{
"NDC": [
{
"NDCCode": "67046-0525-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0525-3) ",
"NDC11Code": "67046-0525-03",
"ProductNDC": "67046-0525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202862",
"LabelerName": "Coupler LLC",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260511",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the: Treatment of depressive episodes associated with bipolar I disorder. ( 1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. ( 1.6) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg)."
},
{
"NDCCode": "0135-0525-11",
"PackageDescription": "3 CARTON in 1 CARTON (0135-0525-11) / 1 TUBE in 1 CARTON / 184 g in 1 TUBE",
"NDC11Code": "00135-0525-11",
"ProductNDC": "0135-0525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sensodyne",
"ProprietaryNameSuffix": "Extra Whitening",
"NonProprietaryName": "Potassium Nitrate And Sodium Fluoride",
"DosageFormName": "PASTE",
"RouteName": "DENTAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"StrengthNumber": "50; 1.11",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2024-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19900930",
"SamplePackage": "N",
"IndicationAndUsage": "builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities."
},
{
"NDCCode": "0525-0971-30",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (0525-0971-30) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00525-0971-30",
"ProductNDC": "0525-0971",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zelnorm",
"NonProprietaryName": "Tegaserod",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021200",
"LabelerName": "Alfasigma USA, Inc.",
"SubstanceName": "TEGASEROD",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 4 Receptor Agonists [MoA],Serotonin-4 Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Limitations of Use: 1 The safety and effectiveness of ZELNORM in men with IBS-C have not been established [see Clinical Studies (14)].",
"Description": "ZELNORM oral tablets contain tegaserod, a serotonin-4 (5-HT4) receptor agonist, as the hydrogen maleate salt. As the maleate salt, tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. Its empirical formula is C16H23N5OC4H4O4. The molecular weight is 417.47 and the structural formula is. Tegaserod as the maleate salt is a white to off-white crystalline powder and is slightly soluble in ethanol and very slightly soluble in water. Each ZELNORM tablet contains 6 mg of tegaserod (equivalent to 8.31 mg of tegaserod maleate) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, hypromellose, and lactose monohydrate."
},
{
"NDCCode": "15631-0525-3",
"PackageDescription": "100 TABLET in 1 CONTAINER (15631-0525-3)",
"NDC11Code": "15631-0525-03",
"ProductNDC": "15631-0525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arsenicum Sulphuratum Flavum",
"NonProprietaryName": "Arsenicum Sulphuratum Flavum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151230",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "ARSENIC TRISULFIDE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "37662-0525-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-0525-3) ",
"NDC11Code": "37662-0525-03",
"ProductNDC": "37662-0525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colocynthis",
"NonProprietaryName": "Colocynthis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220613",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "CITRULLUS COLOCYNTHIS FRUIT PULP",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220613",
"SamplePackage": "N"
},
{
"NDCCode": "63419-0525-3",
"PackageDescription": "2 BOTTLE in 1 BOX (63419-0525-3) / 3692 g in 1 BOTTLE",
"NDC11Code": "63419-0525-03",
"ProductNDC": "63419-0525",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dulaglutide",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20140115",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Eli Lilly Kinsale Limited",
"SubstanceName": "DULAGLUTIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-09-01",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "14-JUN-23"
},
{
"NDCCode": "68968-0525-8",
"PackageDescription": "8 POUCH in 1 CARTON (68968-0525-8) / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH",
"NDC11Code": "68968-0525-08",
"ProductNDC": "68968-0525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Combipatch (estradiol/norethindrone Acetate Transdermal System)",
"NonProprietaryName": "Estradiol/norethindrone Acetate Transdermal System",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "19980807",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020870",
"LabelerName": "Noven Therapeutics, LLC",
"SubstanceName": "ESTRADIOL; NORETHINDRONE ACETATE",
"StrengthNumber": ".05; .25",
"StrengthUnit": "mg/d; mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19980807",
"SamplePackage": "N",
