{
"NDC": [
{
"NDCCode": "64679-557-04",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (64679-557-04) ",
"NDC11Code": "64679-0557-04",
"ProductNDC": "64679-557",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078871",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone tablets contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in methanol and dissolves in dilute acid solution. Risperidone tablets are for oral administration and available in 0.25 mg (yellow), 0.5 mg (brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, sodium starch glycolate. The 0.25 mg tablets also contains talc, iron oxide yellow, iron oxide black and iron oxide red; the 0.5 mg tablets also contains talc, iron oxide red and titanium dioxide; the 2 mg tablets also contains talc, FD&C yellow no. 6/sunset yellow FCF aluminum lake and titanium dioxide; the 3 mg tablets also contains talc, D&C yellow no. 10 aluminum lake, titanium dioxide and iron oxide yellow; and the 4 mg tablets also contains talc, FD&C blue no.2/indigo carmine aluminum lake, titanium dioxide and D&C yellow no.10 aluminum lake."
},
{
"NDCCode": "64679-557-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (64679-557-01) ",
"NDC11Code": "64679-0557-01",
"ProductNDC": "64679-557",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078871",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone tablets contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in methanol and dissolves in dilute acid solution. Risperidone tablets are for oral administration and available in 0.25 mg (yellow), 0.5 mg (brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, sodium starch glycolate. The 0.25 mg tablets also contains talc, iron oxide yellow, iron oxide black and iron oxide red; the 0.5 mg tablets also contains talc, iron oxide red and titanium dioxide; the 2 mg tablets also contains talc, FD&C yellow no. 6/sunset yellow FCF aluminum lake and titanium dioxide; the 3 mg tablets also contains talc, D&C yellow no. 10 aluminum lake, titanium dioxide and iron oxide yellow; and the 4 mg tablets also contains talc, FD&C blue no.2/indigo carmine aluminum lake, titanium dioxide and D&C yellow no.10 aluminum lake."
},
{
"NDCCode": "64679-557-02",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64679-557-02) ",
"NDC11Code": "64679-0557-02",
"ProductNDC": "64679-557",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078871",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone tablets contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in methanol and dissolves in dilute acid solution. Risperidone tablets are for oral administration and available in 0.25 mg (yellow), 0.5 mg (brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, sodium starch glycolate. The 0.25 mg tablets also contains talc, iron oxide yellow, iron oxide black and iron oxide red; the 0.5 mg tablets also contains talc, iron oxide red and titanium dioxide; the 2 mg tablets also contains talc, FD&C yellow no. 6/sunset yellow FCF aluminum lake and titanium dioxide; the 3 mg tablets also contains talc, D&C yellow no. 10 aluminum lake, titanium dioxide and iron oxide yellow; and the 4 mg tablets also contains talc, FD&C blue no.2/indigo carmine aluminum lake, titanium dioxide and D&C yellow no.10 aluminum lake."
},
{
"NDCCode": "64679-557-03",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (64679-557-03) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64679-0557-03",
"ProductNDC": "64679-557",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078871",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone tablets contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in methanol and dissolves in dilute acid solution. Risperidone tablets are for oral administration and available in 0.25 mg (yellow), 0.5 mg (brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, sodium starch glycolate. The 0.25 mg tablets also contains talc, iron oxide yellow, iron oxide black and iron oxide red; the 0.5 mg tablets also contains talc, iron oxide red and titanium dioxide; the 2 mg tablets also contains talc, FD&C yellow no. 6/sunset yellow FCF aluminum lake and titanium dioxide; the 3 mg tablets also contains talc, D&C yellow no. 10 aluminum lake, titanium dioxide and iron oxide yellow; and the 4 mg tablets also contains talc, FD&C blue no.2/indigo carmine aluminum lake, titanium dioxide and D&C yellow no.10 aluminum lake."
},
{
"NDCCode": "42549-557-04",
"PackageDescription": "140 TABLET in 1 BOTTLE (42549-557-04)",
"NDC11Code": "42549-0557-04",
"ProductNDC": "42549-557",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040405",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets are supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet USP contains. In addition each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, and stearic acid. The 10 mg/650 mg tablet also contains FD & C Blue No. 1 Aluminum Lake 12%. Meets USP Dissolution Test 1."
