{
"NDC": [
{
"NDCCode": "80708-326-18",
"PackageDescription": "4000 mL in 1 JUG (80708-326-18) ",
"NDC11Code": "80708-0326-18",
"ProductNDC": "80708-326",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rosemary Yuzu Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201116",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Cleanli Brands LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201116",
"SamplePackage": "N"
},
{
"NDCCode": "47335-326-18",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (47335-326-18) ",
"NDC11Code": "47335-0326-18",
"ProductNDC": "47335-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naltrexone Hydrochloride",
"NonProprietaryName": "Naltrexone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090356",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "NALTREXONE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120229",
"SamplePackage": "N",
"IndicationAndUsage": "Naltrexone hydrochloride tablets are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.",
"Description": "Naltrexone hydrochloride, an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone hydrochloride differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl group. Naltrexone hydrochloride is also related to the potent opioid antagonist, naloxone, or n-allylnoroxymorphone. The chemical name for naltrexone hydrochloride is Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, hydrochloride, (5⛙)-. The structural formula is as follows. Naltrexone hydrochloride is a white, crystalline compound. The hydrochloride salt is soluble in water to the extent of about 100 mg/mL. Naltrexone hydrochloride is available in scored film-coated tablets containing 50 mg of naltrexone hydrochloride, USP. Naltrexone hydrochloride tablets, USP also contain: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "61703-326-18",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61703-326-18) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "61703-0326-18",
"ProductNDC": "61703-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pamidronate Disodium",
"NonProprietaryName": "Pamidronate Disodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20051001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075841",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "PAMIDRONATE DISODIUM",
"StrengthNumber": "9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20051001",
"SamplePackage": "N",
"IndicationAndUsage": "Hypercalcemia of Malignancy. Pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. Patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium. Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). Patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. Diuretic therapy should not be employed prior to correction of hypovolemia. The safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established. Paget’s Disease. Pamidronate disodium is indicated for the treatment of patients with moderate to severe Paget’s disease of bone. The effectiveness of pamidronate disodium was demonstrated primarily in patients with serum alkaline phosphatase ≥ 3 times the upper limit of normal. Pamidronate disodium therapy in patients with Paget’s disease has been effective in reducing serum alkaline phosphatase and urinary hydroxyproline levels by ≥ 50% in at least 50% of patients, and by ≥ 30% in at least 80% of patients. Pamidronate disodium therapy has also been effective in reducing these biochemical markers in patients with Paget’s disease who failed to respond, or no longer responded to other treatments. Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma. Pamidronate disodium is indicated, in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma. The pamidronate disodium treatment effect appeared to be smaller in the study of breast cancer patients receiving hormonal therapy than in the study of those receiving chemotherapy, however, overall evidence of clinical benefit has been demonstrated (see CLINICAL PHARMACOLOGY, Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma, Clinical Trials section).",
"Description": "Pamidronate disodium is a bisphosphonate available in 30 mg, 60 mg, or 90 mg vials for intravenous administration. The pamidronate disodium obtained by combining pamidronic acid and sodium hydroxide is provided in a sterile, ready to use solution for injection. Each mL of the 30 mg vial contains: 3 mg Pamidronate Disodium; 47 mg Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric Acid and/or Sodium Hydroxide, as necessary to adjust pH. Each mL of the 60 mg vial contains: 6 mg Pamidronate Disodium; 40 mg Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric Acid and/or Sodium Hydroxide, as necessary to adjust pH. Each mL of the 90 mg vial contains: 9 mg Pamidronate Disodium; 37.5 mg Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric Acid and/or Sodium Hydroxide, as necessary to adjust pH. The pH of a 1% solution of pamidronate disodium in distilled water is approximately 8.3. Pamidronate, a member of the group of chemical compounds known as bisphosphonates, is an analog of pyrophosphate. Pamidronate disodium is designated chemically as phosphonic acid (3-amino-1-hydroxypropylidene) bis-, disodium salt, and its structural formula is. Pamidronate disodium is soluble in water and in 2N sodium hydroxide, sparingly soluble in 0.1N hydrochloric acid and in 0.1N acetic acid, and practically insoluble in organic solvents. Its molecular formula is C3H9NO7P2Na2 and its molecular weight is 279.1 (calculated as the anhydrous form). Inactive Ingredients. Mannitol, USP, Phosphoric Acid and/or Sodium Hydroxide, as necessary (for adjustment to pH range of 6.0 - 7.0) and Water for Injection, USP."
},
{
"NDCCode": "0093-5376-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5376-01) ",
"NDC11Code": "00093-5376-01",
"ProductNDC": "0093-5376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20200730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090308",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200730",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine."
},
{
"NDCCode": "0093-5376-84",
"PackageDescription": "48 BLISTER PACK in 1 CARTON (0093-5376-84) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5376-19) ",
"NDC11Code": "00093-5376-84",
"ProductNDC": "0093-5376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20200730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090308",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210901",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine."
