{
"NDC": [
{
"NDCCode": "68682-992-10",
"PackageDescription": "1 TUBE in 1 CARTON (68682-992-10) > 120 g in 1 TUBE",
"NDC11Code": "68682-0992-10",
"ProductNDC": "68682-992",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140106",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021758",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140106",
"SamplePackage": "N"
},
{
"NDCCode": "68682-992-30",
"PackageDescription": "1 TUBE in 1 CARTON (68682-992-30) > 30 g in 1 TUBE",
"NDC11Code": "68682-0992-30",
"ProductNDC": "68682-992",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140106",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021758",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140106",
"SamplePackage": "N"
},
{
"NDCCode": "68682-992-60",
"PackageDescription": "1 TUBE in 1 CARTON (68682-992-60) > 60 g in 1 TUBE",
"NDC11Code": "68682-0992-60",
"ProductNDC": "68682-992",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140106",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021758",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140106",
"SamplePackage": "N"
},
{
"NDCCode": "16590-992-10",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (16590-992-10)",
"NDC11Code": "16590-0992-10",
"ProductNDC": "16590-992",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110813",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076361",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Levofloxacin tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testing. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Clinical Pharmacology (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.",
"Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. C18H20FN3O4½ H2O M.W. 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3 > Cu+2 > Zn+2 > Mg+2 > Ca+2. Excipients and Description of Dosage Form. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 2 500 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "42385-992-68",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (42385-992-68) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-992-10) ",
"NDC11Code": "42385-0992-68",
"ProductNDC": "42385-992",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218897",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260422",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2) Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
"Description": "Valsartan tablets, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as L-Valine, N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-. Its molecular formula is C24H29N5O3, its molecular weight is 435.53 g/mol, and its structural formula is. Valsartan, USP is a white to almost white powder. It is freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride and practically insoluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, iron oxides (yellow, black and/or red), hypromellose, polyethylene glycol 8000, and titanium dioxide."
},
{
"NDCCode": "54458-992-10",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (54458-992-10) ",
"NDC11Code": "54458-0992-10",
"ProductNDC": "54458-992",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril And Hydrochlorothiazide",
"NonProprietaryName": "Lisinopril And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077912",
"LabelerName": "International Laboratories, LLC",
"SubstanceName": "LISINOPRIL; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "20; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20071215",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets USP, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS). In considering use of lisinopril and hydrochlorothiazide tablets USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients. (See WARNINGS, Lisinopril).",
"Description": "Lisinopril and hydrochlorothiazide tablet USP combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril Chem Structure. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets USP are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide; lisinopril and hydrochlorothiazide tablets USP, 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide; and lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg, containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch and starch (corn). Lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg also contains FD&C Blue No. 2 Aluminum Lake. Lisinopril and hydrochlorothiazide tablets USP, 20 mg/12.5 mg also contains yellow iron oxide and lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg also contain red iron oxide."
},
{
"NDCCode": "55315-992-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (55315-992-10)",
"NDC11Code": "55315-0992-10",
"ProductNDC": "55315-992",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091353",
"LabelerName": "FREDS INC",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "■ temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ muscular aches ■ backache ■ menstrual cramps ■ headache ■ toothache ■ the common cold ■ temporarily reduces fever."
},
{
"NDCCode": "55648-992-06",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-992-06) > 8 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "55648-0992-06",
"ProductNDC": "55648-992",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziprasidone Hydrochloride",
"NonProprietaryName": "Ziprasidone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090348",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Ziprasidone hydrochloride capsule is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone hydrochloride to prolong the QT interval and may consider the use of other drugs first (5.2). Ziprasidone hydrochloride capsule is indicated as an oral formulation for the:. Treatment of schizophrenia. (1.1) : 1 Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in adult patients with schizophrenia (14.1) .",
"Description": "Ziprasidone hydrochloride is available as capsules for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2- benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone hydrochloride capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The molecular formula is C21H21ClN4OS·HCl·H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. Ziprasidone HCl capsules are supplied for oral administration in 20 mg, 40 mg, 60 mg, and 80 mg capsules. Ziprasidone HCl capsules contain ziprasidone hydrochloride monohydrate, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, talc and magnesium stearate, titanium dioxide, gelatin. Additionally, the 40 mg capsule shell contains FD&C blue #1 and FD&C red #3, the 60 mg capsule shell contains D & C red # 28, FD&C red # 40 and FD&C yellow # 6 and the 80 mg capsule shell contains FD&C blue # 1 and FD&C red # 3."