},
{
"NDCCode": "43063-557-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-557-04) ",
"NDC11Code": "43063-0557-04",
"ProductNDC": "43063-557",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065435",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161213",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium and other antibacterial drugs, penicillin V potassium 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. Penicillin V potassium tablets are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriologic studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following infections will usually respond to adequate dosage of penicillin V. Streptococcal Infections (without bacteremia)Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant. Pneumococcal Infections Mild to moderately severe infections of the respiratory tract. Staphylococcal infections – penicillin G-sensitive Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent’s gingivitis and pharyngitis) Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract 1. Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association 1.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V potassium tablets, for oral administration, contain 250 mg (400,000 units) or 500 mg (800,000 units). The 250 mg tablet is equivalent to 250 mg (400,000 units) penicillin V and the 500 mg tablet is equivalent to 500 mg (800,000 units) penicillin V. In addition, each tablet contains the following inactive ingredients: povidone, microcrystalline cellulose, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "53113-557-04",
"PackageDescription": "118 mL in 1 BOTTLE (53113-557-04)",
"NDC11Code": "53113-0557-04",
"ProductNDC": "53113-557",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gadavyt Cough",
"ProprietaryNameSuffix": "Dm",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Guaifenesin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Gadal Laboratories Inc",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "10; 100",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Other informationstore at room temperature 15 - 30 degrees C (59 - 86 degrees F)TAMPER-EVIDENT: Do not use if seal under cap is torn,broken or missing."
},
{
"NDCCode": "55648-557-04",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (55648-557-04)",
"NDC11Code": "55648-0557-04",
"ProductNDC": "55648-557",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078871",
"LabelerName": "WOCKHARDT LIMITED",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63187-557-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (63187-557-04) / 118 mL in 1 BOTTLE",
"NDC11Code": "63187-0557-04",
"ProductNDC": "63187-557",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense Lice Killing",
"NonProprietaryName": "Piperonyl Butoxide, Pyrethrum Extract",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20071208",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M031",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT",
"StrengthNumber": "4; .33",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "treats head, pubic (crab), and body lice."
},
{
"NDCCode": "63941-557-04",
"PackageDescription": "113 g in 1 CANISTER (63941-557-04) ",
"NDC11Code": "63941-0557-04",
"ProductNDC": "63941-557",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tolnafate",
"NonProprietaryName": "Foot Odor Control Powder Spray",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171212",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "VALU MERCHANDISERS, CO",
"SubstanceName": "TOLNAFTATE",
"StrengthNumber": "1.3",
"StrengthUnit": "g/113g",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171212",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "cures most athlete's foot (tinea pedis) and ringworm (tinea corporis). if used daily, can prevent recurrence of athlete's foot. relieves sypmtoms of athlete's foot, including itching, burning and cracking."
},
{
"NDCCode": "65585-557-04",
"PackageDescription": "6 BOTTLE, PUMP in 1 BOX (65585-557-04) / 1750 mL in 1 BOTTLE, PUMP",
"NDC11Code": "65585-0557-04",
"ProductNDC": "65585-557",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whiskcare 357",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200325",
"EndMarketingDate": "20270630",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Whisk Products, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200325",
"EndMarketingDatePackage": "20270531",
"SamplePackage": "N",
"IndicationAndUsage": "Reduces amount of bacteria on hand. Recommended for repeated use."
},
{
"NDCCode": "84756-557-04",
"PackageDescription": "50 g in 1 BOX (84756-557-04) ",
"NDC11Code": "84756-0557-04",
"ProductNDC": "84756-557",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Corrector Cream",
"NonProprietaryName": "Trstay Corrector Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241202",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Yucheng E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241202",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "64679-105-04",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-105-04) ",
"NDC11Code": "64679-0105-04",
"ProductNDC": "64679-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "(sr)",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201331",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120515",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1) .",
"Description": "Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ammonium Chloride, colloidal silicon dioxide, glyceryl behenate, ydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 1 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains FD&C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2."