},
{
"NDCCode": "0093-5377-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5377-01) ",
"NDC11Code": "00093-5377-01",
"ProductNDC": "0093-5377",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20200730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090308",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200730",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine."
},
{
"NDCCode": "0093-5377-84",
"PackageDescription": "48 BLISTER PACK in 1 CARTON (0093-5377-84) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5377-19) ",
"NDC11Code": "00093-5377-84",
"ProductNDC": "0093-5377",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20200730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090308",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200730",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine."
},
{
"NDCCode": "0093-5416-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5416-01) ",
"NDC11Code": "00093-5416-01",
"ProductNDC": "0093-5416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20180417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090308",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180417",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine."
},
{
"NDCCode": "0093-5417-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5417-01) ",
"NDC11Code": "00093-5417-01",
"ProductNDC": "0093-5417",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20170725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090308",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170725",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine."
},
{
"NDCCode": "0093-5417-84",
"PackageDescription": "48 BLISTER PACK in 1 CARTON (0093-5417-84) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5417-19) ",
"NDC11Code": "00093-5417-84",
"ProductNDC": "0093-5417",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20170725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090308",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170725",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine."
},
{
"NDCCode": "0093-5419-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5419-01) ",
"NDC11Code": "00093-5419-01",
"ProductNDC": "0093-5419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20170725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090308",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170725",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine."
},
{
"NDCCode": "0093-5419-84",
"PackageDescription": "48 BLISTER PACK in 1 CARTON (0093-5419-84) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5419-19) ",
"NDC11Code": "00093-5419-84",
"ProductNDC": "0093-5419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20170725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090308",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170725",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine."
},
{
"NDCCode": "11673-326-40",
"PackageDescription": "40 PATCH in 1 CANISTER (11673-326-40) / 4.7 mL in 1 PATCH",
"NDC11Code": "11673-0326-40",
"ProductNDC": "11673-326",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up 70 Isopropyl Alcohol Wipes",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191215",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Target Corporation",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2023-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191215",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent the risk of infection in. minor cuts scrapes burns."
},
{
"NDCCode": "33342-326-87",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (33342-326-87) / 59 mL in 1 BOTTLE, PUMP",
"NDC11Code": "33342-0326-87",
"ProductNDC": "33342-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214345",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241203",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. (1.1). Limitations of Use: Do not use on the face, axillae or groin. (1.2) Do not use if atrophy is present at the treatment site. (1.2) Do not use for rosacea or perioral dermatitis. (1.2).",
"Description": "Clobetasol propionate spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17- propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP is a white to almost white crystalline powder that is practically insoluble in water. Each gram of clobetasol propionate spray, 0.05% contains 0.5 mg of clobetasol propionate, USP in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid."
},
{
"NDCCode": "33342-326-88",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (33342-326-88) / 125 mL in 1 BOTTLE, PUMP",
"NDC11Code": "33342-0326-88",
"ProductNDC": "33342-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214345",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241203",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. (1.1). Limitations of Use: Do not use on the face, axillae or groin. (1.2) Do not use if atrophy is present at the treatment site. (1.2) Do not use for rosacea or perioral dermatitis. (1.2).",
"Description": "Clobetasol propionate spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17- propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP is a white to almost white crystalline powder that is practically insoluble in water. Each gram of clobetasol propionate spray, 0.05% contains 0.5 mg of clobetasol propionate, USP in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid."
},
{
"NDCCode": "60687-326-25",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-326-25) / 1 CAPSULE in 1 BLISTER PACK (60687-326-95) ",
"NDC11Code": "60687-0326-25",
"ProductNDC": "60687-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "American Health Packaging",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170908",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)- N-Methyl-3-phenyl-3-( o-tolyloxy)-propylamine hydrochloride. The molecular formula is C 17H 21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "63736-326-26",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (63736-326-26) > 29.6 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "63736-0326-26",
"ProductNDC": "63736-326",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Auro Homeopathic Ear Relief Drops",
"NonProprietaryName": "Atropa Belladonna, Oyster Shell Calcium Carbonate, Crude, Capsicum, Matricaria Recutita, Potassium Dichromate, Plantago Major, And Verbascum Thapsus",
"DosageFormName": "LIQUID",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20131115",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Insight Pharmaceuticals LLC",
"SubstanceName": "ATROPA BELLADONNA; CAPSICUM; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PLANTAGO MAJOR; POTASSIUM DICHROMATE; VERBASCUM THAPSUS",
"StrengthNumber": "18; 6; 15; 12; 4; 12; 4",
"StrengthUnit": "[hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20131115",
"SamplePackage": "N"
},
{
"NDCCode": "68382-326-04",
"PackageDescription": "4 POUCH in 1 CARTON (68382-326-04) / 1 PATCH in 1 POUCH (68382-326-01) / 7 d in 1 PATCH",
"NDC11Code": "68382-0326-04",
"ProductNDC": "68382-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20231102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202985",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".05",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231102",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol Transdermal System is indicated for.",
"Description": "Estradiol Transdermal System, USP is designed to release estradiol continuously upon application to intact skin. Six (7.5, 11.25, 15, 18, 22.5 and 30 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.5, 11.25, 15, 18, 22.5 or 30 cm2, and contains 1.888, 2.832, 3.777, 4.532, 5.665 or 7.553 mg of estradiol USP respectively. The composition of the systems per unit area is identical. Estradiol USP is a white or creamy white, small crystals or crystalline powder, odorless, stable in air and hygroscopic. Estradiol USP is chemically described as estra-1,3,5(10)-triene-3, 17ß-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.38. The structural formula is. The Estradiol Transdermal System, USP comprises three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are: 1 A translucent polyethylene film., 2 An acrylate adhesive matrix containing estradiol USP., 3 A protective liner of silicone coated polyester film is attached to the adhesive surface and must be removed before the system can be used."
