{
"NDC": [
{
"NDCCode": "0078-0386-66",
"PackageDescription": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0386-66) ",
"NDC11Code": "00078-0386-66",
"ProductNDC": "0078-0386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Myfortic",
"NonProprietaryName": "Mycophenolic Acid",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040227",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050791",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "MYCOPHENOLATE SODIUM",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040227",
"SamplePackage": "N"
},
{
"NDCCode": "0078-0385-66",
"PackageDescription": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0385-66) ",
"NDC11Code": "00078-0385-66",
"ProductNDC": "0078-0385",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Myfortic",
"NonProprietaryName": "Mycophenolic Acid",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040227",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050791",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "MYCOPHENOLATE SODIUM",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040227",
"SamplePackage": "N"
},
{
"NDCCode": "0078-0670-66",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (0078-0670-66) ",
"NDC11Code": "00078-0670-66",
"ProductNDC": "0078-0670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Votrient",
"NonProprietaryName": "Pazopanib Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160712",
"EndMarketingDate": "20241031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022465",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "PAZOPANIB HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160712",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "VOTRIENT is a kinase inhibitor indicated for the treatment of adults with: 1 advanced renal cell carcinoma (RCC). (1.1) , 2 advanced soft tissue sarcoma (STS) who have received prior chemotherapy. (1.2).",
"Description": "Pazopanib is a kinase inhibitor. Pazopanib is presented as the hydrochloride salt, with the chemical name 5-[[4-[(2,3-dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2-methylbenzenesulfonamide monohydrochloride. It has the molecular formula C21H23N7O2SHCl and a molecular weight of 473.99 g/mol. Pazopanib hydrochloride has the following chemical structure. Pazopanib hydrochloride is a white to slightly yellow solid. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media. VOTRIENT tablets are for oral use. Each 200-mg tablet of VOTRIENT contains 200 mg of pazopanib equivalent to 216.7 mg of pazopanib hydrochloride. The inactive ingredients of VOTRIENT are: Tablet Core: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Coating: Gray or pink film-coat: hypromellose, iron oxide black, macrogol/polyethylene glycol 400 (PEG 400), polysorbate 80, and titanium dioxide."
},
{
"NDCCode": "0078-0681-66",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (0078-0681-66) ",
"NDC11Code": "00078-0681-66",
"ProductNDC": "0078-0681",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tafinlar",
"NonProprietaryName": "Dabrafenib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202806",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "DABRAFENIB MESYLATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Kinase Inhibitor [EPC], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. (1.1, 2.1). TAFINLAR is indicated, in combination with trametinib, for: 1 the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. (1.2, 2.1) , 2 the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. (1.3, 2.1), 3 the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. (1.4, 2.1) , 4 the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options. (1.5, 2.1) , 5 the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1.6, 2.1), 6 the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. (1.7, 2.1) .",
"Description": "Dabrafenib mesylate is a kinase inhibitor. The chemical name for dabrafenib mesylate is N-{3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzene sulfonamide, methanesulfonate salt. It has the molecular formula C23H20F3N5O2S2CH4O3S and a molecular weight of 615.68 g/mol. Dabrafenib mesylate has the following chemical structure. Dabrafenib mesylate is a white to slightly colored solid with three pKas: 6.6, 2.2, and -1.5. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media. TAFINLAR (dabrafenib) capsules for oral use are supplied as 50 mg and 75 mg capsules for oral administration. Each 50 mg capsule contains 59.25 mg dabrafenib mesylate equivalent to 50 mg of dabrafenib free base. Each 75 mg capsule contains 88.88 mg dabrafenib mesylate equivalent to 75 mg of dabrafenib free base. The inactive ingredients of TAFINLAR capsules are colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose. Capsule shells contain hypromellose, red iron oxide (E172), and titanium dioxide (E171). TAFINLAR (dabrafenib) tablets for oral suspension are supplied as 10 mg tablets for oral administration. Each 10 mg tablet contains 11.85 mg dabrafenib mesylate equivalent to 10 mg of dabrafenib base. The inactive ingredients of TAFINLAR tablets are acesulfame potassium, artificial berry flavor, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose."
