{
"NDC": [
{
"NDCCode": "45963-733-55",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-55) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "45963-0733-55",
"ProductNDC": "45963-733",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxorubicin Hydrochloride",
"NonProprietaryName": "Doxorubicin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20141101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203622",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141101",
"SamplePackage": "N",
"IndicationAndUsage": "Doxorubicin Hydrochloride Injection is an anthracycline topoisomerase inhibitor indicated: 1 as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer (1.1)., 2 for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms’ tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma (1.2).",
"Description": "Doxorubicin hydrochloride, USP is an anthracycline topoisomerase inhibitor isolated from cultures of Streptomyces peucetius var. caesius. The chemical name of doxorubicin hydrochloride, USP is: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10 tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, hydrochloride (8S-cis)-. The molecular weight of doxorubicin hydrochloride, USP is 579.98, and the molecular formula is C27H29NO11HCl. The chemical structure of doxorubicin hydrochloride, USP is. Doxorubicin Hydrochloride Injection USP, for intravenous use, is a clear red, sterile, isotonic aqueous solution provided in vials containing 10 mg/5 mL doxorubicin hydrochloride, USP (equivalent to 9.37 mg of doxorubicin free base), 20 mg/10 mL doxorubicin hydrochloride, USP (equivalent to 18.74 mg of doxorubicin free base), 50 mg/25 mL doxorubicin hydrochloride, USP (equivalent to 46.86 mg of doxorubicin free base), or 200 mg/100 mL of doxorubicin hydrochloride, USP (equivalent to 187.43 mg of doxorubicin free base). The drug product has demonstrated inherent antimicrobial activity suitable for a multiple dose presentation. Each milliliter of solution contains 2 mg of doxorubicin hydrochloride, USP Inactive ingredients include 9 mg Sodium Chloride, USP and Water for Injection, USP, quantity sufficient. The pH of the solution is adjusted to 3.0 with hydrochloric acid, USP."
},
{
"NDCCode": "45963-733-57",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-57) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "45963-0733-57",
"ProductNDC": "45963-733",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxorubicin Hydrochloride",
"NonProprietaryName": "Doxorubicin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20141101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203622",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141101",
"SamplePackage": "N",
"IndicationAndUsage": "Doxorubicin Hydrochloride Injection is an anthracycline topoisomerase inhibitor indicated: 1 as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer (1.1)., 2 for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms’ tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma (1.2).",
"Description": "Doxorubicin hydrochloride, USP is an anthracycline topoisomerase inhibitor isolated from cultures of Streptomyces peucetius var. caesius. The chemical name of doxorubicin hydrochloride, USP is: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10 tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, hydrochloride (8S-cis)-. The molecular weight of doxorubicin hydrochloride, USP is 579.98, and the molecular formula is C27H29NO11HCl. The chemical structure of doxorubicin hydrochloride, USP is. Doxorubicin Hydrochloride Injection USP, for intravenous use, is a clear red, sterile, isotonic aqueous solution provided in vials containing 10 mg/5 mL doxorubicin hydrochloride, USP (equivalent to 9.37 mg of doxorubicin free base), 20 mg/10 mL doxorubicin hydrochloride, USP (equivalent to 18.74 mg of doxorubicin free base), 50 mg/25 mL doxorubicin hydrochloride, USP (equivalent to 46.86 mg of doxorubicin free base), or 200 mg/100 mL of doxorubicin hydrochloride, USP (equivalent to 187.43 mg of doxorubicin free base). The drug product has demonstrated inherent antimicrobial activity suitable for a multiple dose presentation. Each milliliter of solution contains 2 mg of doxorubicin hydrochloride, USP Inactive ingredients include 9 mg Sodium Chloride, USP and Water for Injection, USP, quantity sufficient. The pH of the solution is adjusted to 3.0 with hydrochloric acid, USP."
