{
"NDC": [
{
"NDCCode": "71288-807-02",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (71288-807-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-807-01) ",
"NDC11Code": "71288-0807-02",
"ProductNDC": "71288-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210334",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180427",
"SamplePackage": "N",
"IndicationAndUsage": "Phenylephrine Hydrochloride Injection 10 mg per mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock.",
"Description": "Phenylephrine Hydrochloride Injection, USP contains active pharmaceutical ingredient phenylephrine in the form of hydrochloride salt. Phenylephrine is a synthetic sympathomimetic agent in sterile form for parenteral injection. Phenylephrine hydrochloride chemical name is (-)-m-Hydroxy-α [(methylamino)methyl]benzyl alcohol hydrochloride and has the following structural formula. Phenylephrine hydrochloride is very soluble in water, freely soluble in ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine hydrochloride is sensitive to light. Phenylephrine Hydrochloride Injection, USP, 10 mg per mL. Phenylephrine Hydrochloride Injection, USP is a clear, colorless, aqueous solution that is essentially free of visible foreign matter. It MUST BE DILUTED before administration as bolus intravenous infusion or continuous intravenous infusion. Each mL contains: 10 mg of Phenylephrine Hydrochloride (equivalent to 8.2 mg of phenylephrine base); 3.5 mg of Sodium Chloride USP as tonicity agent; 1 mg of Citric Acid Monohydrate USP and 4 mg of Sodium Citrate Dihydrate USP, as buffering agents; 2 mg of Sodium Metabisulfite NF, as antioxidant, and Sodium Hydroxide NF and Hydrochloric Acid NF, as pH adjusters in Water for Injection. Phenylephrine Hydrochloride Injection, USP pH range is 3.0 to 6.5."
},
{
"NDCCode": "13537-807-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-807-02) > 4 g in 1 TUBE (13537-807-01)",
"NDC11Code": "13537-0807-02",
"ProductNDC": "13537-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25",
"ProprietaryNameSuffix": "(fucsia Cautivante) - Pink",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161109",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".0664; .0151",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "31722-807-02",
"PackageDescription": "200 TABLET in 1 BOTTLE (31722-807-02) ",
"NDC11Code": "31722-0807-02",
"ProductNDC": "31722-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204389",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220926",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride tablets, USP are an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C 12H 21N.HCl and the molecular weight is 215.76. Memantine hydrochloride USP occurs as a white to off-white powder and is freely soluble in methanol, soluble in water and sparingly soluble in dimethylformamide. Memantine hydrochloride tablets USP are available for oral administration as modified capsule shaped, film coated tablets containing 5 mg and 10 mg of memantine hydrochloride USP. The tablets also contain the following inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, isopropyl alcohol, lactose monohydrate, magnesium stearate, povidone and talc. The 5 mg tablets are coated with Opadry Orange which contains FD & C blue # 2, FD & C yellow # 6, hypromellose, polyethylene glycol and titanium dioxide, 10 mg tablets are coated with Opadry Grey which contains hypromellose, iron oxide black, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "49035-714-02",
"PackageDescription": "1 KIT in 1 CARTON (49035-714-02) * 355 mL in 1 BOTTLE (49035-807-40) * 355 mL in 1 BOTTLE (49035-476-40) ",
"NDC11Code": "49035-0714-02",
"ProductNDC": "49035-714",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Daytime Nighttime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20200318",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Wal-Mart Stores Inc",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200318",
"SamplePackage": "N"
},
{
"NDCCode": "49349-807-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (49349-807-02)",
"NDC11Code": "49349-0807-02",
"ProductNDC": "49349-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prezista",
"NonProprietaryName": "Darunavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130509",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021976",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "DARUNAVIR ETHANOLATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "49884-807-02",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (49884-807-02) ",
"NDC11Code": "49884-0807-02",
"ProductNDC": "49884-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161101",
"EndMarketingDate": "20190930",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022047",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161101",
"EndMarketingDatePackage": "20190930",
"SamplePackage": "N"
},
{
"NDCCode": "51706-807-02",
"PackageDescription": "244 mL in 1 BOTTLE (51706-807-02) ",
"NDC11Code": "51706-0807-02",
"ProductNDC": "51706-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitiser Foam",
"NonProprietaryName": "Benzalonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Landy International",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "13",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N"
},
{
"NDCCode": "52125-807-02",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52125-807-02)",
"NDC11Code": "52125-0807-02",
"ProductNDC": "52125-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200503",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "53329-807-02",
"PackageDescription": "3 APPLICATOR in 1 POUCH (53329-807-02) / 5 mL in 1 APPLICATOR",
"NDC11Code": "53329-0807-02",
"ProductNDC": "53329-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medline Alcohol Swabstick",
"ProprietaryNameSuffix": "Triples",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070101",
"EndMarketingDate": "20280930",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Medline Industries, LP",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070101",
"EndMarketingDatePackage": "20280930",
"SamplePackage": "N",
"IndicationAndUsage": "for preparation of the skin prior to injection."