},
{
"NDCCode": "84525-326-01",
"PackageDescription": "5 mL in 1 BOTTLE (84525-326-01) ",
"NDC11Code": "84525-0326-01",
"ProductNDC": "84525-326",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hair Strengthening Oil",
"NonProprietaryName": "Hair Strengthening Oil",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Luoxin E Commerce Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "80708-325-30",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (80708-325-30) ",
"NDC11Code": "80708-0325-30",
"ProductNDC": "80708-325",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rosemary Yuzu Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201116",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Cleanli Brands LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201116",
"SamplePackage": "N"
},
{
"NDCCode": "0093-1135-56",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0093-1135-56) ",
"NDC11Code": "00093-1135-56",
"ProductNDC": "0093-1135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acitretin",
"NonProprietaryName": "Acitretin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091455",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ACITRETIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130719",
"SamplePackage": "N",
"IndicationAndUsage": "Acitretin Capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — Acitretin Capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.",
"Description": "Acitretin, USP (micronized), a retinoid, is available in 10 mg, 17.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow crystalline powder. The structural formula is. C21H26O3 M.W. 326.43. Each capsule contains acitretin, USP (micronized) 10 mg, 17.5 mg, and 25 mg. Inactive ingredients are crospovidone, microcrystalline cellulose, poloxamer, povidone, sodium ascorbate and sodium lauryl sulfate. The 10 mg, 17.5, and 25 mg gelatin capsule shells contain gelatin and titanium dioxide. The 10 mg and 25 mg capsule shells also contain D&C yellow no. 10, FD&C blue no. 1, and FD&C red no. 40. The 17.5 mg capsule shells also contain red iron oxide and yellow iron oxide. The 25 mg gelatin capsule shells also contain FD&C yellow no. 6. The edible imprinting ink contains black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 2."
},
{
"NDCCode": "0093-1136-56",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0093-1136-56) ",
"NDC11Code": "00093-1136-56",
"ProductNDC": "0093-1136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acitretin",
"NonProprietaryName": "Acitretin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091455",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ACITRETIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
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"LastUpdate": "2025-09-25",
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"IndicationAndUsage": "Acitretin Capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — Acitretin Capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.",
"Description": "Acitretin, USP (micronized), a retinoid, is available in 10 mg, 17.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow crystalline powder. The structural formula is. C21H26O3 M.W. 326.43. Each capsule contains acitretin, USP (micronized) 10 mg, 17.5 mg, and 25 mg. Inactive ingredients are crospovidone, microcrystalline cellulose, poloxamer, povidone, sodium ascorbate and sodium lauryl sulfate. The 10 mg, 17.5, and 25 mg gelatin capsule shells contain gelatin and titanium dioxide. The 10 mg and 25 mg capsule shells also contain D&C yellow no. 10, FD&C blue no. 1, and FD&C red no. 40. The 17.5 mg capsule shells also contain red iron oxide and yellow iron oxide. The 25 mg gelatin capsule shells also contain FD&C yellow no. 6. The edible imprinting ink contains black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 2."
},
{
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"PackageDescription": "30 CAPSULE in 1 BOTTLE (0093-1138-56) ",
"NDC11Code": "00093-1138-56",
"ProductNDC": "0093-1138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acitretin",
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"RouteName": "ORAL",
"StartMarketingDate": "20130719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202897",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ACITRETIN",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
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"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Acitretin Capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — Acitretin Capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.",
"Description": "Acitretin, USP (micronized), a retinoid, is available in 10 mg, 17.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow crystalline powder. The structural formula is. C21H26O3 M.W. 326.43. Each capsule contains acitretin, USP (micronized) 10 mg, 17.5 mg, and 25 mg. Inactive ingredients are crospovidone, microcrystalline cellulose, poloxamer, povidone, sodium ascorbate and sodium lauryl sulfate. The 10 mg, 17.5, and 25 mg gelatin capsule shells contain gelatin and titanium dioxide. The 10 mg and 25 mg capsule shells also contain D&C yellow no. 10, FD&C blue no. 1, and FD&C red no. 40. The 17.5 mg capsule shells also contain red iron oxide and yellow iron oxide. The 25 mg gelatin capsule shells also contain FD&C yellow no. 6. The edible imprinting ink contains black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 2."
