722-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090515</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4.</Description>
</NDC>
<NDC>
<NDCCode>43598-536-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-536-05) </PackageDescription>
<NDC11Code>43598-0536-05</NDC11Code>
<ProductNDC>43598-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Sr</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205794</ApplicationNumber>
<LabelerName>Dr. Reddy�s Laboratories Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, powder, soluble in 0.1N HCl, alcohol 96% and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: copovidone, cysteine hydrochloride,hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,polysorbate 80 and titanium dioxide.In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>53489-536-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (53489-536-05)</PackageDescription>
<NDC11Code>53489-0536-05</NDC11Code>
<ProductNDC>53489-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074499</ApplicationNumber>
<LabelerName>Mutual Pharmaceutical Company, Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atenolol is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol is available as 25 mg, 50 mg, and 100 mg tablets for oral administration. Inactive ingredients are: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>63304-536-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (63304-536-05)</PackageDescription>
<NDC11Code>63304-0536-05</NDC11Code>
<ProductNDC>63304-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076007</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LISINOPRIL; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>10; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lisinopril and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets, USP, consideration should be given to the fact that an angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk (See WARNINGS). In considering the use of lisinopril and hydrochlorothiazide tablets, USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients (see WARNINGS, Lisinopril).</IndicationAndUsage>
<Description>Lisinopril and hydrochlorothiazide tablets, USP combine an angiotensin converting enzyme inhibitor, lisinopril, USP, and a diuretic, hydrochlorothiazide, USP. Lisinopril, USP, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its molecular formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril, USP is a white crystalline powder, with a molecular weight of 441.52. It is soluble in water and sparingly soluble in methanol and practically insoluble in alcohol, in acetone, in acetonitrile and in chloroform. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Lisinopril and hydrochlorothiazide is available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 containing 10 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; lisinopril and hydrochlorothiazide tablets, USP 20-12.5 containing 20 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; and, lisinopril and hydrochlorothiazide tablets, USP 20-25 containing 20 mg lisinopril, USP and 25 mg hydrochlorothiazide, USP. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch, and starch (corn). Lisinopril and hydrochlorothiazide tablets, USP 10-12.5 mg also contain FD&C blue #2 aluminum lake. Lisinopril and hydrochlorothiazide tablets, USP 20-12.5 mg contain yellow iron oxide. Lisinopril and hydrochlorothiazide tablets, USP 20-25 mg contain yellow and red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>65841-536-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-536-05) </PackageDescription>
<NDC11Code>65841-0536-05</NDC11Code>
<ProductNDC>65841-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Citrate</ProprietaryName>
<NonProprietaryName>Potassium Citrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140812</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203546</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>POTASSIUM CITRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium citrate extended-release tablet is a citrate salt of potassium indicated for the management of: : 1 Renal tubular acidosis (RTA) with calcium stones (1.1) , 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).</IndicationAndUsage>
<Description>Potassium citrate is a citrate salt of potassium. Its molecular formula is K3C6H5O7 H2O, and it has the following chemical structure. Potassium citrate, USP is a transparent crystals or white, granular powder. It is freely soluble in water and slightly soluble in alcohol. Potassium citrate extended-release tablets, USP intended for oral administration, each contains 5 mEq (540 mg), 10 mEq (1,080 mg) or 15 mEq (1,620 mg) of potassium citrate, USP as monohydrate. In addition, each tablet contains the following inactive ingredients: carnauba wax and magnesium stearate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68382-536-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-536-05) </PackageDescription>
<NDC11Code>68382-0536-05</NDC11Code>
<ProductNDC>68382-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Citrate</ProprietaryName>
<NonProprietaryName>Potassium Citrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140812</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203546</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>POTASSIUM CITRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium citrate extended-release tablet is a citrate salt of potassium indicated for the management of: : 1 Renal tubular acidosis (RTA) with calcium stones (1.1) , 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).</IndicationAndUsage>
<Description>Potassium citrate is a citrate salt of potassium. Its molecular formula is K3C6H5O7 H2O, and it has the following chemical structure. Potassium citrate, USP is a transparent crystals or white, granular powder. It is freely soluble in water and slightly soluble in alcohol. Potassium citrate extended-release tablets, USP intended for oral administration, each contains 5 mEq (540 mg), 10 mEq (1,080 mg) or 15 mEq (1,620 mg) of potassium citrate, USP as monohydrate. In addition, each tablet contains the following inactive ingredients: carnauba wax and magnesium stearate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68428-536-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-536-05) </PackageDescription>