"IndicationAndUsage": "CombiPatch is indicated in a woman with a uterus for: 1 Treatment of moderate to severe vasomotor symptoms due to menopause., 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.",
"Description": "CombiPatch® (estradiol/norethindrone acetate transdermal system) is an adhesive-based matrix transdermal patch designed to release both estradiol, an estrogen, and norethindrone acetate (NETA), a progestational agent, continuously upon application to intact skin. Two systems are available, providing the following in vivo delivery rates of estradiol and NETA. Estradiol USP (estradiol) is a white to creamy white, odorless, crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17 β-diol. The molecular weight of estradiol is 272.39 and the molecular formula is C18H24O2. NETA USP is a white to creamy white, odorless, crystalline powder, chemically described as 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate. The molecular weight of NETA is 340.47 and the molecular formula is C22H28O3. The structural formulas for estradiol and NETA are. CombiPatch is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film backing, (2) an adhesive layer containing estradiol, NETA, acrylic adhesive, silicone adhesive, oleic acid NF, povidone USP and dipropylene glycol, and (3) a polyester release protective liner, which is attached to the adhesive surface and must be removed before the system can be used. The active components of the system are estradiol USP and NETA USP. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "71335-0525-3",
"PackageDescription": "60 TABLET in 1 BOTTLE (71335-0525-3) ",
"NDC11Code": "71335-0525-03",
"ProductNDC": "71335-0525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076890",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N"
},
{
"NDCCode": "80425-0525-3",
"PackageDescription": "90 TABLET in 1 BOTTLE (80425-0525-3) ",
"NDC11Code": "80425-0525-03",
"ProductNDC": "80425-0525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorzoxazone",
"NonProprietaryName": "Chlorzoxazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089853",
"LabelerName": "Advanced Rx of Tennessee, LLC",
"SubstanceName": "CHLORZOXAZONE",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250529",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.",
"Description": "Each 375 mg chlorzoxazone tablet contains: Chlorzoxazone USP 375 mg. Each 500 mg chlorzoxazone tablet contains: Chlorzoxazone USP 500 mg. Each 750 mg chlorzoxazone tablet contains: Chlorzoxazone USP 750 mg. Chemical Name: 5-Chloro-2-benzoxazolinone. Structural Formula. Molecular Formula: C 7H 4ClNO 2. Molecular Weight: 169.56. Chlorzoxazone, USP is a white or practically white, practically odorless, crystalline powder. Chlorzoxazone USP is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia. Inactive ingredients. 375 mg contains colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium with sodium benzoate, lactose monohydrate, magnesium stearate and microcrystalline cellulose. 500 mg contains D&C Red 27/Phloxine Aluminium lake, FD&C Yellow 6/Sunset Yellow FCF Aluminium lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium starch glycolate. 750 mg contains colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium with sodium benzoate, lactose monohydrate, magnesium stearate and microcrystalline cellulose. Meets USP dissolution test 5 for 500 mg. FDA approved dissolution method differs from that of the USP for 375 mg and 750 mg."
},
{
"NDCCode": "67046-525-07",
"PackageDescription": "7 TABLET, FILM COATED in 1 BLISTER PACK (67046-525-07)",
"NDC11Code": "67046-0525-07",
"ProductNDC": "67046-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202862",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg)."
},
{
"NDCCode": "67046-525-14",
"PackageDescription": "14 TABLET, FILM COATED in 1 BLISTER PACK (67046-525-14)",
"NDC11Code": "67046-0525-14",
"ProductNDC": "67046-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202862",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg)."
},
{
"NDCCode": "67046-525-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BLISTER PACK (67046-525-15)",
"NDC11Code": "67046-0525-15",
"ProductNDC": "67046-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202862",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg)."
},
{
"NDCCode": "67046-525-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BLISTER PACK (67046-525-20)",
"NDC11Code": "67046-0525-20",
"ProductNDC": "67046-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202862",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg)."
},
{
"NDCCode": "67046-525-21",
"PackageDescription": "21 TABLET, FILM COATED in 1 BLISTER PACK (67046-525-21)",
"NDC11Code": "67046-0525-21",
"ProductNDC": "67046-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202862",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg)."