},
{
"NDCCode": "61786-807-02",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BLISTER PACK (61786-807-02)",
"NDC11Code": "61786-0807-02",
"ProductNDC": "61786-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Low Dose Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20160802",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-12-02",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "62157-807-02",
"PackageDescription": "5 kg in 1 DRUM (62157-807-02)",
"NDC11Code": "62157-0807-02",
"ProductNDC": "62157-807",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20190425",
"MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
"LabelerName": "AX Pharmaceutical Corp",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "62588-807-02",
"PackageDescription": "57 g in 1 BOTTLE (62588-807-02) ",
"NDC11Code": "62588-0807-02",
"ProductNDC": "62588-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Earth Baby Sun N Fun",
"ProprietaryNameSuffix": "Baby Sunscreen Spf 30",
"NonProprietaryName": "Sunscreen",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161207",
"EndMarketingDate": "20190131",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Earth Baby, Inc.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "5; 3",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161207",
"EndMarketingDatePackage": "20190131",
"SamplePackage": "N"
},
{
"NDCCode": "62713-807-02",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (62713-807-02) ",
"NDC11Code": "62713-0807-02",
"ProductNDC": "62713-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergena",
"ProprietaryNameSuffix": "Zone 7",
"NonProprietaryName": "Echinacea,baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-graecum, Zone 7 Tree, Zone 7 Weed, Zone 7 Grass",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19870101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Meditrend, Inc. DBA Progena Professional Formulations",
"SubstanceName": "ACER NEGUNDO POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA LUDOVICIANA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ATRIPLEX CANESCENS POLLEN; ATRIPLEX CONFERTIFOLIA POLLEN; AVENA SATIVA POLLEN; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; BROMUS INERMIS POLLEN; CARYA ALBA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA, UNSPECIFIED; FAGUS GRANDIFOLIA POLLEN; FENUGREEK LEAF; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; GOLDENSEAL; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOELERIA MACRANTHA POLLEN; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; MYRRH; NASTURTIUM OFFICINALE; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PICEA PUNGENS POLLEN; PINUS STROBUS POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES POLLEN; QUERCUS VIRGINIANA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SALSOLA TRAGUS POLLEN; SOLIDAGO CANADENSIS POLLEN; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII POLLEN; TRITICUM AESTIVUM POLLEN; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 3; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 3; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19870101",
"SamplePackage": "N",
"IndicationAndUsage": "Use:This product is a Homeopathic Dilution formulated to support the body's immunity for the temporary relief of allergies."
},
{
"NDCCode": "63545-807-02",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (63545-807-02) ",
"NDC11Code": "63545-0807-02",
"ProductNDC": "63545-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allium Sativum",
"NonProprietaryName": "Allium Sativum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200110",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
"SubstanceName": "GARLIC",
"StrengthNumber": "100",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200110",
"SamplePackage": "N"
},
{
"NDCCode": "68479-807-02",
"PackageDescription": "1 TUBE in 1 CARTON (68479-807-02) / 59 mL in 1 TUBE",
"NDC11Code": "68479-0807-02",
"ProductNDC": "68479-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clearing Defense Spf 30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Dermalogica, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 80; 50; 80",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "74397-807-02",
"PackageDescription": "266.16 mL in 1 BOTTLE (74397-807-02) ",
"NDC11Code": "74397-0807-02",
"ProductNDC": "74397-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rx 2020 Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200406",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Santa Croce LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200406",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "84522-807-02",
"PackageDescription": "15 g in 1 BOX (84522-807-02) ",
"NDC11Code": "84522-0807-02",
"ProductNDC": "84522-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Super Aqua Max",
"NonProprietaryName": "Super Aqua Max",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250108",
"EndMarketingDate": "20310108",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250108",
"EndMarketingDatePackage": "20310108",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84756-807-02",
"PackageDescription": "15 mL in 1 BOTTLE (84756-807-02) ",
"NDC11Code": "84756-0807-02",
"ProductNDC": "84756-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay 3 In 1 Makeup Emulsion",
"NonProprietaryName": "Trstay 3 In 1 Makeup Emulsion",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241209",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Zhixin Trade Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241209",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84845-807-02",
"PackageDescription": "1 CARTON in 1 CARTON (84845-807-02) / 10 BAG in 1 CARTON / 1000 mL in 1 BAG (84845-807-01) ",
"NDC11Code": "84845-0807-02",
"ProductNDC": "84845-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride And Water Solution",
"NonProprietaryName": "Sodium Chloride, Water",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241202",
"EndMarketingDate": "20341201",
"MarketingCategoryName": "EMERGENCY USE AUTHORIZATION",
"LabelerName": "Global Guard Services LLC",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "9",
"StrengthUnit": "g/9mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241202",
"EndMarketingDatePackage": "20341201",
"SamplePackage": "N",