},
{
"NDCCode": "55910-992-73",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (55910-992-73) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55910-0992-73",
"ProductNDC": "55910-992",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief Dm",
"NonProprietaryName": "Guaifenesin And Dextromethorphan Hbr",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206941",
"LabelerName": "Dolgencorp, LLC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "30; 600",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170317",
"SamplePackage": "N"
},
{
"NDCCode": "59630-992-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (59630-992-10)",
"NDC11Code": "59630-0992-10",
"ProductNDC": "59630-992",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Magnacet",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040687",
"LabelerName": "Shionogi Inc",
"SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "400; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2015-04-10"
},
{
"NDCCode": "61919-992-30",
"PackageDescription": "30 BOTTLE in 1 BOTTLE (61919-992-30) > 14 BOTTLE in 1 BOTTLE (61919-992-14) > 10 BOTTLE in 1 BOTTLE (61919-992-10) > 7 TABLET, FILM COATED in 1 BOTTLE (61919-992-07)",
"NDC11Code": "61919-0992-30",
"ProductNDC": "61919-992",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076361",
"LabelerName": "Direct RX",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Levofloxacin tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Culture and Susceptibility Testing. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4)]. Therapy with levofloxacin tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance. 1.1 Nosocomial Pneumonia. Levofloxacin tablets are indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1)]. 1.2 Community-Acquired Pneumonia: 7 to 14 Day Treatment Regimen. Levofloxacin tablets are indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2)]. MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥ 2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. 1.3 Community-Acquired Pneumonia: 5 Day Treatment Regimen. Levofloxacin tablets are indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.3)]. 1.4 Acute Bacterial Sinusitis: 5 Day and 10 to 14 Day Treatment Regimens. Levofloxacin tablets are indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)]. 1.5 Acute Bacterial Exacerbation of Chronic Bronchitis. Levofloxacin tablets are indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis. 1.6 Complicated Skin and Skin Structure Infections. Levofloxacin tablets are indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)]. 1.7 Uncomplicated Skin and Skin Structure Infections. Levofloxacin tablets are indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes. 1.8 Chronic Bacterial Prostatitis. Levofloxacin tablets are indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)]. 1.9 Complicated Urinary Tract Infections: 5 Day Treatment Regimen. Levofloxacin tablets are indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)]. 1.10 Complicated Urinary Tract Infections: 10 Day Treatment Regimen. Levofloxacin tablets are indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies (14.8)]. 1.11 Acute Pyelonephritis: 5 or 10 Day Treatment Regimen. Levofloxacin tablets are indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies (14.7, 14.8)]. 1.12 Uncomplicated Urinary Tract Infections. Levofloxacin tablets are indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. 1.13 Inhalational Anthrax (Post-Exposure). Levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin tablets is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin tablets have not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.9)]. 1.14 Plague. Levofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of levofloxacin tablets could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.10)].",
"Description": "Levofloxacin tablets are a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, USP, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin, USP. Levofloxacin, USP is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin, USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3 > Cu+2 > Zn+2 > Mg+2 > Ca+2. Excipients and Description of Dosage Form. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 2 500 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "62207-992-01",
"PackageDescription": "10 kg in 1 DRUM (62207-992-01) ",
"NDC11Code": "62207-0992-01",
"ProductNDC": "62207-992",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Sodium Oxybate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Granules India Limited",
"SubstanceName": "SODIUM OXYBATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CI",
"Status": "Unfinished",
"LastUpdate": "2025-12-31",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-DEC-25"
},
{
"NDCCode": "63739-992-10",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-992-10) / 10 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "63739-0992-10",
"ProductNDC": "63739-992",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol Tablets",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210722",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209312",
"LabelerName": "McKesson Corporation dba SKY Packaging",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210722",
"EndMarketingDatePackage": "20260331",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol tablet, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-.(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24g/mol. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with \"G\" above the score line on one side and \"500\" on other side. Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with \"G\" on one side and \"750\" on other side. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. The tabets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide."
},
{
"NDCCode": "64679-992-06",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (64679-992-06) > 8 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "64679-0992-06",
"ProductNDC": "64679-992",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziprasidone Hydrochloride",
"NonProprietaryName": "Ziprasidone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090348",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20120901",
"SamplePackage": "N",
"IndicationAndUsage": "Ziprasidone hydrochloride capsule is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone hydrochloride to prolong the QT interval and may consider the use of other drugs first (5.2). Ziprasidone hydrochloride capsule is indicated as an oral formulation for the: Treatment of schizophrenia. (1.1): 1 Adults: Efficacy was established in four 4 to 6 week trials and one maintenance trial in adult patients with schizophrenia. (14.1).",
"Description": "Ziprasidone hydrochloride is available as capsules for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone hydrochloride capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The molecular formula is C21H21ClN4OSHClH2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. Ziprasidone hydrochloride capsules are supplied for oral administration in 20 mg (white/white), 40 mg (blue/white), 60 mg (pink/white), and 80 mg (blue/blue) capsules. Ziprasidone hydrochloride capsules contain ziprasidone hydrochloride monohydrate, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, talc and magnesium stearate, titanium dioxide, and gelatin. Additionally, the 40 mg capsule shell contains FD&C blue #1 and FD&C red #3, the 60 mg capsule shell contains D & C red #28, FD&C red #40 and FD&C yellow #6 and the 80 mg capsule shell contains FD&C blue #1 and FD&C red #3."
