{
"NDC": [
{
"NDCCode": "62713-993-01",
"PackageDescription": "90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62713-993-01) ",
"NDC11Code": "62713-0993-01",
"ProductNDC": "62713-993",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergena Texas Cedar Fever Tabs",
"NonProprietaryName": "Allergy Relief",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20240901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Meditrend, Inc. DBA Progena Professional Formulations",
"SubstanceName": "QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PINUS STROBUS POLLEN; POPULUS ALBA POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; BACCHARIS HALIMIFOLIA POLLEN; AMARANTHUS PALMERI POLLEN; XANTHIUM STRUMARIUM POLLEN; RUMEX CRISPUS POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA POLLEN; ARTEMISIA VULGARIS POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; PASPALUM NOTATUM POLLEN; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; LOLIUM PERENNE POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ECHINACEA, UNSPECIFIED; ACACIA POLLEN; ALNUS RUBRA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; FRAXINUS VELUTINA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN; POPULUS TREMULOIDES POLLEN; MORELLA CERIFERA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA LENTA POLLEN; ROBINIA PSEUDOACACIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; CUPRESSUS ARIZONICA POLLEN; TAXODIUM DISTICHUM POLLEN; PHOENIX DACTYLIFERA POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; ULMUS RUBRA POLLEN; EUCALYPTUS GLOBULUS POLLEN; PSEUDOTSUGA MENZIESII POLLEN; CELTIS OCCIDENTALIS POLLEN; CARYA GLABRA POLLEN; CARYA OVATA POLLEN; CARYA LACINIOSA POLLEN; CARYA ALBA POLLEN; LIGUSTRUM VULGARE POLLEN; ACER SACCHARUM POLLEN; ACER RUBRUM POLLEN; MORUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 5; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"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], 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], Increased Histamine Release [PE], Increased Histamine Release [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240901",
"SamplePackage": "N",
"IndicationAndUsage": "Use: This product is a Homeopathic dilution formulated to support the body's immunity for the temporary relief of allergies.*."
},
{
"NDCCode": "10812-993-99",
"PackageDescription": "1 KIT in 1 CARTON (10812-993-99) * 200 mL in 1 BOTTLE * 15 g in 1 TUBE * 40 g in 1 TUBE (10812-978-01)",
"NDC11Code": "10812-0993-99",
"ProductNDC": "10812-993",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Healthy Skin Anti-wrinkle System",
"NonProprietaryName": "Avobenzone, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "KIT",
"StartMarketingDate": "20150916",
"EndMarketingDate": "20180701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"Status": "Deprecated",
"LastUpdate": "2018-07-02",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "11673-993-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (11673-993-01) ",
"NDC11Code": "11673-0993-01",
"ProductNDC": "11673-993",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091237",
"LabelerName": "TARGET CORPORATION",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. temporarily relieves minor aches and pains due to: 1 headache, 2 muscular aches, 3 minor pain of arthritis, 4 toothache, 5 backache, 6 the common cold, 7 menstrual cramps."
},
{
"NDCCode": "13537-993-02",
"PackageDescription": "1 BOTTLE in 1 BOX (13537-993-02) > 30 mL in 1 BOTTLE (13537-993-01)",
"NDC11Code": "13537-0993-02",
"ProductNDC": "13537-993",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Brightening And Moisturizing Facial Spf 30",
"NonProprietaryName": "Avobenzone, Ensulizole, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160926",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": ".03; .03; .05; .05; .06",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16714-993-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16714-993-01) ",
"NDC11Code": "16714-0993-01",
"ProductNDC": "16714-993",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200316",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211383",
"LabelerName": "Northstar Rx LLC.",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200316",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "33261-993-01",
"PackageDescription": "4 BLISTER PACK in 1 BOX (33261-993-01) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "33261-0993-01",
"ProductNDC": "33261-993",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075710",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC],Diphosphonates [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Alendronate Sodium Tablets USP are a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2) , 2 Treatment to increase bone mass in men with osteoporosis (1.3) , 3 Treatment of glucocorticoid-induced osteoporosis (1.4) , 4 Treatment of Paget's disease of bone (1.5) .",
"Description": "Alendronate Sodium Tablets USP is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium, USP is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The structural formula is:. C4H12NNaO7P23H2O M.W. 325.12. Alendronate sodium, USP is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet for oral administration contains 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. Alendronate Sodium Tablets USP meet USP Dissolution Test 2."
