{
"NDC": [
{
"NDCCode": "83831-134-01",
"PackageDescription": "1 KIT in 1 CARTON (83831-134-01) * 2 mL in 1 VIAL, SINGLE-DOSE (83831-150-22) * 2 mL in 1 SYRINGE (83831-135-02) ",
"NDC11Code": "83831-0134-01",
"ProductNDC": "83831-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lutrate Depot",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "20250326",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205054",
"LabelerName": "Avyxa Pharma, LLC",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250326",
"SamplePackage": "N",
"IndicationAndUsage": "LUTRATE DEPOT 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula. Where: n=1 or 2. Leuprolide acetate has a molecular weight of 1209.41 as \"free base”. Leuprolide is freely soluble in water. LUTRATE DEPOT 22.5 mg for 3-month administration is available in a vial containing white to off white sterile lyophilized microspheres together with the corresponding sterile reconstitution diluent in a pre-filled syringe. When LUTRATE DEPOT and the diluent are mixed together they become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS as a single dose. Each vial of LUTRATE DEPOT 22.5 mg for 3-month administration delivers leuprolide acetate (22.5 mg), polylactic acid (188.4 mg), triethylcitrate (10.4 mg), polysorbate 80 (3.8 mg), mannitol (88.4 mg) and carmellose sodium (25 mg). The prefilled syringe containing the clear reconstitution diluent (2 mL) contains mannitol (16 mg), water for injection, and sodium hydroxide and hydrochloric acid to control pH. LUTRATE DEPOT is an extended release sterile, single dose injection in suspension form for intramuscular administration."
},
{
"NDCCode": "83831-105-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (83831-105-01) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "83831-0105-01",
"ProductNDC": "83831-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Posfrea",
"NonProprietaryName": "Palonosetron",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203050",
"LabelerName": "Avyxa Pharma, LLC",
"SubstanceName": "PALONOSETRON HYDROCHLORIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "POSFREA is indicated in adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)., 2 acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC)., 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.",
"Description": "POSFREA Injection contains palonosetron as palonosetron HCl, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron HCl is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct 3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenz[de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron HCl exists as a single isomer and has the following structural formula. Palonosetron HCl is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. POSFREA Injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. POSFREA Injection is available as a 5 mL or 1.5 mL single-dose vial. Each mL of aqueous solution contains 0.05 mg palonosetron (equivalent to 0.056 mg palonosetron hydrochloride). Each mL also contains 41.5 mg mannitol, 3.0 mg sodium acetate trihydrate, and water for injection (q.s. to 1.0 mL). The pH of the solution in the 5 mL and 1.5 mL vials is 4.5 to 5.5. Hydrochloric acid or sodium hydroxide may have been added to adjust pH."
},
{
"NDCCode": "83831-111-01",
"PackageDescription": "1 VIAL in 1 CARTON (83831-111-01) / 4 mL in 1 VIAL",
"NDC11Code": "83831-0111-01",
"ProductNDC": "83831-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pemetrexed Dipotassium",
"NonProprietaryName": "Pemetrexed Dipotassium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210661",
"LabelerName": "Avyxa Pharma, LLC",
"SubstanceName": "PEMETREXED",
"StrengthNumber": "100",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "Pemetrexed for Injection is a folate analog metabolic inhibitor indicated: 1 in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. (1.1), 2 as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 3 as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1).",
"Description": "Pemetrexed is a folate analog metabolic inhibitor. The drug substance is pemetrexed dipotassium heptahydrate, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, dipotassium salt, heptahydrate. It is a white to off-white powder having blue or green tinge with a molecular formula of C20H19K2N5O6 .7 H2O and a molecular weight of 629.49. Pemetrexed dipotassium is freely soluble in water. The reported pKaS are 3.6 and 4.5. The structural formula of pemetrexed dipotassium heptahydrate is as follows. Pemetrexed for Injection is supplied as a sterile white to light-yellow or green-yellow lyophilized powder or cake for intravenous infusion available in single-dose vials. Each 100-mg or 500-mg vial of Pemetrexed for Injection contains 100 mg pemetrexed equivalent to 118.3 mg pemetrexed dipotassium and 106 mg mannitol or 500 mg pemetrexed equivalent to 591.5 mg pemetrexed dipotassium and 500 mg mannitol, respectively. Hydrochloric acid may have been added to adjust the pH."
},
{
"NDCCode": "83831-112-01",
"PackageDescription": "1 VIAL in 1 CARTON (83831-112-01) / 20 mL in 1 VIAL",
"NDC11Code": "83831-0112-01",
"ProductNDC": "83831-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pemetrexed Dipotassium",
"NonProprietaryName": "Pemetrexed Dipotassium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210661",
"LabelerName": "Avyxa Pharma, LLC",
"SubstanceName": "PEMETREXED",
"StrengthNumber": "500",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "Pemetrexed for Injection is a folate analog metabolic inhibitor indicated: 1 in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. (1.1), 2 as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 3 as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1).",
"Description": "Pemetrexed is a folate analog metabolic inhibitor. The drug substance is pemetrexed dipotassium heptahydrate, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, dipotassium salt, heptahydrate. It is a white to off-white powder having blue or green tinge with a molecular formula of C20H19K2N5O6 .7 H2O and a molecular weight of 629.49. Pemetrexed dipotassium is freely soluble in water. The reported pKaS are 3.6 and 4.5. The structural formula of pemetrexed dipotassium heptahydrate is as follows. Pemetrexed for Injection is supplied as a sterile white to light-yellow or green-yellow lyophilized powder or cake for intravenous infusion available in single-dose vials. Each 100-mg or 500-mg vial of Pemetrexed for Injection contains 100 mg pemetrexed equivalent to 118.3 mg pemetrexed dipotassium and 106 mg mannitol or 500 mg pemetrexed equivalent to 591.5 mg pemetrexed dipotassium and 500 mg mannitol, respectively. Hydrochloric acid may have been added to adjust the pH."
},
{
"NDCCode": "83831-116-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (83831-116-01) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "83831-0116-01",
"ProductNDC": "83831-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclophosphamide",
"NonProprietaryName": "Cyclophosphamide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210852",
"LabelerName": "Avyxa Pharma, LLC",
"SubstanceName": "CYCLOPHOSPHAMIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240801",
"SamplePackage": "N",
"IndicationAndUsage": "Malignant Diseases. Cyclophosphamide Injection is indicated for the treatment of adult and pediatric patients with: 1 malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma Burkitt's lymphoma, 2 multiple myeloma, 3 leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration), 4 mycosis fungoides (advanced disease), 5 neuroblastoma (disseminated disease), 6 adenocarcinoma of the ovary, 7 retinoblastoma, 8 carcinoma of the breast.",
"Description": "Cyclophosphamide is an alkylating drug. It is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is (±)-2-[Bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide is a white crystalline powder with the molecular formula C7H15Cl2N2O2 PH2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. The pKa of cyclophosphamide is 5.7. Cyclophosphamide Injection is a clear, colorless to slight yellow sterile solution available as 500 mg/mL, 1 g/2 mL, and 2 g/4 mL in single dose vials for dilution prior to intravenous administration. : 1 500 mg/mL vial contains 534.5 mg cyclophosphamide monohydrate, equivalent to 500 mg cyclophosphamide and 500 mg dehydrated alcohol (equivalent to 63% v/v)., 2 1 g/2 mL vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide and 1000 mg dehydrated alcohol (equivalent to 63% v/v)., 3 2 g/4 mL vial contains 2138.0 mg cyclophosphamide monohydrate, equivalent to 2 g cyclophosphamide and 2000 mg dehydrated alcohol (equivalent to 63% v/v)."