},
{
"NDCCode": "64679-107-04",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-107-04) ",
"NDC11Code": "64679-0107-04",
"ProductNDC": "64679-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "(sr)",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201331",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120515",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1) .",
"Description": "Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ammonium Chloride, colloidal silicon dioxide, glyceryl behenate, ydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 1 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains FD&C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2."
},
{
"NDCCode": "64679-152-04",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64679-152-04) ",
"NDC11Code": "64679-0152-04",
"ProductNDC": "64679-152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090216",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100524",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir tablets, USP are a nucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients ( 1.1). ● Cold Sores (Herpes Labialis). ● Genital Herpes. ● Treatment in immunocompetent patients (initial or recurrent episode). ● Suppression in immunocompetent or HIV-infected patients. ● Reduction of transmission. ● Herpes Zoster. Pediatric Patients ( 1.2). ● Cold Sores (Herpes Labialis). ● Chickenpox. Limitations of Use ( 1.3). ● The efficacy and safety of valacyclovir tablets, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients croscarmellose sodium, FD&C Blue No. 2 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6- dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C 13H 20N 6O 4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
},
{
"NDCCode": "64679-153-04",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64679-153-04) ",
"NDC11Code": "64679-0153-04",
"ProductNDC": "64679-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090216",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100524",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir tablets, USP are a nucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients ( 1.1). ● Cold Sores (Herpes Labialis). ● Genital Herpes. ● Treatment in immunocompetent patients (initial or recurrent episode). ● Suppression in immunocompetent or HIV-infected patients. ● Reduction of transmission. ● Herpes Zoster. Pediatric Patients ( 1.2). ● Cold Sores (Herpes Labialis). ● Chickenpox. Limitations of Use ( 1.3). ● The efficacy and safety of valacyclovir tablets, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients croscarmellose sodium, FD&C Blue No. 2 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6- dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C 13H 20N 6O 4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
},
{
"NDCCode": "64679-154-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (64679-154-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64679-0154-04",
"ProductNDC": "64679-154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).",
"Description": "Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2."
},
{
"NDCCode": "64679-155-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (64679-155-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64679-0155-04",
"ProductNDC": "64679-155",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).",
"Description": "Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2."
},
{
"NDCCode": "64679-171-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (64679-171-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64679-0171-04",
"ProductNDC": "64679-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).",
"Description": "Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2."
},
{
"NDCCode": "64679-172-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (64679-172-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64679-0172-04",
"ProductNDC": "64679-172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).",
"Description": "Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2."
},
{
"NDCCode": "64679-174-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (64679-174-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64679-0174-04",
"ProductNDC": "64679-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).",
"Description": "Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2."
},
{
"NDCCode": "64679-175-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (64679-175-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64679-0175-04",
"ProductNDC": "64679-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).",
"Description": "Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2."
},
{
"NDCCode": "64679-177-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (64679-177-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64679-0177-04",
"ProductNDC": "64679-177",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079050",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).",
"Description": "Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2."
},
{
"NDCCode": "64679-215-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (64679-215-04) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "64679-0215-04",
"ProductNDC": "64679-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium And Misoprostol",
"NonProprietaryName": "Diclofenac Sodium And Misoprostol",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201948",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "DICLOFENAC SODIUM; MISOPROSTOL",
"StrengthNumber": "50; .2",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "64679-217-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (64679-217-04) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
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"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pK a of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is:. Lamotrigine extended-release tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet), and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg, and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels."
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"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pK a of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is:. Lamotrigine extended-release tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet), and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg, and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels."
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"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pK a of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is:. Lamotrigine extended-release tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet), and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg, and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels."
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"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pK a of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is:. Lamotrigine extended-release tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet), and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg, and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels."
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"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pK a of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is:. Lamotrigine extended-release tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet), and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg, and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels."