},
{
"NDCCode": "45963-733-60",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (45963-733-60) / 100 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "45963-0733-60",
"ProductNDC": "45963-733",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxorubicin Hydrochloride",
"NonProprietaryName": "Doxorubicin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20141101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203622",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141101",
"SamplePackage": "N",
"IndicationAndUsage": "Doxorubicin Hydrochloride Injection is an anthracycline topoisomerase inhibitor indicated: 1 as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer (1.1)., 2 for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms’ tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma (1.2).",
"Description": "Doxorubicin hydrochloride, USP is an anthracycline topoisomerase inhibitor isolated from cultures of Streptomyces peucetius var. caesius. The chemical name of doxorubicin hydrochloride, USP is: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10 tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, hydrochloride (8S-cis)-. The molecular weight of doxorubicin hydrochloride, USP is 579.98, and the molecular formula is C27H29NO11HCl. The chemical structure of doxorubicin hydrochloride, USP is. Doxorubicin Hydrochloride Injection USP, for intravenous use, is a clear red, sterile, isotonic aqueous solution provided in vials containing 10 mg/5 mL doxorubicin hydrochloride, USP (equivalent to 9.37 mg of doxorubicin free base), 20 mg/10 mL doxorubicin hydrochloride, USP (equivalent to 18.74 mg of doxorubicin free base), 50 mg/25 mL doxorubicin hydrochloride, USP (equivalent to 46.86 mg of doxorubicin free base), or 200 mg/100 mL of doxorubicin hydrochloride, USP (equivalent to 187.43 mg of doxorubicin free base). The drug product has demonstrated inherent antimicrobial activity suitable for a multiple dose presentation. Each milliliter of solution contains 2 mg of doxorubicin hydrochloride, USP Inactive ingredients include 9 mg Sodium Chloride, USP and Water for Injection, USP, quantity sufficient. The pH of the solution is adjusted to 3.0 with hydrochloric acid, USP."
},
{
"NDCCode": "45963-733-68",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-68) / 25 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "45963-0733-68",
"ProductNDC": "45963-733",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxorubicin Hydrochloride",
"NonProprietaryName": "Doxorubicin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20141101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203622",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141101",
"SamplePackage": "N",
"IndicationAndUsage": "Doxorubicin Hydrochloride Injection is an anthracycline topoisomerase inhibitor indicated: 1 as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer (1.1)., 2 for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms’ tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma (1.2).",
"Description": "Doxorubicin hydrochloride, USP is an anthracycline topoisomerase inhibitor isolated from cultures of Streptomyces peucetius var. caesius. The chemical name of doxorubicin hydrochloride, USP is: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10 tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, hydrochloride (8S-cis)-. The molecular weight of doxorubicin hydrochloride, USP is 579.98, and the molecular formula is C27H29NO11HCl. The chemical structure of doxorubicin hydrochloride, USP is. Doxorubicin Hydrochloride Injection USP, for intravenous use, is a clear red, sterile, isotonic aqueous solution provided in vials containing 10 mg/5 mL doxorubicin hydrochloride, USP (equivalent to 9.37 mg of doxorubicin free base), 20 mg/10 mL doxorubicin hydrochloride, USP (equivalent to 18.74 mg of doxorubicin free base), 50 mg/25 mL doxorubicin hydrochloride, USP (equivalent to 46.86 mg of doxorubicin free base), or 200 mg/100 mL of doxorubicin hydrochloride, USP (equivalent to 187.43 mg of doxorubicin free base). The drug product has demonstrated inherent antimicrobial activity suitable for a multiple dose presentation. Each milliliter of solution contains 2 mg of doxorubicin hydrochloride, USP Inactive ingredients include 9 mg Sodium Chloride, USP and Water for Injection, USP, quantity sufficient. The pH of the solution is adjusted to 3.0 with hydrochloric acid, USP."
},
{
"NDCCode": "45963-440-55",
"PackageDescription": "1 VIAL in 1 CARTON (45963-440-55) > 5 mL in 1 VIAL",
"NDC11Code": "45963-0440-55",
"ProductNDC": "45963-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoledronic Acid",
"NonProprietaryName": "Zoledronic Acid",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150413",
"EndMarketingDate": "20190531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202472",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "ZOLEDRONIC ACID",
"StrengthNumber": "4",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Diphosphonates [CS],Bisphosphonate [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150413",
"EndMarketingDatePackage": "20190531",
"SamplePackage": "N"
},
{
"NDCCode": "45963-607-55",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-55) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "45963-0607-55",
"ProductNDC": "45963-607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vinorelbine",
"NonProprietaryName": "Vinorelbine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078011",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "VINORELBINE TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vinca Alkaloid [EPC], Vinca Alkaloids [CS]",
"Status": "Active",
"LastUpdate": "2023-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150301",
"SamplePackage": "N",
"IndicationAndUsage": "Vinorelbine injection is indicated: 1 In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), 2 As a single agent for the treatment of patients with metastatic NSCLC.",
"Description": "Vinorelbine tartrate, USP is a semi-synthetic vinca alkaloid for intravenous injection. Chemically, vinorelbine tartrate, USP is 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R-(R*,R*)-2, 3-dihydroxybutanedioate (1:2)(tartrate)] and has the following structure:. C45H54N4O82C4H6O6 M.W. 1079.12. Vinorelbine Injection, USP is a sterile nonpyrogenic aqueous solution. Each milliliter of solution contains vinorelbine tartrate, USP equivalent to 10 mg vinorelbine in Water for Injection USP. The pH of Vinorelbine Injection, USP is approximately 3.5."