"IndicationAndUsage": "This product is an isotonic sterilizing aqueous solution of sodium chloride. Chemical Name: Sodium chloride Molecular Formula: NaCl Molecular Weight: 58.44 Osmolality: 260~320 mOsmol/kg. [Character] This product is colorless and clear liquid. [Indications] It is used to regulate the balance of water and electrolytes in the body. [Specification] 50ml: 0.45g; 100ml: 0.9g; 250ml: 2.25g; 500ml: 4.5g; 1000ml: 9g [Dosage and Usage] Intravenous infusion, dosage according to the need of the disease. [Adverse Reactions] Excessive and rapid infusion can cause water and sodium retention, edema, elevated blood pressure, rapid heart rate, chest tightness, dyspnea, and even acute left heart failure. [Precautions] (1) Use with caution in the following cases: ① Edematous diseases, such as nephrotic syndrome, cirrhosis ascites, congestive heart failure, acute left heart failure, brain edema and idiopathic edema; ② Acute renal failure oliguria stage, chronic renal failure urine volume decreased and poor response to diuretic drugs; ③ Hypertension; ④ Hypokalemia. (2) Follow-up examination: ① Serum sodium, potassium, chlorine concentration; ② Blood acid-base balance index; ③ Kidney function; ④ Blood pressure and cardiopulmonary function. [Medication in pregnant women and lactating women] Not clear. [Medication in children] The amount and speed of fluid supplementation should be strictly controlled. [Medication in the elderly] The amount and speed of fluid supplementation should be strictly controlled. [Drug interactions] Should not be used with drugs with known incompatibility contraindications. [Drug overdose] For those with existing acidosis, a large amount of this product can cause hyperchloric acidosis. [Pharmacology and toxicology] Sodium and chlorine are important electrolytes in the body, mainly in the extracellular fluid, and play a very important role in maintaining the normal blood and extracellular fluid volume and osmotic pressure of the human body. The normal serum sodium concentration is 135~145mmol/L, accounting for 92% of the plasma cation and 90% of the total osmotic pressure, so the amount of plasma sodium plays a decisive role in the osmotic pressure. The normal serum chlorine concentration is 98~106mmol/L, which is mainly regulated by the human body through the hypothalamus, posterior pituitary and kidney to maintain the stability of body fluid volume and osmotic pressure. [Pharmacokinetics] In the gastrointestinal tract, sodium is absorbed almost entirely through the active transport of intestinal mucosal cells. Sodium is excreted primarily by the kidneys. [Storage] Sealed storage. [Package] 1. Plastic infusion bag (non-PVC co-extruded film, double hard tube, easy to fold, double valve and double plug). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 1000ml/ bag. 2. Plastic infusion bag (non-PVC co-extruded film, double hard tube, easy to fold, double valve double plug, double aseptic packaging). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 1000ml/ bag. [Validity] (1) The product of 50ml,100ml and 1000ml specifications is valid for 24 months. (2) The validity period of 250ml,500ml is 36 months. [Executive standard] Pharmacopoeia of the People's Republic of China (2020, Volume II) [Approval Number] (1) GuoYaoZhunZi: H20033208 (50ml: 0.45g) (2) GuoYaoZhunZi: H20023682 (100ml: 0.9g) (3) GuoYaoZhunZi: H20023146 (250ml: 2.25g) (4) GuoYaoZhunZi: H20023145 (500ml: 4.5g) (5) GuoYaoZhunZi: H20023750 (1000ml: 9g) [Pharmaceutical marketing authorization holder] Name: Huaren Pharmaceutical Co., Ltd. Registered Address: No. 187, Zhuzhou Road, Qingdao High-tech Park, China. [Manufacturer] Enterprise Name: Huaren Pharmaceutical Co., Ltd. Production Address: No. 187, Zhuzhou Road, Qingdao High-tech Park, China. Zip code: 266101 Tel.: 400-0648885 0532-67709071 Fax: 0532-88702625 Website：http//www.qdhuaren.com."
},
{
"NDCCode": "71288-129-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-129-02) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "71288-0129-02",
"ProductNDC": "71288-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dactinomycin",
"NonProprietaryName": "Dactinomycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213463",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "DACTINOMYCIN",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Actinomycin [EPC], Nucleic Acid Synthesis Inhibitors [MoA], Protein Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2020-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201113",
"SamplePackage": "N",
"IndicationAndUsage": "Dactinomycin for Injection is an actinomycin indicated for the treatment of: : 1 adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. (1.1) , 2 adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. (1.2) , 3 adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. (1.3) , 4 adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. (1.4) , 5 post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. (1.5) , 6 adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion. (1.6) .",
"Description": "Dactinomycin is an actinomycin. Dactinomycin is produced by Streptomyces parvullus. The chemical name is 8-amino-N-(2-amino-4,6-dimethyl-3-oxo-phenoxazin-1-yl)carbonyl-N'-[8-amino-4,6-dimethyl-7-oxo-9-[[3,6,10-trimethyl-7,14-bis(1-methylethyl)-2,5,8,12,15-pentaoxo-9-oxa-3,6,13,16-tetrazabicyclo[14.3.0]nonadec-11-yl]carbamoyl]phenoxazin-1-yl]carbonyl-4,6-dimethyl-7-oxo-N,N'-bis[3,6,10-trimethyl-7,14-bis(1-methylethyl)-2,5,8,12,15-pentaoxo-9-oxa-3,6,13,16 tetrazabicyclo[14.3.0]nonadec-11-yl]-1,9-bis[[3,6,10-trimethyl-7,14-bis(1-methylethyl)-2,5,8,12,15-pentaoxo-9-oxa-3,6,13,16-tetrazabicyclo[14.3.0] nonadec-11-yl]carbamoyl]phenoxazine-1,9-dicarboxamide. The molecular formula is C62H86N12O16 and the molecular weight is 1255.42 daltons. The structural formula of dactinomycin is shown below:. Dactinomycin for Injection, USP for intravenous use is a sterile, amorphous yellow to orange, lyophilized powder in a single-dose vial. Each vial contains 500 mcg of dactinomycin and 20 mg of mannitol."
},
{
"NDCCode": "71288-143-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-143-02) > 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "71288-0143-02",
"ProductNDC": "71288-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel Anhydrous",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209634",
"LabelerName": "Meitheal Pharmaceuticals Inc",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "20",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180824",
"SamplePackage": "N"
},
{
"NDCCode": "71288-202-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-202-02) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "71288-0202-02",
"ProductNDC": "71288-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Nitroprusside",
"NonProprietaryName": "Sodium Nitroprusside",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211016",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "SODIUM NITROPRUSSIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Vasodilation [PE], Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191206",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized. Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium nitroprusside is also indicated for the treatment of acute congestive heart failure.",
"Description": "Sodium nitroprusside is disodium pentacyanonitrosylferrate (2-) dihydrate, a hypotensive agent whose structural formula is. whose molecular formula is Na2[Fe(CN)5NO] 2H2O, and whose molecular weight is 297.95. Dry sodium nitroprusside is a reddish-brown powder, soluble in water. In an aqueous solution infused intravenously, sodium nitroprusside is a rapid-acting vasodilator, active on both arteries and veins. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes. (See DOSAGE AND ADMINISTRATION section.) The solution is also sensitive to certain wavelengths of light, and it must be protected from light in clinical use. Sodium nitroprusside injection is available as. 50 mg Fliptop Vial – Each 2 mL vial contains the equivalent of 50 mg sodium nitroprusside dihydrate in sterile water for injection."
