{
"NDC": [
{
"NDCCode": "68220-084-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (68220-084-90)",
"NDC11Code": "68220-0084-90",
"ProductNDC": "68220-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Preferaob",
"NonProprietaryName": "Folic Acid, Heme Iron Polypeptide, Iron Dextran, Potassium Iodide, Zinc Oxide, Selenium, Cupric Sulfate, Cholecalciferol, Thiamine Mononitrate, Alpha-tocopherol Succinate, D-, Riboflavin, Niacinamide,",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100927",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Alaven Pharmaceutical LLC",
"SubstanceName": "FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; POTASSIUM IODIDE; ZINC OXIDE; SELENIUM; CUPRIC SULFATE; CHOLECALCIFEROL; THIAMINE MONONITRATE; ALPHA-TOCOPHEROL SUCCINATE, D-; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE",
"StrengthNumber": "1; 6; 28; 250; 4.5; 65; .8; 400; 1.5; 10; 1.6; 17; 50; 12; 30; 10",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "68220-085-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (68220-085-90)",
"NDC11Code": "68220-0085-90",
"ProductNDC": "68220-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Biferarx",
"NonProprietaryName": "Folic Acid, Heme Iron Polypeptide, Iron Dextran, And Cyanocobalamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100501",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Alaven Pharmaceutical LLC",
"SubstanceName": "FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; CYANOCOBALAMIN",
"StrengthNumber": "1; 6; 22; 25",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin B 12 [CS],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "27241-084-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (27241-084-09) ",
"NDC11Code": "27241-0084-09",
"ProductNDC": "27241-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Olmesartan Medoxomil",
"NonProprietaryName": "Amlodipine Besylate And Olmesartan Medoxomil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207216",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170206",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10/40 mg.",
"Description": "Amlodipine besylate and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate, USP and the angiotensin II receptor blocker (ARB) olmesartan medoxomil, USP.The amlodipine besylate, USP component of amlodipine and olmesartan medoxomil tablets, USP is chemically described as 3-ethyl-5-methyl (±)-2-[(2- aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S.Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.The olmesartan medoxomil, USP component of amlodipine and olmesartan medoxomil tablets, USP is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl] imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6.The structural formula for amlodipine besylate, USP is:. The structural formula for olmesartan medoxomil, USP is. Amlodipine and olmesartan medoxomil tablets, USP contain amlodipine besylate, USP a white or almost white powder, and olmesartan medoxomil, USP white to off-white crystalline powder. The molecular weights of amlodipine besylate, USP and olmesartan medoxomil, USP are 567.1 and 558.59, respectively. Amlodipine besylate, USP is slightly soluble in water and 2-propanol, sparingly soluble in ethanol, freely soluble in methanol. Olmesartan medoxomil, USP is practically insoluble in water and sparingly soluble in methanol.Each tablet of amlodipine and olmesartan medoxomil also contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, croscarmellose sodium, and magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/polyethylene glycol, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (10/20 mg and 10/40 mg tablets), and iron oxide black (10/20 mg, 10/40 mg tablets)."
},
{
"NDCCode": "31722-084-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (31722-084-90) ",
"NDC11Code": "31722-0084-90",
"ProductNDC": "31722-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lurasidone Hydrochloride",
"NonProprietaryName": "Lurasidone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240821",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218174",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LURASIDONE HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240821",
"SamplePackage": "N",
"IndicationAndUsage": "Lurasidone hydrochloride tablets are indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1)] . Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)]. Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)].",
"Description": "Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a R,4 S,7 R,7a S)-2-{(1 R,2 R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28H 36N 4O 2S·HCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in methanol. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are croscarmellose sodium, hypromellose, magnesium stearate, mannitol, polyethylene glycol, pregelatinized starch (maize), and titanium dioxide."
},
{
"NDCCode": "33261-084-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (33261-084-90)",
"NDC11Code": "33261-0084-90",
"ProductNDC": "33261-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078432",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "275",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Naproxen Sodium Tablets, USP and other treatment options before deciding to use Naproxen Sodium Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight. Naproxen as naproxen sodium tablets are indicated. For the relief of the signs and symptoms of rheumatoid arthritis. For the relief of the signs and symptoms of osteoarthritis. For the relief of the signs and symptoms of ankylosing spondylitis. For the relief of the signs and symptoms of juvenile arthritis. For relief of the signs and symptoms of tendonitis. For relief of the signs and symptoms of bursitis. For relief of the signs and symptoms of acute gout. For the management of pain. For the management of primary dysmenorrhea.",
"Description": "Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen sodium is (S)-6-methoxy-〈-methyl-2-naphthalene acetic acid, sodium salt. Naproxen sodium has the following structure. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen Sodium Tablets, USP are available as blue tablets containing 275 mg of naproxen sodium and as blue tablets containing 550 mg of naproxen sodium. The inactive ingredients are. croscarmellose sodium, macrogol, magnesium stearate, polyvinly alcohol, povidone, talc, titanium dioxide and FD&C Blue #2."