},
{
"NDCCode": "0115-1750-08",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1750-08) ",
"NDC11Code": "00115-1750-08",
"ProductNDC": "0115-1750",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acitretin",
"NonProprietaryName": "Acitretin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202552",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "ACITRETIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-07-17",
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"ListingRecordCertifiedThrough": "20271231",
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"IndicationAndUsage": "Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — acitretin capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.",
"Description": "Acitretin, a retinoid, is available in 10 mg, 17.5 mg, 22.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow powder with a molecular weight of 326.44. The structural formula is. Each capsule contains acitretin, microcrystalline cellulose, maltodextrin, sodium ascorbate, gelatin, black imprinting ink (the solid components are shellac glaze, propylene glycol and iron oxide black). Gelatin capsule shells contain gelatin, red ferric oxide (10 mg, 22.5 mg and 25 mg only), yellow ferric oxide (17.5 mg and 25 mg only), sodium lauryl sulfate, and titanium dioxide (10 mg, 17.5 mg and 25 mg only). USP dissolution test is pending."
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{
"NDCCode": "0115-1751-08",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1751-08) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acitretin",
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"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160104",
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"ApplicationNumber": "ANDA202552",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "ACITRETIN",
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"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
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"IndicationAndUsage": "Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — acitretin capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.",
"Description": "Acitretin, a retinoid, is available in 10 mg, 17.5 mg, 22.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow powder with a molecular weight of 326.44. The structural formula is. Each capsule contains acitretin, microcrystalline cellulose, maltodextrin, sodium ascorbate, gelatin, black imprinting ink (the solid components are shellac glaze, propylene glycol and iron oxide black). Gelatin capsule shells contain gelatin, red ferric oxide (10 mg, 22.5 mg and 25 mg only), yellow ferric oxide (17.5 mg and 25 mg only), sodium lauryl sulfate, and titanium dioxide (10 mg, 17.5 mg and 25 mg only). USP dissolution test is pending."
},
{
"NDCCode": "0115-1752-08",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1752-08) ",
"NDC11Code": "00115-1752-08",
"ProductNDC": "0115-1752",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acitretin",
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"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202552",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "ACITRETIN",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-07-17",
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"IndicationAndUsage": "Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — acitretin capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.",
"Description": "Acitretin, a retinoid, is available in 10 mg, 17.5 mg, 22.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow powder with a molecular weight of 326.44. The structural formula is. Each capsule contains acitretin, microcrystalline cellulose, maltodextrin, sodium ascorbate, gelatin, black imprinting ink (the solid components are shellac glaze, propylene glycol and iron oxide black). Gelatin capsule shells contain gelatin, red ferric oxide (10 mg, 22.5 mg and 25 mg only), yellow ferric oxide (17.5 mg and 25 mg only), sodium lauryl sulfate, and titanium dioxide (10 mg, 17.5 mg and 25 mg only). USP dissolution test is pending."
},
{
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"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1753-08) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Amneal Pharmaceuticals of New York LLC",
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"IndicationAndUsage": "Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — acitretin capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.",
"Description": "Acitretin, a retinoid, is available in 10 mg, 17.5 mg, 22.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow powder with a molecular weight of 326.44. The structural formula is. Each capsule contains acitretin, microcrystalline cellulose, maltodextrin, sodium ascorbate, gelatin, black imprinting ink (the solid components are shellac glaze, propylene glycol and iron oxide black). Gelatin capsule shells contain gelatin, red ferric oxide (10 mg, 22.5 mg and 25 mg only), yellow ferric oxide (17.5 mg and 25 mg only), sodium lauryl sulfate, and titanium dioxide (10 mg, 17.5 mg and 25 mg only). USP dissolution test is pending."
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{
"NDCCode": "0378-7020-93",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (0378-7020-93) ",
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"ProductNDC": "0378-7020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acitretin",
"NonProprietaryName": "Acitretin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202148",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ACITRETIN",
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"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
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"IndicationAndUsage": "Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS - Acitretin capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.",
"Description": "Acitretin capsules, USP (acitretin), a retinoid, are available in 10-mg or 25-mg gelatin capsules for oral administration. Chemically, acitretin, USP is (all-E)-9-(4-Methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow or greenish crystalline powder with a molecular weight of 326.44. The structural formula is. Each capsule contains acitretin, edetate disodium, gelatin, maltodextrin, microcrystalline cellulose, poloxamer 407, red iron oxide, sodium ascorbate and titanium dioxide. The 25 mg capsules also contain black iron oxide and yellow iron oxide. The black imprinting ink for the 10 mg capsules contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The white imprinting ink for the 25 mg capsules contains povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide."