<NDC11Code>68428-0536-05</NDC11Code>
<ProductNDC>68428-536</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nux Moschata</ProprietaryName>
<NonProprietaryName>Nutmeg</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>NUTMEG</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84756-536-05</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (84756-536-05) </PackageDescription>
<NDC11Code>84756-0536-05</NDC11Code>
<ProductNDC>84756-536</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>100% Pure Natural Jojoba Oil</ProprietaryName>
<NonProprietaryName>100% Pure Natural Jojoba Oil</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yiwu Yucheng E Commerce Co Ltd</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84827-536-05</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (84827-536-05) </PackageDescription>
<NDC11Code>84827-0536-05</NDC11Code>
<ProductNDC>84827-536</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Crocodile Repair Serum</ProprietaryName>
<NonProprietaryName>Trstay Crocodile Repair Serum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Luoxin E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47781-174-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-174-05)</PackageDescription>
<NDC11Code>47781-0174-05</NDC11Code>
<ProductNDC>47781-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 5 Mg,cll</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207388</ApplicationNumber>
<LabelerName>Alvogen inc.</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>1.25; 1.25; 1.25; 1.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-09-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47781-175-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-175-05)</PackageDescription>
<NDC11Code>47781-0175-05</NDC11Code>
<ProductNDC>47781-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 7.5 Mg,cll</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207388</ApplicationNumber>
<LabelerName>Alvogen inc.</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>1.875; 1.875; 1.875; 1.875</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-09-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47781-176-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-176-05)</PackageDescription>
<NDC11Code>47781-0176-05</NDC11Code>
<ProductNDC>47781-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 10 Mg,cll</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207388</ApplicationNumber>
<LabelerName>Alvogen inc.</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>2.5; 2.5; 2.5; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-09-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47781-177-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-177-05)</PackageDescription>
<NDC11Code>47781-0177-05</NDC11Code>
<ProductNDC>47781-177</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 12.5 Mg,cll</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207388</ApplicationNumber>
<LabelerName>Alvogen inc.</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>3.125; 3.125; 3.125; 3.125</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-09-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47781-178-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-178-05)</PackageDescription>
<NDC11Code>47781-0178-05</NDC11Code>
<ProductNDC>47781-178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 15 Mg,cll</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207388</ApplicationNumber>
<LabelerName>Alvogen inc.</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>3.75; 3.75; 3.75; 3.75</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-09-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47781-179-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-179-05)</PackageDescription>
<NDC11Code>47781-0179-05</NDC11Code>
<ProductNDC>47781-179</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 20 Mg,cll</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207388</ApplicationNumber>
<LabelerName>Alvogen inc.</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>5; 5; 5; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-09-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47781-180-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-180-05)</PackageDescription>
<NDC11Code>47781-0180-05</NDC11Code>
<ProductNDC>47781-180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 30 Mg,cll</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207388</ApplicationNumber>
<LabelerName>Alvogen inc.</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>7.5; 7.5; 7.5; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-09-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47781-196-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-196-05) </PackageDescription>
<NDC11Code>47781-0196-05</NDC11Code>
<ProductNDC>47781-196</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202677</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients forwhom alternative treatmentoptions are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride, USP.................................... 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Inactive Ingredients. All strengths of Oxycodone and Acetaminophen Tablets, USP contain the inactive ingredients crospovidone, lactose monohydrate, povidone, pregelatinized corn starch, and stearic acid. The 5 mg/325 mg tablets contain FD&C Blue No. 1 Aluminum Lake as a colorant. The 7.5 mg/325 mg tablets contain FD&C Yellow No. 6 Aluminum Lake as a colorant. The 10 mg/325 mg tablets contain D&C Yellow No. 10 Aluminum Lake as a colorant. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>47781-216-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (47781-216-05)</PackageDescription>