},
{
"NDCCode": "43353-084-60",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (43353-084-60)",
"NDC11Code": "43353-0084-60",
"ProductNDC": "43353-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19851119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070213",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"IndicationAndUsage": "Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Each tablet for oral administration contains 10 mg, 20 mg, 40 mg, 60 mg or 80 mg of propranolol hydrochloride and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The coloring agents are. 10 mg: FD&C Yellow No. 6 Aluminum Lake. 20 mg: FD&C Blue No. 1 Aluminum Lake. 40 mg: FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. 60 mg: FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. 80 mg: FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake."
},
{
"NDCCode": "49527-084-90",
"PackageDescription": "5000 mL in 1 PAIL (49527-084-90) ",
"NDC11Code": "49527-0084-90",
"ProductNDC": "49527-084",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Avobenzone,homosalate,octinoxate,octisalate",
"DosageFormName": "CREAM",
"StartMarketingDate": "20221101",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "CLINIQUE LABORATORIES LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE",
"StrengthNumber": "30; 70; 70; 45",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "10-MAY-23",
"EndMarketingDatePackage": "31-DEC-24"
},
{
"NDCCode": "51655-084-26",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-084-26) ",
"NDC11Code": "51655-0084-26",
"ProductNDC": "51655-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213999",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230306",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, crystalline powder or small crystals which is freely soluble in water, in alcohol, in chloroform, in methanol and insoluble in ether. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. Each tablet for oral administration contains 10, 25, 50, 75, 100 or 150 mg amitriptyline hydrochloride USP. Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. The 10 mg also includes Hypromellose, PEG, Titanium Dioxide, , D&C Red #27 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake; 25 mg – Hypromellose, PEG, Titanium Dioxide, FD&C Blue #1 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Red #40 Aluminum Lake; 50 mg - Hypromellose; PEG, Titanium Dioxide, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #2 Aluminum Lake; 75 mg - Hypromellose, PEG, Titanium Dioxide, and FD&C Blue #2 Aluminum Lake; 100 mg – Hypromellose, PEG, Titanium Dioxide, D&C Yellow #10 Aluminum Lake, and D&C Red #30 Aluminum Lake; 150 mg - Hypromellose , PEG, Titanium Dioxide."
},
{
"NDCCode": "55289-084-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (55289-084-90) ",
"NDC11Code": "55289-0084-90",
"ProductNDC": "55289-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076187",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "ug/1",
"Pharm_Classes": "l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100118",
"SamplePackage": "N"
},
{
"NDCCode": "55700-084-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (55700-084-90)",
"NDC11Code": "55700-0084-90",
"ProductNDC": "55700-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201190",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-11-06",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "68382-084-16",
"PackageDescription": "90 TABLET in 1 BOTTLE (68382-084-16) ",
"NDC11Code": "68382-0084-16",
"ProductNDC": "68382-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090472",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190604",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for: 1 Schizophrenia (14.1), 2 Irritability Associated with Autistic Disorder (14.4), 3 Treatment of Tourette's disorder (14.5).",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1- piperazinyl]butoxy]-3,4-dihydrocarbostyril. The molecular formula is C23H27Cl2N3O2 and its molecular weight is 448.39. The chemical structure is. Each aripiprazole tablet intended for oral administration contains 2 mg or 5 mg or 10 mg or 15 mg or 20 mg or 30 mg of aripiprazole, USP. In addition, each tablet contains the following inactive ingredients: aspartame, calcium stearate, crospovidone and mannitol. Each tablet except 2 mg strength also contains flavor firmenich powder peppermint. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "71610-084-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (71610-084-60) ",
"NDC11Code": "71610-0084-60",
"ProductNDC": "71610-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074569",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180606",
"SamplePackage": "N",
"IndicationAndUsage": "Clonazepam tablets are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect).",
"Description": "Each tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg of clonazepam USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP, 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP, 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, clonazepam, USP is 5-( o-chlorophenyl)-1,3-dihydro-7-nitro-2 H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula:. C 15H 10ClN 3O 3 M.W. 315.72."
},
{
"NDCCode": "82868-084-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-084-90) ",
"NDC11Code": "82868-0084-90",
"ProductNDC": "82868-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216916",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250625",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate is a beta-adrenergic blocker indicated for the treatment of. Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Angina Pectoris. (1.2). Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3).",
"Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in alcohol; slightly soluble in isopropyl alcohol. Inactive ingredients: acetyl tributyl citrate, carnauba wax, colloidal silicon dioxide, ethylcellulose, glyceryl dibehenate, hydroxypropyl cellulose, hypromellose, Microcrystalline cellulose PH 105, Microcrystalline cellulose PH 102, polyethylene glycol, sodium stearyl fumarate, titanium dioxide. Meets USP dissolution test 13."
},
{
"NDCCode": "87063-084-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (87063-084-90) ",
"NDC11Code": "87063-0084-90",
"ProductNDC": "87063-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212399",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260206",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7."