},
{
"NDCCode": "0378-7023-93",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (0378-7023-93) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acitretin",
"NonProprietaryName": "Acitretin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202148",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ACITRETIN",
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"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
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"IndicationAndUsage": "Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS - Acitretin capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.",
"Description": "Acitretin capsules, USP (acitretin), a retinoid, are available in 10-mg or 25-mg gelatin capsules for oral administration. Chemically, acitretin, USP is (all-E)-9-(4-Methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow or greenish crystalline powder with a molecular weight of 326.44. The structural formula is. Each capsule contains acitretin, edetate disodium, gelatin, maltodextrin, microcrystalline cellulose, poloxamer 407, red iron oxide, sodium ascorbate and titanium dioxide. The 25 mg capsules also contain black iron oxide and yellow iron oxide. The black imprinting ink for the 10 mg capsules contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The white imprinting ink for the 25 mg capsules contains povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide."
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{
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"NDC11Code": "10122-0326-10",
"ProductNDC": "10122-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardene Iv",
"NonProprietaryName": "Nicardipine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19920130",
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"ApplicationNumber": "NDA019734",
"LabelerName": "Chiesi USA, Inc.",
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"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
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<IndicationAndUsage>Hypercalcemia of Malignancy. Pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. Patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium. Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). Patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. Diuretic therapy should not be employed prior to correction of hypovolemia. The safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established. Paget’s Disease. Pamidronate disodium is indicated for the treatment of patients with moderate to severe Paget’s disease of bone. The effectiveness of pamidronate disodium was demonstrated primarily in patients with serum alkaline phosphatase ≥ 3 times the upper limit of normal. Pamidronate disodium therapy in patients with Paget’s disease has been effective in reducing serum alkaline phosphatase and urinary hydroxyproline levels by ≥ 50% in at least 50% of patients, and by ≥ 30% in at least 80% of patients. Pamidronate disodium therapy has also been effective in reducing these biochemical markers in patients with Paget’s disease who failed to respond, or no longer responded to other treatments. Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma. Pamidronate disodium is indicated, in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma. The pamidronate disodium treatment effect appeared to be smaller in the study of breast cancer patients receiving hormonal therapy than in the study of those receiving chemotherapy, however, overall evidence of clinical benefit has been demonstrated (see CLINICAL PHARMACOLOGY, Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma, Clinical Trials section).</IndicationAndUsage>
<Description>Pamidronate disodium is a bisphosphonate available in 30 mg, 60 mg, or 90 mg vials for intravenous administration. The pamidronate disodium obtained by combining pamidronic acid and sodium hydroxide is provided in a sterile, ready to use solution for injection. Each mL of the 30 mg vial contains: 3 mg Pamidronate Disodium; 47 mg Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric Acid and/or Sodium Hydroxide, as necessary to adjust pH. Each mL of the 60 mg vial contains: 6 mg Pamidronate Disodium; 40 mg Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric Acid and/or Sodium Hydroxide, as necessary to adjust pH. Each mL of the 90 mg vial contains: 9 mg Pamidronate Disodium; 37.5 mg Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric Acid and/or Sodium Hydroxide, as necessary to adjust pH. The pH of a 1% solution of pamidronate disodium in distilled water is approximately 8.3. Pamidronate, a member of the group of chemical compounds known as bisphosphonates, is an analog of pyrophosphate. Pamidronate disodium is designated chemically as phosphonic acid (3-amino-1-hydroxypropylidene) bis-, disodium salt, and its structural formula is. Pamidronate disodium is soluble in water and in 2N sodium hydroxide, sparingly soluble in 0.1N hydrochloric acid and in 0.1N acetic acid, and practically insoluble in organic solvents. Its molecular formula is C3H9NO7P2Na2 and its molecular weight is 279.1 (calculated as the anhydrous form). Inactive Ingredients. Mannitol, USP, Phosphoric Acid and/or Sodium Hydroxide, as necessary (for adjustment to pH range of 6.0 - 7.0) and Water for Injection, USP.</Description>
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<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine.</Description>
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<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine.</Description>
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<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine.</Description>
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<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine.</Description>
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<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine.</Description>
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<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine.</Description>
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<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine.</Description>
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<NDC>