},
{
"NDCCode": "45963-609-55",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (45963-609-55) / 2 mL in 1 VIAL, GLASS",
"NDC11Code": "45963-0609-55",
"ProductNDC": "45963-609",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fludarabine Phosphate",
"NonProprietaryName": "Fludarabine Phosphate",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078610",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "FLUDARABINE PHOSPHATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150105",
"SamplePackage": "N",
"IndicationAndUsage": "Fludarabine Phosphate for Injection is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of Fludarabine Phosphate for Injection in previously untreated or non-refractory patients with CLL have not been established.",
"Description": "Fludarabine Phosphate for Injection, USP contains fludarabine phosphate USP, a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-β-D-arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. Each vial of sterile lyophilized solid cake contains 50 mg of the active ingredient fludarabine phosphate, 50 mg of mannitol, and sodium hydroxide to adjust pH to 7.7. The pH range for the final product is 7.2 to 8.2. Reconstitution with 2 mL of Sterile Water for Injection, USP, results in a solution containing 25 mg/mL of fludarabine phosphate intended for intravenous administration. The chemical name for fludarabine phosphate is 9H-Purin-6-amine, 2-fluoro-9-(5-0-phosphono-β-D-arabino-furanosyl) (2-fluoro-ara-AMP). The molecular formula of fludarabine phosphate is C10H13FN5O7P (MW 365.2) and the structure is."
},
{
"NDCCode": "45963-614-55",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-55) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "45963-0614-55",
"ProductNDC": "45963-614",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irinotecan Hydrochloride",
"NonProprietaryName": "Irinotecan Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150312",
"EndMarketingDate": "20270930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078589",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "IRINOTECAN HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150312",
"EndMarketingDatePackage": "20270930",
"SamplePackage": "N",
"IndicationAndUsage": "Irinotecan Hydrochloride Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. Irinotecan Hydrochloride Injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.",
"Description": "Irinotecan Hydrochloride Injection, USP is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan Hydrochloride Injection, USP is supplied as a sterile, pale yellow, clear, aqueous solution. Each milliliter of solution contains 20 mg of irinotecan hydrochloride, USP (on the basis of the trihydrate salt), 45 mg of sorbitol, and 0.9 mg of lactic acid. The pH of the solution has been adjusted to 3.4 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. Irinotecan Hydrochloride Injection, USP is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP. Irinotecan hydrochloride, USP is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata or is chemically synthesized. The chemical name is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3’,4’:6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4’bipiperidine]-1’-carboxylate, monohydrochloride, trihydrate. Its molecular formula is C33H38N4O6HCl3H2O and molecular weight is 677.19. It is slightly soluble in water and organic solvents. Its structural formula is as follows."
},
{
"NDCCode": "42806-733-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (42806-733-01) ",
"NDC11Code": "42806-0733-01",
"ProductNDC": "42806-733",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitriol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219796",
"LabelerName": "EPIC PHARMA LLC",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": ".5",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260227",
"SamplePackage": "N",
"IndicationAndUsage": "Predialysis Patients Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients Calcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients Calcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.",
"Description": "Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol. All dosage forms contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain medium-chain triglycerides, dehydrated alcohol, and imprinting ink which contains shellac glaze (modified) in SD-45, isopropyl alcohol, black iron oxide non-irradiated, n-butyl alcohol, propylene glycol, and ammonium hydroxide. Gelatin capsule shells contain glycerin, Non-Crystallizing Sorbitol Solution, and Gelatin, with the following dye systems: FD&C Yellow No. 6 and titanium dioxide. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9,10- seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D 3, 1,25-DHCC, 1,25(OH) 2D 3and 1,25-diOHC."