},
{
"NDCCode": "27241-084-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (27241-084-03) ",
"NDC11Code": "27241-0084-03",
"ProductNDC": "27241-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Olmesartan Medoxomil",
"NonProprietaryName": "Amlodipine Besylate And Olmesartan Medoxomil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207216",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170206",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10/40 mg.",
"Description": "Amlodipine besylate and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate, USP and the angiotensin II receptor blocker (ARB) olmesartan medoxomil, USP.The amlodipine besylate, USP component of amlodipine and olmesartan medoxomil tablets, USP is chemically described as 3-ethyl-5-methyl (±)-2-[(2- aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S.Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.The olmesartan medoxomil, USP component of amlodipine and olmesartan medoxomil tablets, USP is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl] imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6.The structural formula for amlodipine besylate, USP is:. The structural formula for olmesartan medoxomil, USP is. Amlodipine and olmesartan medoxomil tablets, USP contain amlodipine besylate, USP a white or almost white powder, and olmesartan medoxomil, USP white to off-white crystalline powder. The molecular weights of amlodipine besylate, USP and olmesartan medoxomil, USP are 567.1 and 558.59, respectively. Amlodipine besylate, USP is slightly soluble in water and 2-propanol, sparingly soluble in ethanol, freely soluble in methanol. Olmesartan medoxomil, USP is practically insoluble in water and sparingly soluble in methanol.Each tablet of amlodipine and olmesartan medoxomil also contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, croscarmellose sodium, and magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/polyethylene glycol, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (10/20 mg and 10/40 mg tablets), and iron oxide black (10/20 mg, 10/40 mg tablets)."
},
{
"NDCCode": "49354-084-01",
"PackageDescription": "400 TUBE in 1 BOX (49354-084-01) > 8 mL in 1 TUBE",
"NDC11Code": "49354-0084-01",
"ProductNDC": "49354-084",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LOTION",
"StartMarketingDate": "20210315",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "HK Kolmar Canada, Inc",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "78; 90",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Unfinished",
"LastUpdate": "2022-07-12",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "15-MAR-21"
},
{
"NDCCode": "68220-022-01",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (68220-022-01) > 60 mL in 1 BOTTLE, WITH APPLICATOR (68220-022-60)",
"NDC11Code": "68220-0022-01",
"ProductNDC": "68220-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sf Rowasa",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "SUSPENSION",
"RouteName": "RECTAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019618",
"LabelerName": "Alaven Pharmaceutical LLC",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/60mL",
"Pharm_Classes": "Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "68220-022-07",
"PackageDescription": "7 BOTTLE, WITH APPLICATOR in 1 CARTON (68220-022-07) > 60 mL in 1 BOTTLE, WITH APPLICATOR (68220-022-60)",
"NDC11Code": "68220-0022-07",
"ProductNDC": "68220-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sf Rowasa",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "SUSPENSION",
"RouteName": "RECTAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019618",
"LabelerName": "Alaven Pharmaceutical LLC",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/60mL",
"Pharm_Classes": "Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "68220-022-14",
"PackageDescription": "14 BOTTLE, WITH APPLICATOR in 1 CARTON (68220-022-14) > 60 mL in 1 BOTTLE, WITH APPLICATOR (68220-022-60)",
"NDC11Code": "68220-0022-14",
"ProductNDC": "68220-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sf Rowasa",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "SUSPENSION",
"RouteName": "RECTAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019618",
"LabelerName": "Alaven Pharmaceutical LLC",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/60mL",
"Pharm_Classes": "Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "68220-022-28",
"PackageDescription": "28 BOTTLE, WITH APPLICATOR in 1 CARTON (68220-022-28) > 60 mL in 1 BOTTLE, WITH APPLICATOR (68220-022-60)",
"NDC11Code": "68220-0022-28",
"ProductNDC": "68220-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sf Rowasa",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "SUSPENSION",
"RouteName": "RECTAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019618",
"LabelerName": "Alaven Pharmaceutical LLC",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/60mL",
"Pharm_Classes": "Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "68220-055-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (68220-055-10) > 100 TABLET in 1 BOTTLE",
"NDC11Code": "68220-0055-10",
"ProductNDC": "68220-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anadrol-50",
"NonProprietaryName": "Oxymetholone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19720601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016848",
"LabelerName": "Alaven Pharmaceutical LLC",
"SubstanceName": "OXYMETHOLONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2021-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19720601",
"SamplePackage": "N"
},
{
"NDCCode": "68220-066-03",
"PackageDescription": "28 BOTTLE in 1 CARTON (68220-066-03) > 60 mL in 1 BOTTLE",
"NDC11Code": "68220-0066-03",
"ProductNDC": "68220-066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rowasa",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "ENEMA",
"RouteName": "RECTAL",
"StartMarketingDate": "19880131",
"EndMarketingDate": "20170930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019618",
"LabelerName": "Alaven Pharmaceutical LLC",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/60mL",
"Pharm_Classes": "Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-10-03"
},
{
"NDCCode": "68220-066-04",