},
{
"NDCCode": "71288-203-03",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-03) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-203-02) ",
"NDC11Code": "71288-0203-03",
"ProductNDC": "71288-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20220127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212803",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220127",
"SamplePackage": "N",
"IndicationAndUsage": "Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection, USP 10 mg per mL is a sterile, nonpyrogenic solution in vials for intravenous and intramuscular injection. Furosemide is a white to slightly yellow odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each mL contains: Furosemide 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3."
},
{
"NDCCode": "71288-205-02",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (71288-205-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-205-01) ",
"NDC11Code": "71288-0205-02",
"ProductNDC": "71288-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20250602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217501",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250602",
"SamplePackage": "N",
"IndicationAndUsage": "Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.",
"Description": "Hydralazine Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous andintramuscular administration. Hydralazine Hydrochloride Injection, USP is a sterile, nonpyrogenic colorless solution. Each mL contains. Active: Hydralazine Hydrochloride, USP, 20 mgPreservatives: Methylparaben, NF, 0.65 mg; Propylparaben, NF, 0.35 mgInactives: Propylene Glycol, USP, 103.6 mg; Sodium Hydroxide and/or Hydrochloric Acid to adjust pH (3.4 to 4.4)and Water for Injection. Hydralazine Hydrochloride, USP is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. Molecular Formula C8H8N4HCl. Hydralazine Hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightlysoluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecularweight of 196.64."
},
{
"NDCCode": "71288-206-02",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (71288-206-02) / 1 mL in 1 VIAL, SINGLE-USE (71288-206-01) ",
"NDC11Code": "71288-0206-02",
"ProductNDC": "71288-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprostadil",
"NonProprietaryName": "Alprostadil",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20240915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075196",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "ALPROSTADIL",
"StrengthNumber": "500",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2024-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240915",
"SamplePackage": "N",
"IndicationAndUsage": "Alprostadil injection, USP is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects. In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment pO2 values; that is, patients with low pO2 values respond best, and patients with pO2 values of 40 torr or more usually have little response. Alprostadil injection, USP should be administered only by trained personnel in facilities that provide pediatric intensive care.",
"Description": "Alprostadil injection, USP for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1, in 1 mL dehydrated alcohol. The chemical name for alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid, and the molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 110° and 116°C. Its solubility at 35°C is 8000 micrograms per 100 mL double distilled water. Alprostadil has a molecular formula of C20H34O5."
},
{
"NDCCode": "71288-300-02",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (71288-300-02) / 1 mL in 1 VIAL, MULTI-DOSE (71288-300-01) ",
"NDC11Code": "71288-0300-02",
"ProductNDC": "71288-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyanocobalamin",
"NonProprietaryName": "Cyanocobalamin",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20241115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214316",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "CYANOCOBALAMIN",
"StrengthNumber": "1000",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Vitamin B 12 [CS], Vitamin B12 [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241115",
"SamplePackage": "N",
"IndicationAndUsage": "Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions. Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of pancreas or bowel Folic acid deficiency. It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug/Laboratory Test Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin Injection is also suitable for the vitamin B12 absorption test (Schilling Test).",
"Description": "Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5 to 7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below."
},
{
"NDCCode": "71288-303-02",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (71288-303-02) > 1 mL in 1 VIAL, MULTI-DOSE (71288-303-01) ",
"NDC11Code": "71288-0303-02",
"ProductNDC": "71288-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyanocobalamin",
"NonProprietaryName": "Cyanocobalamin",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214390",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "CYANOCOBALAMIN",
"StrengthNumber": "1000",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Vitamin B 12 [CS], Vitamin B12 [EPC]",
"Status": "Active",
"LastUpdate": "2022-05-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200924",
"SamplePackage": "N",
"IndicationAndUsage": "Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions. It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin Injection, USP is also suitable for the vitamin B12 absorption test (Schilling test).",
"Description": "Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below."
},
{
"NDCCode": "71288-400-03",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (71288-400-03) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-400-02) ",
"NDC11Code": "71288-0400-03",
"ProductNDC": "71288-400",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium",
"NonProprietaryName": "Heparin Sodium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20190615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211005",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "2000",
"StrengthUnit": "[USP'U]/2mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190615",
"SamplePackage": "N",
"IndicationAndUsage": "Heparin Sodium Injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism; , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; , 3 Atrial fibrillation with embolization; , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 5 Prevention of clotting in arterial and cardiac surgery; , 6 Prophylaxis and treatment of peripheral arterial embolism. , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .",
"Description": "Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose 6-sulfate, (3) ß-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)> (1)> (4)> (3)> (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity, in water for injection. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits)."
},
{
"NDCCode": "71288-401-02",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (71288-401-02) / 1 mL in 1 VIAL, MULTI-DOSE (71288-401-01) ",
"NDC11Code": "71288-0401-02",
"ProductNDC": "71288-401",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium",
"NonProprietaryName": "Heparin Sodium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20200224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211004",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "20000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200224",
"SamplePackage": "N",
"IndicationAndUsage": "Heparin Sodium Injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism; , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; , 3 Atrial fibrillation with embolization; , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 5 Prevention of clotting in arterial and cardiac surgery; , 6 Prophylaxis and treatment of peripheral arterial embolism. , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .",
"Description": "Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose 6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)> (1)> (4)> (3)> (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity, in water for injection. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits)."
},
{
"NDCCode": "71288-402-02",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (71288-402-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-402-01) ",
"NDC11Code": "71288-0402-02",
"ProductNDC": "71288-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium",
"NonProprietaryName": "Heparin Sodium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20190615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211007",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "1000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190615",
"SamplePackage": "N",
"IndicationAndUsage": "Heparin Sodium Injection is indicated for: 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism;, 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease;, 3 Atrial fibrillation with embolization;, 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation);, 5 Prevention of clotting in arterial and cardiac surgery;, 6 Prophylaxis and treatment of peripheral arterial embolism., 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.",
"Description": "Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of heparin sodium (representative subunits). Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium Injection, USP preserved with Benzyl Alcohol is available in the following concentrations per mL. pH 5.0-7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment."