},
{
"NDCCode": "67046-525-28",
"PackageDescription": "28 TABLET, FILM COATED in 1 BLISTER PACK (67046-525-28)",
"NDC11Code": "67046-0525-28",
"ProductNDC": "67046-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202862",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg)."
},
{
"NDCCode": "67046-525-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-525-30)",
"NDC11Code": "67046-0525-30",
"ProductNDC": "67046-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202862",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg)."
},
{
"NDCCode": "67046-525-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BLISTER PACK (67046-525-60)",
"NDC11Code": "67046-0525-60",
"ProductNDC": "67046-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202862",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg)."
},
{
"NDCCode": "0409-0525-25",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 TRAY (0409-0525-25) / 50 mL in 1 VIAL, MULTI-DOSE (0409-0525-01) ",
"NDC11Code": "00409-0525-25",
"ProductNDC": "0409-0525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Marcaine",
"NonProprietaryName": "Bupivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERINEURAL",
"StartMarketingDate": "20241209",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016964",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241209",
"SamplePackage": "N",
"IndicationAndUsage": "MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
"Description": "MARCAINE / MARCAINE WITH EPINEPHRINE contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for MARCAINE (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for MARCAINE WITH EPINEPHRINE is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. MARCAINE with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine bitartrate (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine bitartrate is (–) - 3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol (+)-tartrate (1:1) salt. Epinephrine is a vasoconstrictor. It has the following structural formula. MARCAINE (bupivacaine hydrochloride) is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. MARCAINE with epinephrine 1:200,000 (as bitartrate) is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.0091 mg epinephrine bitartrate (equivalent to 0.005 mg of epinephrine), with sodium chloride for isotonicity, 0.5 mg sodium metabisulfite, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. The pH of these solutions is adjusted to between 3.4 and 4.5 with sodium hydroxide or hydrochloric acid. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of MARCAINE 0.5% with epinephrine 1:200,000 (as bitartrate) at 25°C is 1.008 and at 37°C is 1.008."
},
{
"NDCCode": "0525-0971-10",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0525-0971-10) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00525-0971-10",
"ProductNDC": "0525-0971",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zelnorm",
"NonProprietaryName": "Tegaserod",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021200",
"LabelerName": "Alfasigma USA, Inc.",
"SubstanceName": "TEGASEROD",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 4 Receptor Agonists [MoA],Serotonin-4 Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Limitations of Use: 1 The safety and effectiveness of ZELNORM in men with IBS-C have not been established [see Clinical Studies (14)].",
"Description": "ZELNORM oral tablets contain tegaserod, a serotonin-4 (5-HT4) receptor agonist, as the hydrogen maleate salt. As the maleate salt, tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. Its empirical formula is C16H23N5OC4H4O4. The molecular weight is 417.47 and the structural formula is. Tegaserod as the maleate salt is a white to off-white crystalline powder and is slightly soluble in ethanol and very slightly soluble in water. Each ZELNORM tablet contains 6 mg of tegaserod (equivalent to 8.31 mg of tegaserod maleate) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, hypromellose, and lactose monohydrate."
},
{
"NDCCode": "0525-0971-60",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (0525-0971-60) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00525-0971-60",
"ProductNDC": "0525-0971",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zelnorm",
"NonProprietaryName": "Tegaserod",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021200",
"LabelerName": "Alfasigma USA, Inc.",
"SubstanceName": "TEGASEROD",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 4 Receptor Agonists [MoA],Serotonin-4 Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Limitations of Use: 1 The safety and effectiveness of ZELNORM in men with IBS-C have not been established [see Clinical Studies (14)].",
"Description": "ZELNORM oral tablets contain tegaserod, a serotonin-4 (5-HT4) receptor agonist, as the hydrogen maleate salt. As the maleate salt, tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. Its empirical formula is C16H23N5OC4H4O4. The molecular weight is 417.47 and the structural formula is. Tegaserod as the maleate salt is a white to off-white crystalline powder and is slightly soluble in ethanol and very slightly soluble in water. Each ZELNORM tablet contains 6 mg of tegaserod (equivalent to 8.31 mg of tegaserod maleate) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, hypromellose, and lactose monohydrate."