},
{
"NDCCode": "83831-119-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (83831-119-01) / 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "83831-0119-01",
"ProductNDC": "83831-119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Frindovyx",
"NonProprietaryName": "Cyclophosphamide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250319",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210852",
"LabelerName": "AVYXA Pharma, LLC",
"SubstanceName": "CYCLOPHOSPHAMIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250319",
"SamplePackage": "N",
"IndicationAndUsage": "Malignant Diseases. FRINDOVYX is indicated for the treatment of adult and pediatric patients with: 1 malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma Burkitt's lymphoma, 2 multiple myeloma, 3 leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration), 4 mycosis fungoides (advanced disease), 5 neuroblastoma (disseminated disease), 6 adenocarcinoma of the ovary, 7 retinoblastoma, 8 carcinoma of the breast.",
"Description": "Cyclophosphamide is an alkylating drug. It is an antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is (±)-2-[Bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide is a white crystalline powder with the molecular formula C7H15Cl2N2O2 PH2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. The pKa of cyclophosphamide is 5.7. FRINDOVYX is a clear, colorless to yellow sterile solution available as 500 mg/mL, 1 g/2 mL, and 2 g/4 mL in multiple dose vial for dilution prior to intravenous administration. : 1 500 mg/mL vial contains 534.5 mg cyclophosphamide monohydrate, equivalent to 500 mg cyclophosphamide and 500 mg dehydrated alcohol (equivalent to 63% v/v)., 2 1 g/2 mL vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide and 1000 mg dehydrated alcohol (equivalent to 63% v/v)., 3 2 g/4 mL vial contains 2138.0 mg cyclophosphamide monohydrate, equivalent to 2 g cyclophosphamide and 2000 mg dehydrated alcohol (equivalent to 63% v/v)."
},
{
"NDCCode": "83831-122-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (83831-122-01) / 5.26 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "83831-0122-01",
"ProductNDC": "83831-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Avgemsi",
"NonProprietaryName": "Gemcitabine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250718",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219920",
"LabelerName": "Avyxa Pharma, LLC",
"SubstanceName": "GEMCITABINE HYDROCHLORIDE",
"StrengthNumber": "38",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250718",
"SamplePackage": "N"
},
{
"NDCCode": "83831-123-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (83831-123-01) / 26.3 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "83831-0123-01",
"ProductNDC": "83831-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Avgemsi",
"NonProprietaryName": "Gemcitabine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250803",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219920",
"LabelerName": "Avyxa Pharma, LLC",
"SubstanceName": "GEMCITABINE HYDROCHLORIDE",
"StrengthNumber": "38",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250803",
"SamplePackage": "N",
"IndicationAndUsage": "AVGEMSI is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).",
"Description": "Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine hydrochloride, is 2'-deoxy-2',2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows. Gemcitabine hydrochloride, USP is a white to off-white solid with a molecular formula of C9H11F2N3O4 HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. AVGEMSI is a sterile solution in multiple-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.57 mg, 1.137 g, or 2.275 g of gemcitabine hydrochloride, USP. Each mL contains 38 mg of gemcitabine-free base in water for injection equivalent to 43.26 mg of gemcitabine hydrochloride, USP. Sodium hydroxide is used for pH adjustment."
},
{
"NDCCode": "83831-124-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (83831-124-01) / 52.6 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "83831-0124-01",
"ProductNDC": "83831-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Avgemsi",
"NonProprietaryName": "Gemcitabine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250803",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219920",
"LabelerName": "Avyxa Pharma, LLC",
"SubstanceName": "GEMCITABINE HYDROCHLORIDE",
"StrengthNumber": "38",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250803",
"SamplePackage": "N",
"IndicationAndUsage": "AVGEMSI is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).",
"Description": "Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine hydrochloride, is 2'-deoxy-2',2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows. Gemcitabine hydrochloride, USP is a white to off-white solid with a molecular formula of C9H11F2N3O4 HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. AVGEMSI is a sterile solution in multiple-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.57 mg, 1.137 g, or 2.275 g of gemcitabine hydrochloride, USP. Each mL contains 38 mg of gemcitabine-free base in water for injection equivalent to 43.26 mg of gemcitabine hydrochloride, USP. Sodium hydroxide is used for pH adjustment."
},
{
"NDCCode": "83831-131-01",
"PackageDescription": "1 VIAL in 1 CARTON (83831-131-01) / 4 mL in 1 VIAL",
"NDC11Code": "83831-0131-01",
"ProductNDC": "83831-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Axtle",
"NonProprietaryName": "Pemetrexed",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210661",
"LabelerName": "Avyxa Pharma, LLC",
"SubstanceName": "PEMETREXED",
"StrengthNumber": "100",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "AXTLE is a folate analog metabolic inhibitor indicated: : 1 in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. (1.1), 2 in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. (1.1), 3 as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 4 as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1).",
"Description": "Pemetrexed is a folate analog metabolic inhibitor. The drug substance is pemetrexed dipotassium heptahydrate, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, dipotassium salt, heptahydrate. It is a white to off-white powder having blue or green tinge with a molecular formula of C20H19K2N5O6 .7 H2O and a molecular weight of 629.49. Pemetrexed dipotassium is freely soluble in water. The reported pKaS are 3.6 and 4.5. The structural formula of pemetrexed dipotassium heptahydrate is as follows. AXTLE is supplied as a sterile white to light-yellow or green-yellow lyophilized powder or cake for intravenous infusion available in single-dose vials. Each 100-mg or 500-mg vial of AXTLE contains 100 mg pemetrexed equivalent to 118.3 mg pemetrexed dipotassium and 106 mg mannitol or 500 mg pemetrexed equivalent to 591.5 mg pemetrexed dipotassium and 500 mg mannitol, respectively. Hydrochloric acid may have been added to adjust the pH."