},
{
"NDCCode": "61919-733-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (61919-733-90) ",
"NDC11Code": "61919-0733-90",
"ProductNDC": "61919-733",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finasteride",
"NonProprietaryName": "Finasteride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090121",
"LabelerName": "Direct_Rx",
"SubstanceName": "FINASTERIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190118",
"SamplePackage": "N",
"IndicationAndUsage": "1 INDICATIONS AND USAGE 1.1 Monotherapy - Finasteride tablets 5 mg are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to . 1.1 Monotherapy. Finasteride tablets 5 mg are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to. Improve symptoms Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. 1.2 Combination with Alpha-Blocker. Finasteride tablets 5 mg administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score). 1.3 Limitations of Use. Finasteride is not approved for the prevention of prostate cancer.",
"Description": "Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5α,17ß)-. The empirical formula of finasteride is C 23H 36N 2O 2 and its molecular weight is 372.55. Its structural formula is. [structure]. Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride tablets, USP for oral administration are film-coated tablets that contain 5 mg of finasteride and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate, hypromellose, titanium dioxide, magnesium stearate, lauryl macrogolglycerides, FD&C Blue # 2 aluminum lake and polyethylene glycol."
},
{
"NDCCode": "62135-733-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (62135-733-60) ",
"NDC11Code": "62135-0733-60",
"ProductNDC": "62135-733",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide And Metformin Hcl",
"NonProprietaryName": "Glipizide And Metformin Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078728",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "GLIPIZIDE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230815",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide and Metformin HCl Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide and Metformin HCl Tablets, USP contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes, glipizide and metformin hydrochloride. Glipizide is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido) ethyl] phenyl] sulfonyl] urea. Glipizide is a whitish, odorless powder with a molecular formula of C 21H 27N 5O 4S, a molecular weight of 445.55 and a pK a of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. The structural formula is represented below. Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is a white to off-white crystalline compound with a molecular formula of C 4H 12ClN 5(monohydrochloride) and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown:. Glipizide and Metformin HCl Tablets, USP are available for oral administration in tablets containing 2.5 mg glipizide with 250 mg metformin hydrochloride, 2.5 mg glipizide with 500 mg metformin hydrochloride, and 5 mg glipizide with 500 mg metformin hydrochloride. In addition, each tablet contains the following inactive ingredients: Sodium Starch Glycolate, Corn Starch, Povidone, Magnesium Stearate, Colloidal Silicon Dioxide, Hypromellose, Talc, Titanium Dioxide, Polyethylene Glycol 6000, Propylene Glycol and Iron Oxide Red. The tablets are film coated, which provides color differentiation."
},
{
"NDCCode": "45963-125-23",
"PackageDescription": "1 BOTTLE in 1 CARTON (45963-125-23) > 15 mL in 1 BOTTLE",
"NDC11Code": "45963-0125-23",
"ProductNDC": "45963-125",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Infants Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20100511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079058",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1.25mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100511",
"SamplePackage": "N"
},
{
"NDCCode": "45963-125-24",
"PackageDescription": "1 BOTTLE in 1 CARTON (45963-125-24) > 30 mL in 1 BOTTLE",
"NDC11Code": "45963-0125-24",
"ProductNDC": "45963-125",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Infants Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20100511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079058",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1.25mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100511",
"SamplePackage": "N"
},
{
"NDCCode": "45963-141-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-141-05)",
"NDC11Code": "45963-0141-05",
"ProductNDC": "45963-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077285",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-05-23"
},
{
"NDCCode": "45963-141-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-141-30)",
"NDC11Code": "45963-0141-30",
"ProductNDC": "45963-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077285",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-05-23"
},
{
"NDCCode": "45963-141-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-141-90)",
"NDC11Code": "45963-0141-90",
"ProductNDC": "45963-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150205",
"EndMarketingDate": "20171031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077285",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "45963-142-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-05) ",
"NDC11Code": "45963-0142-05",
"ProductNDC": "45963-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077285",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150519",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
"Description": "Bupropion hydrochloride extended-release tablets USP, (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 300 mg, off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: colloidal anhydrous silica, colloidal silicon dioxide, copovidone, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. This drug product conforms to USP Drug Dissolution Test #11."