},
{
"NDCCode": "10135-525-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (10135-525-05)",
"NDC11Code": "10135-0525-05",
"ProductNDC": "10135-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078552",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be use d alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)○ Amlodipine besylate tablets are indicate d for the treatment of hypertension, to lower blood pressure. Lowe ring blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2- chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, and sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "10135-525-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (10135-525-10)",
"NDC11Code": "10135-0525-10",
"ProductNDC": "10135-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078552",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be use d alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)○ Amlodipine besylate tablets are indicate d for the treatment of hypertension, to lower blood pressure. Lowe ring blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2- chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, and sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "10135-525-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (10135-525-90)",
"NDC11Code": "10135-0525-90",
"ProductNDC": "10135-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078552",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be use d alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)○ Amlodipine besylate tablets are indicate d for the treatment of hypertension, to lower blood pressure. Lowe ring blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2- chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, and sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "10544-525-06",
"PackageDescription": "6 TABLET in 1 BOTTLE (10544-525-06)",
"NDC11Code": "10544-0525-06",
"ProductNDC": "10544-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Carinii Pneumonia. For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia. Travelers’ Diarrhea In Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula:. Inactive Ingredients: Magnesium Stearate, povidone, pregelatinized starch and sodium starch glycolate."
},
{
"NDCCode": "10544-525-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (10544-525-10)",
"NDC11Code": "10544-0525-10",
"ProductNDC": "10544-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Carinii Pneumonia. For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia. Travelers’ Diarrhea In Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula:. Inactive Ingredients: Magnesium Stearate, povidone, pregelatinized starch and sodium starch glycolate."
},
{
"NDCCode": "10544-525-12",
"PackageDescription": "12 TABLET in 1 BOTTLE (10544-525-12)",
"NDC11Code": "10544-0525-12",
"ProductNDC": "10544-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Carinii Pneumonia. For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia. Travelers’ Diarrhea In Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula:. Inactive Ingredients: Magnesium Stearate, povidone, pregelatinized starch and sodium starch glycolate."
},
{
"NDCCode": "10544-525-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (10544-525-14)",
"NDC11Code": "10544-0525-14",
"ProductNDC": "10544-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Carinii Pneumonia. For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia. Travelers’ Diarrhea In Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula:. Inactive Ingredients: Magnesium Stearate, povidone, pregelatinized starch and sodium starch glycolate."
},
{
"NDCCode": "10544-525-20",
"PackageDescription": "20 TABLET in 1 BOTTLE (10544-525-20)",
"NDC11Code": "10544-0525-20",
"ProductNDC": "10544-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Carinii Pneumonia. For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia. Travelers’ Diarrhea In Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula:. Inactive Ingredients: Magnesium Stearate, povidone, pregelatinized starch and sodium starch glycolate."
},
{
"NDCCode": "10544-525-28",
"PackageDescription": "28 TABLET in 1 BOTTLE (10544-525-28)",
"NDC11Code": "10544-0525-28",
"ProductNDC": "10544-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Carinii Pneumonia. For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia. Travelers’ Diarrhea In Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula:. Inactive Ingredients: Magnesium Stearate, povidone, pregelatinized starch and sodium starch glycolate."