},
{
"NDCCode": "83831-132-01",
"PackageDescription": "1 VIAL in 1 CARTON (83831-132-01) / 20 mL in 1 VIAL",
"NDC11Code": "83831-0132-01",
"ProductNDC": "83831-132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Axtle",
"NonProprietaryName": "Pemetrexed",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210661",
"LabelerName": "Avyxa Pharma, LLC",
"SubstanceName": "PEMETREXED",
"StrengthNumber": "500",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "AXTLE is a folate analog metabolic inhibitor indicated: : 1 in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. (1.1), 2 in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. (1.1), 3 as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 4 as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1).",
"Description": "Pemetrexed is a folate analog metabolic inhibitor. The drug substance is pemetrexed dipotassium heptahydrate, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, dipotassium salt, heptahydrate. It is a white to off-white powder having blue or green tinge with a molecular formula of C20H19K2N5O6 .7 H2O and a molecular weight of 629.49. Pemetrexed dipotassium is freely soluble in water. The reported pKaS are 3.6 and 4.5. The structural formula of pemetrexed dipotassium heptahydrate is as follows. AXTLE is supplied as a sterile white to light-yellow or green-yellow lyophilized powder or cake for intravenous infusion available in single-dose vials. Each 100-mg or 500-mg vial of AXTLE contains 100 mg pemetrexed equivalent to 118.3 mg pemetrexed dipotassium and 106 mg mannitol or 500 mg pemetrexed equivalent to 591.5 mg pemetrexed dipotassium and 500 mg mannitol, respectively. Hydrochloric acid may have been added to adjust the pH."
},
{
"NDCCode": "83831-143-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (83831-143-01) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "83831-0143-01",
"ProductNDC": "83831-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Favlyxa",
"NonProprietaryName": "Fluorouracil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220201",
"LabelerName": "Avyxa Pharma, LLC",
"SubstanceName": "FLUOROURACIL",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "FAVLYXA is indicated for the treatment of patients with.",
"Description": "FAVLYXA injection contains fluorouracil, a nucleoside metabolic inhibitor. Fluorouracil, a fluorinated pyrimidine, has a chemical name of 5-fluoro-2,4 (1H,3H)-pyrimidinedione. Its structural formula is. Molecular formula: C4H3FN2O2. Molecular weight: 130.08 g/mole. FAVLYXA injection is a sterile, colorless to light yellow clear solution available in 250 mg/10 mL single-dose vials and 2,500 mg/100 mL multiple-dose vials for intravenous bolus or infusion administration. Each mL contains 25 mg fluorouracil in water for injection. Sodium hydroxide is added to adjust the pH to 8.6 to 9.4."
},
{
"NDCCode": "83831-153-01",
"PackageDescription": "1 VIAL in 1 CARTON (83831-153-01) / 5 mL in 1 VIAL",
"NDC11Code": "83831-0153-01",
"ProductNDC": "83831-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Navitrux",
"NonProprietaryName": "Fosaprepitant",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260723",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220436",
"LabelerName": "AVYXA Pharma, LLC",
"SubstanceName": "FOSAPREPITANT DIMEGLUMINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260723",
"SamplePackage": "N",
"IndicationAndUsage": "NAVITRUX, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin., 2 delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).",
"Description": "NAVITRUX (fosaprepitant) for injection is a sterile, lyophilized formulation containing fosaprepitant dimeglumine, a prodrug of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 1-Deoxy-1-(methylamino)-D-glucitol[3-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl) phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-2,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl] phosphonate (2:1) (salt). Its empirical formula is C23H22F7N4O6P · 2(C7H17NO5) and its structural formula is. Fosaprepitant dimeglumine is a white to off-white powder with a molecular weight of 1004.83. It is freely soluble in water and methanol, almost insoluble in isopropanol and acetone. Each vial of NAVITRUX for administration as an intravenous infusion contains 150 mg of fosaprepitant (equivalent to 245.3 mg of fosaprepitant dimeglumine) and the following inactive ingredients: anhydrous lactose (375 mg), edetate disodium (5.4 mg), polysorbate 80 (75 mg) and sodium hydroxide (for pH adjustment). The reconstituted solution is in the pH range 7.0-9.0."
},
{
"NDCCode": "11090-134-01",
"PackageDescription": "1 TUBE in 1 CARTON (11090-134-01) > 30 mL in 1 TUBE",
"NDC11Code": "11090-0134-01",
"ProductNDC": "11090-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Itc Bye Bye Foundation Full Coverage Moisturizer Oil-free Matte Tan",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190601",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Beauty Manufacturing Solutions Corp.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "7.4; 6.3",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190601",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "11489-134-01",
"PackageDescription": "1 JAR in 1 CARTON (11489-134-01) > 50 g in 1 JAR",
"NDC11Code": "11489-0134-01",
"ProductNDC": "11489-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No7 Protect And Perfect Intense Advanced Day Cream Spf 30",
"NonProprietaryName": "Avobenzone,octisalate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180514",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "BCM Ltd",
"SubstanceName": "AVOBENZONE; OCTOCRYLENE; OCTISALATE",
"StrengthNumber": "1.5; 3.75; 2.5",
"StrengthUnit": "g/50g; g/50g; g/50g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180514",
"SamplePackage": "N",
"IndicationAndUsage": "Directions. Apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. Limit time in the sun, especially from 10 a.m - 2 p.m. wear long-sleeved shirts,pants,hats and sunglasses.",
"Description": "No7 Protect and Perfect Intense Advanced Day Cream Sunscreen Broad Spectrum SPF 30."
},
{
"NDCCode": "13537-134-01",
"PackageDescription": "50 mL in 1 BOTTLE (13537-134-01)",
"NDC11Code": "13537-0134-01",
"ProductNDC": "13537-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika",
"ProprietaryNameSuffix": "Valerus For Men Roll-on",
"NonProprietaryName": "Aluminum Sesquichlorohydrate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111213",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Ventura Corporation Ltd.",
"SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
"StrengthNumber": ".17",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "reduces underarm wetness."
},
{
"NDCCode": "13668-134-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-01) ",
"NDC11Code": "13668-0134-01",
"ProductNDC": "13668-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Felodipine",
"NonProprietaryName": "Felodipine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20111128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202170",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "FELODIPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20111128",
"SamplePackage": "N",
"IndicationAndUsage": "Felodipine extended-release tablets are indicated for the treatment of hypertension. Felodipine extended-release tablets may be used alone or concomitantly with other antihypertensive agents.",
"Description": "Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2, 6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula is C18H19Cl2NO4 and its structural formula is. Felodipine, USP is a light yellow to yellow crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in acetone and in methanol; very slightly soluble in heptane. Felodipine is a racemic mixture. Felodipine extended-release tablets provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg or 10 mg of felodipine, USP for oral administration. Inactive ingredients are: colloidal silicon dioxide, hydroxy propyl cellulose, hypromellose, lactose anhydrous, magnesium oxide, microcrystalline cellulose, polyoxyl 40 hydrogenated castor oil, propyl gallate, propylene glycol, sodium stearyl fumarate, talc, titanium dioxide and additional agents listed below. 2.5 mg tablets: Ferric oxide yellow and lake of indigo carmine. 5 and 10 mg tablets: Ferric oxide red and ferric oxide yellow. Meets USP Dissolution Test 3."