},
{
"NDCCode": "0078-0682-66",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (0078-0682-66) ",
"NDC11Code": "00078-0682-66",
"ProductNDC": "0078-0682",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tafinlar",
"NonProprietaryName": "Dabrafenib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160412",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202806",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "DABRAFENIB MESYLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Kinase Inhibitor [EPC], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160412",
"SamplePackage": "N",
"IndicationAndUsage": "TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. (1.1, 2.1). TAFINLAR is indicated, in combination with trametinib, for: 1 the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. (1.2, 2.1) , 2 the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. (1.3, 2.1), 3 the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. (1.4, 2.1) , 4 the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options. (1.5, 2.1) , 5 the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1.6, 2.1), 6 the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. (1.7, 2.1) .",
"Description": "Dabrafenib mesylate is a kinase inhibitor. The chemical name for dabrafenib mesylate is N-{3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzene sulfonamide, methanesulfonate salt. It has the molecular formula C23H20F3N5O2S2CH4O3S and a molecular weight of 615.68 g/mol. Dabrafenib mesylate has the following chemical structure. Dabrafenib mesylate is a white to slightly colored solid with three pKas: 6.6, 2.2, and -1.5. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media. TAFINLAR (dabrafenib) capsules for oral use are supplied as 50 mg and 75 mg capsules for oral administration. Each 50 mg capsule contains 59.25 mg dabrafenib mesylate equivalent to 50 mg of dabrafenib free base. Each 75 mg capsule contains 88.88 mg dabrafenib mesylate equivalent to 75 mg of dabrafenib free base. The inactive ingredients of TAFINLAR capsules are colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose. Capsule shells contain hypromellose, red iron oxide (E172), and titanium dioxide (E171). TAFINLAR (dabrafenib) tablets for oral suspension are supplied as 10 mg tablets for oral administration. Each 10 mg tablet contains 11.85 mg dabrafenib mesylate equivalent to 10 mg of dabrafenib base. The inactive ingredients of TAFINLAR tablets are acesulfame potassium, artificial berry flavor, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose."
},
{
"NDCCode": "0078-0951-66",
"PackageDescription": "120 CAPSULE in 1 BOTTLE, PLASTIC (0078-0951-66) ",
"NDC11Code": "00078-0951-66",
"ProductNDC": "0078-0951",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tasigna",
"NonProprietaryName": "Nilotinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071029",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022068",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "NILOTINIB HYDROCHLORIDE MONOHYDRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180322",
"SamplePackage": "N",
"IndicationAndUsage": "Tasigna is a kinase inhibitor indicated for the treatment of: 1 Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. (1.2) , 3 Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. (1.3) .",
"Description": "Tasigna contains nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, in the form of monohydrochloride monohydrate, is a white to slightly yellowish to slightly greenish yellow powder with the molecular formula and weight, respectively, of C28H22F3N7OHCl H2O and 584 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C28H22F3N7O and 529 g/mol, respectively). The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pKa1 was determined to be 2.1; pKa2 was estimated to be 5.4. The chemical name of nilotinib monohydrochloride monohydrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below. Tasigna (nilotinib) capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 55 mg, 166 mg, and 221 mg nilotinib monohydrochloride monohydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and poloxamer 188. The capsules contain gelatin, iron oxide (red), iron oxide (yellow), iron oxide (black), and titanium dioxide."
},
{
"NDCCode": "0078-1077-66",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (0078-1077-66) ",
"NDC11Code": "00078-1077-66",
"ProductNDC": "0078-1077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Votrient",
"NonProprietaryName": "Pazopanib Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160712",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022465",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "PAZOPANIB HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211213",
"SamplePackage": "N",
"IndicationAndUsage": "VOTRIENT is a kinase inhibitor indicated for the treatment of adults with: 1 advanced renal cell carcinoma (RCC). (1.1) , 2 advanced soft tissue sarcoma (STS) who have received prior chemotherapy. (1.2).",
"Description": "Pazopanib is a kinase inhibitor. Pazopanib is presented as the hydrochloride salt, with the chemical name 5-[[4-[(2,3-dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2-methylbenzenesulfonamide monohydrochloride. It has the molecular formula C21H23N7O2SHCl and a molecular weight of 473.99 g/mol. Pazopanib hydrochloride has the following chemical structure. Pazopanib hydrochloride is a white to slightly yellow solid. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media. VOTRIENT tablets are for oral use. Each 200-mg tablet of VOTRIENT contains 200 mg of pazopanib equivalent to 216.7 mg of pazopanib hydrochloride. The inactive ingredients of VOTRIENT are: Tablet Core: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Coating: Gray or pink film-coat: hypromellose, iron oxide black, macrogol/polyethylene glycol 400 (PEG 400), polysorbate 80, and titanium dioxide."
