{
"NDC": [
{
"NDCCode": "72789-206-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (72789-206-60) ",
"NDC11Code": "72789-0206-60",
"ProductNDC": "72789-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090170",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210927",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine is indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. ( 1.1) .",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. It's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine tablets, USP are supplied for oral administration as 25 mg, 100 mg, 150 mg or 200 mg tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, the 200 mg tablets contain FD&C Blue No. 2 Lake."
},
{
"NDCCode": "16714-206-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (16714-206-01) > 60 mL in 1 BOTTLE",
"NDC11Code": "16714-0206-01",
"ProductNDC": "16714-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefdinir",
"NonProprietaryName": "Cefdinir",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20100806",
"EndMarketingDate": "20140930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065429",
"LabelerName": "Northstar Rx LLC",
"SubstanceName": "CEFDINIR MONOHYDRATE",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-10-03"
},
{
"NDCCode": "35000-206-60",
"PackageDescription": "1 TUBE in 1 CARTON (35000-206-60) > 170 g in 1 TUBE",
"NDC11Code": "35000-0206-60",
"ProductNDC": "35000-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Enamel Health Sensitivity Relief",
"NonProprietaryName": "Potassium Nitrate And Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20140630",
"EndMarketingDate": "20230930",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Colgate-Palmolive",
"SubstanceName": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"StrengthNumber": "50; 1.1",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171130",
"EndMarketingDatePackage": "20230930",
"SamplePackage": "N"
},
{
"NDCCode": "42002-206-02",
"PackageDescription": "2 BOTTLE in 1 CARTON (42002-206-02) > 60 mL in 1 BOTTLE",
"NDC11Code": "42002-0206-02",
"ProductNDC": "42002-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Visine Tears",
"ProprietaryNameSuffix": "Dry Eye Relief",
"NonProprietaryName": "Glycerin, Hypromelloses, And Polyethylene Glycol 400",
"DosageFormName": "LIQUID",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20110909",
"EndMarketingDate": "20171005",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400",
"StrengthNumber": "2.5; 2; 11.28",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-10-10"
},
{
"NDCCode": "42217-206-60",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (42217-206-60)",
"NDC11Code": "42217-0206-60",
"ProductNDC": "42217-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Relief Tincture",
"NonProprietaryName": "Camphor, Menthol",
"DosageFormName": "TINCTURE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100602",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Henan Lingrui Pharmaceutical Co Ltd",
"SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL",
"StrengthNumber": "5; 1.3",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints due to. simple backache. arthritis. strains. bruises. sprains."
},
{
"NDCCode": "49230-206-60",
"PackageDescription": "2 BAG in 1 CARTON (49230-206-60) / 6000 mL in 1 BAG",
"NDC11Code": "49230-0206-60",
"ProductNDC": "49230-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19920819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020171",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "18.4; 1.5; 5.08; 538; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19920819",
"EndMarketingDatePackage": "20230831",
"SamplePackage": "N"
},
{
"NDCCode": "49999-206-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49999-206-60)",
"NDC11Code": "49999-0206-60",
"ProductNDC": "49999-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxazosin",
"NonProprietaryName": "Doxazosin Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20001020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075536",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "DOXAZOSIN MESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-02-03"
},
{
"NDCCode": "53217-206-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (53217-206-60)",
"NDC11Code": "53217-0206-60",
"ProductNDC": "53217-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib 200 Mg",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204519",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].",
"Description": "Celecoxib is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. Celecoxib oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, titanium dioxide and gelatin. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol and red iron oxide. 100 mg capsule contains shellac, propylene glycol and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, titanium dioxide, yellow iron oxide and FD & C Blue No. # 2 aluminum lake."
},
{
"NDCCode": "54235-206-08",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (54235-206-08)",
"NDC11Code": "54235-0206-08",
"ProductNDC": "54235-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fraicheur Cedre Bleu Antiperspirant And Deodorant Roll-on",
"NonProprietaryName": "Aluminum Sesquichlorohydrate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher",
"SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
"StrengthNumber": "15",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "UseReduces underarm perspiration."
},
{
"NDCCode": "55111-206-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (55111-206-60) ",
"NDC11Code": "55111-0206-60",
"ProductNDC": "55111-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076879",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20091024",
"SamplePackage": "N"
},
{
"NDCCode": "55319-206-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (55319-206-02) / 60 mL in 1 BOTTLE",
"NDC11Code": "55319-0206-02",
"ProductNDC": "55319-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dye Free Infants Pain And Fever",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20230508",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "FAMILY DOLLAR SERVICES INC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230508",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: 1 ▪reduces fever, 2 ▪relieves minor aches and pains due to: ▪the common cold▪flu▪headache▪sore throat▪toothache."