},
{
"NDCCode": "14141-134-02",
"PackageDescription": "1 CONTAINER in 1 BOX (14141-134-02) > 9 g in 1 CONTAINER (14141-134-01) ",
"NDC11Code": "14141-0134-02",
"ProductNDC": "14141-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Clarite Clarifying Effect Foundation Spf 30",
"ProprietaryNameSuffix": "Claire 9/brown",
"NonProprietaryName": "Octinoxate And Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180926",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bel Star S.A. (Colombia)",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": ".075; .0784",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180926",
"SamplePackage": "N"
},
{
"NDCCode": "14335-134-01",
"PackageDescription": "1 VIAL in 1 CARTON (14335-134-01) > 100 mL in 1 VIAL",
"NDC11Code": "14335-0134-01",
"ProductNDC": "14335-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Nitroprusside",
"NonProprietaryName": "Sodium Nitroprusside",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20221231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215846",
"LabelerName": "Hainan Poly Pharm. Co., Ltd.",
"SubstanceName": "SODIUM NITROPRUSSIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vasodilation [PE], Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221231",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium nitroprusside is a direct acting vasodilator indicated for. Immediate reduction of blood pressure ( 1.1). Producing controlled hypotension to reduce bleeding during surgery. ( 1.2). Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. ( 1.3).",
"Description": "Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-) dihydrate, a hypotensive agent whose structural formula is. Sodium Nitroprusside has molecular formula Na 2[Fe(CN) 5NO] 2H 2O and molecular weight of 297.95. Dry sodium nitroprusside is a reddish-brown powder, soluble in water. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes [see Dosage and Administration ( 2.1)] . Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 100-mL vial. Each 100 mL of solution in vial contains 50 mg of sodium nitroprusside (0.5 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 100-mL vial. Each 100 mL of solution in vial contains 20 mg of sodium nitroprusside (0.2 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 50-mL vial. Each 50 mL of solution in vial contains 10 mg of sodium nitroprusside (0.2 mg/mL), 450 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP."
},
{
"NDCCode": "14783-134-02",
"PackageDescription": "1 CONTAINER in 1 BOX (14783-134-02) > 12 g in 1 CONTAINER (14783-134-01) ",
"NDC11Code": "14783-0134-02",
"ProductNDC": "14783-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Long Lasting Compact Spf 15",
"ProprietaryNameSuffix": "Claire 3/beige",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180818",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".0575; .049",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180818",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16714-134-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (16714-134-01) ",
"NDC11Code": "16714-0134-01",
"ProductNDC": "16714-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213063",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20201012",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)., 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.",
"Description": "Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NO ∙ HCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[b,e] oxepin-11 (6H )ylidene-N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg empty gelatin capsule shells contain iron oxide red and iron oxide yellow, the 25 mg and 50 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Yellow 6, and the 75 mg and 100 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Blue 1. The imprinting ink may contain ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "16729-134-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (16729-134-01) ",
"NDC11Code": "16729-0134-01",
"ProductNDC": "16729-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203154",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150429",
"SamplePackage": "N",
"IndicationAndUsage": "Allopurinol tablets are indicated for: 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy), 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels, 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables).",
"Description": "Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol is known chemically as 1, 5-dihydro-4 H-pyrazolo [3, 4- d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each white to off white tablet contains 100 mg or 300 mg of allopurinol and the inactive ingredients lactose, crospovidone, magnesium stearate, maize starch, and povidone."
},
{
"NDCCode": "20367-134-01",
"PackageDescription": "200 mL in 1 BOTTLE (20367-134-01)",
"NDC11Code": "20367-0134-01",
"ProductNDC": "20367-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rayito De Sol",
"ProprietaryNameSuffix": "Spf 35",
"NonProprietaryName": "Octinoxate, Octisalate, Octocrylene, Oxybenzone, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130111",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Siscom de Argentina S.A.",
"SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; TITANIUM DIOXIDE",
"StrengthNumber": "15.04; 9.68; 9.68; 7.21; 1.24",
"StrengthUnit": "g/200mL; g/200mL; g/200mL; g/200mL; g/200mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": " helps prevent sunburn."
},
{
"NDCCode": "22431-134-01",
"PackageDescription": "170 g in 1 JAR (22431-134-01) ",
"NDC11Code": "22431-0134-01",
"ProductNDC": "22431-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Petroleum Jelly Baby Fragrance",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190125",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Blue Cross Laboratories, Inc.",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "99.9",
"StrengthUnit": "1/100g",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190125",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor if condition worsens or does not improve after 7 days."
},
{
"NDCCode": "23155-134-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (23155-134-01) ",
"NDC11Code": "23155-0134-01",
"ProductNDC": "23155-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091605",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120501",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated for the treatment of the following infections. Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections. Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent's infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.",
"Description": "Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline 150 mg, 100 mg, 75 mg, and 50 mg tablets contain doxycycline monohydrate equivalent to 150 mg, 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. C22H24N2O8H2O M.W. = 462.45. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hypromellose 2910, magnesium stearate and opadry 04G84829 pink which contains: hypromellose 2910, talc, titanium dioxide, propylene glycol, polyethylene glycol 6000, iron oxide yellow and iron oxide red."
},
{
"NDCCode": "24765-134-01",
"PackageDescription": "20 mL in 1 BOTTLE, SPRAY (24765-134-01) ",
"NDC11Code": "24765-0134-01",
"ProductNDC": "24765-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Killfire Mouth Freshener",
"NonProprietaryName": "Cetylpyridinium Chloride",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20211029",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Pharmacal-International. Co., Ltd.",
"SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20211029",
"SamplePackage": "N",
"IndicationAndUsage": "Helps remove plaque . Helps remove bad breath. Clean mouth."
},
{
"NDCCode": "29300-134-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-134-01) ",
"NDC11Code": "29300-0134-01",
"ProductNDC": "29300-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078680",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N"
},
{
"NDCCode": "31722-134-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-134-01) ",
"NDC11Code": "31722-0134-01",
"ProductNDC": "31722-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214422",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210120",
"SamplePackage": "N",
"IndicationAndUsage": "BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.",
"Description": "Potassium Chloride Extended-Release Tablets, USP 10 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq K of potassium in a tablet. Potassium Chloride Extended-Release Tablets, USP 15 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq K of potassium in a tablet. Potassium Chloride Extended-Release Tablets, USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq K of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride extended-release tablets is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium chloride extended-release tablets is a tablet formulation (not enteric-coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride extended-release tablets begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride, USP. Inactive Ingredients: croscarmellose sodium, ethylcellulose and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP. FDA approved sample preparation in the assay differs from USP test."