},
{
"NDCCode": "68453-992-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (68453-992-10)",
"NDC11Code": "68453-0992-10",
"ProductNDC": "68453-992",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Magnacet",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040687",
"LabelerName": "Victory Pharma",
"SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "400; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2014-07-21"
},
{
"NDCCode": "68682-003-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (68682-003-10) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "68682-0003-10",
"ProductNDC": "68682-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bexarotene",
"NonProprietaryName": "Bexarotene",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20151217",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021055",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "BEXAROTENE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20151217",
"SamplePackage": "N",
"IndicationAndUsage": "Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.",
"Description": "Bexarotene capsules contain bexarotene, a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). The chemical name of bexarotene is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl)ethenyl]benzoic acid, and the structural formula is as follows:. Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of C24H28O2. It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP. Each bexarotene capsule contains 75 mg of bexarotene for oral administration. It also contains the following inactive ingredients: butylated hydroxyanisole, NF, polyethylene glycol 400, NF, polysorbate 20, NF, and povidone, USP. The capsule shell contains gelatin, NF, sorbitol special glycerin blend, and titanium dioxide, USP."
},
{
"NDCCode": "68682-006-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (68682-006-10) ",
"NDC11Code": "68682-0006-10",
"ProductNDC": "68682-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101225",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018602",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101225",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each tablet contains 30 mg, 60 mg, 90 mg, or 120 mg diltiazem hydrochloride. Also contains: colloidal silicon dioxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake (30 mg and 90 mg), FD&C Yellow #6 Aluminum Lake (60 mg and 120 mg), hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, and polyethylene glycol. For oral administration."
},
{
"NDCCode": "68682-007-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (68682-007-10) ",
"NDC11Code": "68682-0007-10",
"ProductNDC": "68682-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101225",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018602",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101225",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each tablet contains 30 mg, 60 mg, 90 mg, or 120 mg diltiazem hydrochloride. Also contains: colloidal silicon dioxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake (30 mg and 90 mg), FD&C Yellow #6 Aluminum Lake (60 mg and 120 mg), hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, and polyethylene glycol. For oral administration."
},
{
"NDCCode": "68682-008-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (68682-008-10) ",
"NDC11Code": "68682-0008-10",
"ProductNDC": "68682-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101225",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018602",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101225",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each tablet contains 30 mg, 60 mg, 90 mg, or 120 mg diltiazem hydrochloride. Also contains: colloidal silicon dioxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake (30 mg and 90 mg), FD&C Yellow #6 Aluminum Lake (60 mg and 120 mg), hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, and polyethylene glycol. For oral administration."
},
{
"NDCCode": "68682-009-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (68682-009-10) ",
"NDC11Code": "68682-0009-10",
"ProductNDC": "68682-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101225",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018602",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101225",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each tablet contains 30 mg, 60 mg, 90 mg, or 120 mg diltiazem hydrochloride. Also contains: colloidal silicon dioxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake (30 mg and 90 mg), FD&C Yellow #6 Aluminum Lake (60 mg and 120 mg), hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, and polyethylene glycol. For oral administration."
},
{
"NDCCode": "68682-011-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (68682-011-10) ",
"NDC11Code": "68682-0011-10",
"ProductNDC": "68682-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ethacrynic Acid",
"NonProprietaryName": "Ethacrynic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19670110",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA016092",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "ETHACRYNIC ACID",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19670110",
"SamplePackage": "N",
"IndicationAndUsage": "Ethacrynic acid is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. : 1 1.Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome., 2 2.Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema., 3 3.Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome., 4 4.Intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.",
"Description": "Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C 13H 12Cl 2O 4and its structural formula is:. Ethacrynate sodium, the sodium salt of ethacrynic acid, is soluble in water at 25°C to the extent of about 7 percent. Solutions of the sodium salt are relatively stable at about pH 7 at room temperature for short periods, but as the pH or temperature increases the solutions are less stable. The molecular weight of ethacrynate sodium is 325.12. Its empirical formula is C 13H 11Cl 2NaO 4and its structural formula is:. Ethacrynic acid is supplied as 25 mg tablets for oral use. The tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, starch and talc. Intravenous ethacrynate sodium is a sterile freeze-dried powder and is supplied in a vial containing: 1 Ethacrynate sodium equivalent to ethacrynic acid . . . . . . . . . 50.0 mg ."
},
{
"NDCCode": "68682-017-10",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-017-10) ",
"NDC11Code": "68682-0017-10",
"ProductNDC": "68682-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20060801",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021748",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20060801",
"SamplePackage": "N"
},
{
"NDCCode": "68682-020-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (68682-020-10) ",
"NDC11Code": "68682-0020-10",
"ProductNDC": "68682-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillamine",
"NonProprietaryName": "Penicillamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19701204",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019853",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "PENICILLAMINE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antirheumatic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19701204",
"SamplePackage": "N",
"IndicationAndUsage": "Penicillamine Capsules are indicated in the treatment of Wilson's disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. Available evidence suggests that Penicillamine Capsules are not of value in ankylosing spondylitis.",
"Description": "Penicillamine, USP is a chelating agent used in the treatment of Wilson’s disease. It is also used to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis unresponsive to conventional therapy (see INDICATIONS). It is 3-mercapto-D-valine. It is a white, or practically white, crystalline powder, freely soluble in water, slightly soluble in alcohol, and insoluble in ether, acetone, benzene, and carbon tetrachloride. Although its configuration is D, it is levorotatory as usually measured:. calculated on a dried basis. The empirical formula is C5H11NO2S, giving it a molecular weight of 149.21. The structural formula is. It reacts readily with formaldehyde or acetone to form a thiazolidine-carboxylic acid. Penicillamine Capsules for oral administration contain 250 mg of penicillamine. Each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, lactose monohydrate, magnesium stearate, and titanium dioxide."