},
{
"NDCCode": "42385-993-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (42385-993-01) ",
"NDC11Code": "42385-0993-01",
"ProductNDC": "42385-993",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ticagrelor",
"NonProprietaryName": "Ticagrelor",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218869",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "TICAGRELOR",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260820",
"SamplePackage": "N",
"IndicationAndUsage": "Ticagrelor is a P2Y12 platelet inhibitor indicated. to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1) to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes mellitus (T2DM). (1.2) to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3).",
"Description": "Ticagrelor contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S, 2S, 3R, 5S)-3-(7-(((1R, 2S)-2-(3, 4-difluorophenyl) cyclopropyl) amino)-5-(propylthio)-3H-[1, 2, 3] triazolo [4, 5-d] pyrimidin-3-yl)-5-(2-hydroxyethoxy) cyclopentane-1, 2-diol. The molecular formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is. Ticagrelor is a white or off-white to pale pink powder, freely soluble in methanol with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl methylcellulose, iron oxide yellow, magnesium stearate, mannitol, polyethylene glycol 3350, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide. Ticagrelor 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: dibasic calcium phosphate dihydrate, ferrosoferric oxide, hydroxypropyl methylcellulose, iron oxide red, magnesium stearate, mannitol, polyethylene glycol 3350, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "43498-993-01",
"PackageDescription": "50 CARTRIDGE in 1 BOX (43498-993-01) / 1.8 mL in 1 CARTRIDGE",
"NDC11Code": "43498-0993-01",
"ProductNDC": "43498-993",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Articaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Articaine Hydrochloride, Epinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022466",
"LabelerName": "Burkhart Dental Supply Co., Inc",
"SubstanceName": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "40; 5",
"StrengthUnit": "mg/mL; ug/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.",
"Description": "Articaine HCl and Epinephrine Injection, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength. Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)- propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8. Epinephrine bitartrate, (-)-1-(3,4-dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.0 mg/mL), sodium metabisulfite (0.5 mg/mL), and water for injection. The product is formulated with a 10% overage of epinephrine. The pH is adjusted to 3.6 with hydrochloric acid."
},
{
"NDCCode": "47335-993-01",
"PackageDescription": "1 BAG in 1 POUCH (47335-993-01) / 100 mL in 1 BAG",
"NDC11Code": "47335-0993-01",
"ProductNDC": "47335-993",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212435",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "500",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210810",
"SamplePackage": "N",
"IndicationAndUsage": ". To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection and other antibacterial drugs, Metronidazole Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. TREATMENT OF ANAEROBIC INFECTIONS Metronidazole Injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole Injection therapy. In a mixed aerobic and anaerobic infection,antibacterial drugs appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole Injection. Metronidazole Injection is effective in Bacteroides fragilisinfections resistant to clindamycin, chloramphenicol, and penicillin. : 1 Intra-Abdominal Infections, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group ( B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species in adults and pediatric patients less than 4 months of age. , 2 Skin and Skin Structure Infections caused by Bacteroidesspecies including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species in adults. , 3 Gynecologic Infections, including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, and Peptostreptococcus species in adults. , 4 Bacterial Septicemiacaused by Bacteroides species including the B. fragilis group and Clostridium species in adults. , 5 Bone and Joint Infections, as adjunctive therapy, caused by Bacteroides species including the B. fragilis group in adults. , 6 Central Nervous System (CNS) Infections, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group in adults. , 7 Lower Respiratory Tract Infections, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group in adults. , 8 Endocarditiscaused by Bacteroides species including the B. fragilis group in adults. .",
"Description": "Metronidazole Injection USP is a sterile, parenteral dosage form of metronidazole USP in water. Each 100 mL of Metronidazole Injection USP contains a sterile, nonpyrogenic, isotonic, buffered solution of Metronidazole USP 500 mg, Sodium Chloride USP 740 mg, Dibasic Sodium Phosphate7H 2O USP 112 mg, and Citric Acid Anhydrous USP 40 mg in Water for Injection USP. Metronidazole Injection USP has a calculated osmolarity of 297 mOsmol/liter and a pH of 5.8 (4.5–7.0). Sodium content: 13.5 mEq/container. Metronidazole USP is classified as a nitroimidazole antimicrobial and is administered by the intravenous route. Metronidazole USP is chemically designated 2-methyl-5-nitroimidazole-1-ethanol (C 6H 9N 3O 3):. Not made with natural rubber latex, PVC, or DEHP. The plastic container is polypropylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests - Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration."