},
{
"NDCCode": "37000-134-01",
"PackageDescription": "2 CAN in 1 CELLO PACK (37000-134-01) / 170 g in 1 CAN",
"NDC11Code": "37000-0134-01",
"ProductNDC": "37000-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Secret Antiperspirant",
"ProprietaryNameSuffix": "Powder Fresh",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": ".24",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20131106",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness."
},
{
"NDCCode": "42023-134-01",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (42023-134-01)",
"NDC11Code": "42023-0134-01",
"ProductNDC": "42023-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol Valerate",
"NonProprietaryName": "Estradiol Valerate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20120601",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA009402",
"LabelerName": "JHP Pharmaceuticals, LLC",
"SubstanceName": "ESTRADIOL VALERATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-05-02"
}
]
}
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<NDCList>
<NDC>
<NDCCode>83831-134-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (83831-134-01) * 2 mL in 1 VIAL, SINGLE-DOSE (83831-150-22) * 2 mL in 1 SYRINGE (83831-135-02) </PackageDescription>
<NDC11Code>83831-0134-01</NDC11Code>
<ProductNDC>83831-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lutrate Depot</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250326</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205054</ApplicationNumber>
<LabelerName>Avyxa Pharma, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUTRATE DEPOT 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula. Where: n=1 or 2. Leuprolide acetate has a molecular weight of 1209.41 as "free base”. Leuprolide is freely soluble in water. LUTRATE DEPOT 22.5 mg for 3-month administration is available in a vial containing white to off white sterile lyophilized microspheres together with the corresponding sterile reconstitution diluent in a pre-filled syringe. When LUTRATE DEPOT and the diluent are mixed together they become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS as a single dose. Each vial of LUTRATE DEPOT 22.5 mg for 3-month administration delivers leuprolide acetate (22.5 mg), polylactic acid (188.4 mg), triethylcitrate (10.4 mg), polysorbate 80 (3.8 mg), mannitol (88.4 mg) and carmellose sodium (25 mg). The prefilled syringe containing the clear reconstitution diluent (2 mL) contains mannitol (16 mg), water for injection, and sodium hydroxide and hydrochloric acid to control pH. LUTRATE DEPOT is an extended release sterile, single dose injection in suspension form for intramuscular administration.</Description>
</NDC>
<NDC>
<NDCCode>83831-105-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (83831-105-01) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>83831-0105-01</NDC11Code>
<ProductNDC>83831-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Posfrea</ProprietaryName>
<NonProprietaryName>Palonosetron</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240930</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203050</ApplicationNumber>
<LabelerName>Avyxa Pharma, LLC</LabelerName>
<SubstanceName>PALONOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>POSFREA is indicated in adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)., 2 acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC)., 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.</IndicationAndUsage>
<Description>POSFREA Injection contains palonosetron as palonosetron HCl, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron HCl is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct 3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenz[de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron HCl exists as a single isomer and has the following structural formula. Palonosetron HCl is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. POSFREA Injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. POSFREA Injection is available as a 5 mL or 1.5 mL single-dose vial. Each mL of aqueous solution contains 0.05 mg palonosetron (equivalent to 0.056 mg palonosetron hydrochloride). Each mL also contains 41.5 mg mannitol, 3.0 mg sodium acetate trihydrate, and water for injection (q.s. to 1.0 mL). The pH of the solution in the 5 mL and 1.5 mL vials is 4.5 to 5.5. Hydrochloric acid or sodium hydroxide may have been added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>83831-111-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (83831-111-01) / 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>83831-0111-01</NDC11Code>
<ProductNDC>83831-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pemetrexed Dipotassium</ProprietaryName>
<NonProprietaryName>Pemetrexed Dipotassium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210661</ApplicationNumber>
<LabelerName>Avyxa Pharma, LLC</LabelerName>
<SubstanceName>PEMETREXED</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pemetrexed for Injection is a folate analog metabolic inhibitor indicated: 1 in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. (1.1), 2 as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 3 as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1).</IndicationAndUsage>
<Description>Pemetrexed is a folate analog metabolic inhibitor. The drug substance is pemetrexed dipotassium heptahydrate, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, dipotassium salt, heptahydrate. It is a white to off-white powder having blue or green tinge with a molecular formula of C20H19K2N5O6 .7 H2O and a molecular weight of 629.49. Pemetrexed dipotassium is freely soluble in water. The reported pKaS are 3.6 and 4.5. The structural formula of pemetrexed dipotassium heptahydrate is as follows. Pemetrexed for Injection is supplied as a sterile white to light-yellow or green-yellow lyophilized powder or cake for intravenous infusion available in single-dose vials. Each 100-mg or 500-mg vial of Pemetrexed for Injection contains 100 mg pemetrexed equivalent to 118.3 mg pemetrexed dipotassium and 106 mg mannitol or 500 mg pemetrexed equivalent to 591.5 mg pemetrexed dipotassium and 500 mg mannitol, respectively. Hydrochloric acid may have been added to adjust the pH.</Description>
</NDC>
<NDC>
<NDCCode>83831-112-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (83831-112-01) / 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>83831-0112-01</NDC11Code>
<ProductNDC>83831-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pemetrexed Dipotassium</ProprietaryName>
<NonProprietaryName>Pemetrexed Dipotassium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210661</ApplicationNumber>
<LabelerName>Avyxa Pharma, LLC</LabelerName>
<SubstanceName>PEMETREXED</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pemetrexed for Injection is a folate analog metabolic inhibitor indicated: 1 in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. (1.1), 2 as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 3 as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1).</IndicationAndUsage>
<Description>Pemetrexed is a folate analog metabolic inhibitor. The drug substance is pemetrexed dipotassium heptahydrate, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, dipotassium salt, heptahydrate. It is a white to off-white powder having blue or green tinge with a molecular formula of C20H19K2N5O6 .7 H2O and a molecular weight of 629.49. Pemetrexed dipotassium is freely soluble in water. The reported pKaS are 3.6 and 4.5. The structural formula of pemetrexed dipotassium heptahydrate is as follows. Pemetrexed for Injection is supplied as a sterile white to light-yellow or green-yellow lyophilized powder or cake for intravenous infusion available in single-dose vials. Each 100-mg or 500-mg vial of Pemetrexed for Injection contains 100 mg pemetrexed equivalent to 118.3 mg pemetrexed dipotassium and 106 mg mannitol or 500 mg pemetrexed equivalent to 591.5 mg pemetrexed dipotassium and 500 mg mannitol, respectively. Hydrochloric acid may have been added to adjust the pH.</Description>
</NDC>
<NDC>
<NDCCode>83831-116-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (83831-116-01) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>83831-0116-01</NDC11Code>
<ProductNDC>83831-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclophosphamide</ProprietaryName>
<NonProprietaryName>Cyclophosphamide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210852</ApplicationNumber>
<LabelerName>Avyxa Pharma, LLC</LabelerName>
<SubstanceName>CYCLOPHOSPHAMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Malignant Diseases. Cyclophosphamide Injection is indicated for the treatment of adult and pediatric patients with: 1 malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma Burkitt's lymphoma, 2 multiple myeloma, 3 leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration), 4 mycosis fungoides (advanced disease), 5 neuroblastoma (disseminated disease), 6 adenocarcinoma of the ovary, 7 retinoblastoma, 8 carcinoma of the breast.</IndicationAndUsage>