},
{
"NDCCode": "68682-022-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (68682-022-10) ",
"NDC11Code": "68682-0022-10",
"ProductNDC": "68682-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methazolamide",
"NonProprietaryName": "Methazolamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207438",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "METHAZOLAMIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201002",
"SamplePackage": "N",
"IndicationAndUsage": "Methazolamide tablets are indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery.",
"Description": "Methazolamide USP, a sulfonamide derivative, is a white or faintly yellow, crystalline powder having a slight odor, soluble in dimethylformamide, slightly soluble in acetone, very slightly soluble in water and in alcohol. The chemical name for methazolamide is: N-[5-(aminosulfonyl)-3-methyl-1,3,4-thiadiazol-2(3H)-ylidene]-acetamide and it has the following structural formula. Each tablet, for oral administration, contains 25 mg or 50 mg methazolamide USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, and microcrystalline cellulose."
},
{
"NDCCode": "68682-023-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (68682-023-10) ",
"NDC11Code": "68682-0023-10",
"ProductNDC": "68682-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methazolamide",
"NonProprietaryName": "Methazolamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207438",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "METHAZOLAMIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201002",
"SamplePackage": "N",
"IndicationAndUsage": "Methazolamide tablets are indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery.",
"Description": "Methazolamide USP, a sulfonamide derivative, is a white or faintly yellow, crystalline powder having a slight odor, soluble in dimethylformamide, slightly soluble in acetone, very slightly soluble in water and in alcohol. The chemical name for methazolamide is: N-[5-(aminosulfonyl)-3-methyl-1,3,4-thiadiazol-2(3H)-ylidene]-acetamide and it has the following structural formula. Each tablet, for oral administration, contains 25 mg or 50 mg methazolamide USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, and microcrystalline cellulose."
},
{
"NDCCode": "68682-065-10",
"PackageDescription": "50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68682-065-10) ",
"NDC11Code": "68682-0065-10",
"ProductNDC": "68682-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methoxsalen",
"NonProprietaryName": "Methoxsalen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20140715",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019600",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "METHOXSALEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Psoralen [EPC],Psoralens [CS],Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140715",
"SamplePackage": "N"
},
{
"NDCCode": "68682-101-10",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-101-10) ",
"NDC11Code": "68682-0101-10",
"ProductNDC": "68682-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pentoxifylline",
"NonProprietaryName": "Pentoxifylline",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075028",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "PENTOXIFYLLINE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Viscosity Reducer [EPC], Hematologic Activity Alteration [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20140822",
"SamplePackage": "N",
"IndicationAndUsage": "Pentoxifylline Extended-Release Tablets are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline Extended-Release Tablets can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.",
"Description": "Pentoxifylline Extended-Release Tablets for oral administration, contain 400 mg of the active drug and the following inactive ingredients: hydroxyethyl cellulose, magnesium stearate, povidone, and talc in an extended-release formulation. Pentoxifylline is a tri-substituted xanthine derivative designated chemically as 1-(5-oxohexyl)-3, 7-dimethylxanthine that, unlike theophylline, is a hemorrheologic agent, i.e. an agent that affects blood viscosity. Pentoxifylline is soluble in water and ethanol, and sparingly soluble in toluene. The chemical structure is. Molecular weight: 278.31. Molecular formula: C13H18N4O3."
},
{
"NDCCode": "68682-105-10",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-105-10) ",
"NDC11Code": "68682-0105-10",
"ProductNDC": "68682-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075269",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121018",
"SamplePackage": "N",
"IndicationAndUsage": "Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Nifedipine extended-release tablets are an extended-release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)- dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets contain 30 mg of nifedipine for once-a-day oral administration. In addition, each tablet contains the following inactive ingredients: ethylcellulose, ferric oxide yellow, hydroxyethyl cellulose, hypromellose, anhydrous lactose, magnesium stearate, microcrystalline cellulose, amino methacrylate copolymer, polyethylene glycol, colloidal silicon dioxide, sodium lauryl sulfate, talc, and titanium dioxide."
},
{
"NDCCode": "68682-106-10",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-106-10) ",
"NDC11Code": "68682-0106-10",
"ProductNDC": "68682-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20001204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075269",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20001204",
"SamplePackage": "N",
"IndicationAndUsage": "Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Nifedipine extended-release tablets are an extended-release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)- dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets contain 60 mg of nifedipine for once-a-day oral administration. In addition, each tablet contains the following inactive ingredients: ethylcellulose, ferric oxide yellow, hydroxyethyl cellulose, hypromellose, anhydrous lactose, magnesium stearate, microcrystalline cellulose, amino methacrylate copolymer, polyethylene glycol, colloidal silicon dioxide, sodium lauryl sulfate, talc, and titanium dioxide."