},
{
"NDCCode": "58809-206-60",
"PackageDescription": "57 mL in 1 BOTTLE, DROPPER (58809-206-60) ",
"NDC11Code": "58809-0206-60",
"ProductNDC": "58809-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Homeopathic Allergy Relief",
"NonProprietaryName": "Over 100 Extracts",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20200801",
"EndMarketingDate": "20250101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS RHOMBIFOLIA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA OCCIDENTALIS WHOLE; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HYDRASTIS CANADENSIS WHOLE; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPER BERRY; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS PONDEROSA POLLEN; PINUS STROBUS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALSOLA KALI WHOLE; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; TAXODIUM DISTICHUM POLLEN; THUJA OCCIDENTALIS LEAF; THUJA PLICATA LEAF; TRIADICA SEBIFERA WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30; 6; 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]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], 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], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200801",
"EndMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "this product is a Homeopathic Dilution, formulated to support the body’s immunity for the temporary relief of allergies*."
},
{
"NDCCode": "59310-206-06",
"PackageDescription": "1 INHALER in 1 CARTON (59310-206-06) > 60 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "59310-0206-06",
"ProductNDC": "59310-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qnasl",
"NonProprietaryName": "Beclomethasone Dipropionate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20150201",
"EndMarketingDate": "20191017",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202813",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "BECLOMETHASONE DIPROPIONATE",
"StrengthNumber": "40",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150202",
"EndMarketingDatePackage": "20191017",
"SamplePackage": "N"
},
{
"NDCCode": "59310-206-08",
"PackageDescription": "1 INHALER in 1 CARTON (59310-206-08) > 60 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "59310-0206-08",
"ProductNDC": "59310-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qnasl",
"NonProprietaryName": "Beclomethasone Dipropionate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20150201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202813",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "BECLOMETHASONE DIPROPIONATE",
"StrengthNumber": "40",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150201",
"EndMarketingDatePackage": "20190122",
"SamplePackage": "N"
},
{
"NDCCode": "61748-206-60",
"PackageDescription": "1 TUBE in 1 CARTON (61748-206-60) > 60 g in 1 TUBE",
"NDC11Code": "61748-0206-60",
"ProductNDC": "61748-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201005",
"LabelerName": "VersaPharm Incorporated",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-03-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140912",
"SamplePackage": "N"
},
{
"NDCCode": "63187-206-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (63187-206-60) ",
"NDC11Code": "63187-0206-60",
"ProductNDC": "63187-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077666",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2022-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150202",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine tablets, USP in the treatment of major depressive disorder was established in six week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders – 3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effectiveness of mirtazapine tablets, USP in hospitalized depressed patients has not been adequately studied. The efficacy of mirtazapine tablets, USP in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine tablets, USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY).",
"Description": "Mirtazapine tablets, USP are an orally administered drug. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1α] pyrido [2,3-c] [2] benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder, which is sparingly soluble in water. Mirtazapine tablets, USP are supplied for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet also contains the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. In addition, mirtazapine tablets, USP 15 mg and 30 mg contain yellow iron oxide and mirtazapine tablets, USP 30 mg contains red iron oxide."
},
{
"NDCCode": "63402-206-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (63402-206-60) ",
"NDC11Code": "63402-0206-60",
"ProductNDC": "63402-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aptiom",
"NonProprietaryName": "Eslicarbazepine Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022416",
"LabelerName": "Sumitomo Pharma America, Inc.",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140407",
"SamplePackage": "N",
"IndicationAndUsage": "APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone."
},
{
"NDCCode": "67544-206-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-206-60)",
"NDC11Code": "67544-0206-60",
"ProductNDC": "67544-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19970911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040218",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-05-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "68016-206-60",
"PackageDescription": "1 BOTTLE in 1 BOX (68016-206-60) > 60 TABLET in 1 BOTTLE",
"NDC11Code": "68016-0206-60",
"ProductNDC": "68016-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Senna S Stool Softener With Laxative",
"NonProprietaryName": "Docusate Sodium, Sennosides",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130308",
"EndMarketingDate": "20200308",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Chain Drug Consortium, LLC",
"SubstanceName": "DOCUSATE SODIUM; SENNOSIDES",
"StrengthNumber": "50; 8.6",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130308",
"EndMarketingDatePackage": "20200308",
"SamplePackage": "N"
},
{
"NDCCode": "70625-206-01",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70625-206-01) ",
"NDC11Code": "70625-0206-01",
"ProductNDC": "70625-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212781",
"LabelerName": "SunGen Pharma LLC",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C 24H 33N 3O 4, a molecular weight of 427.54 g/mole, and the following structural formula:. Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, ethanol, acetonitrile, and acetone;slightly soluble in ethyl acetate, isopropanol, toluene, and ethyl ether; and very slightly soluble in water. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose (5 mPas), hypromellose (6 mPas), lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol 3350, polysorbate 80, sodium lauryl sulfate, titanium dioxide, triacetin, sodium hydroxide. Additional inactive ingredient for the 500 mg tablet includes FD&C yellow #6 and additional inactive ingredients for the 1000 mg tablet include iron oxide yellow and iron oxide red."