}
]
}
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<Description>Risperidone tablets contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in methanol and dissolves in dilute acid solution. Risperidone tablets are for oral administration and available in 0.25 mg (yellow), 0.5 mg (brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, sodium starch glycolate. The 0.25 mg tablets also contains talc, iron oxide yellow, iron oxide black and iron oxide red; the 0.5 mg tablets also contains talc, iron oxide red and titanium dioxide; the 2 mg tablets also contains talc, FD&C yellow no. 6/sunset yellow FCF aluminum lake and titanium dioxide; the 3 mg tablets also contains talc, D&C yellow no. 10 aluminum lake, titanium dioxide and iron oxide yellow; and the 4 mg tablets also contains talc, FD&C blue no.2/indigo carmine aluminum lake, titanium dioxide and D&C yellow no.10 aluminum lake.</Description>
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<Description>Risperidone tablets contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in methanol and dissolves in dilute acid solution. Risperidone tablets are for oral administration and available in 0.25 mg (yellow), 0.5 mg (brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, sodium starch glycolate. The 0.25 mg tablets also contains talc, iron oxide yellow, iron oxide black and iron oxide red; the 0.5 mg tablets also contains talc, iron oxide red and titanium dioxide; the 2 mg tablets also contains talc, FD&C yellow no. 6/sunset yellow FCF aluminum lake and titanium dioxide; the 3 mg tablets also contains talc, D&C yellow no. 10 aluminum lake, titanium dioxide and iron oxide yellow; and the 4 mg tablets also contains talc, FD&C blue no.2/indigo carmine aluminum lake, titanium dioxide and D&C yellow no.10 aluminum lake.</Description>
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<Description>Risperidone tablets contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in methanol and dissolves in dilute acid solution. Risperidone tablets are for oral administration and available in 0.25 mg (yellow), 0.5 mg (brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, sodium starch glycolate. The 0.25 mg tablets also contains talc, iron oxide yellow, iron oxide black and iron oxide red; the 0.5 mg tablets also contains talc, iron oxide red and titanium dioxide; the 2 mg tablets also contains talc, FD&C yellow no. 6/sunset yellow FCF aluminum lake and titanium dioxide; the 3 mg tablets also contains talc, D&C yellow no. 10 aluminum lake, titanium dioxide and iron oxide yellow; and the 4 mg tablets also contains talc, FD&C blue no.2/indigo carmine aluminum lake, titanium dioxide and D&C yellow no.10 aluminum lake.</Description>
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<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
<Description>Risperidone tablets contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in methanol and dissolves in dilute acid solution. Risperidone tablets are for oral administration and available in 0.25 mg (yellow), 0.5 mg (brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, sodium starch glycolate. The 0.25 mg tablets also contains talc, iron oxide yellow, iron oxide black and iron oxide red; the 0.5 mg tablets also contains talc, iron oxide red and titanium dioxide; the 2 mg tablets also contains talc, FD&C yellow no. 6/sunset yellow FCF aluminum lake and titanium dioxide; the 3 mg tablets also contains talc, D&C yellow no. 10 aluminum lake, titanium dioxide and iron oxide yellow; and the 4 mg tablets also contains talc, FD&C blue no.2/indigo carmine aluminum lake, titanium dioxide and D&C yellow no.10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>42549-557-04</NDCCode>
<PackageDescription>140 TABLET in 1 BOTTLE (42549-557-04)</PackageDescription>
<NDC11Code>42549-0557-04</NDC11Code>
<ProductNDC>42549-557</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040405</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets are supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet USP contains. In addition each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, and stearic acid. The 10 mg/650 mg tablet also contains FD & C Blue No. 1 Aluminum Lake 12%. Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>43063-557-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-557-04) </PackageDescription>
<NDC11Code>43063-0557-04</NDC11Code>
<ProductNDC>43063-557</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin V Potassium</ProprietaryName>
<NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065435</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium and other antibacterial drugs, penicillin V potassium 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. Penicillin V potassium tablets are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriologic studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following infections will usually respond to adequate dosage of penicillin V. Streptococcal Infections (without bacteremia)Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant. Pneumococcal Infections Mild to moderately severe infections of the respiratory tract. Staphylococcal infections – penicillin G-sensitive Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent’s gingivitis and pharyngitis) Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract 1. Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association 1.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V potassium tablets, for oral administration, contain 250 mg (400,000 units) or 500 mg (800,000 units). The 250 mg tablet is equivalent to 250 mg (400,000 units) penicillin V and the 500 mg tablet is equivalent to 500 mg (800,000 units) penicillin V. In addition, each tablet contains the following inactive ingredients: povidone, microcrystalline cellulose, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>53113-557-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (53113-557-04)</PackageDescription>
<NDC11Code>53113-0557-04</NDC11Code>
<ProductNDC>53113-557</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gadavyt Cough</ProprietaryName>
<ProprietaryNameSuffix>Dm</ProprietaryNameSuffix>
<NonProprietaryName>Dextromethorphan Hydrobromide, Guaifenesin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Gadal Laboratories Inc</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>10; 100</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Other informationstore at room temperature 15 - 30 degrees C (59 - 86 degrees F)TAMPER-EVIDENT: Do not use if seal under cap is torn,broken or missing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55648-557-04</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (55648-557-04)</PackageDescription>
<NDC11Code>55648-0557-04</NDC11Code>