},
{
"NDCCode": "0078-0331-84",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0078-0331-84) / 5 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00078-0331-84",
"ProductNDC": "0078-0331",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simulect",
"NonProprietaryName": "Basiliximab",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19980512",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103764",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "BASILIXIMAB",
"StrengthNumber": "20",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Interleukin 2 Receptor Antagonists [MoA], Interleukin 2 Receptor-directed Antibody Interactions [MoA], Interleukin-2 Receptor Blocking Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19980512",
"SamplePackage": "N",
"IndicationAndUsage": "Simulect® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.",
"Description": "Basiliximab is a chimeric (murine/human) monoclonal antibody (IgG1к), produced by recombinant DNA technology, that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor α-chain (IL-2Rα, also known as CD25 antigen) on the surface of activated T-lymphocytes. Based on the amino acid sequence, the calculated molecular weight of the protein is 144 kilodaltons. It is a glycoprotein obtained from fermentation of an established mouse myeloma cell line genetically engineered to express plasmids containing the human heavy and light chain constant region genes and mouse heavy and light chain variable region genes encoding the RFT5 antibody that binds selectively to the IL-2Rα. Simulect® (basiliximab) for injection is a sterile, preservative-free lyophilisate, which is available in single-dose vials and is available in 10 mg and 20 mg strengths for intravenous administration after reconstitution. Each 10-mg vial contains 10 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.50 mg), glycine (20.3 mg), mannitol (40.6 mg), monobasic potassium phosphate (3.66 mg), sodium chloride (0.82 mg), and sucrose (10.1 mg) to be reconstituted in 2.5 mL of Sterile Water for Injection, USP. Each 20-mg vial contains 20 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.99 mg), glycine (40.1 mg), mannitol (80.1 mg), monobasic potassium phosphate (7.22 mg), sodium chloride (1.61 mg), and sucrose (20 mg) to be reconstituted in 5 mL of Sterile Water for Injection, USP."
},
{
"NDCCode": "0078-0393-61",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0078-0393-61) / 2.5 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00078-0393-61",
"ProductNDC": "0078-0393",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simulect",
"NonProprietaryName": "Basiliximab",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19980512",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103764",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "BASILIXIMAB",
"StrengthNumber": "10",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Interleukin 2 Receptor Antagonists [MoA], Interleukin 2 Receptor-directed Antibody Interactions [MoA], Interleukin-2 Receptor Blocking Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19980512",
"SamplePackage": "N",
"IndicationAndUsage": "Simulect® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.",
"Description": "Basiliximab is a chimeric (murine/human) monoclonal antibody (IgG1к), produced by recombinant DNA technology, that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor α-chain (IL-2Rα, also known as CD25 antigen) on the surface of activated T-lymphocytes. Based on the amino acid sequence, the calculated molecular weight of the protein is 144 kilodaltons. It is a glycoprotein obtained from fermentation of an established mouse myeloma cell line genetically engineered to express plasmids containing the human heavy and light chain constant region genes and mouse heavy and light chain variable region genes encoding the RFT5 antibody that binds selectively to the IL-2Rα. Simulect® (basiliximab) for injection is a sterile, preservative-free lyophilisate, which is available in single-dose vials and is available in 10 mg and 20 mg strengths for intravenous administration after reconstitution. Each 10-mg vial contains 10 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.50 mg), glycine (20.3 mg), mannitol (40.6 mg), monobasic potassium phosphate (3.66 mg), sodium chloride (0.82 mg), and sucrose (10.1 mg) to be reconstituted in 2.5 mL of Sterile Water for Injection, USP. Each 20-mg vial contains 20 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.99 mg), glycine (40.1 mg), mannitol (80.1 mg), monobasic potassium phosphate (7.22 mg), sodium chloride (1.61 mg), and sucrose (20 mg) to be reconstituted in 5 mL of Sterile Water for Injection, USP."
},
{
"NDCCode": "64896-078-09",
"PackageDescription": "90 PACKET in 1 CARTON (64896-078-09) / 1 GRANULE in 1 PACKET",
"NDC11Code": "64896-0078-09",
"ProductNDC": "64896-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyvispah",
"NonProprietaryName": "Baclofen",
"DosageFormName": "GRANULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215422",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230601",
"SamplePackage": "N",
"IndicationAndUsage": "LYVISPAH is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. LYVISPAH may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use. LYVISPAH is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.",
"Description": "LYVISPAH (baclofen) oral granules is a gamma-aminobutyric acid (GABA-ergic) agonist available as 5 mg, 10 mg, or 20 mg of baclofen oral granules in a packet. Its chemical name is 4-amino-3-(4- chlorophenyl)-butanoic acid and its structural formula is. Molecular formula is C10H12ClNO2 Molecular Weight is 213.66. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. LYVISPAH (baclofen) oral granules inactive ingredients include amino methacrylate copolymer, calcium stearate, colloidal silicon dioxide, crospovidone, hypromellose, mannitol, saccharin sodium, strawberry flavor, talc, and xylitol."