},
{
"NDCCode": "45963-142-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-30) ",
"NDC11Code": "45963-0142-30",
"ProductNDC": "45963-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077285",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150217",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
"Description": "Bupropion hydrochloride extended-release tablets USP, (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 300 mg, off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: colloidal anhydrous silica, colloidal silicon dioxide, copovidone, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. This drug product conforms to USP Drug Dissolution Test #11."
},
{
"NDCCode": "45963-142-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-90) ",
"NDC11Code": "45963-0142-90",
"ProductNDC": "45963-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077285",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150615",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
"Description": "Bupropion hydrochloride extended-release tablets USP, (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 300 mg, off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: colloidal anhydrous silica, colloidal silicon dioxide, copovidone, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. This drug product conforms to USP Drug Dissolution Test #11."
},
{
"NDCCode": "45963-152-02",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-152-02) ",
"NDC11Code": "45963-0152-02",
"ProductNDC": "45963-152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120525",
"EndMarketingDate": "20200831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077899",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120531",
"EndMarketingDatePackage": "20200831",
"SamplePackage": "N"
},
{
"NDCCode": "45963-152-50",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-152-50)",
"NDC11Code": "45963-0152-50",
"ProductNDC": "45963-152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077899",
"LabelerName": "Actavis Inc.",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "45963-200-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-200-01)",
"NDC11Code": "45963-0200-01",
"ProductNDC": "45963-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078458",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2016-01-22"
},
{
"NDCCode": "45963-200-11",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-200-11)",
"NDC11Code": "45963-0200-11",
"ProductNDC": "45963-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160126",
"EndMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078458",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2017-10-03"
},
{
"NDCCode": "45963-200-25",
"PackageDescription": "250 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-200-25)",
"NDC11Code": "45963-0200-25",
"ProductNDC": "45963-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078458",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2017-07-25"
},
{
"NDCCode": "45963-201-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-201-01)",
"NDC11Code": "45963-0201-01",
"ProductNDC": "45963-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078458",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2016-01-22"
},
{
"NDCCode": "45963-201-11",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-201-11)",
"NDC11Code": "45963-0201-11",
"ProductNDC": "45963-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151228",
"EndMarketingDate": "20170828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078458",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2017-08-29"
},
{
"NDCCode": "45963-201-25",
"PackageDescription": "250 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-201-25)",
"NDC11Code": "45963-0201-25",
"ProductNDC": "45963-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078458",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2017-07-25"
},
{
"NDCCode": "45963-202-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-202-01)",
"NDC11Code": "45963-0202-01",
"ProductNDC": "45963-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078458",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2016-01-22"
},
{
"NDCCode": "45963-202-11",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-202-11)",
"NDC11Code": "45963-0202-11",
"ProductNDC": "45963-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151228",
"EndMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078458",
"LabelerName": "Actavis Pharma, Inc.",
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<Description>Doxorubicin hydrochloride, USP is an anthracycline topoisomerase inhibitor isolated from cultures of Streptomyces peucetius var. caesius. The chemical name of doxorubicin hydrochloride, USP is: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10 tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, hydrochloride (8S-cis)-. The molecular weight of doxorubicin hydrochloride, USP is 579.98, and the molecular formula is C27H29NO11HCl. The chemical structure of doxorubicin hydrochloride, USP is. Doxorubicin Hydrochloride Injection USP, for intravenous use, is a clear red, sterile, isotonic aqueous solution provided in vials containing 10 mg/5 mL doxorubicin hydrochloride, USP (equivalent to 9.37 mg of doxorubicin free base), 20 mg/10 mL doxorubicin hydrochloride, USP (equivalent to 18.74 mg of doxorubicin free base), 50 mg/25 mL doxorubicin hydrochloride, USP (equivalent to 46.86 mg of doxorubicin free base), or 200 mg/100 mL of doxorubicin hydrochloride, USP (equivalent to 187.43 mg of doxorubicin free base). The drug product has demonstrated inherent antimicrobial activity suitable for a multiple dose presentation. Each milliliter of solution contains 2 mg of doxorubicin hydrochloride, USP Inactive ingredients include 9 mg Sodium Chloride, USP and Water for Injection, USP, quantity sufficient. The pH of the solution is adjusted to 3.0 with hydrochloric acid, USP.</Description>
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<ProductNDC>45963-733</ProductNDC>