"PackageDescription": "14 BOTTLE in 1 CARTON (68220-066-04) > 60 mL in 1 BOTTLE",
"NDC11Code": "68220-0066-04",
"ProductNDC": "68220-066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rowasa",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "ENEMA",
"RouteName": "RECTAL",
"StartMarketingDate": "19880131",
"EndMarketingDate": "20170930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019618",
"LabelerName": "Alaven Pharmaceutical LLC",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/60mL",
"Pharm_Classes": "Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-10-03"
},
{
"NDCCode": "68220-066-05",
"PackageDescription": "7 BOTTLE in 1 CARTON (68220-066-05) > 60 mL in 1 BOTTLE",
"NDC11Code": "68220-0066-05",
"ProductNDC": "68220-066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rowasa",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "ENEMA",
"RouteName": "RECTAL",
"StartMarketingDate": "19880131",
"EndMarketingDate": "20170930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019618",
"LabelerName": "Alaven Pharmaceutical LLC",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/60mL",
"Pharm_Classes": "Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-10-03"
},
{
"NDCCode": "68220-066-06",
"PackageDescription": "60 mL in 1 BOTTLE (68220-066-06)",
"NDC11Code": "68220-0066-06",
"ProductNDC": "68220-066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rowasa",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "ENEMA",
"RouteName": "RECTAL",
"StartMarketingDate": "19880131",
"EndMarketingDate": "20170930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019618",
"LabelerName": "Alaven Pharmaceutical LLC",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/60mL",
"Pharm_Classes": "Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-10-03"
},
{
"NDCCode": "68220-083-05",
"PackageDescription": "5 TABLET in 1 BLISTER PACK (68220-083-05)",
"NDC11Code": "68220-0083-05",
"ProductNDC": "68220-083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Preferaob Plus Dha",
"NonProprietaryName": "Folic Acid, Heme Iron Polypeptide, Iron Dextran, Potassium Iodide, Zinc Oxide, Selenium, Cupric Sulfate, Cholecalciferol, Thiamine Mononitrate, Alpha-tocopherol Succinate, D-, Riboflavin, Niacinamide,",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101115",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Alaven Pharmaceutical LLC",
"SubstanceName": "FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; POTASSIUM IODIDE; ZINC OXIDE; SELENIUM; CUPRIC SULFATE; CHOLECALCIFEROL; THIAMINE MONONITRATE; ALPHA-TOCOPHEROL SUCCINATE, D-; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE",
"StrengthNumber": "1; 6; 28; 250; 4.5; 65; .8; 400; 1.5; 10; 1.6; 17; 50; 12; 30; 10",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "68220-083-30",
"PackageDescription": "30 TABLET in 1 CARTON (68220-083-30)",
"NDC11Code": "68220-0083-30",
"ProductNDC": "68220-083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Preferaob Plus Dha",
"NonProprietaryName": "Folic Acid, Heme Iron Polypeptide, Iron Dextran, Potassium Iodide, Zinc Oxide, Selenium, Cupric Sulfate, Cholecalciferol, Thiamine Mononitrate, Alpha-tocopherol Succinate, D-, Riboflavin, Niacinamide,",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101115",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Alaven Pharmaceutical LLC",
"SubstanceName": "FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; POTASSIUM IODIDE; ZINC OXIDE; SELENIUM; CUPRIC SULFATE; CHOLECALCIFEROL; THIAMINE MONONITRATE; ALPHA-TOCOPHEROL SUCCINATE, D-; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE",
"StrengthNumber": "1; 6; 28; 250; 4.5; 65; .8; 400; 1.5; 10; 1.6; 17; 50; 12; 30; 10",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "68220-085-25",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (68220-085-25) > 5 TABLET in 1 BLISTER PACK (68220-085-05)",
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"ProductNDC": "68220-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Biferarx",
"NonProprietaryName": "Folic Acid, Heme Iron Polypeptide, Iron Dextran, And Cyanocobalamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100501",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Alaven Pharmaceutical LLC",
"SubstanceName": "FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; CYANOCOBALAMIN",
"StrengthNumber": "1; 6; 22; 25",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin B 12 [CS],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "68220-086-25",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (68220-086-25) > 5 CAPSULE in 1 BLISTER PACK (68220-086-05)",
"NDC11Code": "68220-0086-25",
"ProductNDC": "68220-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Preferaob One",
"NonProprietaryName": "Folic Acid, Heme Iron Polypeptide, Iron Dextran, Potassium Iodide, Zinc Oxide, Ascorbic Acid, Cholecalciferol, Doconexent, .alpha.-tocopherol Acetate, Dl-, Niacinamide, Pyridoxine Hydrochloride, Cyano",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Alaven Pharmaceutical LLC",
"SubstanceName": "FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; POTASSIUM IODIDE; ZINC OXIDE; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; .ALPHA.-TOCOPHEROL ACETATE, DL-; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE",
"StrengthNumber": "1; 6; 22; 175; 15; 25; 400; 200; 10; 17; 50; 12; 30; 10",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "68220-086-30",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (68220-086-30) > 5 CAPSULE in 1 BLISTER PACK (68220-086-05)",
"NDC11Code": "68220-0086-30",
"ProductNDC": "68220-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Preferaob One",
"NonProprietaryName": "Folic Acid, Heme Iron Polypeptide, Iron Dextran, Potassium Iodide, Zinc Oxide, Ascorbic Acid, Cholecalciferol, Doconexent, .alpha.-tocopherol Acetate, Dl-, Niacinamide, Pyridoxine Hydrochloride, Cyano",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Alaven Pharmaceutical LLC",
"SubstanceName": "FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; POTASSIUM IODIDE; ZINC OXIDE; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; .ALPHA.-TOCOPHEROL ACETATE, DL-; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE",
"StrengthNumber": "1; 6; 22; 175; 15; 25; 400; 200; 10; 17; 50; 12; 30; 10",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