},
{
"NDCCode": "68682-107-10",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-107-10) ",
"NDC11Code": "68682-0107-10",
"ProductNDC": "68682-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20020816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076070",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020816",
"SamplePackage": "N",
"IndicationAndUsage": "Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Nifedipine extended-release tablets are an extended-release tablet dosage form of the calcium channel blocker nifedipine. The product is provided as a general matrix tablet with a polymer coating. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)- dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets contain 90 mg of nifedipine for once-a-day oral administration. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, ethylcellulose, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin. Contains FD&C Yellow No. 5 (tartrazine) as a color additive."
}
]
}
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<NDCList>
<NDC>
<NDCCode>68682-992-10</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68682-992-10) > 120 g in 1 TUBE</PackageDescription>
<NDC11Code>68682-0992-10</NDC11Code>
<ProductNDC>68682-992</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140106</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021758</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68682-992-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68682-992-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>68682-0992-30</NDC11Code>
<ProductNDC>68682-992</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140106</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021758</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68682-992-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68682-992-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>68682-0992-60</NDC11Code>
<ProductNDC>68682-992</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140106</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021758</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16590-992-10</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (16590-992-10)</PackageDescription>
<NDC11Code>16590-0992-10</NDC11Code>
<ProductNDC>16590-992</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110813</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076361</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Levofloxacin tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testing. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Clinical Pharmacology (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.</IndicationAndUsage>
<Description>Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. C18H20FN3O4½ H2O M.W. 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3 > Cu+2 > Zn+2 > Mg+2 > Ca+2. Excipients and Description of Dosage Form. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 2 500 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42385-992-68</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (42385-992-68) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-992-10) </PackageDescription>
<NDC11Code>42385-0992-68</NDC11Code>
<ProductNDC>42385-992</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218897</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2) Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan tablets, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as L-Valine, N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-. Its molecular formula is C24H29N5O3, its molecular weight is 435.53 g/mol, and its structural formula is. Valsartan, USP is a white to almost white powder. It is freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride and practically insoluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, iron oxides (yellow, black and/or red), hypromellose, polyethylene glycol 8000, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54458-992-10</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (54458-992-10) </PackageDescription>
<NDC11Code>54458-0992-10</NDC11Code>
<ProductNDC>54458-992</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077912</ApplicationNumber>
<LabelerName>International Laboratories, LLC</LabelerName>
<SubstanceName>LISINOPRIL; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>20; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets USP, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS). In considering use of lisinopril and hydrochlorothiazide tablets USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients. (See WARNINGS, Lisinopril).</IndicationAndUsage>
<Description>Lisinopril and hydrochlorothiazide tablet USP combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril Chem Structure. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets USP are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide; lisinopril and hydrochlorothiazide tablets USP, 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide; and lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg, containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch and starch (corn). Lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg also contains FD&C Blue No. 2 Aluminum Lake. Lisinopril and hydrochlorothiazide tablets USP, 20 mg/12.5 mg also contains yellow iron oxide and lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg also contain red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>55315-992-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (55315-992-10)</PackageDescription>
<NDC11Code>55315-0992-10</NDC11Code>
<ProductNDC>55315-992</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091353</ApplicationNumber>
<LabelerName>FREDS INC</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>■ temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ muscular aches ■ backache ■ menstrual cramps ■ headache ■ toothache ■ the common cold ■ temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55648-992-06</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55648-992-06) > 8 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55648-0992-06</NDC11Code>
<ProductNDC>55648-992</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziprasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090348</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ziprasidone hydrochloride capsule is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone hydrochloride to prolong the QT interval and may consider the use of other drugs first (5.2). Ziprasidone hydrochloride capsule is indicated as an oral formulation for the:. Treatment of schizophrenia. (1.1) : 1 Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in adult patients with schizophrenia (14.1) .</IndicationAndUsage>
<Description>Ziprasidone hydrochloride is available as capsules for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2- benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone hydrochloride capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The molecular formula is C21H21ClN4OS·HCl·H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. Ziprasidone HCl capsules are supplied for oral administration in 20 mg, 40 mg, 60 mg, and 80 mg capsules. Ziprasidone HCl capsules contain ziprasidone hydrochloride monohydrate, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, talc and magnesium stearate, titanium dioxide, gelatin. Additionally, the 40 mg capsule shell contains FD&C blue #1 and FD&C red #3, the 60 mg capsule shell contains D & C red # 28, FD&C red # 40 and FD&C yellow # 6 and the 80 mg capsule shell contains FD&C blue # 1 and FD&C red # 3.</Description>
</NDC>
<NDC>