},
{
"NDCCode": "0054-0386-63",
"PackageDescription": "473 mL in 1 BOTTLE (0054-0386-63) ",
"NDC11Code": "00054-0386-63",
"ProductNDC": "0054-0386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20120301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074653",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120301",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid agonist. Hydromorphone hydrochloride, USP is a white to off-white powder. It is soluble in water and sparingly soluble in alcohol. The chemical name of hydromorphone hydrochloride is 4,5α-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is: 1 , 2 C17H19NO3 ●HCl M.W. 321.80."
},
{
"NDCCode": "0220-0386-41",
"PackageDescription": "200 [kp_C] in 1 TUBE (0220-0386-41) ",
"NDC11Code": "00220-0386-41",
"ProductNDC": "0220-0386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimonium Tartaricum",
"NonProprietaryName": "Antimony Potassium Tartrate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE",
"StrengthNumber": "200",
"StrengthUnit": "[kp_C]/200[kp_C]",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Thick Mucus And Non Productive Cough*."
},
{
"NDCCode": "0360-0386-01",
"PackageDescription": "1 g in 1 BOTTLE, PLASTIC (0360-0386-01) ",
"NDC11Code": "00360-0386-01",
"ProductNDC": "0360-0386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Urtica Urens",
"NonProprietaryName": "Urtica Urens",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "19970217",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "STANDARD HOMEOPATHIC COMPANY",
"SubstanceName": "URTICA URENS",
"StrengthNumber": "30",
"StrengthUnit": "[hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19970217",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "0363-0386-12",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0363-0386-12) / 100 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "00363-0386-12",
"ProductNDC": "0363-0386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep Aid",
"NonProprietaryName": "Doxylamine Succinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040564",
"LabelerName": "Walgreen Company",
"SubstanceName": "DOXYLAMINE SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "helps to reduce difficulty in falling asleep."
},
{
"NDCCode": "0363-0386-22",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (0363-0386-22) / 16 TABLET in 1 BLISTER PACK",
"NDC11Code": "00363-0386-22",
"ProductNDC": "0363-0386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep Aid",
"NonProprietaryName": "Doxylamine Succinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040564",
"LabelerName": "Walgreen Company",
"SubstanceName": "DOXYLAMINE SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240405",
"SamplePackage": "N",
"IndicationAndUsage": "helps to reduce difficulty in falling asleep."
},
{
"NDCCode": "0363-0386-31",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0363-0386-31) / 80 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "00363-0386-31",
"ProductNDC": "0363-0386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep Aid",
"NonProprietaryName": "Doxylamine Succinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040564",
"LabelerName": "Walgreen Company",
"SubstanceName": "DOXYLAMINE SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240405",
"SamplePackage": "N",
"IndicationAndUsage": "helps to reduce difficulty in falling asleep."
},
{
"NDCCode": "10812-386-01",
"PackageDescription": "5.5 g in 1 CASE (10812-386-01)",
"NDC11Code": "10812-0386-01",
"ProductNDC": "10812-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Mineral Sheers",
"ProprietaryNameSuffix": "Spf20 - Natural Beige 60",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110620",
"EndMarketingDate": "20160801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Neutrogena Corporation",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "11014-0386-1",
"PackageDescription": "1 BAG in 1 BOX (11014-0386-1) / 5000 CAPSULE in 1 BAG",
"NDC11Code": "11014-0386-01",
"ProductNDC": "11014-0386",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Testosterone Undecanoate",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Catalent Pharma Solutions, LLC",
"SubstanceName": "TESTOSTERONE UNDECANOATE",
"StrengthNumber": "198",
"StrengthUnit": "mg/1",
"DEASchedule": "CIII",
"Status": "Unfinished",
"LastUpdate": "2026-05-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "28-SEP-17"
},
{
"NDCCode": "11822-0386-2",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (11822-0386-2) > 8 TABLET in 1 BLISTER PACK",
"NDC11Code": "11822-0386-02",
"ProductNDC": "11822-0386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep Aid",
"NonProprietaryName": "Doxylamine Succinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020411",
"EndMarketingDate": "20220801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040564",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "DOXYLAMINE SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20020411",
"EndMarketingDatePackage": "20220801",
"SamplePackage": "N"
},
{
"NDCCode": "11822-0386-7",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (11822-0386-7) > 8 TABLET in 1 BLISTER PACK",
"NDC11Code": "11822-0386-07",
"ProductNDC": "11822-0386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep Aid",
"NonProprietaryName": "Doxylamine Succinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040564",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "DOXYLAMINE SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "12527-0386-1",
"PackageDescription": "50 kg in 1 DRUM (12527-0386-1) ",
"NDC11Code": "12527-0386-01",
"ProductNDC": "12527-0386",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Pradofloxacin Trihydrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20210809",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Bayer AG",
"SubstanceName": "PRADOFLOXACIN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-12-13",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "09-AUG-21"
},
{
"NDCCode": "13537-386-02",
"PackageDescription": "1 BOTTLE in 1 BOX (13537-386-02) > 60 g in 1 BOTTLE (13537-386-01)",
"NDC11Code": "13537-0386-02",
"ProductNDC": "13537-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natural Care Concha De Nacar And Rosa Mosqueta Crema Facial Fps 15 Para Una Apariencia Mas Clara Fm",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151022",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".075; .045",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ayuda a prevenir quemaduras solares."