<NDC11Code>47781-0216-05</NDC11Code>
<ProductNDC>47781-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202114</ApplicationNumber>
<LabelerName>ALVOGEN</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-09-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>47781-217-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (47781-217-05)</PackageDescription>
<NDC11Code>47781-0217-05</NDC11Code>
<ProductNDC>47781-217</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202114</ApplicationNumber>
<LabelerName>ALVOGEN</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-09-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>47781-219-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-219-05)</PackageDescription>
<NDC11Code>47781-0219-05</NDC11Code>
<ProductNDC>47781-219</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202076</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 37.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-09-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>47781-229-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-229-05) </PackageDescription>
<NDC11Code>47781-0229-05</NDC11Code>
<ProductNDC>47781-229</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202677</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients forwhom alternative treatmentoptions are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride, USP.................................... 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Inactive Ingredients. All strengths of Oxycodone and Acetaminophen Tablets, USP contain the inactive ingredients crospovidone, lactose monohydrate, povidone, pregelatinized corn starch, and stearic acid. The 5 mg/325 mg tablets contain FD&C Blue No. 1 Aluminum Lake as a colorant. The 7.5 mg/325 mg tablets contain FD&C Yellow No. 6 Aluminum Lake as a colorant. The 10 mg/325 mg tablets contain D&C Yellow No. 10 Aluminum Lake as a colorant. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>47781-230-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-230-05) </PackageDescription>
<NDC11Code>47781-0230-05</NDC11Code>
<ProductNDC>47781-230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202677</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients forwhom alternative treatmentoptions are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride, USP.................................... 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Inactive Ingredients. All strengths of Oxycodone and Acetaminophen Tablets, USP contain the inactive ingredients crospovidone, lactose monohydrate, povidone, pregelatinized corn starch, and stearic acid. The 5 mg/325 mg tablets contain FD&C Blue No. 1 Aluminum Lake as a colorant. The 7.5 mg/325 mg tablets contain FD&C Yellow No. 6 Aluminum Lake as a colorant. The 10 mg/325 mg tablets contain D&C Yellow No. 10 Aluminum Lake as a colorant. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>47781-263-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-263-05) </PackageDescription>
<NDC11Code>47781-0263-05</NDC11Code>
<ProductNDC>47781-263</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202116</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Oxycodone hydrochloride tablets contain the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized corn starch, stearic acid, D&C Yellow No. 10 (15 mg tablet) and FD&C Blue No. 2 (15 mg and 30 mg tablet). The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27.0 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>47781-264-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-264-05) </PackageDescription>
<NDC11Code>47781-0264-05</NDC11Code>
<ProductNDC>47781-264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202116</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Oxycodone hydrochloride tablets contain the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized corn starch, stearic acid, D&C Yellow No. 10 (15 mg tablet) and FD&C Blue No. 2 (15 mg and 30 mg tablet). The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27.0 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>47781-265-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-265-05) </PackageDescription>
<NDC11Code>47781-0265-05</NDC11Code>
<ProductNDC>47781-265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202116</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Oxycodone hydrochloride tablets contain the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized corn starch, stearic acid, D&C Yellow No. 10 (15 mg tablet) and FD&C Blue No. 2 (15 mg and 30 mg tablet). The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27.0 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>47781-275-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-275-05)</PackageDescription>
<NDC11Code>47781-0275-05</NDC11Code>
<ProductNDC>47781-275</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075522</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-09-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>47781-332-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (47781-332-05) </PackageDescription>
<NDC11Code>47781-0332-05</NDC11Code>
<ProductNDC>47781-332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa Tablets, 25 Mg</ProprietaryName>
<NonProprietaryName>Carbidopa Tablets, 25 Mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204291</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>CARBIDOPA</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47781-490-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (47781-490-05) </PackageDescription>
<NDC11Code>47781-0490-05</NDC11Code>
<ProductNDC>47781-490</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160627</StartMarketingDate>
<EndMarketingDate>20211001</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062500</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160628</StartMarketingDatePackage>
<EndMarketingDatePackage>20201101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>