<NDCCode>55910-992-73</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (55910-992-73) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55910-0992-73</NDC11Code>
<ProductNDC>55910-992</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief Dm</ProprietaryName>
<NonProprietaryName>Guaifenesin And Dextromethorphan Hbr</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206941</ApplicationNumber>
<LabelerName>Dolgencorp, LLC</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>30; 600</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59630-992-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (59630-992-10)</PackageDescription>
<NDC11Code>59630-0992-10</NDC11Code>
<ProductNDC>59630-992</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Magnacet</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040687</ApplicationNumber>
<LabelerName>Shionogi Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-04-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>61919-992-30</NDCCode>
<PackageDescription>30 BOTTLE in 1 BOTTLE (61919-992-30) > 14 BOTTLE in 1 BOTTLE (61919-992-14) > 10 BOTTLE in 1 BOTTLE (61919-992-10) > 7 TABLET, FILM COATED in 1 BOTTLE (61919-992-07)</PackageDescription>
<NDC11Code>61919-0992-30</NDC11Code>
<ProductNDC>61919-992</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076361</ApplicationNumber>
<LabelerName>Direct RX</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Levofloxacin tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Culture and Susceptibility Testing. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4)]. Therapy with levofloxacin tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance. 1.1 Nosocomial Pneumonia. Levofloxacin tablets are indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1)]. 1.2 Community-Acquired Pneumonia: 7 to 14 Day Treatment Regimen. Levofloxacin tablets are indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2)]. MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥ 2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. 1.3 Community-Acquired Pneumonia: 5 Day Treatment Regimen. Levofloxacin tablets are indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.3)]. 1.4 Acute Bacterial Sinusitis: 5 Day and 10 to 14 Day Treatment Regimens. Levofloxacin tablets are indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)]. 1.5 Acute Bacterial Exacerbation of Chronic Bronchitis. Levofloxacin tablets are indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis. 1.6 Complicated Skin and Skin Structure Infections. Levofloxacin tablets are indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)]. 1.7 Uncomplicated Skin and Skin Structure Infections. Levofloxacin tablets are indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes. 1.8 Chronic Bacterial Prostatitis. Levofloxacin tablets are indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)]. 1.9 Complicated Urinary Tract Infections: 5 Day Treatment Regimen. Levofloxacin tablets are indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)]. 1.10 Complicated Urinary Tract Infections: 10 Day Treatment Regimen. Levofloxacin tablets are indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies (14.8)]. 1.11 Acute Pyelonephritis: 5 or 10 Day Treatment Regimen. Levofloxacin tablets are indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies (14.7, 14.8)]. 1.12 Uncomplicated Urinary Tract Infections. Levofloxacin tablets are indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. 1.13 Inhalational Anthrax (Post-Exposure). Levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin tablets is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin tablets have not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.9)]. 1.14 Plague. Levofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of levofloxacin tablets could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.10)].</IndicationAndUsage>
<Description>Levofloxacin tablets are a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, USP, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin, USP. Levofloxacin, USP is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin, USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3 > Cu+2 > Zn+2 > Mg+2 > Ca+2. Excipients and Description of Dosage Form. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 2 500 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>62207-992-01</NDCCode>
<PackageDescription>10 kg in 1 DRUM (62207-992-01) </PackageDescription>
<NDC11Code>62207-0992-01</NDC11Code>
<ProductNDC>62207-992</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Sodium Oxybate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Granules India Limited</LabelerName>
<SubstanceName>SODIUM OXYBATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CI</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2025-12-31</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-DEC-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>63739-992-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-992-10) / 10 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0992-10</NDC11Code>
<ProductNDC>63739-992</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol Tablets</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210722</StartMarketingDate>
<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209312</ApplicationNumber>
<LabelerName>McKesson Corporation dba SKY Packaging</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210722</StartMarketingDatePackage>
<EndMarketingDatePackage>20260331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol tablet, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-.(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24g/mol. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with "G" above the score line on one side and "500" on other side. Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with "G" on one side and "750" on other side. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. The tabets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>64679-992-06</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (64679-992-06) > 8 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0992-06</NDC11Code>
<ProductNDC>64679-992</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziprasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090348</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ziprasidone hydrochloride capsule is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone hydrochloride to prolong the QT interval and may consider the use of other drugs first (5.2). Ziprasidone hydrochloride capsule is indicated as an oral formulation for the: Treatment of schizophrenia. (1.1): 1 Adults: Efficacy was established in four 4 to 6 week trials and one maintenance trial in adult patients with schizophrenia. (14.1).</IndicationAndUsage>
<Description>Ziprasidone hydrochloride is available as capsules for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone hydrochloride capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The molecular formula is C21H21ClN4OSHClH2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. Ziprasidone hydrochloride capsules are supplied for oral administration in 20 mg (white/white), 40 mg (blue/white), 60 mg (pink/white), and 80 mg (blue/blue) capsules. Ziprasidone hydrochloride capsules contain ziprasidone hydrochloride monohydrate, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, talc and magnesium stearate, titanium dioxide, and gelatin. Additionally, the 40 mg capsule shell contains FD&C blue #1 and FD&C red #3, the 60 mg capsule shell contains D & C red #28, FD&C red #40 and FD&C yellow #6 and the 80 mg capsule shell contains FD&C blue #1 and FD&C red #3.</Description>