},
{
"NDCCode": "12634-525-00",
"PackageDescription": "10 TABLET in 1 BOTTLE (12634-525-00)",
"NDC11Code": "12634-0525-00",
"ProductNDC": "12634-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20000118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074215",
"LabelerName": "Apotheca, Inc",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Anxiety Disorders. Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or ‘lump in throat’); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or ‘mind going blank’ because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder. Alprazolam is also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES ). Panic Disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Alprazolam tablets contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is represented below. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam. Alprazolam tablets, 2 mg, are multi-scored and may be divided as shown below. INACTIVE INGREDIENT. Corn starch, lactose monohydrate, sodium starch glycolate, hypromellose, colloidal silicon dioxide, magnesium stearate. In addition, the 0.5 mg tablet contains FD&C Yellow No. 6 Aluminum Lake and the 1 mg tablet contains FD&C Blue No. 2 Aluminum Lake."
}
]
}
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<ProductNDC>67046-0525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202862</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
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<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the: Treatment of depressive episodes associated with bipolar I disorder. ( 1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. ( 1.6) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg).</Description>
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<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>POTASSIUM NITRATE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>50; 1.11</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.</IndicationAndUsage>
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<PackageDescription>3 BLISTER PACK in 1 CARTON (0525-0971-30) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zelnorm</ProprietaryName>
<NonProprietaryName>Tegaserod</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021200</ApplicationNumber>
<LabelerName>Alfasigma USA, Inc.</LabelerName>
<SubstanceName>TEGASEROD</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 4 Receptor Agonists [MoA],Serotonin-4 Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Limitations of Use: 1 The safety and effectiveness of ZELNORM in men with IBS-C have not been established [see Clinical Studies (14)].</IndicationAndUsage>
<Description>ZELNORM oral tablets contain tegaserod, a serotonin-4 (5-HT4) receptor agonist, as the hydrogen maleate salt. As the maleate salt, tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. Its empirical formula is C16H23N5OC4H4O4. The molecular weight is 417.47 and the structural formula is. Tegaserod as the maleate salt is a white to off-white crystalline powder and is slightly soluble in ethanol and very slightly soluble in water. Each ZELNORM tablet contains 6 mg of tegaserod (equivalent to 8.31 mg of tegaserod maleate) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, hypromellose, and lactose monohydrate.</Description>
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<PackageDescription>100 TABLET in 1 CONTAINER (15631-0525-3)</PackageDescription>
<NDC11Code>15631-0525-03</NDC11Code>
<ProductNDC>15631-0525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arsenicum Sulphuratum Flavum</ProprietaryName>
<NonProprietaryName>Arsenicum Sulphuratum Flavum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151230</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>ARSENIC TRISULFIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
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<NDCCode>37662-0525-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-0525-3) </PackageDescription>
<NDC11Code>37662-0525-03</NDC11Code>
<ProductNDC>37662-0525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colocynthis</ProprietaryName>
<NonProprietaryName>Colocynthis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220613</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>CITRULLUS COLOCYNTHIS FRUIT PULP</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>63419-0525-3</NDCCode>
<PackageDescription>2 BOTTLE in 1 BOX (63419-0525-3) / 3692 g in 1 BOTTLE</PackageDescription>
<NDC11Code>63419-0525-03</NDC11Code>
<ProductNDC>63419-0525</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dulaglutide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20140115</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Eli Lilly Kinsale Limited</LabelerName>
<SubstanceName>DULAGLUTIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-09-01</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>14-JUN-23</StartMarketingDatePackage>
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<NDC>
<NDCCode>68968-0525-8</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (68968-0525-8) / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>68968-0525-08</NDC11Code>
<ProductNDC>68968-0525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Combipatch (estradiol/norethindrone Acetate Transdermal System)</ProprietaryName>
<NonProprietaryName>Estradiol/norethindrone Acetate Transdermal System</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>19980807</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020870</ApplicationNumber>
<LabelerName>Noven Therapeutics, LLC</LabelerName>
<SubstanceName>ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
<StrengthNumber>.05; .25</StrengthNumber>