}
]
}
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<NDCList>
<NDC>
<NDCCode>68220-084-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68220-084-90)</PackageDescription>
<NDC11Code>68220-0084-90</NDC11Code>
<ProductNDC>68220-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Preferaob</ProprietaryName>
<NonProprietaryName>Folic Acid, Heme Iron Polypeptide, Iron Dextran, Potassium Iodide, Zinc Oxide, Selenium, Cupric Sulfate, Cholecalciferol, Thiamine Mononitrate, Alpha-tocopherol Succinate, D-, Riboflavin, Niacinamide,</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100927</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Alaven Pharmaceutical LLC</LabelerName>
<SubstanceName>FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; POTASSIUM IODIDE; ZINC OXIDE; SELENIUM; CUPRIC SULFATE; CHOLECALCIFEROL; THIAMINE MONONITRATE; ALPHA-TOCOPHEROL SUCCINATE, D-; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE</SubstanceName>
<StrengthNumber>1; 6; 28; 250; 4.5; 65; .8; 400; 1.5; 10; 1.6; 17; 50; 12; 30; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68220-085-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68220-085-90)</PackageDescription>
<NDC11Code>68220-0085-90</NDC11Code>
<ProductNDC>68220-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Biferarx</ProprietaryName>
<NonProprietaryName>Folic Acid, Heme Iron Polypeptide, Iron Dextran, And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Alaven Pharmaceutical LLC</LabelerName>
<SubstanceName>FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>1; 6; 22; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin B 12 [CS],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>27241-084-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (27241-084-09) </PackageDescription>
<NDC11Code>27241-0084-09</NDC11Code>
<ProductNDC>27241-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207216</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10/40 mg.</IndicationAndUsage>
<Description>Amlodipine besylate and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate, USP and the angiotensin II receptor blocker (ARB) olmesartan medoxomil, USP.The amlodipine besylate, USP component of amlodipine and olmesartan medoxomil tablets, USP is chemically described as 3-ethyl-5-methyl (±)-2-[(2- aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S.Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.The olmesartan medoxomil, USP component of amlodipine and olmesartan medoxomil tablets, USP is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl] imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6.The structural formula for amlodipine besylate, USP is:. The structural formula for olmesartan medoxomil, USP is. Amlodipine and olmesartan medoxomil tablets, USP contain amlodipine besylate, USP a white or almost white powder, and olmesartan medoxomil, USP white to off-white crystalline powder. The molecular weights of amlodipine besylate, USP and olmesartan medoxomil, USP are 567.1 and 558.59, respectively. Amlodipine besylate, USP is slightly soluble in water and 2-propanol, sparingly soluble in ethanol, freely soluble in methanol. Olmesartan medoxomil, USP is practically insoluble in water and sparingly soluble in methanol.Each tablet of amlodipine and olmesartan medoxomil also contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, croscarmellose sodium, and magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/polyethylene glycol, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (10/20 mg and 10/40 mg tablets), and iron oxide black (10/20 mg, 10/40 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>31722-084-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (31722-084-90) </PackageDescription>
<NDC11Code>31722-0084-90</NDC11Code>
<ProductNDC>31722-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240821</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218174</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lurasidone hydrochloride tablets are indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1)] . Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)]. Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)].</IndicationAndUsage>
<Description>Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a R,4 S,7 R,7a S)-2-{(1 R,2 R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28H 36N 4O 2S·HCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in methanol. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are croscarmellose sodium, hypromellose, magnesium stearate, mannitol, polyethylene glycol, pregelatinized starch (maize), and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>33261-084-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (33261-084-90)</PackageDescription>
<NDC11Code>33261-0084-90</NDC11Code>
<ProductNDC>33261-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078432</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>275</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Naproxen Sodium Tablets, USP and other treatment options before deciding to use Naproxen Sodium Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight. Naproxen as naproxen sodium tablets are indicated. For the relief of the signs and symptoms of rheumatoid arthritis. For the relief of the signs and symptoms of osteoarthritis. For the relief of the signs and symptoms of ankylosing spondylitis. For the relief of the signs and symptoms of juvenile arthritis. For relief of the signs and symptoms of tendonitis. For relief of the signs and symptoms of bursitis. For relief of the signs and symptoms of acute gout. For the management of pain. For the management of primary dysmenorrhea.</IndicationAndUsage>
<Description>Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen sodium is (S)-6-methoxy-〈-methyl-2-naphthalene acetic acid, sodium salt. Naproxen sodium has the following structure. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen Sodium Tablets, USP are available as blue tablets containing 275 mg of naproxen sodium and as blue tablets containing 550 mg of naproxen sodium. The inactive ingredients are. croscarmellose sodium, macrogol, magnesium stearate, polyvinly alcohol, povidone, talc, titanium dioxide and FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>43353-084-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (43353-084-60)</PackageDescription>