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<Description>Doxorubicin hydrochloride, USP is an anthracycline topoisomerase inhibitor isolated from cultures of Streptomyces peucetius var. caesius. The chemical name of doxorubicin hydrochloride, USP is: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10 tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, hydrochloride (8S-cis)-. The molecular weight of doxorubicin hydrochloride, USP is 579.98, and the molecular formula is C27H29NO11HCl. The chemical structure of doxorubicin hydrochloride, USP is. Doxorubicin Hydrochloride Injection USP, for intravenous use, is a clear red, sterile, isotonic aqueous solution provided in vials containing 10 mg/5 mL doxorubicin hydrochloride, USP (equivalent to 9.37 mg of doxorubicin free base), 20 mg/10 mL doxorubicin hydrochloride, USP (equivalent to 18.74 mg of doxorubicin free base), 50 mg/25 mL doxorubicin hydrochloride, USP (equivalent to 46.86 mg of doxorubicin free base), or 200 mg/100 mL of doxorubicin hydrochloride, USP (equivalent to 187.43 mg of doxorubicin free base). The drug product has demonstrated inherent antimicrobial activity suitable for a multiple dose presentation. Each milliliter of solution contains 2 mg of doxorubicin hydrochloride, USP Inactive ingredients include 9 mg Sodium Chloride, USP and Water for Injection, USP, quantity sufficient. The pH of the solution is adjusted to 3.0 with hydrochloric acid, USP.</Description>
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<Description>Doxorubicin hydrochloride, USP is an anthracycline topoisomerase inhibitor isolated from cultures of Streptomyces peucetius var. caesius. The chemical name of doxorubicin hydrochloride, USP is: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10 tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, hydrochloride (8S-cis)-. The molecular weight of doxorubicin hydrochloride, USP is 579.98, and the molecular formula is C27H29NO11HCl. The chemical structure of doxorubicin hydrochloride, USP is. Doxorubicin Hydrochloride Injection USP, for intravenous use, is a clear red, sterile, isotonic aqueous solution provided in vials containing 10 mg/5 mL doxorubicin hydrochloride, USP (equivalent to 9.37 mg of doxorubicin free base), 20 mg/10 mL doxorubicin hydrochloride, USP (equivalent to 18.74 mg of doxorubicin free base), 50 mg/25 mL doxorubicin hydrochloride, USP (equivalent to 46.86 mg of doxorubicin free base), or 200 mg/100 mL of doxorubicin hydrochloride, USP (equivalent to 187.43 mg of doxorubicin free base). The drug product has demonstrated inherent antimicrobial activity suitable for a multiple dose presentation. Each milliliter of solution contains 2 mg of doxorubicin hydrochloride, USP Inactive ingredients include 9 mg Sodium Chloride, USP and Water for Injection, USP, quantity sufficient. The pH of the solution is adjusted to 3.0 with hydrochloric acid, USP.</Description>
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<NDCCode>45963-440-55</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (45963-440-55) > 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>45963-0440-55</NDC11Code>
<ProductNDC>45963-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoledronic Acid</ProprietaryName>
<NonProprietaryName>Zoledronic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150413</StartMarketingDate>
<EndMarketingDate>20190531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202472</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>ZOLEDRONIC ACID</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Diphosphonates [CS],Bisphosphonate [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150413</StartMarketingDatePackage>
<EndMarketingDatePackage>20190531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC11Code>45963-0607-55</NDC11Code>
<ProductNDC>45963-607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vinorelbine</ProprietaryName>
<NonProprietaryName>Vinorelbine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078011</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>VINORELBINE TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vinca Alkaloid [EPC], Vinca Alkaloids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vinorelbine injection is indicated: 1 In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), 2 As a single agent for the treatment of patients with metastatic NSCLC.</IndicationAndUsage>
<Description>Vinorelbine tartrate, USP is a semi-synthetic vinca alkaloid for intravenous injection. Chemically, vinorelbine tartrate, USP is 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R-(R*,R*)-2, 3-dihydroxybutanedioate (1:2)(tartrate)] and has the following structure:. C45H54N4O82C4H6O6 M.W. 1079.12. Vinorelbine Injection, USP is a sterile nonpyrogenic aqueous solution. Each milliliter of solution contains vinorelbine tartrate, USP equivalent to 10 mg vinorelbine in Water for Injection USP. The pH of Vinorelbine Injection, USP is approximately 3.5.</Description>
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<PackageDescription>1 VIAL, GLASS in 1 CARTON (45963-609-55) / 2 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>45963-0609-55</NDC11Code>
<ProductNDC>45963-609</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fludarabine Phosphate</ProprietaryName>
<NonProprietaryName>Fludarabine Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078610</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>FLUDARABINE PHOSPHATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<StartMarketingDatePackage>20150105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fludarabine Phosphate for Injection is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of Fludarabine Phosphate for Injection in previously untreated or non-refractory patients with CLL have not been established.</IndicationAndUsage>