},
{
"NDCCode": "13668-386-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (13668-386-05) ",
"NDC11Code": "13668-0386-05",
"ProductNDC": "13668-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg",
"NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161026",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203580",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5; 12.5; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161026",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1).",
"Description": "lmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients."
},
{
"NDCCode": "13668-386-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13668-386-30) ",
"NDC11Code": "13668-0386-30",
"ProductNDC": "13668-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg",
"NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161026",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203580",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5; 12.5; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161026",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1).",
"Description": "lmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients."
},
{
"NDCCode": "13668-386-74",
"PackageDescription": "100 TABLET in 1 CARTON (13668-386-74) ",
"NDC11Code": "13668-0386-74",
"ProductNDC": "13668-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg",
"NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203580",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5; 12.5; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-03-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20161026",
"SamplePackage": "N"
},
{
"NDCCode": "13668-386-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (13668-386-90) ",
"NDC11Code": "13668-0386-90",
"ProductNDC": "13668-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg",
"NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161026",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203580",
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"IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1).",
"Description": "lmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients."
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<Description>Pazopanib is a kinase inhibitor. Pazopanib is presented as the hydrochloride salt, with the chemical name 5-[[4-[(2,3-dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2-methylbenzenesulfonamide monohydrochloride. It has the molecular formula C21H23N7O2SHCl and a molecular weight of 473.99 g/mol. Pazopanib hydrochloride has the following chemical structure. Pazopanib hydrochloride is a white to slightly yellow solid. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media. VOTRIENT tablets are for oral use. Each 200-mg tablet of VOTRIENT contains 200 mg of pazopanib equivalent to 216.7 mg of pazopanib hydrochloride. The inactive ingredients of VOTRIENT are: Tablet Core: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Coating: Gray or pink film-coat: hypromellose, iron oxide black, macrogol/polyethylene glycol 400 (PEG 400), polysorbate 80, and titanium dioxide.</Description>
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<Description>Dabrafenib mesylate is a kinase inhibitor. The chemical name for dabrafenib mesylate is N-{3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzene sulfonamide, methanesulfonate salt. It has the molecular formula C23H20F3N5O2S2CH4O3S and a molecular weight of 615.68 g/mol. Dabrafenib mesylate has the following chemical structure. Dabrafenib mesylate is a white to slightly colored solid with three pKas: 6.6, 2.2, and -1.5. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media. TAFINLAR (dabrafenib) capsules for oral use are supplied as 50 mg and 75 mg capsules for oral administration. Each 50 mg capsule contains 59.25 mg dabrafenib mesylate equivalent to 50 mg of dabrafenib free base. Each 75 mg capsule contains 88.88 mg dabrafenib mesylate equivalent to 75 mg of dabrafenib free base. The inactive ingredients of TAFINLAR capsules are colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose. Capsule shells contain hypromellose, red iron oxide (E172), and titanium dioxide (E171). TAFINLAR (dabrafenib) tablets for oral suspension are supplied as 10 mg tablets for oral administration. Each 10 mg tablet contains 11.85 mg dabrafenib mesylate equivalent to 10 mg of dabrafenib base. The inactive ingredients of TAFINLAR tablets are acesulfame potassium, artificial berry flavor, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose.</Description>
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<Description>Dabrafenib mesylate is a kinase inhibitor. The chemical name for dabrafenib mesylate is N-{3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzene sulfonamide, methanesulfonate salt. It has the molecular formula C23H20F3N5O2S2CH4O3S and a molecular weight of 615.68 g/mol. Dabrafenib mesylate has the following chemical structure. Dabrafenib mesylate is a white to slightly colored solid with three pKas: 6.6, 2.2, and -1.5. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media. TAFINLAR (dabrafenib) capsules for oral use are supplied as 50 mg and 75 mg capsules for oral administration. Each 50 mg capsule contains 59.25 mg dabrafenib mesylate equivalent to 50 mg of dabrafenib free base. Each 75 mg capsule contains 88.88 mg dabrafenib mesylate equivalent to 75 mg of dabrafenib free base. The inactive ingredients of TAFINLAR capsules are colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose. Capsule shells contain hypromellose, red iron oxide (E172), and titanium dioxide (E171). TAFINLAR (dabrafenib) tablets for oral suspension are supplied as 10 mg tablets for oral administration. Each 10 mg tablet contains 11.85 mg dabrafenib mesylate equivalent to 10 mg of dabrafenib base. The inactive ingredients of TAFINLAR tablets are acesulfame potassium, artificial berry flavor, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tasigna is a kinase inhibitor indicated for the treatment of: 1 Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. (1.2) , 3 Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. (1.3) .</IndicationAndUsage>