<NDC11Code>43353-0084-60</NDC11Code>
<ProductNDC>43353-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19851119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070213</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Each tablet for oral administration contains 10 mg, 20 mg, 40 mg, 60 mg or 80 mg of propranolol hydrochloride and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The coloring agents are. 10 mg: FD&C Yellow No. 6 Aluminum Lake. 20 mg: FD&C Blue No. 1 Aluminum Lake. 40 mg: FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. 60 mg: FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. 80 mg: FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>49527-084-90</NDCCode>
<PackageDescription>5000 mL in 1 PAIL (49527-084-90) </PackageDescription>
<NDC11Code>49527-0084-90</NDC11Code>
<ProductNDC>49527-084</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Avobenzone,homosalate,octinoxate,octisalate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<StartMarketingDate>20221101</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>CLINIQUE LABORATORIES LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>30; 70; 70; 45</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>10-MAY-23</StartMarketingDatePackage>
<EndMarketingDatePackage>31-DEC-24</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51655-084-26</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-084-26) </PackageDescription>
<NDC11Code>51655-0084-26</NDC11Code>
<ProductNDC>51655-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213999</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, crystalline powder or small crystals which is freely soluble in water, in alcohol, in chloroform, in methanol and insoluble in ether. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. Each tablet for oral administration contains 10, 25, 50, 75, 100 or 150 mg amitriptyline hydrochloride USP. Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. The 10 mg also includes Hypromellose, PEG, Titanium Dioxide, , D&C Red #27 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake; 25 mg – Hypromellose, PEG, Titanium Dioxide, FD&C Blue #1 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Red #40 Aluminum Lake; 50 mg - Hypromellose; PEG, Titanium Dioxide, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #2 Aluminum Lake; 75 mg - Hypromellose, PEG, Titanium Dioxide, and FD&C Blue #2 Aluminum Lake; 100 mg – Hypromellose, PEG, Titanium Dioxide, D&C Yellow #10 Aluminum Lake, and D&C Red #30 Aluminum Lake; 150 mg - Hypromellose , PEG, Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55289-084-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (55289-084-90) </PackageDescription>
<NDC11Code>55289-0084-90</NDC11Code>
<ProductNDC>55289-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076187</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55700-084-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (55700-084-90)</PackageDescription>
<NDC11Code>55700-0084-90</NDC11Code>
<ProductNDC>55700-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201190</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-06</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68382-084-16</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68382-084-16) </PackageDescription>
<NDC11Code>68382-0084-16</NDC11Code>
<ProductNDC>68382-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090472</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for: 1 Schizophrenia (14.1), 2 Irritability Associated with Autistic Disorder (14.4), 3 Treatment of Tourette's disorder (14.5).</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1- piperazinyl]butoxy]-3,4-dihydrocarbostyril. The molecular formula is C23H27Cl2N3O2 and its molecular weight is 448.39. The chemical structure is. Each aripiprazole tablet intended for oral administration contains 2 mg or 5 mg or 10 mg or 15 mg or 20 mg or 30 mg of aripiprazole, USP. In addition, each tablet contains the following inactive ingredients: aspartame, calcium stearate, crospovidone and mannitol. Each tablet except 2 mg strength also contains flavor firmenich powder peppermint. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>71610-084-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71610-084-60) </PackageDescription>
<NDC11Code>71610-0084-60</NDC11Code>
<ProductNDC>71610-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074569</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonazepam tablets are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect).</IndicationAndUsage>
<Description>Each tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg of clonazepam USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP, 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP, 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, clonazepam, USP is 5-( o-chlorophenyl)-1,3-dihydro-7-nitro-2 H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula:. C 15H 10ClN 3O 3 M.W. 315.72.</Description>
</NDC>
<NDC>
<NDCCode>82868-084-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-084-90) </PackageDescription>
<NDC11Code>82868-0084-90</NDC11Code>
<ProductNDC>82868-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216916</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate is a beta-adrenergic blocker indicated for the treatment of. Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Angina Pectoris. (1.2). Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in alcohol; slightly soluble in isopropyl alcohol. Inactive ingredients: acetyl tributyl citrate, carnauba wax, colloidal silicon dioxide, ethylcellulose, glyceryl dibehenate, hydroxypropyl cellulose, hypromellose, Microcrystalline cellulose PH 105, Microcrystalline cellulose PH 102, polyethylene glycol, sodium stearyl fumarate, titanium dioxide. Meets USP dissolution test 13.</Description>
</NDC>
<NDC>
<NDCCode>87063-084-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (87063-084-90) </PackageDescription>
<NDC11Code>87063-0084-90</NDC11Code>