<Description>Fludarabine Phosphate for Injection, USP contains fludarabine phosphate USP, a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-β-D-arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. Each vial of sterile lyophilized solid cake contains 50 mg of the active ingredient fludarabine phosphate, 50 mg of mannitol, and sodium hydroxide to adjust pH to 7.7. The pH range for the final product is 7.2 to 8.2. Reconstitution with 2 mL of Sterile Water for Injection, USP, results in a solution containing 25 mg/mL of fludarabine phosphate intended for intravenous administration. The chemical name for fludarabine phosphate is 9H-Purin-6-amine, 2-fluoro-9-(5-0-phosphono-β-D-arabino-furanosyl) (2-fluoro-ara-AMP). The molecular formula of fludarabine phosphate is C10H13FN5O7P (MW 365.2) and the structure is.</Description>
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<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-55) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>45963-0614-55</NDC11Code>
<ProductNDC>45963-614</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Irinotecan Hydrochloride</ProprietaryName>
<NonProprietaryName>Irinotecan Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
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<EndMarketingDate>20270930</EndMarketingDate>
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<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>IRINOTECAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2026-04-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150312</StartMarketingDatePackage>
<EndMarketingDatePackage>20270930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Irinotecan Hydrochloride Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. Irinotecan Hydrochloride Injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.</IndicationAndUsage>
<Description>Irinotecan Hydrochloride Injection, USP is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan Hydrochloride Injection, USP is supplied as a sterile, pale yellow, clear, aqueous solution. Each milliliter of solution contains 20 mg of irinotecan hydrochloride, USP (on the basis of the trihydrate salt), 45 mg of sorbitol, and 0.9 mg of lactic acid. The pH of the solution has been adjusted to 3.4 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. Irinotecan Hydrochloride Injection, USP is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP. Irinotecan hydrochloride, USP is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata or is chemically synthesized. The chemical name is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3’,4’:6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4’bipiperidine]-1’-carboxylate, monohydrochloride, trihydrate. Its molecular formula is C33H38N4O6HCl3H2O and molecular weight is 677.19. It is slightly soluble in water and organic solvents. Its structural formula is as follows.</Description>
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<PackageDescription>100 CAPSULE in 1 BOTTLE (42806-733-01) </PackageDescription>
<NDC11Code>42806-0733-01</NDC11Code>
<ProductNDC>42806-733</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitriol</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219796</ApplicationNumber>
<LabelerName>EPIC PHARMA LLC</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
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<StartMarketingDatePackage>20260227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Predialysis Patients Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients Calcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients Calcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.</IndicationAndUsage>
<Description>Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol. All dosage forms contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain medium-chain triglycerides, dehydrated alcohol, and imprinting ink which contains shellac glaze (modified) in SD-45, isopropyl alcohol, black iron oxide non-irradiated, n-butyl alcohol, propylene glycol, and ammonium hydroxide. Gelatin capsule shells contain glycerin, Non-Crystallizing Sorbitol Solution, and Gelatin, with the following dye systems: FD&C Yellow No. 6 and titanium dioxide. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9,10- seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D 3, 1,25-DHCC, 1,25(OH) 2D 3and 1,25-diOHC.</Description>
</NDC>
<NDC>
<NDCCode>61919-733-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (61919-733-90) </PackageDescription>
<NDC11Code>61919-0733-90</NDC11Code>
<ProductNDC>61919-733</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finasteride</ProprietaryName>
<NonProprietaryName>Finasteride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090121</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>FINASTERIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1 INDICATIONS AND USAGE 1.1 Monotherapy - Finasteride tablets 5 mg are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to . 1.1 Monotherapy. Finasteride tablets 5 mg are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to. Improve symptoms Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. 1.2 Combination with Alpha-Blocker. Finasteride tablets 5 mg administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score). 1.3 Limitations of Use. Finasteride is not approved for the prevention of prostate cancer.</IndicationAndUsage>
<Description>Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5α,17ß)-. The empirical formula of finasteride is C 23H 36N 2O 2 and its molecular weight is 372.55. Its structural formula is. [structure]. Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride tablets, USP for oral administration are film-coated tablets that contain 5 mg of finasteride and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate, hypromellose, titanium dioxide, magnesium stearate, lauryl macrogolglycerides, FD&C Blue # 2 aluminum lake and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>62135-733-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (62135-733-60) </PackageDescription>
<NDC11Code>62135-0733-60</NDC11Code>
<ProductNDC>62135-733</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide And Metformin Hcl</ProprietaryName>