},
{
"NDCCode": "71205-206-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71205-206-60) ",
"NDC11Code": "71205-0206-60",
"ProductNDC": "71205-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseltamivir Phosphate",
"NonProprietaryName": "Oseltamivir Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208348",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "OSELTAMIVIR PHOSPHATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Oseltamivir phosphate capsule is an influenza neuraminidase inhibitor (NAI) indicated for: 1 Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1), 2 Prophylaxis of influenza A and B in patients 1 year and older. (1.2).",
"Description": "Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: 1 Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate."
},
{
"NDCCode": "72603-206-01",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (72603-206-01) ",
"NDC11Code": "72603-0206-01",
"ProductNDC": "72603-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202726",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150916",
"SamplePackage": "N",
"IndicationAndUsage": "Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I).The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.",
"Description": "Gemfibrozil is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, colloidal silicon dioxide, hypromellose, low substituted hydroxypropyl cellulose, low viscosity hydroxypropyl cellulose, microcrystalline cellulose, polyethylene glycol, polysorbate, pregelatinized starch (maize), and titanium dioxide. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The molecular formula is C15H22O3 and the molecular weight is 250.35; practically insoluble in water, soluble in alcohol, in methanol and in chloroform. The melting point is 58° to 61°C. Gemfibrozil USP is a white or almost white, waxy crystalline solid."
},
{
"NDCCode": "73027-206-01",
"PackageDescription": "60 mL in 1 BOTTLE (73027-206-01) ",
"NDC11Code": "73027-0206-01",
"ProductNDC": "73027-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Better For Daily Use Eaae Disinfectant",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200616",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "JIANGSU HANHE DAILY CHEMICALS CO., LTD.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200616",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "73828-206-60",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (73828-206-60) ",
"NDC11Code": "73828-0206-60",
"ProductNDC": "73828-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200413",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "WSD Labs USA Inc.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200413",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "76138-206-02",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (76138-206-02)",
"NDC11Code": "76138-0206-02",
"ProductNDC": "76138-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "5298 Sunscreen",
"NonProprietaryName": "Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170515",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Innovation Specialties",
"SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE",
"StrengthNumber": "7.5; 2; 4; 2.5",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "84347-206-60",
"PackageDescription": "100 g in 1 BOTTLE (84347-206-60) ",
"NDC11Code": "84347-0206-60",
"ProductNDC": "84347-206",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Cjc-1295",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260104",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Shenzhen Alvantis Pharma Co., Ltd.",
"SubstanceName": "CJC-1295",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-09-03",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "04-JAN-26"
},
{
"NDCCode": "87063-206-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (87063-206-60) ",
"NDC11Code": "87063-0206-60",
"ProductNDC": "87063-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077731",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260513",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candidainfections including candidemia, disseminated candidiasis, and pneumonia. , 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIESsection. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α 1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C 13H 12F 2N 6O and molecular weight of 306.3. The structural formula is:. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline. Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "72789-003-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-003-60) ",
"NDC11Code": "72789-0003-60",
"ProductNDC": "72789-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091432",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190820",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen delayed-release tablets are indicated for. The relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis.",
"Description": "Naproxen delayed-release tablets are nonsteroidal anti-inflammatory drugs available as follows. Naproxen delayed-release tablets USP are available as enteric coated, white tablets containing 375 mg of naproxen or 500 mg of naproxen, USP for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen has the following structural formula:. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen, USP at pH 7.4 is 1.6 to 1.8. The inactive ingredients are croscarmellose sodium, povidone, colloidal silicon dioxide and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer dispersion, talc, titanium dioxide, triethyl citrate and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4."