},
{
"NDCCode": "49967-993-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (49967-993-01) > 50 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "49967-0993-01",
"ProductNDC": "49967-993",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "La Roche Posay Laboratoire Dermatologique Anthelios 60 Ultra Light Sunscreen Fluid",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "L'Oreal USA Products Inc",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 107.2; 32.1; 60; 38.6",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "50241-993-02",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (50241-993-02) > 3.80564 kg in 1 BOTTLE, PLASTIC (50241-993-01) ",
"NDC11Code": "50241-0993-02",
"ProductNDC": "50241-993",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Foam Hand",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180916",
"EndMarketingDate": "20220324",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "13",
"StrengthUnit": "kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2022-03-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180916",
"EndMarketingDatePackage": "20220324",
"SamplePackage": "N"
},
{
"NDCCode": "51079-993-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-993-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-993-01) ",
"NDC11Code": "51079-0993-20",
"ProductNDC": "51079-993",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluvoxamine Maleate",
"NonProprietaryName": "Fluvoxamine Maleate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20020915",
"EndMarketingDate": "20200331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075889",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "FLUVOXAMINE MALEATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20020915",
"EndMarketingDatePackage": "20200331",
"SamplePackage": "N"
},
{
"NDCCode": "55118-993-01",
"PackageDescription": "1 KIT in 1 CARTON (55118-993-01) * 14 mL in 1 CUP * 2 g in 1 TUBE",
"NDC11Code": "55118-0993-01",
"ProductNDC": "55118-993",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kimvent Oral Care Suction Swab Pack",
"NonProprietaryName": "Hydrogen Peroxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20080826",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Halyard Health",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Aids in the removal of phlegm, mucus, or other secretions in the temporary relief of discomfort due to occasional sore throat and sore mouth."
},
{
"NDCCode": "55648-993-01",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (55648-993-01)",
"NDC11Code": "55648-0993-01",
"ProductNDC": "55648-993",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziprasidone Hydrochloride",
"NonProprietaryName": "Ziprasidone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090348",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Ziprasidone hydrochloride capsule is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone hydrochloride to prolong the QT interval and may consider the use of other drugs first (5.2). Ziprasidone hydrochloride capsule is indicated as an oral formulation for the:. Treatment of schizophrenia. (1.1) : 1 Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in adult patients with schizophrenia (14.1) .",
"Description": "Ziprasidone hydrochloride is available as capsules for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2- benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone hydrochloride capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The molecular formula is C21H21ClN4OS·HCl·H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. Ziprasidone HCl capsules are supplied for oral administration in 20 mg, 40 mg, 60 mg, and 80 mg capsules. Ziprasidone HCl capsules contain ziprasidone hydrochloride monohydrate, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, talc and magnesium stearate, titanium dioxide, gelatin. Additionally, the 40 mg capsule shell contains FD&C blue #1 and FD&C red #3, the 60 mg capsule shell contains D & C red # 28, FD&C red # 40 and FD&C yellow # 6 and the 80 mg capsule shell contains FD&C blue # 1 and FD&C red # 3."
},
{
"NDCCode": "57664-993-01",
"PackageDescription": "13 mL in 1 BOTTLE (57664-993-01) ",
"NDC11Code": "57664-0993-01",
"ProductNDC": "57664-993",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deflazacort Oral Suspension",
"NonProprietaryName": "Deflazacort Oral",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20260202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219930",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DEFLAZACORT",
"StrengthNumber": "22.75",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260202",
"SamplePackage": "N",
"IndicationAndUsage": "Deflazacort oral suspension is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.",
"Description": "The active ingredient in deflazacort oral suspension is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C 25H 31NO 6. The chemical name for deflazacort is (11β,16β)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, and the structure is:. Deflazacort is a white or almost white crystalline powder and has a molecular weight of 441.52. Deflazacort is soluble in dichloromethane and chloroform, slightly soluble in ethanol and ethyl acetate, almost insoluble in water. Deflazacort oral suspension for oral administration is available as an immediate-release oral suspension in a strength of 22.75 mg/mL. The oral suspension contains deflazacort and the following inactive ingredients: benzyl alcohol, glacial acetic acid, magnesium aluminum silicate, noncrystallizing sorbitol solution, polysorbate 80, purified water, sodium carboxymethylcellulose, and sodium hydroxide."
},
{
"NDCCode": "59779-993-01",
"PackageDescription": "89 g in 1 PACKAGE (59779-993-01)",
"NDC11Code": "59779-0993-01",
"ProductNDC": "59779-993",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Pharmacy",
"ProprietaryNameSuffix": "Maximum Strength Feminine Wipes",
"NonProprietaryName": "Pramoxine Hydrochloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130321",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Temporarily relieves itching."