<NDCCode>0093-5419-01</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5419-01) </PackageDescription>
<NDC11Code>00093-5419-01</NDC11Code>
<ProductNDC>0093-5419</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clozapine</ProprietaryName>
<NonProprietaryName>Clozapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090308</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>CLOZAPINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine.</Description>
</NDC>
<NDC>
<NDCCode>0093-5419-84</NDCCode>
<PackageDescription>48 BLISTER PACK in 1 CARTON (0093-5419-84) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5419-19) </PackageDescription>
<NDC11Code>00093-5419-84</NDC11Code>
<ProductNDC>0093-5419</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clozapine</ProprietaryName>
<NonProprietaryName>Clozapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090308</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>CLOZAPINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: : 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) , 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. C18H19CIN4 M.W. 326.82. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine.</Description>
</NDC>
<NDC>
<NDCCode>11673-326-40</NDCCode>
<PackageDescription>40 PATCH in 1 CANISTER (11673-326-40) / 4.7 mL in 1 PATCH</PackageDescription>
<NDC11Code>11673-0326-40</NDC11Code>
<ProductNDC>11673-326</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up 70 Isopropyl Alcohol Wipes</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help prevent the risk of infection in. minor cuts scrapes burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33342-326-87</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (33342-326-87) / 59 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>33342-0326-87</NDC11Code>
<ProductNDC>33342-326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214345</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. (1.1). Limitations of Use: Do not use on the face, axillae or groin. (1.2) Do not use if atrophy is present at the treatment site. (1.2) Do not use for rosacea or perioral dermatitis. (1.2).</IndicationAndUsage>
<Description>Clobetasol propionate spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17- propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP is a white to almost white crystalline powder that is practically insoluble in water. Each gram of clobetasol propionate spray, 0.05% contains 0.5 mg of clobetasol propionate, USP in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.</Description>
</NDC>
<NDC>
<NDCCode>33342-326-88</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (33342-326-88) / 125 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>33342-0326-88</NDC11Code>
<ProductNDC>33342-326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214345</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. (1.1). Limitations of Use: Do not use on the face, axillae or groin. (1.2) Do not use if atrophy is present at the treatment site. (1.2) Do not use for rosacea or perioral dermatitis. (1.2).</IndicationAndUsage>
<Description>Clobetasol propionate spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17- propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP is a white to almost white crystalline powder that is practically insoluble in water. Each gram of clobetasol propionate spray, 0.05% contains 0.5 mg of clobetasol propionate, USP in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.</Description>
</NDC>
<NDC>
<NDCCode>60687-326-25</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-326-25) / 1 CAPSULE in 1 BLISTER PACK (60687-326-95) </PackageDescription>
<NDC11Code>60687-0326-25</NDC11Code>
<ProductNDC>60687-326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)- N-Methyl-3-phenyl-3-( o-tolyloxy)-propylamine hydrochloride. The molecular formula is C 17H 21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>63736-326-26</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (63736-326-26) > 29.6 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>63736-0326-26</NDC11Code>
<ProductNDC>63736-326</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Auro Homeopathic Ear Relief Drops</ProprietaryName>
<NonProprietaryName>Atropa Belladonna, Oyster Shell Calcium Carbonate, Crude, Capsicum, Matricaria Recutita, Potassium Dichromate, Plantago Major, And Verbascum Thapsus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20131115</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Insight Pharmaceuticals LLC</LabelerName>
<SubstanceName>ATROPA BELLADONNA; CAPSICUM; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PLANTAGO MAJOR; POTASSIUM DICHROMATE; VERBASCUM THAPSUS</SubstanceName>
<StrengthNumber>18; 6; 15; 12; 4; 12; 4</StrengthNumber>
<StrengthUnit>[hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-326-04</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (68382-326-04) / 1 PATCH in 1 POUCH (68382-326-01) / 7 d in 1 PATCH</PackageDescription>
<NDC11Code>68382-0326-04</NDC11Code>
<ProductNDC>68382-326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20231102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202985</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol Transdermal System is indicated for.</IndicationAndUsage>
<Description>Estradiol Transdermal System, USP is designed to release estradiol continuously upon application to intact skin. Six (7.5, 11.25, 15, 18, 22.5 and 30 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.5, 11.25, 15, 18, 22.5 or 30 cm2, and contains 1.888, 2.832, 3.777, 4.532, 5.665 or 7.553 mg of estradiol USP respectively. The composition of the systems per unit area is identical. Estradiol USP is a white or creamy white, small crystals or crystalline powder, odorless, stable in air and hygroscopic. Estradiol USP is chemically described as estra-1,3,5(10)-triene-3, 17ß-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.38. The structural formula is. The Estradiol Transdermal System, USP comprises three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are: 1 A translucent polyethylene film., 2 An acrylate adhesive matrix containing estradiol USP., 3 A protective liner of silicone coated polyester film is attached to the adhesive surface and must be removed before the system can be used.</Description>