<StrengthUnit>mg/d; mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CombiPatch is indicated in a woman with a uterus for: 1 Treatment of moderate to severe vasomotor symptoms due to menopause., 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.</IndicationAndUsage>
<Description>CombiPatch® (estradiol/norethindrone acetate transdermal system) is an adhesive-based matrix transdermal patch designed to release both estradiol, an estrogen, and norethindrone acetate (NETA), a progestational agent, continuously upon application to intact skin. Two systems are available, providing the following in vivo delivery rates of estradiol and NETA. Estradiol USP (estradiol) is a white to creamy white, odorless, crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17 β-diol. The molecular weight of estradiol is 272.39 and the molecular formula is C18H24O2. NETA USP is a white to creamy white, odorless, crystalline powder, chemically described as 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate. The molecular weight of NETA is 340.47 and the molecular formula is C22H28O3. The structural formulas for estradiol and NETA are. CombiPatch is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film backing, (2) an adhesive layer containing estradiol, NETA, acrylic adhesive, silicone adhesive, oleic acid NF, povidone USP and dipropylene glycol, and (3) a polyester release protective liner, which is attached to the adhesive surface and must be removed before the system can be used. The active components of the system are estradiol USP and NETA USP. The remaining components of the system are pharmacologically inactive.</Description>
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<NDC>
<NDCCode>71335-0525-3</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71335-0525-3) </PackageDescription>
<NDC11Code>71335-0525-03</NDC11Code>
<ProductNDC>71335-0525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076890</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>80425-0525-3</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (80425-0525-3) </PackageDescription>
<NDC11Code>80425-0525-03</NDC11Code>
<ProductNDC>80425-0525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorzoxazone</ProprietaryName>
<NonProprietaryName>Chlorzoxazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089853</ApplicationNumber>
<LabelerName>Advanced Rx of Tennessee, LLC</LabelerName>
<SubstanceName>CHLORZOXAZONE</SubstanceName>
<StrengthNumber>375</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Each 375 mg chlorzoxazone tablet contains: Chlorzoxazone USP 375 mg. Each 500 mg chlorzoxazone tablet contains: Chlorzoxazone USP 500 mg. Each 750 mg chlorzoxazone tablet contains: Chlorzoxazone USP 750 mg. Chemical Name: 5-Chloro-2-benzoxazolinone. Structural Formula. Molecular Formula: C 7H 4ClNO 2. Molecular Weight: 169.56. Chlorzoxazone, USP is a white or practically white, practically odorless, crystalline powder. Chlorzoxazone USP is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia. Inactive ingredients. 375 mg contains colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium with sodium benzoate, lactose monohydrate, magnesium stearate and microcrystalline cellulose. 500 mg contains D&C Red 27/Phloxine Aluminium lake, FD&C Yellow 6/Sunset Yellow FCF Aluminium lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium starch glycolate. 750 mg contains colloidal silicon dioxide, corn starch, croscarmellose sodium, docusate sodium with sodium benzoate, lactose monohydrate, magnesium stearate and microcrystalline cellulose. Meets USP dissolution test 5 for 500 mg. FDA approved dissolution method differs from that of the USP for 375 mg and 750 mg.</Description>
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<NDC>
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<PackageDescription>7 TABLET, FILM COATED in 1 BLISTER PACK (67046-525-07)</PackageDescription>
<NDC11Code>67046-0525-07</NDC11Code>
<ProductNDC>67046-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202862</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg).</Description>
</NDC>
<NDC>
<NDCCode>67046-525-14</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BLISTER PACK (67046-525-14)</PackageDescription>
<NDC11Code>67046-0525-14</NDC11Code>
<ProductNDC>67046-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202862</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg).</Description>
</NDC>
<NDC>
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<PackageDescription>15 TABLET, FILM COATED in 1 BLISTER PACK (67046-525-15)</PackageDescription>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202862</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg).</Description>
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<NDC>
<NDCCode>67046-525-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BLISTER PACK (67046-525-20)</PackageDescription>
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<ProductNDC>67046-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
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<StartMarketingDate>20171004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202862</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg).</Description>
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<ProductNDC>67046-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202862</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg).</Description>
</NDC>
<NDC>
<NDCCode>67046-525-28</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BLISTER PACK (67046-525-28)</PackageDescription>
<NDC11Code>67046-0525-28</NDC11Code>
<ProductNDC>67046-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202862</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg).</Description>