}
]
}
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<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (71288-807-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-807-01) </PackageDescription>
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<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
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<IndicationAndUsage>Phenylephrine Hydrochloride Injection 10 mg per mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock.</IndicationAndUsage>
<Description>Phenylephrine Hydrochloride Injection, USP contains active pharmaceutical ingredient phenylephrine in the form of hydrochloride salt. Phenylephrine is a synthetic sympathomimetic agent in sterile form for parenteral injection. Phenylephrine hydrochloride chemical name is (-)-m-Hydroxy-α [(methylamino)methyl]benzyl alcohol hydrochloride and has the following structural formula. Phenylephrine hydrochloride is very soluble in water, freely soluble in ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine hydrochloride is sensitive to light. Phenylephrine Hydrochloride Injection, USP, 10 mg per mL. Phenylephrine Hydrochloride Injection, USP is a clear, colorless, aqueous solution that is essentially free of visible foreign matter. It MUST BE DILUTED before administration as bolus intravenous infusion or continuous intravenous infusion. Each mL contains: 10 mg of Phenylephrine Hydrochloride (equivalent to 8.2 mg of phenylephrine base); 3.5 mg of Sodium Chloride USP as tonicity agent; 1 mg of Citric Acid Monohydrate USP and 4 mg of Sodium Citrate Dihydrate USP, as buffering agents; 2 mg of Sodium Metabisulfite NF, as antioxidant, and Sodium Hydroxide NF and Hydrochloric Acid NF, as pH adjusters in Water for Injection. Phenylephrine Hydrochloride Injection, USP pH range is 3.0 to 6.5.</Description>
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<PackageDescription>1 TUBE in 1 BOX (13537-807-02) > 4 g in 1 TUBE (13537-807-01)</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25</ProprietaryName>
<ProprietaryNameSuffix>(fucsia Cautivante) - Pink</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.0664; .0151</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
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<PackageDescription>200 TABLET in 1 BOTTLE (31722-807-02) </PackageDescription>
<NDC11Code>31722-0807-02</NDC11Code>
<ProductNDC>31722-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204389</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride tablets, USP are an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C 12H 21N.HCl and the molecular weight is 215.76. Memantine hydrochloride USP occurs as a white to off-white powder and is freely soluble in methanol, soluble in water and sparingly soluble in dimethylformamide. Memantine hydrochloride tablets USP are available for oral administration as modified capsule shaped, film coated tablets containing 5 mg and 10 mg of memantine hydrochloride USP. The tablets also contain the following inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, isopropyl alcohol, lactose monohydrate, magnesium stearate, povidone and talc. The 5 mg tablets are coated with Opadry Orange which contains FD & C blue # 2, FD & C yellow # 6, hypromellose, polyethylene glycol and titanium dioxide, 10 mg tablets are coated with Opadry Grey which contains hypromellose, iron oxide black, polyethylene glycol and titanium dioxide.</Description>
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<PackageDescription>1 KIT in 1 CARTON (49035-714-02) * 355 mL in 1 BOTTLE (49035-807-40) * 355 mL in 1 BOTTLE (49035-476-40) </PackageDescription>
<NDC11Code>49035-0714-02</NDC11Code>
<ProductNDC>49035-714</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Daytime Nighttime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
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<StartMarketingDate>20200318</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Wal-Mart Stores Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (49349-807-02)</PackageDescription>
<NDC11Code>49349-0807-02</NDC11Code>
<ProductNDC>49349-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prezista</ProprietaryName>
<NonProprietaryName>Darunavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130509</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021976</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>DARUNAVIR ETHANOLATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
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<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (49884-807-02) </PackageDescription>
<NDC11Code>49884-0807-02</NDC11Code>
<ProductNDC>49884-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161101</StartMarketingDate>
<EndMarketingDate>20190930</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022047</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161101</StartMarketingDatePackage>
<EndMarketingDatePackage>20190930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>244 mL in 1 BOTTLE (51706-807-02) </PackageDescription>
<NDC11Code>51706-0807-02</NDC11Code>
<ProductNDC>51706-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitiser Foam</ProprietaryName>
<NonProprietaryName>Benzalonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Landy International</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>13</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC>
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<ProductNDC>52125-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200503</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
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<PackageDescription>3 APPLICATOR in 1 POUCH (53329-807-02) / 5 mL in 1 APPLICATOR</PackageDescription>
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<ProductNDC>53329-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medline Alcohol Swabstick</ProprietaryName>
<ProprietaryNameSuffix>Triples</ProprietaryNameSuffix>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20070101</StartMarketingDate>
<EndMarketingDate>20280930</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Medline Industries, LP</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070101</StartMarketingDatePackage>
<EndMarketingDatePackage>20280930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for preparation of the skin prior to injection.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>30 TABLET, CHEWABLE in 1 BLISTER PACK (61786-807-02)</PackageDescription>
<NDC11Code>61786-0807-02</NDC11Code>
<ProductNDC>61786-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Low Dose Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160802</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-02</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62157-807-02</NDCCode>
<PackageDescription>5 kg in 1 DRUM (62157-807-02)</PackageDescription>
<NDC11Code>62157-0807-02</NDC11Code>
<ProductNDC>62157-807</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20190425</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</MarketingCategoryName>
<LabelerName>AX Pharmaceutical Corp</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62588-807-02</NDCCode>
<PackageDescription>57 g in 1 BOTTLE (62588-807-02) </PackageDescription>
<NDC11Code>62588-0807-02</NDC11Code>
<ProductNDC>62588-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Earth Baby Sun N Fun</ProprietaryName>