<Description>Tasigna contains nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, in the form of monohydrochloride monohydrate, is a white to slightly yellowish to slightly greenish yellow powder with the molecular formula and weight, respectively, of C28H22F3N7OHCl H2O and 584 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C28H22F3N7O and 529 g/mol, respectively). The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pKa1 was determined to be 2.1; pKa2 was estimated to be 5.4. The chemical name of nilotinib monohydrochloride monohydrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below. Tasigna (nilotinib) capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 55 mg, 166 mg, and 221 mg nilotinib monohydrochloride monohydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and poloxamer 188. The capsules contain gelatin, iron oxide (red), iron oxide (yellow), iron oxide (black), and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0078-1077-66</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (0078-1077-66) </PackageDescription>
<NDC11Code>00078-1077-66</NDC11Code>
<ProductNDC>0078-1077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Votrient</ProprietaryName>
<NonProprietaryName>Pazopanib Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160712</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022465</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>PAZOPANIB HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VOTRIENT is a kinase inhibitor indicated for the treatment of adults with: 1 advanced renal cell carcinoma (RCC). (1.1) , 2 advanced soft tissue sarcoma (STS) who have received prior chemotherapy. (1.2).</IndicationAndUsage>
<Description>Pazopanib is a kinase inhibitor. Pazopanib is presented as the hydrochloride salt, with the chemical name 5-[[4-[(2,3-dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2-methylbenzenesulfonamide monohydrochloride. It has the molecular formula C21H23N7O2SHCl and a molecular weight of 473.99 g/mol. Pazopanib hydrochloride has the following chemical structure. Pazopanib hydrochloride is a white to slightly yellow solid. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media. VOTRIENT tablets are for oral use. Each 200-mg tablet of VOTRIENT contains 200 mg of pazopanib equivalent to 216.7 mg of pazopanib hydrochloride. The inactive ingredients of VOTRIENT are: Tablet Core: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Coating: Gray or pink film-coat: hypromellose, iron oxide black, macrogol/polyethylene glycol 400 (PEG 400), polysorbate 80, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0078-0331-84</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0078-0331-84) / 5 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00078-0331-84</NDC11Code>
<ProductNDC>0078-0331</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simulect</ProprietaryName>
<NonProprietaryName>Basiliximab</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19980512</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103764</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>BASILIXIMAB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Interleukin 2 Receptor Antagonists [MoA], Interleukin 2 Receptor-directed Antibody Interactions [MoA], Interleukin-2 Receptor Blocking Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simulect® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.</IndicationAndUsage>
<Description>Basiliximab is a chimeric (murine/human) monoclonal antibody (IgG1к), produced by recombinant DNA technology, that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor α-chain (IL-2Rα, also known as CD25 antigen) on the surface of activated T-lymphocytes. Based on the amino acid sequence, the calculated molecular weight of the protein is 144 kilodaltons. It is a glycoprotein obtained from fermentation of an established mouse myeloma cell line genetically engineered to express plasmids containing the human heavy and light chain constant region genes and mouse heavy and light chain variable region genes encoding the RFT5 antibody that binds selectively to the IL-2Rα. Simulect® (basiliximab) for injection is a sterile, preservative-free lyophilisate, which is available in single-dose vials and is available in 10 mg and 20 mg strengths for intravenous administration after reconstitution. Each 10-mg vial contains 10 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.50 mg), glycine (20.3 mg), mannitol (40.6 mg), monobasic potassium phosphate (3.66 mg), sodium chloride (0.82 mg), and sucrose (10.1 mg) to be reconstituted in 2.5 mL of Sterile Water for Injection, USP. Each 20-mg vial contains 20 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.99 mg), glycine (40.1 mg), mannitol (80.1 mg), monobasic potassium phosphate (7.22 mg), sodium chloride (1.61 mg), and sucrose (20 mg) to be reconstituted in 5 mL of Sterile Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0078-0393-61</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0078-0393-61) / 2.5 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00078-0393-61</NDC11Code>
<ProductNDC>0078-0393</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simulect</ProprietaryName>
<NonProprietaryName>Basiliximab</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19980512</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103764</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>BASILIXIMAB</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Interleukin 2 Receptor Antagonists [MoA], Interleukin 2 Receptor-directed Antibody Interactions [MoA], Interleukin-2 Receptor Blocking Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simulect® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.</IndicationAndUsage>
<Description>Basiliximab is a chimeric (murine/human) monoclonal antibody (IgG1к), produced by recombinant DNA technology, that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor α-chain (IL-2Rα, also known as CD25 antigen) on the surface of activated T-lymphocytes. Based on the amino acid sequence, the calculated molecular weight of the protein is 144 kilodaltons. It is a glycoprotein obtained from fermentation of an established mouse myeloma cell line genetically engineered to express plasmids containing the human heavy and light chain constant region genes and mouse heavy and light chain variable region genes encoding the RFT5 antibody that binds selectively to the IL-2Rα. Simulect® (basiliximab) for injection is a sterile, preservative-free lyophilisate, which is available in single-dose vials and is available in 10 mg and 20 mg strengths for intravenous administration after reconstitution. Each 10-mg vial contains 10 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.50 mg), glycine (20.3 mg), mannitol (40.6 mg), monobasic potassium phosphate (3.66 mg), sodium chloride (0.82 mg), and sucrose (10.1 mg) to be reconstituted in 2.5 mL of Sterile Water for Injection, USP. Each 20-mg vial contains 20 mg of basiliximab, and dibasic sodium phosphate (anhydrous) (0.99 mg), glycine (40.1 mg), mannitol (80.1 mg), monobasic potassium phosphate (7.22 mg), sodium chloride (1.61 mg), and sucrose (20 mg) to be reconstituted in 5 mL of Sterile Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>64896-078-09</NDCCode>