</NDC>
<NDC>
<NDCCode>84525-326-01</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE (84525-326-01) </PackageDescription>
<NDC11Code>84525-0326-01</NDC11Code>
<ProductNDC>84525-326</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hair Strengthening Oil</ProprietaryName>
<NonProprietaryName>Hair Strengthening Oil</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yiwu Luoxin E Commerce Co Ltd</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80708-325-30</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (80708-325-30) </PackageDescription>
<NDC11Code>80708-0325-30</NDC11Code>
<ProductNDC>80708-325</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rosemary Yuzu Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201116</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Cleanli Brands LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0093-1135-56</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0093-1135-56) </PackageDescription>
<NDC11Code>00093-1135-56</NDC11Code>
<ProductNDC>0093-1135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acitretin</ProprietaryName>
<NonProprietaryName>Acitretin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091455</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ACITRETIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acitretin Capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — Acitretin Capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.</IndicationAndUsage>
<Description>Acitretin, USP (micronized), a retinoid, is available in 10 mg, 17.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow crystalline powder. The structural formula is. C21H26O3 M.W. 326.43. Each capsule contains acitretin, USP (micronized) 10 mg, 17.5 mg, and 25 mg. Inactive ingredients are crospovidone, microcrystalline cellulose, poloxamer, povidone, sodium ascorbate and sodium lauryl sulfate. The 10 mg, 17.5, and 25 mg gelatin capsule shells contain gelatin and titanium dioxide. The 10 mg and 25 mg capsule shells also contain D&C yellow no. 10, FD&C blue no. 1, and FD&C red no. 40. The 17.5 mg capsule shells also contain red iron oxide and yellow iron oxide. The 25 mg gelatin capsule shells also contain FD&C yellow no. 6. The edible imprinting ink contains black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Acitretin Capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — Acitretin Capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.</IndicationAndUsage>
<Description>Acitretin, USP (micronized), a retinoid, is available in 10 mg, 17.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow crystalline powder. The structural formula is. C21H26O3 M.W. 326.43. Each capsule contains acitretin, USP (micronized) 10 mg, 17.5 mg, and 25 mg. Inactive ingredients are crospovidone, microcrystalline cellulose, poloxamer, povidone, sodium ascorbate and sodium lauryl sulfate. The 10 mg, 17.5, and 25 mg gelatin capsule shells contain gelatin and titanium dioxide. The 10 mg and 25 mg capsule shells also contain D&C yellow no. 10, FD&C blue no. 1, and FD&C red no. 40. The 17.5 mg capsule shells also contain red iron oxide and yellow iron oxide. The 25 mg gelatin capsule shells also contain FD&C yellow no. 6. The edible imprinting ink contains black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Acitretin Capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — Acitretin Capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.</IndicationAndUsage>
<Description>Acitretin, USP (micronized), a retinoid, is available in 10 mg, 17.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow crystalline powder. The structural formula is. C21H26O3 M.W. 326.43. Each capsule contains acitretin, USP (micronized) 10 mg, 17.5 mg, and 25 mg. Inactive ingredients are crospovidone, microcrystalline cellulose, poloxamer, povidone, sodium ascorbate and sodium lauryl sulfate. The 10 mg, 17.5, and 25 mg gelatin capsule shells contain gelatin and titanium dioxide. The 10 mg and 25 mg capsule shells also contain D&C yellow no. 10, FD&C blue no. 1, and FD&C red no. 40. The 17.5 mg capsule shells also contain red iron oxide and yellow iron oxide. The 25 mg gelatin capsule shells also contain FD&C yellow no. 6. The edible imprinting ink contains black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 2.</Description>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202552</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>ACITRETIN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — acitretin capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.</IndicationAndUsage>
<Description>Acitretin, a retinoid, is available in 10 mg, 17.5 mg, 22.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow powder with a molecular weight of 326.44. The structural formula is. Each capsule contains acitretin, microcrystalline cellulose, maltodextrin, sodium ascorbate, gelatin, black imprinting ink (the solid components are shellac glaze, propylene glycol and iron oxide black). Gelatin capsule shells contain gelatin, red ferric oxide (10 mg, 22.5 mg and 25 mg only), yellow ferric oxide (17.5 mg and 25 mg only), sodium lauryl sulfate, and titanium dioxide (10 mg, 17.5 mg and 25 mg only). USP dissolution test is pending.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>CAPSULE</DosageFormName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202552</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>ACITRETIN</SubstanceName>
<StrengthNumber>17.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
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<IndicationAndUsage>Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — acitretin capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.</IndicationAndUsage>
<Description>Acitretin, a retinoid, is available in 10 mg, 17.5 mg, 22.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow powder with a molecular weight of 326.44. The structural formula is. Each capsule contains acitretin, microcrystalline cellulose, maltodextrin, sodium ascorbate, gelatin, black imprinting ink (the solid components are shellac glaze, propylene glycol and iron oxide black). Gelatin capsule shells contain gelatin, red ferric oxide (10 mg, 22.5 mg and 25 mg only), yellow ferric oxide (17.5 mg and 25 mg only), sodium lauryl sulfate, and titanium dioxide (10 mg, 17.5 mg and 25 mg only). USP dissolution test is pending.</Description>