<ProprietaryNameSuffix>Baby Sunscreen Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Sunscreen</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161207</StartMarketingDate>
<EndMarketingDate>20190131</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Earth Baby, Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>5; 3</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161207</StartMarketingDatePackage>
<EndMarketingDatePackage>20190131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62713-807-02</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (62713-807-02) </PackageDescription>
<NDC11Code>62713-0807-02</NDC11Code>
<ProductNDC>62713-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergena</ProprietaryName>
<ProprietaryNameSuffix>Zone 7</ProprietaryNameSuffix>
<NonProprietaryName>Echinacea,baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-graecum, Zone 7 Tree, Zone 7 Weed, Zone 7 Grass</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Meditrend, Inc. DBA Progena Professional Formulations</LabelerName>
<SubstanceName>ACER NEGUNDO POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA LUDOVICIANA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ATRIPLEX CANESCENS POLLEN; ATRIPLEX CONFERTIFOLIA POLLEN; AVENA SATIVA POLLEN; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; BROMUS INERMIS POLLEN; CARYA ALBA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA, UNSPECIFIED; FAGUS GRANDIFOLIA POLLEN; FENUGREEK LEAF; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; GOLDENSEAL; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOELERIA MACRANTHA POLLEN; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; MYRRH; NASTURTIUM OFFICINALE; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PICEA PUNGENS POLLEN; PINUS STROBUS POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES POLLEN; QUERCUS VIRGINIANA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SALSOLA TRAGUS POLLEN; SOLIDAGO CANADENSIS POLLEN; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII POLLEN; TRITICUM AESTIVUM POLLEN; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 3; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 3; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use:This product is a Homeopathic Dilution formulated to support the body's immunity for the temporary relief of allergies.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63545-807-02</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (63545-807-02) </PackageDescription>
<NDC11Code>63545-0807-02</NDC11Code>
<ProductNDC>63545-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allium Sativum</ProprietaryName>
<NonProprietaryName>Allium Sativum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
<SubstanceName>GARLIC</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68479-807-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68479-807-02) / 59 mL in 1 TUBE</PackageDescription>
<NDC11Code>68479-0807-02</NDC11Code>
<ProductNDC>68479-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clearing Defense Spf 30</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Dermalogica, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 80; 50; 80</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>74397-807-02</NDCCode>
<PackageDescription>266.16 mL in 1 BOTTLE (74397-807-02) </PackageDescription>
<NDC11Code>74397-0807-02</NDC11Code>
<ProductNDC>74397-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rx 2020 Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200406</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Santa Croce LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84522-807-02</NDCCode>
<PackageDescription>15 g in 1 BOX (84522-807-02) </PackageDescription>
<NDC11Code>84522-0807-02</NDC11Code>
<ProductNDC>84522-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Super Aqua Max</ProprietaryName>
<NonProprietaryName>Super Aqua Max</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250108</StartMarketingDate>
<EndMarketingDate>20310108</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250108</StartMarketingDatePackage>
<EndMarketingDatePackage>20310108</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-807-02</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (84756-807-02) </PackageDescription>
<NDC11Code>84756-0807-02</NDC11Code>
<ProductNDC>84756-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay 3 In 1 Makeup Emulsion</ProprietaryName>
<NonProprietaryName>Trstay 3 In 1 Makeup Emulsion</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Zhixin Trade Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84845-807-02</NDCCode>
<PackageDescription>1 CARTON in 1 CARTON (84845-807-02) / 10 BAG in 1 CARTON / 1000 mL in 1 BAG (84845-807-01) </PackageDescription>
<NDC11Code>84845-0807-02</NDC11Code>
<ProductNDC>84845-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride And Water Solution</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Water</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20241202</StartMarketingDate>
<EndMarketingDate>20341201</EndMarketingDate>
<MarketingCategoryName>EMERGENCY USE AUTHORIZATION</MarketingCategoryName>
<LabelerName>Global Guard Services LLC</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>g/9mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241202</StartMarketingDatePackage>
<EndMarketingDatePackage>20341201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is an isotonic sterilizing aqueous solution of sodium chloride. Chemical Name: Sodium chloride Molecular Formula: NaCl Molecular Weight: 58.44 Osmolality: 260~320 mOsmol/kg. [Character] This product is colorless and clear liquid. [Indications] It is used to regulate the balance of water and electrolytes in the body. [Specification] 50ml: 0.45g; 100ml: 0.9g; 250ml: 2.25g; 500ml: 4.5g; 1000ml: 9g [Dosage and Usage] Intravenous infusion, dosage according to the need of the disease. [Adverse Reactions] Excessive and rapid infusion can cause water and sodium retention, edema, elevated blood pressure, rapid heart rate, chest tightness, dyspnea, and even acute left heart failure. [Precautions] (1) Use with caution in the following cases: ① Edematous diseases, such as nephrotic syndrome, cirrhosis ascites, congestive heart failure, acute left heart failure, brain edema and idiopathic edema; ② Acute renal failure oliguria stage, chronic renal failure urine volume decreased and poor response to diuretic drugs; ③ Hypertension; ④ Hypokalemia. (2) Follow-up examination: ① Serum sodium, potassium, chlorine concentration; ② Blood acid-base balance index; ③ Kidney function; ④ Blood pressure and cardiopulmonary function. [Medication in pregnant women and lactating women] Not clear. [Medication in children] The amount and speed of fluid supplementation should be strictly controlled. [Medication in the elderly] The amount and speed of fluid supplementation should be strictly controlled. [Drug interactions] Should not be used with drugs with known incompatibility contraindications. [Drug overdose] For those with existing acidosis, a large amount of this product can cause hyperchloric acidosis. [Pharmacology and toxicology] Sodium and chlorine are important electrolytes in the body, mainly in the extracellular fluid, and play a very important role in maintaining the normal blood and extracellular fluid volume and osmotic pressure of the human body. The normal serum sodium concentration is 135~145mmol/L, accounting for 92% of the plasma cation and 90% of the total osmotic pressure, so the amount of plasma sodium plays a decisive role in the osmotic pressure. The normal serum chlorine concentration is 98~106mmol/L, which is mainly regulated by the human body through the hypothalamus, posterior pituitary and kidney to maintain the stability of body fluid volume and osmotic pressure. [Pharmacokinetics] In the gastrointestinal tract, sodium is absorbed almost entirely through the active transport of intestinal mucosal cells. Sodium is excreted primarily by the kidneys. [Storage] Sealed storage. [Package] 1. Plastic infusion bag (non-PVC co-extruded film, double hard tube, easy to fold, double valve and double plug). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 1000ml/ bag. 2. Plastic infusion bag (non-PVC co-extruded film, double hard tube, easy to fold, double valve double plug, double aseptic packaging). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 1000ml/ bag. [Validity] (1) The product of 50ml,100ml and 1000ml specifications is valid for 24 months. (2) The validity period of 250ml,500ml is 36 months. [Executive standard] Pharmacopoeia of the People's Republic of China (2020, Volume II) [Approval Number] (1) GuoYaoZhunZi: H20033208 (50ml: 0.45g) (2) GuoYaoZhunZi: H20023682 (100ml: 0.9g) (3) GuoYaoZhunZi: H20023146 (250ml: 2.25g) (4) GuoYaoZhunZi: H20023145 (500ml: 4.5g) (5) GuoYaoZhunZi: H20023750 (1000ml: 9g) [Pharmaceutical marketing authorization holder] Name: Huaren Pharmaceutical Co., Ltd. Registered Address: No. 187, Zhuzhou Road, Qingdao High-tech Park, China. [Manufacturer] Enterprise Name: Huaren Pharmaceutical Co., Ltd. Production Address: No. 187, Zhuzhou Road, Qingdao High-tech Park, China. Zip code: 266101 Tel.: 400-0648885 0532-67709071 Fax: 0532-88702625 Website：http//www.qdhuaren.com.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71288-129-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (71288-129-02) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>71288-0129-02</NDC11Code>
<ProductNDC>71288-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dactinomycin</ProprietaryName>
<NonProprietaryName>Dactinomycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213463</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DACTINOMYCIN</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Actinomycin [EPC], Nucleic Acid Synthesis Inhibitors [MoA], Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-11-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dactinomycin for Injection is an actinomycin indicated for the treatment of: : 1 adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. (1.1) , 2 adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. (1.2) , 3 adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. (1.3) , 4 adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. (1.4) , 5 post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. (1.5) , 6 adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion. (1.6) .</IndicationAndUsage>
<Description>Dactinomycin is an actinomycin. Dactinomycin is produced by Streptomyces parvullus. The chemical name is 8-amino-N-(2-amino-4,6-dimethyl-3-oxo-phenoxazin-1-yl)carbonyl-N'-[8-amino-4,6-dimethyl-7-oxo-9-[[3,6,10-trimethyl-7,14-bis(1-methylethyl)-2,5,8,12,15-pentaoxo-9-oxa-3,6,13,16-tetrazabicyclo[14.3.0]nonadec-11-yl]carbamoyl]phenoxazin-1-yl]carbonyl-4,6-dimethyl-7-oxo-N,N'-bis[3,6,10-trimethyl-7,14-bis(1-methylethyl)-2,5,8,12,15-pentaoxo-9-oxa-3,6,13,16 tetrazabicyclo[14.3.0]nonadec-11-yl]-1,9-bis[[3,6,10-trimethyl-7,14-bis(1-methylethyl)-2,5,8,12,15-pentaoxo-9-oxa-3,6,13,16-tetrazabicyclo[14.3.0] nonadec-11-yl]carbamoyl]phenoxazine-1,9-dicarboxamide. The molecular formula is C62H86N12O16 and the molecular weight is 1255.42 daltons. The structural formula of dactinomycin is shown below:. Dactinomycin for Injection, USP for intravenous use is a sterile, amorphous yellow to orange, lyophilized powder in a single-dose vial. Each vial contains 500 mcg of dactinomycin and 20 mg of mannitol.</Description>
</NDC>
<NDC>
<NDCCode>71288-143-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (71288-143-02) > 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>71288-0143-02</NDC11Code>
<ProductNDC>71288-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel Anhydrous</ProprietaryName>
<NonProprietaryName>Docetaxel Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209634</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc</LabelerName>
<SubstanceName>DOCETAXEL ANHYDROUS</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71288-202-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (71288-202-02) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>71288-0202-02</NDC11Code>
<ProductNDC>71288-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Nitroprusside</ProprietaryName>
<NonProprietaryName>Sodium Nitroprusside</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211016</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SODIUM NITROPRUSSIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Vasodilation [PE], Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized. Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium nitroprusside is also indicated for the treatment of acute congestive heart failure.</IndicationAndUsage>
<Description>Sodium nitroprusside is disodium pentacyanonitrosylferrate (2-) dihydrate, a hypotensive agent whose structural formula is. whose molecular formula is Na2[Fe(CN)5NO] 2H2O, and whose molecular weight is 297.95. Dry sodium nitroprusside is a reddish-brown powder, soluble in water. In an aqueous solution infused intravenously, sodium nitroprusside is a rapid-acting vasodilator, active on both arteries and veins. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes. (See DOSAGE AND ADMINISTRATION section.) The solution is also sensitive to certain wavelengths of light, and it must be protected from light in clinical use. Sodium nitroprusside injection is available as. 50 mg Fliptop Vial – Each 2 mL vial contains the equivalent of 50 mg sodium nitroprusside dihydrate in sterile water for injection.</Description>
</NDC>
<NDC>
<NDCCode>71288-203-03</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-03) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-203-02) </PackageDescription>
<NDC11Code>71288-0203-03</NDC11Code>
<ProductNDC>71288-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20220127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212803</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.</IndicationAndUsage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection, USP 10 mg per mL is a sterile, nonpyrogenic solution in vials for intravenous and intramuscular injection. Furosemide is a white to slightly yellow odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each mL contains: Furosemide 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.</Description>
</NDC>
<NDC>
<NDCCode>71288-205-02</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (71288-205-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-205-01) </PackageDescription>
<NDC11Code>71288-0205-02</NDC11Code>
<ProductNDC>71288-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20250602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217501</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.</IndicationAndUsage>