</NDC>
<NDC>
<NDCCode>68453-992-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68453-992-10)</PackageDescription>
<NDC11Code>68453-0992-10</NDC11Code>
<ProductNDC>68453-992</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Magnacet</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040687</ApplicationNumber>
<LabelerName>Victory Pharma</LabelerName>
<SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-07-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>68682-003-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68682-003-10) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>68682-0003-10</NDC11Code>
<ProductNDC>68682-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bexarotene</ProprietaryName>
<NonProprietaryName>Bexarotene</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151217</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021055</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>BEXAROTENE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.</IndicationAndUsage>
<Description>Bexarotene capsules contain bexarotene, a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). The chemical name of bexarotene is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl)ethenyl]benzoic acid, and the structural formula is as follows:. Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of C24H28O2. It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP. Each bexarotene capsule contains 75 mg of bexarotene for oral administration. It also contains the following inactive ingredients: butylated hydroxyanisole, NF, polyethylene glycol 400, NF, polysorbate 20, NF, and povidone, USP. The capsule shell contains gelatin, NF, sorbitol special glycerin blend, and titanium dioxide, USP.</Description>
</NDC>
<NDC>
<NDCCode>68682-006-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68682-006-10) </PackageDescription>
<NDC11Code>68682-0006-10</NDC11Code>
<ProductNDC>68682-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101225</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018602</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each tablet contains 30 mg, 60 mg, 90 mg, or 120 mg diltiazem hydrochloride. Also contains: colloidal silicon dioxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake (30 mg and 90 mg), FD&C Yellow #6 Aluminum Lake (60 mg and 120 mg), hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, and polyethylene glycol. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>68682-007-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68682-007-10) </PackageDescription>
<NDC11Code>68682-0007-10</NDC11Code>
<ProductNDC>68682-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101225</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018602</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each tablet contains 30 mg, 60 mg, 90 mg, or 120 mg diltiazem hydrochloride. Also contains: colloidal silicon dioxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake (30 mg and 90 mg), FD&C Yellow #6 Aluminum Lake (60 mg and 120 mg), hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, and polyethylene glycol. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>68682-008-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68682-008-10) </PackageDescription>
<NDC11Code>68682-0008-10</NDC11Code>
<ProductNDC>68682-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101225</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018602</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each tablet contains 30 mg, 60 mg, 90 mg, or 120 mg diltiazem hydrochloride. Also contains: colloidal silicon dioxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake (30 mg and 90 mg), FD&C Yellow #6 Aluminum Lake (60 mg and 120 mg), hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, and polyethylene glycol. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>68682-009-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68682-009-10) </PackageDescription>
<NDC11Code>68682-0009-10</NDC11Code>
<ProductNDC>68682-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101225</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018602</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each tablet contains 30 mg, 60 mg, 90 mg, or 120 mg diltiazem hydrochloride. Also contains: colloidal silicon dioxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake (30 mg and 90 mg), FD&C Yellow #6 Aluminum Lake (60 mg and 120 mg), hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, and polyethylene glycol. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>68682-011-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68682-011-10) </PackageDescription>
<NDC11Code>68682-0011-10</NDC11Code>
<ProductNDC>68682-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ethacrynic Acid</ProprietaryName>
<NonProprietaryName>Ethacrynic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19670110</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA016092</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>ETHACRYNIC ACID</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19670110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ethacrynic acid is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. : 1 1.Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome., 2 2.Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema., 3 3.Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome., 4 4.Intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.</IndicationAndUsage>
<Description>Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C 13H 12Cl 2O 4and its structural formula is:. Ethacrynate sodium, the sodium salt of ethacrynic acid, is soluble in water at 25°C to the extent of about 7 percent. Solutions of the sodium salt are relatively stable at about pH 7 at room temperature for short periods, but as the pH or temperature increases the solutions are less stable. The molecular weight of ethacrynate sodium is 325.12. Its empirical formula is C 13H 11Cl 2NaO 4and its structural formula is:. Ethacrynic acid is supplied as 25 mg tablets for oral use. The tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, starch and talc. Intravenous ethacrynate sodium is a sterile freeze-dried powder and is supplied in a vial containing: 1 Ethacrynate sodium equivalent to ethacrynic acid . . . . . . . . . 50.0 mg .</Description>
</NDC>
<NDC>
<NDCCode>68682-017-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-017-10) </PackageDescription>
<NDC11Code>68682-0017-10</NDC11Code>
<ProductNDC>68682-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060801</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021748</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68682-020-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (68682-020-10) </PackageDescription>
<NDC11Code>68682-0020-10</NDC11Code>
<ProductNDC>68682-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillamine</ProprietaryName>
<NonProprietaryName>Penicillamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19701204</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019853</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>PENICILLAMINE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19701204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Penicillamine Capsules are indicated in the treatment of Wilson's disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. Available evidence suggests that Penicillamine Capsules are not of value in ankylosing spondylitis.</IndicationAndUsage>