</NDC>
<NDC>
<NDCCode>67046-525-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-525-30)</PackageDescription>
<NDC11Code>67046-0525-30</NDC11Code>
<ProductNDC>67046-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202862</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg).</Description>
</NDC>
<NDC>
<NDCCode>67046-525-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BLISTER PACK (67046-525-60)</PackageDescription>
<NDC11Code>67046-0525-60</NDC11Code>
<ProductNDC>67046-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202862</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg).</Description>
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<NDC>
<NDCCode>0409-0525-25</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (0409-0525-25) / 50 mL in 1 VIAL, MULTI-DOSE (0409-0525-01) </PackageDescription>
<NDC11Code>00409-0525-25</NDC11Code>
<ProductNDC>0409-0525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Marcaine</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERINEURAL</RouteName>
<StartMarketingDate>20241209</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016964</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>MARCAINE / MARCAINE WITH EPINEPHRINE contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for MARCAINE (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for MARCAINE WITH EPINEPHRINE is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. MARCAINE with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine bitartrate (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine bitartrate is (–) - 3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol (+)-tartrate (1:1) salt. Epinephrine is a vasoconstrictor. It has the following structural formula. MARCAINE (bupivacaine hydrochloride) is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. MARCAINE with epinephrine 1:200,000 (as bitartrate) is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.0091 mg epinephrine bitartrate (equivalent to 0.005 mg of epinephrine), with sodium chloride for isotonicity, 0.5 mg sodium metabisulfite, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. The pH of these solutions is adjusted to between 3.4 and 4.5 with sodium hydroxide or hydrochloric acid. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of MARCAINE 0.5% with epinephrine 1:200,000 (as bitartrate) at 25°C is 1.008 and at 37°C is 1.008.</Description>
</NDC>
<NDC>
<NDCCode>0525-0971-10</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0525-0971-10) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00525-0971-10</NDC11Code>
<ProductNDC>0525-0971</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zelnorm</ProprietaryName>
<NonProprietaryName>Tegaserod</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021200</ApplicationNumber>
<LabelerName>Alfasigma USA, Inc.</LabelerName>
<SubstanceName>TEGASEROD</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 4 Receptor Agonists [MoA],Serotonin-4 Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Limitations of Use: 1 The safety and effectiveness of ZELNORM in men with IBS-C have not been established [see Clinical Studies (14)].</IndicationAndUsage>
<Description>ZELNORM oral tablets contain tegaserod, a serotonin-4 (5-HT4) receptor agonist, as the hydrogen maleate salt. As the maleate salt, tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. Its empirical formula is C16H23N5OC4H4O4. The molecular weight is 417.47 and the structural formula is. Tegaserod as the maleate salt is a white to off-white crystalline powder and is slightly soluble in ethanol and very slightly soluble in water. Each ZELNORM tablet contains 6 mg of tegaserod (equivalent to 8.31 mg of tegaserod maleate) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, hypromellose, and lactose monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>0525-0971-60</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (0525-0971-60) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00525-0971-60</NDC11Code>
<ProductNDC>0525-0971</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zelnorm</ProprietaryName>
<NonProprietaryName>Tegaserod</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021200</ApplicationNumber>
<LabelerName>Alfasigma USA, Inc.</LabelerName>
<SubstanceName>TEGASEROD</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 4 Receptor Agonists [MoA],Serotonin-4 Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Limitations of Use: 1 The safety and effectiveness of ZELNORM in men with IBS-C have not been established [see Clinical Studies (14)].</IndicationAndUsage>
<Description>ZELNORM oral tablets contain tegaserod, a serotonin-4 (5-HT4) receptor agonist, as the hydrogen maleate salt. As the maleate salt, tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. Its empirical formula is C16H23N5OC4H4O4. The molecular weight is 417.47 and the structural formula is. Tegaserod as the maleate salt is a white to off-white crystalline powder and is slightly soluble in ethanol and very slightly soluble in water. Each ZELNORM tablet contains 6 mg of tegaserod (equivalent to 8.31 mg of tegaserod maleate) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, hypromellose, and lactose monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>10135-525-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (10135-525-05)</PackageDescription>
<NDC11Code>10135-0525-05</NDC11Code>