<Description>Hydralazine Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous andintramuscular administration. Hydralazine Hydrochloride Injection, USP is a sterile, nonpyrogenic colorless solution. Each mL contains. Active: Hydralazine Hydrochloride, USP, 20 mgPreservatives: Methylparaben, NF, 0.65 mg; Propylparaben, NF, 0.35 mgInactives: Propylene Glycol, USP, 103.6 mg; Sodium Hydroxide and/or Hydrochloric Acid to adjust pH (3.4 to 4.4)and Water for Injection. Hydralazine Hydrochloride, USP is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. Molecular Formula C8H8N4HCl. Hydralazine Hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightlysoluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecularweight of 196.64.</Description>
</NDC>
<NDC>
<NDCCode>71288-206-02</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (71288-206-02) / 1 mL in 1 VIAL, SINGLE-USE (71288-206-01) </PackageDescription>
<NDC11Code>71288-0206-02</NDC11Code>
<ProductNDC>71288-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprostadil</ProprietaryName>
<NonProprietaryName>Alprostadil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20240915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075196</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ALPROSTADIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alprostadil injection, USP is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects. In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment pO2 values; that is, patients with low pO2 values respond best, and patients with pO2 values of 40 torr or more usually have little response. Alprostadil injection, USP should be administered only by trained personnel in facilities that provide pediatric intensive care.</IndicationAndUsage>
<Description>Alprostadil injection, USP for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1, in 1 mL dehydrated alcohol. The chemical name for alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid, and the molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 110° and 116°C. Its solubility at 35°C is 8000 micrograms per 100 mL double distilled water. Alprostadil has a molecular formula of C20H34O5.</Description>
</NDC>
<NDC>
<NDCCode>71288-300-02</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (71288-300-02) / 1 mL in 1 VIAL, MULTI-DOSE (71288-300-01) </PackageDescription>
<NDC11Code>71288-0300-02</NDC11Code>
<ProductNDC>71288-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyanocobalamin</ProprietaryName>
<NonProprietaryName>Cyanocobalamin</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20241115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214316</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Vitamin B 12 [CS], Vitamin B12 [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions. Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of pancreas or bowel Folic acid deficiency. It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug/Laboratory Test Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin Injection is also suitable for the vitamin B12 absorption test (Schilling Test).</IndicationAndUsage>
<Description>Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5 to 7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below.</Description>
</NDC>
<NDC>
<NDCCode>71288-303-02</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (71288-303-02) > 1 mL in 1 VIAL, MULTI-DOSE (71288-303-01) </PackageDescription>
<NDC11Code>71288-0303-02</NDC11Code>
<ProductNDC>71288-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyanocobalamin</ProprietaryName>
<NonProprietaryName>Cyanocobalamin</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200924</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214390</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Vitamin B 12 [CS], Vitamin B12 [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-05-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions. It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin Injection, USP is also suitable for the vitamin B12 absorption test (Schilling test).</IndicationAndUsage>
<Description>Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below.</Description>
</NDC>
<NDC>
<NDCCode>71288-400-03</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (71288-400-03) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-400-02) </PackageDescription>
<NDC11Code>71288-0400-03</NDC11Code>
<ProductNDC>71288-400</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium</ProprietaryName>
<NonProprietaryName>Heparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211005</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>2000</StrengthNumber>
<StrengthUnit>[USP'U]/2mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Heparin Sodium Injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism; , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; , 3 Atrial fibrillation with embolization; , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 5 Prevention of clotting in arterial and cardiac surgery; , 6 Prophylaxis and treatment of peripheral arterial embolism. , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .</IndicationAndUsage>
<Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose 6-sulfate, (3) ß-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)> (1)> (4)> (3)> (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity, in water for injection. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits).</Description>
</NDC>
<NDC>
<NDCCode>71288-401-02</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (71288-401-02) / 1 mL in 1 VIAL, MULTI-DOSE (71288-401-01) </PackageDescription>
<NDC11Code>71288-0401-02</NDC11Code>
<ProductNDC>71288-401</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium</ProprietaryName>
<NonProprietaryName>Heparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211004</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Heparin Sodium Injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism; , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; , 3 Atrial fibrillation with embolization; , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 5 Prevention of clotting in arterial and cardiac surgery; , 6 Prophylaxis and treatment of peripheral arterial embolism. , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .</IndicationAndUsage>
<Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose 6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)> (1)> (4)> (3)> (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity, in water for injection. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits).</Description>
</NDC>
<NDC>
<NDCCode>71288-402-02</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (71288-402-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-402-01) </PackageDescription>
<NDC11Code>71288-0402-02</NDC11Code>
<ProductNDC>71288-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium</ProprietaryName>
<NonProprietaryName>Heparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211007</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Heparin Sodium Injection is indicated for: 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism;, 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease;, 3 Atrial fibrillation with embolization;, 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation);, 5 Prevention of clotting in arterial and cardiac surgery;, 6 Prophylaxis and treatment of peripheral arterial embolism., 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.</IndicationAndUsage>
<Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of heparin sodium (representative subunits). Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium Injection, USP preserved with Benzyl Alcohol is available in the following concentrations per mL. pH 5.0-7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.</Description>
</NDC>
</NDCList>