},
{
"NDCCode": "62207-993-01",
"PackageDescription": "10 kg in 1 DRUM (62207-993-01) ",
"NDC11Code": "62207-0993-01",
"ProductNDC": "62207-993",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Potassium Oxybate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20251226",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Granules India Limited",
"SubstanceName": "POTASSIUM OXYBATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-31",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "26-DEC-25"
},
{
"NDCCode": "63545-993-01",
"PackageDescription": "80 PELLET in 1 VIAL, GLASS (63545-993-01) ",
"NDC11Code": "63545-0993-01",
"ProductNDC": "63545-993",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anethum Graveolens",
"NonProprietaryName": "Anethum Graveolens",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201216",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
"SubstanceName": "DILL",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201216",
"SamplePackage": "N"
},
{
"NDCCode": "64117-993-01",
"PackageDescription": "1.875 mL in 1 BOTTLE, GLASS (64117-993-01) ",
"NDC11Code": "64117-0993-01",
"ProductNDC": "64117-993",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Motion Sickness 1",
"NonProprietaryName": "Tobacco Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19980604",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Health Supply",
"SubstanceName": "TOBACCO LEAF",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19980604",
"SamplePackage": "N",
"IndicationAndUsage": "Indications: To be used for acute self-limiting conditions according to standard homeopathic indications."
},
{
"NDCCode": "64220-993-01",
"PackageDescription": "20 kg in 1 DRUM (64220-993-01) ",
"NDC11Code": "64220-0993-01",
"ProductNDC": "64220-993",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ropinirole 5% W/w Triturate With Lactose",
"DosageFormName": "POWDER",
"StartMarketingDate": "20210501",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Zhejiang Huahai Pharmaceutical Co., LTD",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": ".0057",
"StrengthUnit": "kg/.1kg",
"Status": "Unfinished",
"LastUpdate": "2026-07-07",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "02-JUL-26"
},
{
"NDCCode": "64679-993-01",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (64679-993-01) ",
"NDC11Code": "64679-0993-01",
"ProductNDC": "64679-993",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziprasidone Hydrochloride",
"NonProprietaryName": "Ziprasidone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090348",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20120901",
"SamplePackage": "N",
"IndicationAndUsage": "Ziprasidone hydrochloride capsule is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone hydrochloride to prolong the QT interval and may consider the use of other drugs first (5.2). Ziprasidone hydrochloride capsule is indicated as an oral formulation for the: Treatment of schizophrenia. (1.1): 1 Adults: Efficacy was established in four 4 to 6 week trials and one maintenance trial in adult patients with schizophrenia. (14.1).",
"Description": "Ziprasidone hydrochloride is available as capsules for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone hydrochloride capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The molecular formula is C21H21ClN4OSHClH2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. Ziprasidone hydrochloride capsules are supplied for oral administration in 20 mg (white/white), 40 mg (blue/white), 60 mg (pink/white), and 80 mg (blue/blue) capsules. Ziprasidone hydrochloride capsules contain ziprasidone hydrochloride monohydrate, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, talc and magnesium stearate, titanium dioxide, and gelatin. Additionally, the 40 mg capsule shell contains FD&C blue #1 and FD&C red #3, the 60 mg capsule shell contains D & C red #28, FD&C red #40 and FD&C yellow #6 and the 80 mg capsule shell contains FD&C blue #1 and FD&C red #3."
},
{
"NDCCode": "65862-993-25",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (65862-993-25) > 1 mL in 1 VIAL, MULTI-DOSE (65862-993-01) ",
"NDC11Code": "65862-0993-25",
"ProductNDC": "65862-993",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium",
"NonProprietaryName": "Heparin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20140612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202957",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "5000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Anti-coagulant [EPC],Heparin [CS],Unfractionated Heparin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-03-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140612",
"SamplePackage": "N"
},
{
"NDCCode": "68320-993-02",
"PackageDescription": "1 PACKET in 1 BOX (68320-993-02) > 3 mL in 1 PACKET (68320-993-01) ",
"NDC11Code": "68320-0993-02",
"ProductNDC": "68320-993",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Missoni Hand Sanitizer Gel",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200921",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Orlandi Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "2.4",
"StrengthUnit": "mL/3mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200921",
"SamplePackage": "Y"
},
{
"NDCCode": "68511-993-01",
"PackageDescription": "10000 mg in 1 CARTON (68511-993-01) ",
"NDC11Code": "68511-0993-01",
"ProductNDC": "68511-993",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mayinglong Hemorrhoids",
"NonProprietaryName": "Zinc Oxide, Petrolatum, Lanolin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20031215",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "Mayinglong Pharmaceutical Group Co Ltd",
"SubstanceName": "ZINC OXIDE; PETROLATUM",
"StrengthNumber": "800; 7850",
"StrengthUnit": "mg/10000mg; mg/10000mg",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20171025",
"SamplePackage": "N",
"IndicationAndUsage": "helps relieve the local itching and discomfort associated with hemorrhoids. temporarily shrinks hemorrhoidal tissue and relieves burning. temporarily provides a coating for relief of anorectal discomforts. temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful."