<PackageDescription>90 PACKET in 1 CARTON (64896-078-09) / 1 GRANULE in 1 PACKET</PackageDescription>
<NDC11Code>64896-0078-09</NDC11Code>
<ProductNDC>64896-078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyvispah</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215422</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYVISPAH is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. LYVISPAH may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use. LYVISPAH is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.</IndicationAndUsage>
<Description>LYVISPAH (baclofen) oral granules is a gamma-aminobutyric acid (GABA-ergic) agonist available as 5 mg, 10 mg, or 20 mg of baclofen oral granules in a packet. Its chemical name is 4-amino-3-(4- chlorophenyl)-butanoic acid and its structural formula is. Molecular formula is C10H12ClNO2 Molecular Weight is 213.66. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. LYVISPAH (baclofen) oral granules inactive ingredients include amino methacrylate copolymer, calcium stearate, colloidal silicon dioxide, crospovidone, hypromellose, mannitol, saccharin sodium, strawberry flavor, talc, and xylitol.</Description>
</NDC>
<NDC>
<NDCCode>0054-0386-63</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (0054-0386-63) </PackageDescription>
<NDC11Code>00054-0386-63</NDC11Code>
<ProductNDC>0054-0386</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074653</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid agonist. Hydromorphone hydrochloride, USP is a white to off-white powder. It is soluble in water and sparingly soluble in alcohol. The chemical name of hydromorphone hydrochloride is 4,5α-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is: 1 , 2 C17H19NO3 ●HCl M.W. 321.80.</Description>
</NDC>
<NDC>
<NDCCode>0220-0386-41</NDCCode>
<PackageDescription>200 [kp_C] in 1 TUBE (0220-0386-41) </PackageDescription>
<NDC11Code>00220-0386-41</NDC11Code>
<ProductNDC>0220-0386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antimonium Tartaricum</ProprietaryName>
<NonProprietaryName>Antimony Potassium Tartrate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[kp_C]/200[kp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Thick Mucus And Non Productive Cough*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0360-0386-01</NDCCode>
<PackageDescription>1 g in 1 BOTTLE, PLASTIC (0360-0386-01) </PackageDescription>
<NDC11Code>00360-0386-01</NDC11Code>
<ProductNDC>0360-0386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Urtica Urens</ProprietaryName>
<NonProprietaryName>Urtica Urens</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>19970217</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>STANDARD HOMEOPATHIC COMPANY</LabelerName>
<SubstanceName>URTICA URENS</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970217</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0363-0386-12</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0363-0386-12) / 100 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00363-0386-12</NDC11Code>
<ProductNDC>0363-0386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sleep Aid</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040564</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps to reduce difficulty in falling asleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-0386-22</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (0363-0386-22) / 16 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00363-0386-22</NDC11Code>
<ProductNDC>0363-0386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sleep Aid</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040564</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps to reduce difficulty in falling asleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-0386-31</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0363-0386-31) / 80 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00363-0386-31</NDC11Code>
<ProductNDC>0363-0386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sleep Aid</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040564</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps to reduce difficulty in falling asleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10812-386-01</NDCCode>
<PackageDescription>5.5 g in 1 CASE (10812-386-01)</PackageDescription>
<NDC11Code>10812-0386-01</NDC11Code>
<ProductNDC>10812-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Mineral Sheers</ProprietaryName>
<ProprietaryNameSuffix>Spf20 - Natural Beige 60</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110620</StartMarketingDate>
<EndMarketingDate>20160801</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Neutrogena Corporation</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>11014-0386-1</NDCCode>
<PackageDescription>1 BAG in 1 BOX (11014-0386-1) / 5000 CAPSULE in 1 BAG</PackageDescription>
<NDC11Code>11014-0386-01</NDC11Code>
<ProductNDC>11014-0386</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Testosterone Undecanoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
<SubstanceName>TESTOSTERONE UNDECANOATE</SubstanceName>
<StrengthNumber>198</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIII</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2026-05-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>28-SEP-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>11822-0386-2</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (11822-0386-2) > 8 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11822-0386-02</NDC11Code>
<ProductNDC>11822-0386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sleep Aid</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020411</StartMarketingDate>