<Description>Penicillamine, USP is a chelating agent used in the treatment of Wilson’s disease. It is also used to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis unresponsive to conventional therapy (see INDICATIONS). It is 3-mercapto-D-valine. It is a white, or practically white, crystalline powder, freely soluble in water, slightly soluble in alcohol, and insoluble in ether, acetone, benzene, and carbon tetrachloride. Although its configuration is D, it is levorotatory as usually measured:. calculated on a dried basis. The empirical formula is C5H11NO2S, giving it a molecular weight of 149.21. The structural formula is. It reacts readily with formaldehyde or acetone to form a thiazolidine-carboxylic acid. Penicillamine Capsules for oral administration contain 250 mg of penicillamine. Each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, lactose monohydrate, magnesium stearate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68682-022-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68682-022-10) </PackageDescription>
<NDC11Code>68682-0022-10</NDC11Code>
<ProductNDC>68682-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methazolamide</ProprietaryName>
<NonProprietaryName>Methazolamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207438</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>METHAZOLAMIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methazolamide tablets are indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery.</IndicationAndUsage>
<Description>Methazolamide USP, a sulfonamide derivative, is a white or faintly yellow, crystalline powder having a slight odor, soluble in dimethylformamide, slightly soluble in acetone, very slightly soluble in water and in alcohol. The chemical name for methazolamide is: N-[5-(aminosulfonyl)-3-methyl-1,3,4-thiadiazol-2(3H)-ylidene]-acetamide and it has the following structural formula. Each tablet, for oral administration, contains 25 mg or 50 mg methazolamide USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>68682-023-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68682-023-10) </PackageDescription>
<NDC11Code>68682-0023-10</NDC11Code>
<ProductNDC>68682-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methazolamide</ProprietaryName>
<NonProprietaryName>Methazolamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207438</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>METHAZOLAMIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methazolamide tablets are indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery.</IndicationAndUsage>
<Description>Methazolamide USP, a sulfonamide derivative, is a white or faintly yellow, crystalline powder having a slight odor, soluble in dimethylformamide, slightly soluble in acetone, very slightly soluble in water and in alcohol. The chemical name for methazolamide is: N-[5-(aminosulfonyl)-3-methyl-1,3,4-thiadiazol-2(3H)-ylidene]-acetamide and it has the following structural formula. Each tablet, for oral administration, contains 25 mg or 50 mg methazolamide USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>68682-065-10</NDCCode>
<PackageDescription>50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68682-065-10) </PackageDescription>
<NDC11Code>68682-0065-10</NDC11Code>
<ProductNDC>68682-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methoxsalen</ProprietaryName>
<NonProprietaryName>Methoxsalen</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140715</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019600</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>METHOXSALEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Psoralen [EPC],Psoralens [CS],Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68682-101-10</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-101-10) </PackageDescription>
<NDC11Code>68682-0101-10</NDC11Code>
<ProductNDC>68682-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pentoxifylline</ProprietaryName>
<NonProprietaryName>Pentoxifylline</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075028</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>PENTOXIFYLLINE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Viscosity Reducer [EPC], Hematologic Activity Alteration [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pentoxifylline Extended-Release Tablets are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline Extended-Release Tablets can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.</IndicationAndUsage>
<Description>Pentoxifylline Extended-Release Tablets for oral administration, contain 400 mg of the active drug and the following inactive ingredients: hydroxyethyl cellulose, magnesium stearate, povidone, and talc in an extended-release formulation. Pentoxifylline is a tri-substituted xanthine derivative designated chemically as 1-(5-oxohexyl)-3, 7-dimethylxanthine that, unlike theophylline, is a hemorrheologic agent, i.e. an agent that affects blood viscosity. Pentoxifylline is soluble in water and ethanol, and sparingly soluble in toluene. The chemical structure is. Molecular weight: 278.31. Molecular formula: C13H18N4O3.</Description>
</NDC>
<NDC>
<NDCCode>68682-105-10</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-105-10) </PackageDescription>
<NDC11Code>68682-0105-10</NDC11Code>
<ProductNDC>68682-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075269</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Nifedipine extended-release tablets are an extended-release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)- dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets contain 30 mg of nifedipine for once-a-day oral administration. In addition, each tablet contains the following inactive ingredients: ethylcellulose, ferric oxide yellow, hydroxyethyl cellulose, hypromellose, anhydrous lactose, magnesium stearate, microcrystalline cellulose, amino methacrylate copolymer, polyethylene glycol, colloidal silicon dioxide, sodium lauryl sulfate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68682-106-10</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-106-10) </PackageDescription>
<NDC11Code>68682-0106-10</NDC11Code>
<ProductNDC>68682-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075269</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20001204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Nifedipine extended-release tablets are an extended-release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)- dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets contain 60 mg of nifedipine for once-a-day oral administration. In addition, each tablet contains the following inactive ingredients: ethylcellulose, ferric oxide yellow, hydroxyethyl cellulose, hypromellose, anhydrous lactose, magnesium stearate, microcrystalline cellulose, amino methacrylate copolymer, polyethylene glycol, colloidal silicon dioxide, sodium lauryl sulfate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68682-107-10</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-107-10) </PackageDescription>
<NDC11Code>68682-0107-10</NDC11Code>
<ProductNDC>68682-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076070</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Nifedipine extended-release tablets are an extended-release tablet dosage form of the calcium channel blocker nifedipine. The product is provided as a general matrix tablet with a polymer coating. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)- dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets contain 90 mg of nifedipine for once-a-day oral administration. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, ethylcellulose, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin. Contains FD&C Yellow No. 5 (tartrazine) as a color additive.</Description>
</NDC>
</NDCList>