<ProductNDC>10135-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078552</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be use d alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)○ Amlodipine besylate tablets are indicate d for the treatment of hypertension, to lower blood pressure. Lowe ring blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2- chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, and sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>10135-525-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (10135-525-10)</PackageDescription>
<NDC11Code>10135-0525-10</NDC11Code>
<ProductNDC>10135-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078552</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be use d alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)○ Amlodipine besylate tablets are indicate d for the treatment of hypertension, to lower blood pressure. Lowe ring blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2- chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, and sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>10135-525-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (10135-525-90)</PackageDescription>
<NDC11Code>10135-0525-90</NDC11Code>
<ProductNDC>10135-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078552</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be use d alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1)○ Amlodipine besylate tablets are indicate d for the treatment of hypertension, to lower blood pressure. Lowe ring blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2- chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, and sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>10544-525-06</NDCCode>
<PackageDescription>6 TABLET in 1 BOTTLE (10544-525-06)</PackageDescription>
<NDC11Code>10544-0525-06</NDC11Code>
<ProductNDC>10544-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Carinii Pneumonia. For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia. Travelers’ Diarrhea In Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula:. Inactive Ingredients: Magnesium Stearate, povidone, pregelatinized starch and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>10544-525-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (10544-525-10)</PackageDescription>
<NDC11Code>10544-0525-10</NDC11Code>
<ProductNDC>10544-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Carinii Pneumonia. For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia. Travelers’ Diarrhea In Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula:. Inactive Ingredients: Magnesium Stearate, povidone, pregelatinized starch and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>10544-525-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (10544-525-12)</PackageDescription>
<NDC11Code>10544-0525-12</NDC11Code>
<ProductNDC>10544-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Carinii Pneumonia. For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia. Travelers’ Diarrhea In Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula:. Inactive Ingredients: Magnesium Stearate, povidone, pregelatinized starch and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>10544-525-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (10544-525-14)</PackageDescription>
<NDC11Code>10544-0525-14</NDC11Code>
<ProductNDC>10544-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Carinii Pneumonia. For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia. Travelers’ Diarrhea In Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula:. Inactive Ingredients: Magnesium Stearate, povidone, pregelatinized starch and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>10544-525-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (10544-525-20)</PackageDescription>
<NDC11Code>10544-0525-20</NDC11Code>
<ProductNDC>10544-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Carinii Pneumonia. For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia. Travelers’ Diarrhea In Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula:. Inactive Ingredients: Magnesium Stearate, povidone, pregelatinized starch and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>10544-525-28</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (10544-525-28)</PackageDescription>
<NDC11Code>10544-0525-28</NDC11Code>
<ProductNDC>10544-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Carinii Pneumonia. For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia. Travelers’ Diarrhea In Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. It has the following structural formula:. Inactive Ingredients: Magnesium Stearate, povidone, pregelatinized starch and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>12634-525-00</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (12634-525-00)</PackageDescription>
<NDC11Code>12634-0525-00</NDC11Code>
<ProductNDC>12634-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074215</ApplicationNumber>
<LabelerName>Apotheca, Inc</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Anxiety Disorders. Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or ‘lump in throat’); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or ‘mind going blank’ because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder. Alprazolam is also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES ). Panic Disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Alprazolam tablets contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is represented below. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam. Alprazolam tablets, 2 mg, are multi-scored and may be divided as shown below. INACTIVE INGREDIENT. Corn starch, lactose monohydrate, sodium starch glycolate, hypromellose, colloidal silicon dioxide, magnesium stearate. In addition, the 0.5 mg tablet contains FD&C Yellow No. 6 Aluminum Lake and the 1 mg tablet contains FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
</NDCList>