<EndMarketingDate>20220801</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040564</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20020411</StartMarketingDatePackage>
<EndMarketingDatePackage>20220801</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>11822-0386-7</NDCCode>
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<ProductNDC>11822-0386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sleep Aid</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20020411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040564</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>12527-0386-1</NDCCode>
<PackageDescription>50 kg in 1 DRUM (12527-0386-1) </PackageDescription>
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<ProductNDC>12527-0386</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Pradofloxacin Trihydrate</NonProprietaryName>
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<StartMarketingDate>20210809</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Bayer AG</LabelerName>
<SubstanceName>PRADOFLOXACIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-12-13</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>09-AUG-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>13537-386-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (13537-386-02) > 60 g in 1 BOTTLE (13537-386-01)</PackageDescription>
<NDC11Code>13537-0386-02</NDC11Code>
<ProductNDC>13537-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natural Care Concha De Nacar And Rosa Mosqueta Crema Facial Fps 15 Para Una Apariencia Mas Clara Fm</ProprietaryName>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151022</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.075; .045</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ayuda a prevenir quemaduras solares.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-386-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (13668-386-05) </PackageDescription>
<NDC11Code>13668-0386-05</NDC11Code>
<ProductNDC>13668-386</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/12.5 Mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161026</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203580</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5; 12.5; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161026</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1).</IndicationAndUsage>
<Description>lmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients.</Description>
</NDC>
<NDC>
<NDCCode>13668-386-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13668-386-30) </PackageDescription>
<NDC11Code>13668-0386-30</NDC11Code>
<ProductNDC>13668-386</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161026</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203580</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5; 12.5; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161026</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1).</IndicationAndUsage>
<Description>lmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients.</Description>
</NDC>
<NDC>
<NDCCode>13668-386-74</NDCCode>
<PackageDescription>100 TABLET in 1 CARTON (13668-386-74) </PackageDescription>
<NDC11Code>13668-0386-74</NDC11Code>
<ProductNDC>13668-386</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20161026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203580</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL</SubstanceName>
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<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13668-386-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (13668-386-90) </PackageDescription>
<NDC11Code>13668-0386-90</NDC11Code>
<ProductNDC>13668-386</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 40/5/12.5 Mg</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20161026</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203580</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5; 12.5; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161026</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1).</IndicationAndUsage>
<Description>lmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil, USP is. The structural formula for amlodipine besylate, USP is. The structural formula for hydrochlorothiazide, USP is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients.</Description>
</NDC>
<NDC>
<NDCCode>14141-386-01</NDCCode>
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<NDC11Code>14141-0386-01</NDC11Code>
<ProductNDC>14141-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Divine Double Use Longwear 36h Spf 15 Capuccino 310</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250304</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>BELSTAR S.A.</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>30; 49</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-0386-0</NDCCode>
<PackageDescription>100 PELLET in 1 PACKAGE (15631-0386-0) </PackageDescription>
<NDC11Code>15631-0386-00</NDC11Code>
<ProductNDC>15631-0386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salvia Officinalis</ProprietaryName>
<NonProprietaryName>Salvia Officinalis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151030</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>SAGE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-0386-1</NDCCode>
<PackageDescription>200 PELLET in 1 PACKAGE (15631-0386-1) </PackageDescription>
<NDC11Code>15631-0386-01</NDC11Code>
<ProductNDC>15631-0386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salvia Officinalis</ProprietaryName>
<NonProprietaryName>Salvia Officinalis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151030</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>SAGE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-0386-2</NDCCode>
<PackageDescription>400 PELLET in 1 PACKAGE (15631-0386-2) </PackageDescription>
<NDC11Code>15631-0386-02</NDC11Code>
<ProductNDC>15631-0386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salvia Officinalis</ProprietaryName>
<NonProprietaryName>Salvia Officinalis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151030</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>SAGE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
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