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<NDC>
<NDCCode>0115-1752-08</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1752-08) </PackageDescription>
<NDC11Code>00115-1752-08</NDC11Code>
<ProductNDC>0115-1752</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acitretin</ProprietaryName>
<NonProprietaryName>Acitretin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202552</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>ACITRETIN</SubstanceName>
<StrengthNumber>22.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — acitretin capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.</IndicationAndUsage>
<Description>Acitretin, a retinoid, is available in 10 mg, 17.5 mg, 22.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow powder with a molecular weight of 326.44. The structural formula is. Each capsule contains acitretin, microcrystalline cellulose, maltodextrin, sodium ascorbate, gelatin, black imprinting ink (the solid components are shellac glaze, propylene glycol and iron oxide black). Gelatin capsule shells contain gelatin, red ferric oxide (10 mg, 22.5 mg and 25 mg only), yellow ferric oxide (17.5 mg and 25 mg only), sodium lauryl sulfate, and titanium dioxide (10 mg, 17.5 mg and 25 mg only). USP dissolution test is pending.</Description>
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<NDCCode>0115-1753-08</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1753-08) </PackageDescription>
<NDC11Code>00115-1753-08</NDC11Code>
<ProductNDC>0115-1753</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acitretin</ProprietaryName>
<NonProprietaryName>Acitretin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202552</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>ACITRETIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — acitretin capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.</IndicationAndUsage>
<Description>Acitretin, a retinoid, is available in 10 mg, 17.5 mg, 22.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow powder with a molecular weight of 326.44. The structural formula is. Each capsule contains acitretin, microcrystalline cellulose, maltodextrin, sodium ascorbate, gelatin, black imprinting ink (the solid components are shellac glaze, propylene glycol and iron oxide black). Gelatin capsule shells contain gelatin, red ferric oxide (10 mg, 22.5 mg and 25 mg only), yellow ferric oxide (17.5 mg and 25 mg only), sodium lauryl sulfate, and titanium dioxide (10 mg, 17.5 mg and 25 mg only). USP dissolution test is pending.</Description>
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<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (0378-7020-93) </PackageDescription>
<NDC11Code>00378-7020-93</NDC11Code>
<ProductNDC>0378-7020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acitretin</ProprietaryName>
<NonProprietaryName>Acitretin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202148</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ACITRETIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-23</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS - Acitretin capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.</IndicationAndUsage>
<Description>Acitretin capsules, USP (acitretin), a retinoid, are available in 10-mg or 25-mg gelatin capsules for oral administration. Chemically, acitretin, USP is (all-E)-9-(4-Methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow or greenish crystalline powder with a molecular weight of 326.44. The structural formula is. Each capsule contains acitretin, edetate disodium, gelatin, maltodextrin, microcrystalline cellulose, poloxamer 407, red iron oxide, sodium ascorbate and titanium dioxide. The 25 mg capsules also contain black iron oxide and yellow iron oxide. The black imprinting ink for the 10 mg capsules contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The white imprinting ink for the 25 mg capsules contains povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide.</Description>
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<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (0378-7023-93) </PackageDescription>
<NDC11Code>00378-7023-93</NDC11Code>
<ProductNDC>0378-7023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acitretin</ProprietaryName>
<NonProprietaryName>Acitretin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202148</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ACITRETIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS - Acitretin capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.</IndicationAndUsage>
<Description>Acitretin capsules, USP (acitretin), a retinoid, are available in 10-mg or 25-mg gelatin capsules for oral administration. Chemically, acitretin, USP is (all-E)-9-(4-Methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow or greenish crystalline powder with a molecular weight of 326.44. The structural formula is. Each capsule contains acitretin, edetate disodium, gelatin, maltodextrin, microcrystalline cellulose, poloxamer 407, red iron oxide, sodium ascorbate and titanium dioxide. The 25 mg capsules also contain black iron oxide and yellow iron oxide. The black imprinting ink for the 10 mg capsules contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The white imprinting ink for the 25 mg capsules contains povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide.</Description>
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<PackageDescription>10 CARTON in 1 BOX (10122-326-10) > 1 BAG in 1 CARTON (10122-326-01) > 200 mL in 1 BAG</PackageDescription>
<NDC11Code>10122-0326-10</NDC11Code>
<ProductNDC>10122-326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardene Iv</ProprietaryName>
<NonProprietaryName>Nicardipine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19920130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019734</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>NICARDIPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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