<NonProprietaryName>Glipizide And Metformin Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078728</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>GLIPIZIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide and Metformin HCl Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide and Metformin HCl Tablets, USP contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes, glipizide and metformin hydrochloride. Glipizide is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido) ethyl] phenyl] sulfonyl] urea. Glipizide is a whitish, odorless powder with a molecular formula of C 21H 27N 5O 4S, a molecular weight of 445.55 and a pK a of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. The structural formula is represented below. Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is a white to off-white crystalline compound with a molecular formula of C 4H 12ClN 5(monohydrochloride) and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown:. Glipizide and Metformin HCl Tablets, USP are available for oral administration in tablets containing 2.5 mg glipizide with 250 mg metformin hydrochloride, 2.5 mg glipizide with 500 mg metformin hydrochloride, and 5 mg glipizide with 500 mg metformin hydrochloride. In addition, each tablet contains the following inactive ingredients: Sodium Starch Glycolate, Corn Starch, Povidone, Magnesium Stearate, Colloidal Silicon Dioxide, Hypromellose, Talc, Titanium Dioxide, Polyethylene Glycol 6000, Propylene Glycol and Iron Oxide Red. The tablets are film coated, which provides color differentiation.</Description>
</NDC>
<NDC>
<NDCCode>45963-125-23</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45963-125-23) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>45963-0125-23</NDC11Code>
<ProductNDC>45963-125</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Infants Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079058</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1.25mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45963-125-24</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45963-125-24) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>45963-0125-24</NDC11Code>
<ProductNDC>45963-125</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Infants Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079058</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1.25mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45963-141-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-141-05)</PackageDescription>
<NDC11Code>45963-0141-05</NDC11Code>
<ProductNDC>45963-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077285</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>45963-141-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-141-30)</PackageDescription>
<NDC11Code>45963-0141-30</NDC11Code>
<ProductNDC>45963-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077285</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>45963-141-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-141-90)</PackageDescription>
<NDC11Code>45963-0141-90</NDC11Code>
<ProductNDC>45963-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150205</StartMarketingDate>
<EndMarketingDate>20171031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077285</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>45963-142-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-05) </PackageDescription>
<NDC11Code>45963-0142-05</NDC11Code>
<ProductNDC>45963-142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077285</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets USP, (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 300 mg, off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: colloidal anhydrous silica, colloidal silicon dioxide, copovidone, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. This drug product conforms to USP Drug Dissolution Test #11.</Description>
</NDC>
<NDC>
<NDCCode>45963-142-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-30) </PackageDescription>
<NDC11Code>45963-0142-30</NDC11Code>
<ProductNDC>45963-142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077285</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets USP, (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 300 mg, off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: colloidal anhydrous silica, colloidal silicon dioxide, copovidone, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. This drug product conforms to USP Drug Dissolution Test #11.</Description>
</NDC>
<NDC>
<NDCCode>45963-142-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-90) </PackageDescription>
<NDC11Code>45963-0142-90</NDC11Code>
<ProductNDC>45963-142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077285</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets USP, (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 300 mg, off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: colloidal anhydrous silica, colloidal silicon dioxide, copovidone, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. This drug product conforms to USP Drug Dissolution Test #11.</Description>
</NDC>
<NDC>
<NDCCode>45963-152-02</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-152-02) </PackageDescription>
<NDC11Code>45963-0152-02</NDC11Code>
<ProductNDC>45963-152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120525</StartMarketingDate>
<EndMarketingDate>20200831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077899</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120531</StartMarketingDatePackage>
<EndMarketingDatePackage>20200831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45963-152-50</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-152-50)</PackageDescription>
<NDC11Code>45963-0152-50</NDC11Code>
<ProductNDC>45963-152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077899</ApplicationNumber>
<LabelerName>Actavis Inc.</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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