<ProductNDC>55648-557</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078871</ApplicationNumber>
<LabelerName>WOCKHARDT LIMITED</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63187-557-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (63187-557-04) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63187-0557-04</NDC11Code>
<ProductNDC>63187-557</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Sense Lice Killing</ProprietaryName>
<NonProprietaryName>Piperonyl Butoxide, Pyrethrum Extract</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20071208</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M031</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT</SubstanceName>
<StrengthNumber>4; .33</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats head, pubic (crab), and body lice.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63941-557-04</NDCCode>
<PackageDescription>113 g in 1 CANISTER (63941-557-04) </PackageDescription>
<NDC11Code>63941-0557-04</NDC11Code>
<ProductNDC>63941-557</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tolnafate</ProprietaryName>
<NonProprietaryName>Foot Odor Control Powder Spray</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171212</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>VALU MERCHANDISERS, CO</LabelerName>
<SubstanceName>TOLNAFTATE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>g/113g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171212</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>cures most athlete's foot (tinea pedis) and ringworm (tinea corporis). if used daily, can prevent recurrence of athlete's foot. relieves sypmtoms of athlete's foot, including itching, burning and cracking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65585-557-04</NDCCode>
<PackageDescription>6 BOTTLE, PUMP in 1 BOX (65585-557-04) / 1750 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>65585-0557-04</NDC11Code>
<ProductNDC>65585-557</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whiskcare 357</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200325</StartMarketingDate>
<EndMarketingDate>20270630</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Whisk Products, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200325</StartMarketingDatePackage>
<EndMarketingDatePackage>20270531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Reduces amount of bacteria on hand. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-557-04</NDCCode>
<PackageDescription>50 g in 1 BOX (84756-557-04) </PackageDescription>
<NDC11Code>84756-0557-04</NDC11Code>
<ProductNDC>84756-557</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Corrector Cream</ProprietaryName>
<NonProprietaryName>Trstay Corrector Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241202</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Yucheng E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64679-105-04</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-105-04) </PackageDescription>
<NDC11Code>64679-0105-04</NDC11Code>
<ProductNDC>64679-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>(sr)</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201331</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1) .</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ammonium Chloride, colloidal silicon dioxide, glyceryl behenate, ydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 1 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains FD&C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>64679-107-04</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-107-04) </PackageDescription>
<NDC11Code>64679-0107-04</NDC11Code>
<ProductNDC>64679-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>(sr)</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201331</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1) .</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ammonium Chloride, colloidal silicon dioxide, glyceryl behenate, ydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 1 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains FD&C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>64679-152-04</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (64679-152-04) </PackageDescription>
<NDC11Code>64679-0152-04</NDC11Code>
<ProductNDC>64679-152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090216</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir tablets, USP are a nucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients ( 1.1). ● Cold Sores (Herpes Labialis). ● Genital Herpes. ● Treatment in immunocompetent patients (initial or recurrent episode). ● Suppression in immunocompetent or HIV-infected patients. ● Reduction of transmission. ● Herpes Zoster. Pediatric Patients ( 1.2). ● Cold Sores (Herpes Labialis). ● Chickenpox. Limitations of Use ( 1.3). ● The efficacy and safety of valacyclovir tablets, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients croscarmellose sodium, FD&C Blue No. 2 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6- dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C 13H 20N 6O 4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
</NDC>
<NDC>
<NDCCode>64679-153-04</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (64679-153-04) </PackageDescription>
<NDC11Code>64679-0153-04</NDC11Code>
<ProductNDC>64679-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090216</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir tablets, USP are a nucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients ( 1.1). ● Cold Sores (Herpes Labialis). ● Genital Herpes. ● Treatment in immunocompetent patients (initial or recurrent episode). ● Suppression in immunocompetent or HIV-infected patients. ● Reduction of transmission. ● Herpes Zoster. Pediatric Patients ( 1.2). ● Cold Sores (Herpes Labialis). ● Chickenpox. Limitations of Use ( 1.3). ● The efficacy and safety of valacyclovir tablets, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients croscarmellose sodium, FD&C Blue No. 2 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6- dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C 13H 20N 6O 4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
</NDC>
<NDC>
<NDCCode>64679-154-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (64679-154-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0154-04</NDC11Code>
<ProductNDC>64679-154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079050</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).</IndicationAndUsage>
<Description>Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>64679-155-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (64679-155-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0155-04</NDC11Code>