<Description>Cyclophosphamide is an alkylating drug. It is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is (±)-2-[Bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide is a white crystalline powder with the molecular formula C7H15Cl2N2O2 PH2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. The pKa of cyclophosphamide is 5.7. Cyclophosphamide Injection is a clear, colorless to slight yellow sterile solution available as 500 mg/mL, 1 g/2 mL, and 2 g/4 mL in single dose vials for dilution prior to intravenous administration. : 1 500 mg/mL vial contains 534.5 mg cyclophosphamide monohydrate, equivalent to 500 mg cyclophosphamide and 500 mg dehydrated alcohol (equivalent to 63% v/v)., 2 1 g/2 mL vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide and 1000 mg dehydrated alcohol (equivalent to 63% v/v)., 3 2 g/4 mL vial contains 2138.0 mg cyclophosphamide monohydrate, equivalent to 2 g cyclophosphamide and 2000 mg dehydrated alcohol (equivalent to 63% v/v).</Description>
</NDC>
<NDC>
<NDCCode>83831-119-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (83831-119-01) / 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>83831-0119-01</NDC11Code>
<ProductNDC>83831-119</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Frindovyx</ProprietaryName>
<NonProprietaryName>Cyclophosphamide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250319</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210852</ApplicationNumber>
<LabelerName>AVYXA Pharma, LLC</LabelerName>
<SubstanceName>CYCLOPHOSPHAMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Malignant Diseases. FRINDOVYX is indicated for the treatment of adult and pediatric patients with: 1 malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma Burkitt's lymphoma, 2 multiple myeloma, 3 leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration), 4 mycosis fungoides (advanced disease), 5 neuroblastoma (disseminated disease), 6 adenocarcinoma of the ovary, 7 retinoblastoma, 8 carcinoma of the breast.</IndicationAndUsage>
<Description>Cyclophosphamide is an alkylating drug. It is an antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is (±)-2-[Bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide is a white crystalline powder with the molecular formula C7H15Cl2N2O2 PH2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. The pKa of cyclophosphamide is 5.7. FRINDOVYX is a clear, colorless to yellow sterile solution available as 500 mg/mL, 1 g/2 mL, and 2 g/4 mL in multiple dose vial for dilution prior to intravenous administration. : 1 500 mg/mL vial contains 534.5 mg cyclophosphamide monohydrate, equivalent to 500 mg cyclophosphamide and 500 mg dehydrated alcohol (equivalent to 63% v/v)., 2 1 g/2 mL vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide and 1000 mg dehydrated alcohol (equivalent to 63% v/v)., 3 2 g/4 mL vial contains 2138.0 mg cyclophosphamide monohydrate, equivalent to 2 g cyclophosphamide and 2000 mg dehydrated alcohol (equivalent to 63% v/v).</Description>
</NDC>
<NDC>
<NDCCode>83831-122-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (83831-122-01) / 5.26 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>83831-0122-01</NDC11Code>
<ProductNDC>83831-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Avgemsi</ProprietaryName>
<NonProprietaryName>Gemcitabine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250718</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219920</ApplicationNumber>
<LabelerName>Avyxa Pharma, LLC</LabelerName>
<SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>38</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83831-123-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (83831-123-01) / 26.3 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>83831-0123-01</NDC11Code>
<ProductNDC>83831-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Avgemsi</ProprietaryName>
<NonProprietaryName>Gemcitabine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250803</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219920</ApplicationNumber>
<LabelerName>Avyxa Pharma, LLC</LabelerName>
<SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>38</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AVGEMSI is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).</IndicationAndUsage>
<Description>Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine hydrochloride, is 2'-deoxy-2',2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows. Gemcitabine hydrochloride, USP is a white to off-white solid with a molecular formula of C9H11F2N3O4 HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. AVGEMSI is a sterile solution in multiple-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.57 mg, 1.137 g, or 2.275 g of gemcitabine hydrochloride, USP. Each mL contains 38 mg of gemcitabine-free base in water for injection equivalent to 43.26 mg of gemcitabine hydrochloride, USP. Sodium hydroxide is used for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>83831-124-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (83831-124-01) / 52.6 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>83831-0124-01</NDC11Code>
<ProductNDC>83831-124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Avgemsi</ProprietaryName>
<NonProprietaryName>Gemcitabine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250803</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219920</ApplicationNumber>
<LabelerName>Avyxa Pharma, LLC</LabelerName>
<SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>38</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AVGEMSI is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).</IndicationAndUsage>
<Description>Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine hydrochloride, is 2'-deoxy-2',2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows. Gemcitabine hydrochloride, USP is a white to off-white solid with a molecular formula of C9H11F2N3O4 HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. AVGEMSI is a sterile solution in multiple-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.57 mg, 1.137 g, or 2.275 g of gemcitabine hydrochloride, USP. Each mL contains 38 mg of gemcitabine-free base in water for injection equivalent to 43.26 mg of gemcitabine hydrochloride, USP. Sodium hydroxide is used for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>83831-131-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (83831-131-01) / 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>83831-0131-01</NDC11Code>
<ProductNDC>83831-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Axtle</ProprietaryName>
<NonProprietaryName>Pemetrexed</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210661</ApplicationNumber>
<LabelerName>Avyxa Pharma, LLC</LabelerName>
<SubstanceName>PEMETREXED</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AXTLE is a folate analog metabolic inhibitor indicated: : 1 in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. (1.1), 2 in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. (1.1), 3 as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 4 as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1).</IndicationAndUsage>
<Description>Pemetrexed is a folate analog metabolic inhibitor. The drug substance is pemetrexed dipotassium heptahydrate, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, dipotassium salt, heptahydrate. It is a white to off-white powder having blue or green tinge with a molecular formula of C20H19K2N5O6 .7 H2O and a molecular weight of 629.49. Pemetrexed dipotassium is freely soluble in water. The reported pKaS are 3.6 and 4.5. The structural formula of pemetrexed dipotassium heptahydrate is as follows. AXTLE is supplied as a sterile white to light-yellow or green-yellow lyophilized powder or cake for intravenous infusion available in single-dose vials. Each 100-mg or 500-mg vial of AXTLE contains 100 mg pemetrexed equivalent to 118.3 mg pemetrexed dipotassium and 106 mg mannitol or 500 mg pemetrexed equivalent to 591.5 mg pemetrexed dipotassium and 500 mg mannitol, respectively. Hydrochloric acid may have been added to adjust the pH.</Description>
</NDC>
<NDC>
<NDCCode>83831-132-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (83831-132-01) / 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>83831-0132-01</NDC11Code>
<ProductNDC>83831-132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Axtle</ProprietaryName>
<NonProprietaryName>Pemetrexed</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210661</ApplicationNumber>
<LabelerName>Avyxa Pharma, LLC</LabelerName>
<SubstanceName>PEMETREXED</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AXTLE is a folate analog metabolic inhibitor indicated: : 1 in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. (1.1), 2 in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. (1.1), 3 as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 4 as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1).</IndicationAndUsage>