},
{
"NDCCode": "69697-993-01",
"PackageDescription": "1 KIT in 1 CARTON (69697-993-01) * 14 mL in 1 CUP * 2 g in 1 TUBE",
"NDC11Code": "69697-0993-01",
"ProductNDC": "69697-993",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kimvent Oral Care Suction Swab Pack",
"NonProprietaryName": "Hydrogen Peroxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20080826",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Halyard Health",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Aids in the removal of phlegm, mucus, or other secretions in the temporary relief of discomfort due to occasional sore throat and sore mouth."
},
{
"NDCCode": "69842-993-01",
"PackageDescription": "30 VIAL, SINGLE-USE in 1 BOX (69842-993-01) / .4 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "69842-0993-01",
"ProductNDC": "69842-993",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Lubricant Eye Drops 30 Ct",
"NonProprietaryName": "Carboxymethylcellulose Soduim",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20190715",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "CVS Pharmacy, Inc.",
"SubstanceName": "CARBOXYMETHYLCELLULOSE SODIUM",
"StrengthNumber": ".5",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
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},
{
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{
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<ApplicationNumber>part352</ApplicationNumber>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
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<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075710</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC],Diphosphonates [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Alendronate Sodium Tablets USP are a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2) , 2 Treatment to increase bone mass in men with osteoporosis (1.3) , 3 Treatment of glucocorticoid-induced osteoporosis (1.4) , 4 Treatment of Paget's disease of bone (1.5) .</IndicationAndUsage>
<Description>Alendronate Sodium Tablets USP is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium, USP is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The structural formula is:. C4H12NNaO7P23H2O M.W. 325.12. Alendronate sodium, USP is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet for oral administration contains 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. Alendronate Sodium Tablets USP meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>42385-993-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (42385-993-01) </PackageDescription>
<NDC11Code>42385-0993-01</NDC11Code>
<ProductNDC>42385-993</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ticagrelor</ProprietaryName>
<NonProprietaryName>Ticagrelor</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218869</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>TICAGRELOR</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ticagrelor is a P2Y12 platelet inhibitor indicated. to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1) to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes mellitus (T2DM). (1.2) to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). (1.3).</IndicationAndUsage>
<Description>Ticagrelor contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S, 2S, 3R, 5S)-3-(7-(((1R, 2S)-2-(3, 4-difluorophenyl) cyclopropyl) amino)-5-(propylthio)-3H-[1, 2, 3] triazolo [4, 5-d] pyrimidin-3-yl)-5-(2-hydroxyethoxy) cyclopentane-1, 2-diol. The molecular formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is. Ticagrelor is a white or off-white to pale pink powder, freely soluble in methanol with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl methylcellulose, iron oxide yellow, magnesium stearate, mannitol, polyethylene glycol 3350, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide. Ticagrelor 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: dibasic calcium phosphate dihydrate, ferrosoferric oxide, hydroxypropyl methylcellulose, iron oxide red, magnesium stearate, mannitol, polyethylene glycol 3350, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43498-993-01</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 BOX (43498-993-01) / 1.8 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>43498-0993-01</NDC11Code>
<ProductNDC>43498-993</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Articaine Hydrochloride And Epinephrine</ProprietaryName>
<NonProprietaryName>Articaine Hydrochloride, Epinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20241104</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022466</ApplicationNumber>
<LabelerName>Burkhart Dental Supply Co., Inc</LabelerName>
<SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>40; 5</StrengthNumber>
<StrengthUnit>mg/mL; ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
<Description>Articaine HCl and Epinephrine Injection, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength. Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)- propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8. Epinephrine bitartrate, (-)-1-(3,4-dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.0 mg/mL), sodium metabisulfite (0.5 mg/mL), and water for injection. The product is formulated with a 10% overage of epinephrine. The pH is adjusted to 3.6 with hydrochloric acid.</Description>
</NDC>
<NDC>
<NDCCode>47335-993-01</NDCCode>
<PackageDescription>1 BAG in 1 POUCH (47335-993-01) / 100 mL in 1 BAG</PackageDescription>
<NDC11Code>47335-0993-01</NDC11Code>