<ProductNDC>64679-155</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079050</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).</IndicationAndUsage>
<Description>Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>64679-171-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (64679-171-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0171-04</NDC11Code>
<ProductNDC>64679-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079050</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).</IndicationAndUsage>
<Description>Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>64679-172-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (64679-172-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0172-04</NDC11Code>
<ProductNDC>64679-172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079050</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).</IndicationAndUsage>
<Description>Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>64679-174-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (64679-174-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0174-04</NDC11Code>
<ProductNDC>64679-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079050</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).</IndicationAndUsage>
<Description>Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>64679-175-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (64679-175-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0175-04</NDC11Code>
<ProductNDC>64679-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079050</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).</IndicationAndUsage>
<Description>Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>64679-177-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (64679-177-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0177-04</NDC11Code>
<ProductNDC>64679-177</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079050</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).</IndicationAndUsage>
<Description>Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream coloured crystalline powder with a melting range of 241° to 245°C. It is soluble in water and methanol, very slightly soluble in ethyl alcohol. Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, iron oxide black, iron oxide yellow, iron oxide red, polyethylene glycol 400, titanium dioxide. Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>64679-215-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (64679-215-04) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0215-04</NDC11Code>
<ProductNDC>64679-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium And Misoprostol</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201948</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>50; .2</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64679-217-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (64679-217-04) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0217-04</NDC11Code>
<ProductNDC>64679-217</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium And Misoprostol</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201948</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>75; .2</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64679-271-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (64679-271-04) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (64679-271-03) </PackageDescription>
<NDC11Code>64679-0271-04</NDC11Code>
<ProductNDC>64679-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202498</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121129</StartMarketingDatePackage>
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<IndicationAndUsage>Lamotrigine extended-release tablet is an antiepileptic drug (AED) indicated for: 1 Adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1) , 2 Conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single AED. ( 1.2) .</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pK a of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is:. Lamotrigine extended-release tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet), and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg, and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
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<IndicationAndUsage>Lamotrigine extended-release tablet is an antiepileptic drug (AED) indicated for: 1 Adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1) , 2 Conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single AED. ( 1.2) .</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pK a of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is:. Lamotrigine extended-release tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet), and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg, and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
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<IndicationAndUsage>Lamotrigine extended-release tablet is an antiepileptic drug (AED) indicated for: 1 Adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1) , 2 Conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single AED. ( 1.2) .</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pK a of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is:. Lamotrigine extended-release tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet), and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg, and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
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<IndicationAndUsage>Lamotrigine extended-release tablet is an antiepileptic drug (AED) indicated for: 1 Adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1) , 2 Conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single AED. ( 1.2) .</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pK a of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is:. Lamotrigine extended-release tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet), and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg, and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
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<IndicationAndUsage>Lamotrigine extended-release tablet is an antiepileptic drug (AED) indicated for: 1 Adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1) , 2 Conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single AED. ( 1.2) .</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pK a of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is:. Lamotrigine extended-release tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet), and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg, and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
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