<Description>Pemetrexed is a folate analog metabolic inhibitor. The drug substance is pemetrexed dipotassium heptahydrate, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, dipotassium salt, heptahydrate. It is a white to off-white powder having blue or green tinge with a molecular formula of C20H19K2N5O6 .7 H2O and a molecular weight of 629.49. Pemetrexed dipotassium is freely soluble in water. The reported pKaS are 3.6 and 4.5. The structural formula of pemetrexed dipotassium heptahydrate is as follows. AXTLE is supplied as a sterile white to light-yellow or green-yellow lyophilized powder or cake for intravenous infusion available in single-dose vials. Each 100-mg or 500-mg vial of AXTLE contains 100 mg pemetrexed equivalent to 118.3 mg pemetrexed dipotassium and 106 mg mannitol or 500 mg pemetrexed equivalent to 591.5 mg pemetrexed dipotassium and 500 mg mannitol, respectively. Hydrochloric acid may have been added to adjust the pH.</Description>
</NDC>
<NDC>
<NDCCode>83831-143-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (83831-143-01) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>83831-0143-01</NDC11Code>
<ProductNDC>83831-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Favlyxa</ProprietaryName>
<NonProprietaryName>Fluorouracil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220201</ApplicationNumber>
<LabelerName>Avyxa Pharma, LLC</LabelerName>
<SubstanceName>FLUOROURACIL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FAVLYXA is indicated for the treatment of patients with.</IndicationAndUsage>
<Description>FAVLYXA injection contains fluorouracil, a nucleoside metabolic inhibitor. Fluorouracil, a fluorinated pyrimidine, has a chemical name of 5-fluoro-2,4 (1H,3H)-pyrimidinedione. Its structural formula is. Molecular formula: C4H3FN2O2. Molecular weight: 130.08 g/mole. FAVLYXA injection is a sterile, colorless to light yellow clear solution available in 250 mg/10 mL single-dose vials and 2,500 mg/100 mL multiple-dose vials for intravenous bolus or infusion administration. Each mL contains 25 mg fluorouracil in water for injection. Sodium hydroxide is added to adjust the pH to 8.6 to 9.4.</Description>
</NDC>
<NDC>
<NDCCode>83831-153-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (83831-153-01) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>83831-0153-01</NDC11Code>
<ProductNDC>83831-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Navitrux</ProprietaryName>
<NonProprietaryName>Fosaprepitant</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260723</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220436</ApplicationNumber>
<LabelerName>AVYXA Pharma, LLC</LabelerName>
<SubstanceName>FOSAPREPITANT DIMEGLUMINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NAVITRUX, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin., 2 delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).</IndicationAndUsage>
<Description>NAVITRUX (fosaprepitant) for injection is a sterile, lyophilized formulation containing fosaprepitant dimeglumine, a prodrug of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist, an antiemetic agent, chemically described as 1-Deoxy-1-(methylamino)-D-glucitol[3-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl) phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-2,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl] phosphonate (2:1) (salt). Its empirical formula is C23H22F7N4O6P · 2(C7H17NO5) and its structural formula is. Fosaprepitant dimeglumine is a white to off-white powder with a molecular weight of 1004.83. It is freely soluble in water and methanol, almost insoluble in isopropanol and acetone. Each vial of NAVITRUX for administration as an intravenous infusion contains 150 mg of fosaprepitant (equivalent to 245.3 mg of fosaprepitant dimeglumine) and the following inactive ingredients: anhydrous lactose (375 mg), edetate disodium (5.4 mg), polysorbate 80 (75 mg) and sodium hydroxide (for pH adjustment). The reconstituted solution is in the pH range 7.0-9.0.</Description>
</NDC>
<NDC>
<NDCCode>11090-134-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (11090-134-01) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>11090-0134-01</NDC11Code>
<ProductNDC>11090-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Itc Bye Bye Foundation Full Coverage Moisturizer Oil-free Matte Tan</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Beauty Manufacturing Solutions Corp.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>7.4; 6.3</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11489-134-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (11489-134-01) > 50 g in 1 JAR</PackageDescription>
<NDC11Code>11489-0134-01</NDC11Code>
<ProductNDC>11489-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No7 Protect And Perfect Intense Advanced Day Cream Spf 30</ProprietaryName>
<NonProprietaryName>Avobenzone,octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180514</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>BCM Ltd</LabelerName>
<SubstanceName>AVOBENZONE; OCTOCRYLENE; OCTISALATE</SubstanceName>
<StrengthNumber>1.5; 3.75; 2.5</StrengthNumber>
<StrengthUnit>g/50g; g/50g; g/50g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions. Apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. Limit time in the sun, especially from 10 a.m - 2 p.m. wear long-sleeved shirts,pants,hats and sunglasses.</IndicationAndUsage>
<Description>No7 Protect and Perfect Intense Advanced Day Cream Sunscreen Broad Spectrum SPF 30.</Description>
</NDC>
<NDC>
<NDCCode>13537-134-01</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (13537-134-01)</PackageDescription>
<NDC11Code>13537-0134-01</NDC11Code>
<ProductNDC>13537-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika</ProprietaryName>
<ProprietaryNameSuffix>Valerus For Men Roll-on</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Ventura Corporation Ltd.</LabelerName>
<SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
<StrengthNumber>.17</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-134-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-01) </PackageDescription>
<NDC11Code>13668-0134-01</NDC11Code>
<ProductNDC>13668-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Felodipine</ProprietaryName>
<NonProprietaryName>Felodipine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202170</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>FELODIPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Felodipine extended-release tablets are indicated for the treatment of hypertension. Felodipine extended-release tablets may be used alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2, 6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula is C18H19Cl2NO4 and its structural formula is. Felodipine, USP is a light yellow to yellow crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in acetone and in methanol; very slightly soluble in heptane. Felodipine is a racemic mixture. Felodipine extended-release tablets provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg or 10 mg of felodipine, USP for oral administration. Inactive ingredients are: colloidal silicon dioxide, hydroxy propyl cellulose, hypromellose, lactose anhydrous, magnesium oxide, microcrystalline cellulose, polyoxyl 40 hydrogenated castor oil, propyl gallate, propylene glycol, sodium stearyl fumarate, talc, titanium dioxide and additional agents listed below. 2.5 mg tablets: Ferric oxide yellow and lake of indigo carmine. 5 and 10 mg tablets: Ferric oxide red and ferric oxide yellow. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>14141-134-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 BOX (14141-134-02) > 9 g in 1 CONTAINER (14141-134-01) </PackageDescription>
<NDC11Code>14141-0134-02</NDC11Code>
<ProductNDC>14141-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Clarite Clarifying Effect Foundation Spf 30</ProprietaryName>
<ProprietaryNameSuffix>Claire 9/brown</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180926</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bel Star S.A. (Colombia)</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.075; .0784</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>14335-134-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (14335-134-01) > 100 mL in 1 VIAL</PackageDescription>
<NDC11Code>14335-0134-01</NDC11Code>
<ProductNDC>14335-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Nitroprusside</ProprietaryName>
<NonProprietaryName>Sodium Nitroprusside</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20221231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215846</ApplicationNumber>
<LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