<ProductNDC>47335-993</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212435</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection and other antibacterial drugs, Metronidazole Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. TREATMENT OF ANAEROBIC INFECTIONS Metronidazole Injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole Injection therapy. In a mixed aerobic and anaerobic infection,antibacterial drugs appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole Injection. Metronidazole Injection is effective in Bacteroides fragilisinfections resistant to clindamycin, chloramphenicol, and penicillin. : 1 Intra-Abdominal Infections, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group ( B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species in adults and pediatric patients less than 4 months of age. , 2 Skin and Skin Structure Infections caused by Bacteroidesspecies including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species in adults. , 3 Gynecologic Infections, including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, and Peptostreptococcus species in adults. , 4 Bacterial Septicemiacaused by Bacteroides species including the B. fragilis group and Clostridium species in adults. , 5 Bone and Joint Infections, as adjunctive therapy, caused by Bacteroides species including the B. fragilis group in adults. , 6 Central Nervous System (CNS) Infections, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group in adults. , 7 Lower Respiratory Tract Infections, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group in adults. , 8 Endocarditiscaused by Bacteroides species including the B. fragilis group in adults. .</IndicationAndUsage>
<Description>Metronidazole Injection USP is a sterile, parenteral dosage form of metronidazole USP in water. Each 100 mL of Metronidazole Injection USP contains a sterile, nonpyrogenic, isotonic, buffered solution of Metronidazole USP 500 mg, Sodium Chloride USP 740 mg, Dibasic Sodium Phosphate7H 2O USP 112 mg, and Citric Acid Anhydrous USP 40 mg in Water for Injection USP. Metronidazole Injection USP has a calculated osmolarity of 297 mOsmol/liter and a pH of 5.8 (4.5–7.0). Sodium content: 13.5 mEq/container. Metronidazole USP is classified as a nitroimidazole antimicrobial and is administered by the intravenous route. Metronidazole USP is chemically designated 2-methyl-5-nitroimidazole-1-ethanol (C 6H 9N 3O 3):. Not made with natural rubber latex, PVC, or DEHP. The plastic container is polypropylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests - Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration.</Description>
</NDC>
<NDC>
<NDCCode>49967-993-01</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (49967-993-01) > 50 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>49967-0993-01</NDC11Code>
<ProductNDC>49967-993</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>La Roche Posay Laboratoire Dermatologique Anthelios 60 Ultra Light Sunscreen Fluid</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene And Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 107.2; 32.1; 60; 38.6</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>50241-993-02</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (50241-993-02) > 3.80564 kg in 1 BOTTLE, PLASTIC (50241-993-01) </PackageDescription>
<NDC11Code>50241-0993-02</NDC11Code>
<ProductNDC>50241-993</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Foam Hand</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180916</StartMarketingDate>
<EndMarketingDate>20220324</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>13</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180916</StartMarketingDatePackage>
<EndMarketingDatePackage>20220324</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51079-993-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-993-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-993-01) </PackageDescription>
<NDC11Code>51079-0993-20</NDC11Code>
<ProductNDC>51079-993</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluvoxamine Maleate</ProprietaryName>
<NonProprietaryName>Fluvoxamine Maleate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020915</StartMarketingDate>
<EndMarketingDate>20200331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075889</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>FLUVOXAMINE MALEATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20020915</StartMarketingDatePackage>
<EndMarketingDatePackage>20200331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55118-993-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (55118-993-01) * 14 mL in 1 CUP * 2 g in 1 TUBE</PackageDescription>
<NDC11Code>55118-0993-01</NDC11Code>
<ProductNDC>55118-993</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kimvent Oral Care Suction Swab Pack</ProprietaryName>
<NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20080826</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Halyard Health</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Aids in the removal of phlegm, mucus, or other secretions in the temporary relief of discomfort due to occasional sore throat and sore mouth.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55648-993-01</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (55648-993-01)</PackageDescription>
<NDC11Code>55648-0993-01</NDC11Code>
<ProductNDC>55648-993</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziprasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090348</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ziprasidone hydrochloride capsule is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone hydrochloride to prolong the QT interval and may consider the use of other drugs first (5.2). Ziprasidone hydrochloride capsule is indicated as an oral formulation for the:. Treatment of schizophrenia. (1.1) : 1 Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in adult patients with schizophrenia (14.1) .</IndicationAndUsage>
<Description>Ziprasidone hydrochloride is available as capsules for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2- benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone hydrochloride capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The molecular formula is C21H21ClN4OS·HCl·H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. Ziprasidone HCl capsules are supplied for oral administration in 20 mg, 40 mg, 60 mg, and 80 mg capsules. Ziprasidone HCl capsules contain ziprasidone hydrochloride monohydrate, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, talc and magnesium stearate, titanium dioxide, gelatin. Additionally, the 40 mg capsule shell contains FD&C blue #1 and FD&C red #3, the 60 mg capsule shell contains D & C red # 28, FD&C red # 40 and FD&C yellow # 6 and the 80 mg capsule shell contains FD&C blue # 1 and FD&C red # 3.</Description>
</NDC>
<NDC>
<NDCCode>57664-993-01</NDCCode>
<PackageDescription>13 mL in 1 BOTTLE (57664-993-01) </PackageDescription>
<NDC11Code>57664-0993-01</NDC11Code>