<ProductNDC>87063-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212399</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>27241-084-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (27241-084-03) </PackageDescription>
<NDC11Code>27241-0084-03</NDC11Code>
<ProductNDC>27241-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207216</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies (14.1)] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10/40 mg.</IndicationAndUsage>
<Description>Amlodipine besylate and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate, USP and the angiotensin II receptor blocker (ARB) olmesartan medoxomil, USP.The amlodipine besylate, USP component of amlodipine and olmesartan medoxomil tablets, USP is chemically described as 3-ethyl-5-methyl (±)-2-[(2- aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S.Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.The olmesartan medoxomil, USP component of amlodipine and olmesartan medoxomil tablets, USP is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl] imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6.The structural formula for amlodipine besylate, USP is:. The structural formula for olmesartan medoxomil, USP is. Amlodipine and olmesartan medoxomil tablets, USP contain amlodipine besylate, USP a white or almost white powder, and olmesartan medoxomil, USP white to off-white crystalline powder. The molecular weights of amlodipine besylate, USP and olmesartan medoxomil, USP are 567.1 and 558.59, respectively. Amlodipine besylate, USP is slightly soluble in water and 2-propanol, sparingly soluble in ethanol, freely soluble in methanol. Olmesartan medoxomil, USP is practically insoluble in water and sparingly soluble in methanol.Each tablet of amlodipine and olmesartan medoxomil also contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, croscarmellose sodium, and magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/polyethylene glycol, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (10/20 mg and 10/40 mg tablets), and iron oxide black (10/20 mg, 10/40 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>49354-084-01</NDCCode>
<PackageDescription>400 TUBE in 1 BOX (49354-084-01) > 8 mL in 1 TUBE</PackageDescription>
<NDC11Code>49354-0084-01</NDC11Code>
<ProductNDC>49354-084</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<StartMarketingDate>20210315</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>HK Kolmar Canada, Inc</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>78; 90</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-07-12</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-MAR-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68220-022-01</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (68220-022-01) > 60 mL in 1 BOTTLE, WITH APPLICATOR (68220-022-60)</PackageDescription>
<NDC11Code>68220-0022-01</NDC11Code>
<ProductNDC>68220-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sf Rowasa</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019618</ApplicationNumber>
<LabelerName>Alaven Pharmaceutical LLC</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/60mL</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>68220-022-07</NDCCode>
<PackageDescription>7 BOTTLE, WITH APPLICATOR in 1 CARTON (68220-022-07) > 60 mL in 1 BOTTLE, WITH APPLICATOR (68220-022-60)</PackageDescription>
<NDC11Code>68220-0022-07</NDC11Code>
<ProductNDC>68220-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sf Rowasa</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019618</ApplicationNumber>
<LabelerName>Alaven Pharmaceutical LLC</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/60mL</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>68220-022-14</NDCCode>
<PackageDescription>14 BOTTLE, WITH APPLICATOR in 1 CARTON (68220-022-14) > 60 mL in 1 BOTTLE, WITH APPLICATOR (68220-022-60)</PackageDescription>
<NDC11Code>68220-0022-14</NDC11Code>
<ProductNDC>68220-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sf Rowasa</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019618</ApplicationNumber>
<LabelerName>Alaven Pharmaceutical LLC</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/60mL</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>68220-022-28</NDCCode>
<PackageDescription>28 BOTTLE, WITH APPLICATOR in 1 CARTON (68220-022-28) > 60 mL in 1 BOTTLE, WITH APPLICATOR (68220-022-60)</PackageDescription>
<NDC11Code>68220-0022-28</NDC11Code>
<ProductNDC>68220-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sf Rowasa</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019618</ApplicationNumber>
<LabelerName>Alaven Pharmaceutical LLC</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/60mL</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>68220-055-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68220-055-10) > 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>68220-0055-10</NDC11Code>
<ProductNDC>68220-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anadrol-50</ProprietaryName>
<NonProprietaryName>Oxymetholone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19720601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016848</ApplicationNumber>
<LabelerName>Alaven Pharmaceutical LLC</LabelerName>
<SubstanceName>OXYMETHOLONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19720601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68220-066-03</NDCCode>
<PackageDescription>28 BOTTLE in 1 CARTON (68220-066-03) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>68220-0066-03</NDC11Code>
<ProductNDC>68220-066</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rowasa</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>ENEMA</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>19880131</StartMarketingDate>
<EndMarketingDate>20170930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019618</ApplicationNumber>
<LabelerName>Alaven Pharmaceutical LLC</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/60mL</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>68220-066-04</NDCCode>
<PackageDescription>14 BOTTLE in 1 CARTON (68220-066-04) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>68220-0066-04</NDC11Code>
<ProductNDC>68220-066</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rowasa</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>ENEMA</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>19880131</StartMarketingDate>