<SubstanceName>SODIUM NITROPRUSSIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vasodilation [PE], Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium nitroprusside is a direct acting vasodilator indicated for. Immediate reduction of blood pressure ( 1.1). Producing controlled hypotension to reduce bleeding during surgery. ( 1.2). Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. ( 1.3).</IndicationAndUsage>
<Description>Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-) dihydrate, a hypotensive agent whose structural formula is. Sodium Nitroprusside has molecular formula Na 2[Fe(CN) 5NO] 2H 2O and molecular weight of 297.95. Dry sodium nitroprusside is a reddish-brown powder, soluble in water. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes [see Dosage and Administration ( 2.1)] . Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 100-mL vial. Each 100 mL of solution in vial contains 50 mg of sodium nitroprusside (0.5 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 100-mL vial. Each 100 mL of solution in vial contains 20 mg of sodium nitroprusside (0.2 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-dose 50-mL vial. Each 50 mL of solution in vial contains 10 mg of sodium nitroprusside (0.2 mg/mL), 450 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>14783-134-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 BOX (14783-134-02) > 12 g in 1 CONTAINER (14783-134-01) </PackageDescription>
<NDC11Code>14783-0134-02</NDC11Code>
<ProductNDC>14783-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Long Lasting Compact Spf 15</ProprietaryName>
<ProprietaryNameSuffix>Claire 3/beige</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180818</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.0575; .049</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-134-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (16714-134-01) </PackageDescription>
<NDC11Code>16714-0134-01</NDC11Code>
<ProductNDC>16714-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213063</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)., 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.</IndicationAndUsage>
<Description>Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NO ∙ HCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[b,e] oxepin-11 (6H )ylidene-N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg empty gelatin capsule shells contain iron oxide red and iron oxide yellow, the 25 mg and 50 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Yellow 6, and the 75 mg and 100 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Blue 1. The imprinting ink may contain ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>16729-134-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16729-134-01) </PackageDescription>
<NDC11Code>16729-0134-01</NDC11Code>
<ProductNDC>16729-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203154</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allopurinol tablets are indicated for: 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy), 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels, 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables).</IndicationAndUsage>
<Description>Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol is known chemically as 1, 5-dihydro-4 H-pyrazolo [3, 4- d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each white to off white tablet contains 100 mg or 300 mg of allopurinol and the inactive ingredients lactose, crospovidone, magnesium stearate, maize starch, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>20367-134-01</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE (20367-134-01)</PackageDescription>
<NDC11Code>20367-0134-01</NDC11Code>
<ProductNDC>20367-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rayito De Sol</ProprietaryName>
<ProprietaryNameSuffix>Spf 35</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octisalate, Octocrylene, Oxybenzone, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130111</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Siscom de Argentina S.A.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>15.04; 9.68; 9.68; 7.21; 1.24</StrengthNumber>
<StrengthUnit>g/200mL; g/200mL; g/200mL; g/200mL; g/200mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage> helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>22431-134-01</NDCCode>
<PackageDescription>170 g in 1 JAR (22431-134-01) </PackageDescription>
<NDC11Code>22431-0134-01</NDC11Code>
<ProductNDC>22431-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Petroleum Jelly Baby Fragrance</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190125</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Blue Cross Laboratories, Inc.</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>99.9</StrengthNumber>
<StrengthUnit>1/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor if condition worsens or does not improve after 7 days.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23155-134-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (23155-134-01) </PackageDescription>
<NDC11Code>23155-0134-01</NDC11Code>
<ProductNDC>23155-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091605</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated for the treatment of the following infections. Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections. Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent's infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.</IndicationAndUsage>
<Description>Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline 150 mg, 100 mg, 75 mg, and 50 mg tablets contain doxycycline monohydrate equivalent to 150 mg, 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. C22H24N2O8H2O M.W. = 462.45. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hypromellose 2910, magnesium stearate and opadry 04G84829 pink which contains: hypromellose 2910, talc, titanium dioxide, propylene glycol, polyethylene glycol 6000, iron oxide yellow and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>24765-134-01</NDCCode>
<PackageDescription>20 mL in 1 BOTTLE, SPRAY (24765-134-01) </PackageDescription>
<NDC11Code>24765-0134-01</NDC11Code>
<ProductNDC>24765-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Killfire Mouth Freshener</ProprietaryName>
<NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211029</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Pharmacal-International. Co., Ltd.</LabelerName>
<SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps remove plaque . Helps remove bad breath. Clean mouth.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>29300-134-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-134-01) </PackageDescription>
<NDC11Code>29300-0134-01</NDC11Code>
<ProductNDC>29300-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078680</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>31722-134-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-134-01) </PackageDescription>
<NDC11Code>31722-0134-01</NDC11Code>
<ProductNDC>31722-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214422</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.</IndicationAndUsage>
<Description>Potassium Chloride Extended-Release Tablets, USP 10 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq K of potassium in a tablet. Potassium Chloride Extended-Release Tablets, USP 15 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq K of potassium in a tablet. Potassium Chloride Extended-Release Tablets, USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq K of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride extended-release tablets is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium chloride extended-release tablets is a tablet formulation (not enteric-coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride extended-release tablets begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride, USP. Inactive Ingredients: croscarmellose sodium, ethylcellulose and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP. FDA approved sample preparation in the assay differs from USP test.</Description>
</NDC>
<NDC>
<NDCCode>37000-134-01</NDCCode>
<PackageDescription>2 CAN in 1 CELLO PACK (37000-134-01) / 170 g in 1 CAN</PackageDescription>
<NDC11Code>37000-0134-01</NDC11Code>
<ProductNDC>37000-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Secret Antiperspirant</ProprietaryName>
<ProprietaryNameSuffix>Powder Fresh</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20070401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>.24</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42023-134-01</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (42023-134-01)</PackageDescription>
<NDC11Code>42023-0134-01</NDC11Code>
<ProductNDC>42023-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol Valerate</ProprietaryName>
<NonProprietaryName>Estradiol Valerate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA009402</ApplicationNumber>
<LabelerName>JHP Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ESTRADIOL VALERATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-02</LastUpdate>
</NDC>
</NDCList>