<ProductNDC>57664-993</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deflazacort Oral Suspension</ProprietaryName>
<NonProprietaryName>Deflazacort Oral</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219930</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DEFLAZACORT</SubstanceName>
<StrengthNumber>22.75</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deflazacort oral suspension is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.</IndicationAndUsage>
<Description>The active ingredient in deflazacort oral suspension is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C 25H 31NO 6. The chemical name for deflazacort is (11β,16β)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, and the structure is:. Deflazacort is a white or almost white crystalline powder and has a molecular weight of 441.52. Deflazacort is soluble in dichloromethane and chloroform, slightly soluble in ethanol and ethyl acetate, almost insoluble in water. Deflazacort oral suspension for oral administration is available as an immediate-release oral suspension in a strength of 22.75 mg/mL. The oral suspension contains deflazacort and the following inactive ingredients: benzyl alcohol, glacial acetic acid, magnesium aluminum silicate, noncrystallizing sorbitol solution, polysorbate 80, purified water, sodium carboxymethylcellulose, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>59779-993-01</NDCCode>
<PackageDescription>89 g in 1 PACKAGE (59779-993-01)</PackageDescription>
<NDC11Code>59779-0993-01</NDC11Code>
<ProductNDC>59779-993</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Pharmacy</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength Feminine Wipes</ProprietaryNameSuffix>
<NonProprietaryName>Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130321</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Temporarily relieves itching.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62207-993-01</NDCCode>
<PackageDescription>10 kg in 1 DRUM (62207-993-01) </PackageDescription>
<NDC11Code>62207-0993-01</NDC11Code>
<ProductNDC>62207-993</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Potassium Oxybate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20251226</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Granules India Limited</LabelerName>
<SubstanceName>POTASSIUM OXYBATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-31</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>26-DEC-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>63545-993-01</NDCCode>
<PackageDescription>80 PELLET in 1 VIAL, GLASS (63545-993-01) </PackageDescription>
<NDC11Code>63545-0993-01</NDC11Code>
<ProductNDC>63545-993</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anethum Graveolens</ProprietaryName>
<NonProprietaryName>Anethum Graveolens</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201216</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
<SubstanceName>DILL</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64117-993-01</NDCCode>
<PackageDescription>1.875 mL in 1 BOTTLE, GLASS (64117-993-01) </PackageDescription>
<NDC11Code>64117-0993-01</NDC11Code>
<ProductNDC>64117-993</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Motion Sickness 1</ProprietaryName>
<NonProprietaryName>Tobacco Leaf</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980604</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Health Supply</LabelerName>
<SubstanceName>TOBACCO LEAF</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications: To be used for acute self-limiting conditions according to standard homeopathic indications.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64220-993-01</NDCCode>
<PackageDescription>20 kg in 1 DRUM (64220-993-01) </PackageDescription>
<NDC11Code>64220-0993-01</NDC11Code>
<ProductNDC>64220-993</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ropinirole 5% W/w Triturate With Lactose</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20210501</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Zhejiang Huahai Pharmaceutical Co., LTD</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.0057</StrengthNumber>
<StrengthUnit>kg/.1kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-07-07</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-JUL-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64679-993-01</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (64679-993-01) </PackageDescription>
<NDC11Code>64679-0993-01</NDC11Code>
<ProductNDC>64679-993</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziprasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090348</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ziprasidone hydrochloride capsule is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone hydrochloride to prolong the QT interval and may consider the use of other drugs first (5.2). Ziprasidone hydrochloride capsule is indicated as an oral formulation for the: Treatment of schizophrenia. (1.1): 1 Adults: Efficacy was established in four 4 to 6 week trials and one maintenance trial in adult patients with schizophrenia. (14.1).</IndicationAndUsage>
<Description>Ziprasidone hydrochloride is available as capsules for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone hydrochloride capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The molecular formula is C21H21ClN4OSHClH2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. Ziprasidone hydrochloride capsules are supplied for oral administration in 20 mg (white/white), 40 mg (blue/white), 60 mg (pink/white), and 80 mg (blue/blue) capsules. Ziprasidone hydrochloride capsules contain ziprasidone hydrochloride monohydrate, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, talc and magnesium stearate, titanium dioxide, and gelatin. Additionally, the 40 mg capsule shell contains FD&C blue #1 and FD&C red #3, the 60 mg capsule shell contains D & C red #28, FD&C red #40 and FD&C yellow #6 and the 80 mg capsule shell contains FD&C blue #1 and FD&C red #3.</Description>
</NDC>
<NDC>
<NDCCode>65862-993-25</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (65862-993-25) > 1 mL in 1 VIAL, MULTI-DOSE (65862-993-01) </PackageDescription>
<NDC11Code>65862-0993-25</NDC11Code>
<ProductNDC>65862-993</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium</ProprietaryName>