<EndMarketingDate>20170930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019618</ApplicationNumber>
<LabelerName>Alaven Pharmaceutical LLC</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/60mL</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>68220-066-05</NDCCode>
<PackageDescription>7 BOTTLE in 1 CARTON (68220-066-05) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>68220-0066-05</NDC11Code>
<ProductNDC>68220-066</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rowasa</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>ENEMA</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>19880131</StartMarketingDate>
<EndMarketingDate>20170930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019618</ApplicationNumber>
<LabelerName>Alaven Pharmaceutical LLC</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/60mL</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>68220-066-06</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (68220-066-06)</PackageDescription>
<NDC11Code>68220-0066-06</NDC11Code>
<ProductNDC>68220-066</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rowasa</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>ENEMA</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>19880131</StartMarketingDate>
<EndMarketingDate>20170930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019618</ApplicationNumber>
<LabelerName>Alaven Pharmaceutical LLC</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/60mL</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>68220-083-05</NDCCode>
<PackageDescription>5 TABLET in 1 BLISTER PACK (68220-083-05)</PackageDescription>
<NDC11Code>68220-0083-05</NDC11Code>
<ProductNDC>68220-083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Preferaob Plus Dha</ProprietaryName>
<NonProprietaryName>Folic Acid, Heme Iron Polypeptide, Iron Dextran, Potassium Iodide, Zinc Oxide, Selenium, Cupric Sulfate, Cholecalciferol, Thiamine Mononitrate, Alpha-tocopherol Succinate, D-, Riboflavin, Niacinamide,</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101115</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Alaven Pharmaceutical LLC</LabelerName>
<SubstanceName>FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; POTASSIUM IODIDE; ZINC OXIDE; SELENIUM; CUPRIC SULFATE; CHOLECALCIFEROL; THIAMINE MONONITRATE; ALPHA-TOCOPHEROL SUCCINATE, D-; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE</SubstanceName>
<StrengthNumber>1; 6; 28; 250; 4.5; 65; .8; 400; 1.5; 10; 1.6; 17; 50; 12; 30; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68220-083-30</NDCCode>
<PackageDescription>30 TABLET in 1 CARTON (68220-083-30)</PackageDescription>
<NDC11Code>68220-0083-30</NDC11Code>
<ProductNDC>68220-083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Preferaob Plus Dha</ProprietaryName>
<NonProprietaryName>Folic Acid, Heme Iron Polypeptide, Iron Dextran, Potassium Iodide, Zinc Oxide, Selenium, Cupric Sulfate, Cholecalciferol, Thiamine Mononitrate, Alpha-tocopherol Succinate, D-, Riboflavin, Niacinamide,</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101115</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Alaven Pharmaceutical LLC</LabelerName>
<SubstanceName>FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; POTASSIUM IODIDE; ZINC OXIDE; SELENIUM; CUPRIC SULFATE; CHOLECALCIFEROL; THIAMINE MONONITRATE; ALPHA-TOCOPHEROL SUCCINATE, D-; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE</SubstanceName>
<StrengthNumber>1; 6; 28; 250; 4.5; 65; .8; 400; 1.5; 10; 1.6; 17; 50; 12; 30; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68220-085-25</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (68220-085-25) > 5 TABLET in 1 BLISTER PACK (68220-085-05)</PackageDescription>
<NDC11Code>68220-0085-25</NDC11Code>
<ProductNDC>68220-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Biferarx</ProprietaryName>
<NonProprietaryName>Folic Acid, Heme Iron Polypeptide, Iron Dextran, And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Alaven Pharmaceutical LLC</LabelerName>
<SubstanceName>FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>1; 6; 22; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin B 12 [CS],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68220-086-25</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (68220-086-25) > 5 CAPSULE in 1 BLISTER PACK (68220-086-05)</PackageDescription>
<NDC11Code>68220-0086-25</NDC11Code>
<ProductNDC>68220-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Preferaob One</ProprietaryName>
<NonProprietaryName>Folic Acid, Heme Iron Polypeptide, Iron Dextran, Potassium Iodide, Zinc Oxide, Ascorbic Acid, Cholecalciferol, Doconexent, .alpha.-tocopherol Acetate, Dl-, Niacinamide, Pyridoxine Hydrochloride, Cyano</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Alaven Pharmaceutical LLC</LabelerName>
<SubstanceName>FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; POTASSIUM IODIDE; ZINC OXIDE; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; .ALPHA.-TOCOPHEROL ACETATE, DL-; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE</SubstanceName>
<StrengthNumber>1; 6; 22; 175; 15; 25; 400; 200; 10; 17; 50; 12; 30; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68220-086-30</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (68220-086-30) > 5 CAPSULE in 1 BLISTER PACK (68220-086-05)</PackageDescription>
<NDC11Code>68220-0086-30</NDC11Code>
<ProductNDC>68220-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Preferaob One</ProprietaryName>
<NonProprietaryName>Folic Acid, Heme Iron Polypeptide, Iron Dextran, Potassium Iodide, Zinc Oxide, Ascorbic Acid, Cholecalciferol, Doconexent, .alpha.-tocopherol Acetate, Dl-, Niacinamide, Pyridoxine Hydrochloride, Cyano</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Alaven Pharmaceutical LLC</LabelerName>
<SubstanceName>FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; POTASSIUM IODIDE; ZINC OXIDE; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; .ALPHA.-TOCOPHEROL ACETATE, DL-; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE</SubstanceName>
<StrengthNumber>1; 6; 22; 175; 15; 25; 400; 200; 10; 17; 50; 12; 30; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>