<NonProprietaryName>Heparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20140612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202957</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>5000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC],Heparin [CS],Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-03-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68320-993-02</NDCCode>
<PackageDescription>1 PACKET in 1 BOX (68320-993-02) > 3 mL in 1 PACKET (68320-993-01) </PackageDescription>
<NDC11Code>68320-0993-02</NDC11Code>
<ProductNDC>68320-993</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Missoni Hand Sanitizer Gel</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200921</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Orlandi Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>2.4</StrengthNumber>
<StrengthUnit>mL/3mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>68511-993-01</NDCCode>
<PackageDescription>10000 mg in 1 CARTON (68511-993-01) </PackageDescription>
<NDC11Code>68511-0993-01</NDC11Code>
<ProductNDC>68511-993</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mayinglong Hemorrhoids</ProprietaryName>
<NonProprietaryName>Zinc Oxide, Petrolatum, Lanolin</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20031215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>Mayinglong Pharmaceutical Group Co Ltd</LabelerName>
<SubstanceName>ZINC OXIDE; PETROLATUM</SubstanceName>
<StrengthNumber>800; 7850</StrengthNumber>
<StrengthUnit>mg/10000mg; mg/10000mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps relieve the local itching and discomfort associated with hemorrhoids. temporarily shrinks hemorrhoidal tissue and relieves burning. temporarily provides a coating for relief of anorectal discomforts. temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69697-993-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (69697-993-01) * 14 mL in 1 CUP * 2 g in 1 TUBE</PackageDescription>
<NDC11Code>69697-0993-01</NDC11Code>
<ProductNDC>69697-993</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kimvent Oral Care Suction Swab Pack</ProprietaryName>
<NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20080826</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Halyard Health</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Aids in the removal of phlegm, mucus, or other secretions in the temporary relief of discomfort due to occasional sore throat and sore mouth.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-993-01</NDCCode>
<PackageDescription>30 VIAL, SINGLE-USE in 1 BOX (69842-993-01) / .4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>69842-0993-01</NDC11Code>
<ProductNDC>69842-993</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Lubricant Eye Drops 30 Ct</ProprietaryName>
<NonProprietaryName>Carboxymethylcellulose Soduim</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20190715</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>CVS Pharmacy, Inc.</LabelerName>
<SubstanceName>CARBOXYMETHYLCELLULOSE SODIUM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>74177-993-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PLASTIC (74177-993-01) </PackageDescription>
<NDC11Code>74177-0993-01</NDC11Code>
<ProductNDC>74177-993</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Berry Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>K7 Design Group Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>69</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin, only when water is not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82907-993-01</NDCCode>
<PackageDescription>1 g in 1 BOTTLE (82907-993-01) </PackageDescription>
<NDC11Code>82907-0993-01</NDC11Code>
<ProductNDC>82907-993</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Larazotide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240808</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Hangzhou Sinodo Pharm Technology Co.,Ltd</LabelerName>
<SubstanceName>LARAZOTIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>08-AUG-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>84515-993-01</NDCCode>
<PackageDescription>30 g in 1 BOX (84515-993-01) </PackageDescription>
<NDC11Code>84515-0993-01</NDC11Code>
<ProductNDC>84515-993</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kojic Acid Face Cream</ProprietaryName>
<NonProprietaryName>Kojic Acid Face Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241028</StartMarketingDate>
<EndMarketingDate>20311231</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>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<EndMarketingDatePackage>20311231</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>62713-100-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (62713-100-01) </PackageDescription>
<NDC11Code>62713-0100-01</NDC11Code>
<ProductNDC>62713-100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergena</ProprietaryName>
<ProprietaryNameSuffix>Mold Mix</ProprietaryNameSuffix>
<NonProprietaryName>Alternaria Tenuis, Aspergillus Mixture, Botrytis Cinerea, Chaetomium Globosum, Cladosporium Cladosporioides, Curvularia, Epicoccum Nigrum, Fusarium Vasinfectum, Mucor Racemosus, Neurospora, Nigrospora, Penicillium Mixture, Phoma Herbarum, Pullularia Pullulans, Rhizopus, Rhodotorula, Stemphylium, Trichoderma Lignorum, Trichophyton Mentagrophytes, Baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-graecum, Echinacea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250925</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Meditrend, Inc. DBA Progena Professional Formulations</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SPICIFER; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM VASINFECTUM; MUCOR RACEMOSUS; NEUROSPORA SITOPHILA; KHUSKIA ORYZAE; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA EXIGUA VAR. EXIGUA; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; STEMPHYLIUM SARCINIFORME; TRICHODERMA VIRIDE; TRICHOPHYTON MENTAGROPHYTES; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ECHINACEA, UNSPECIFIED</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 3; 3; 3; 3; 3</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</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], 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], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>