},
{
"NDCCode": "72789-004-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-004-60) ",
"NDC11Code": "72789-0004-60",
"ProductNDC": "72789-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090278",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190317",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain: 50 mg tablets: iron oxide yellow 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
},
{
"NDCCode": "72789-009-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-60) ",
"NDC11Code": "72789-0009-60",
"ProductNDC": "72789-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride Extended Release",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090295",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190920",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Extended-Release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride.The chemical name of Metformin hydrochloride is N, N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Extended-Release Tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets, 500 mg or 750 mg contains the inactive ingredients colloidal silicon dioxide, hypromellose and magnesium stearate."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>72789-206-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (72789-206-60) </PackageDescription>
<NDC11Code>72789-0206-60</NDC11Code>
<ProductNDC>72789-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090170</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine is indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. ( 1.1) .</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. It's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine tablets, USP are supplied for oral administration as 25 mg, 100 mg, 150 mg or 200 mg tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, the 200 mg tablets contain FD&C Blue No. 2 Lake.</Description>
</NDC>
<NDC>
<NDCCode>16714-206-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (16714-206-01) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>16714-0206-01</NDC11Code>
<ProductNDC>16714-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefdinir</ProprietaryName>
<NonProprietaryName>Cefdinir</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100806</StartMarketingDate>
<EndMarketingDate>20140930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065429</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<SubstanceName>CEFDINIR MONOHYDRATE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>35000-206-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-206-60) > 170 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0206-60</NDC11Code>
<ProductNDC>35000-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colgate Enamel Health Sensitivity Relief</ProprietaryName>
<NonProprietaryName>Potassium Nitrate And Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20140630</StartMarketingDate>
<EndMarketingDate>20230930</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Colgate-Palmolive</LabelerName>
<SubstanceName>POTASSIUM NITRATE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>50; 1.1</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171130</StartMarketingDatePackage>
<EndMarketingDatePackage>20230930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42002-206-02</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (42002-206-02) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>42002-0206-02</NDC11Code>
<ProductNDC>42002-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Visine Tears</ProprietaryName>
<ProprietaryNameSuffix>Dry Eye Relief</ProprietaryNameSuffix>
<NonProprietaryName>Glycerin, Hypromelloses, And Polyethylene Glycol 400</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20110909</StartMarketingDate>
<EndMarketingDate>20171005</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400</SubstanceName>
<StrengthNumber>2.5; 2; 11.28</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>42217-206-60</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PLASTIC (42217-206-60)</PackageDescription>
<NDC11Code>42217-0206-60</NDC11Code>
<ProductNDC>42217-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Relief Tincture</ProprietaryName>
<NonProprietaryName>Camphor, Menthol</NonProprietaryName>
<DosageFormName>TINCTURE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100602</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Henan Lingrui Pharmaceutical Co Ltd</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL</SubstanceName>
<StrengthNumber>5; 1.3</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints due to. simple backache. arthritis. strains. bruises. sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49230-206-60</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (49230-206-60) / 6000 mL in 1 BAG</PackageDescription>
<NDC11Code>49230-0206-60</NDC11Code>
<ProductNDC>49230-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delflex</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>19920819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020171</ApplicationNumber>
<LabelerName>Fresenius Medical Care North America</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>18.4; 1.5; 5.08; 538; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920819</StartMarketingDatePackage>
<EndMarketingDatePackage>20230831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49999-206-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49999-206-60)</PackageDescription>
<NDC11Code>49999-0206-60</NDC11Code>
<ProductNDC>49999-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxazosin</ProprietaryName>
<NonProprietaryName>Doxazosin Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075536</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>53217-206-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (53217-206-60)</PackageDescription>
<NDC11Code>53217-0206-60</NDC11Code>
<ProductNDC>53217-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib 200 Mg</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204519</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>Celecoxib is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. Celecoxib oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, titanium dioxide and gelatin. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol and red iron oxide. 100 mg capsule contains shellac, propylene glycol and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, titanium dioxide, yellow iron oxide and FD & C Blue No. # 2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>54235-206-08</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PLASTIC (54235-206-08)</PackageDescription>
<NDC11Code>54235-0206-08</NDC11Code>
<ProductNDC>54235-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fraicheur Cedre Bleu Antiperspirant And Deodorant Roll-on</ProprietaryName>
<NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher</LabelerName>
<SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>UseReduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55111-206-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (55111-206-60) </PackageDescription>
<NDC11Code>55111-0206-60</NDC11Code>
<ProductNDC>55111-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076879</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55319-206-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55319-206-02) / 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>55319-0206-02</NDC11Code>
<ProductNDC>55319-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dye Free Infants Pain And Fever</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230508</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>FAMILY DOLLAR SERVICES INC</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: 1 ▪reduces fever, 2 ▪relieves minor aches and pains due to: ▪the common cold▪flu▪headache▪sore throat▪toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-206-60</NDCCode>
<PackageDescription>57 mL in 1 BOTTLE, DROPPER (58809-206-60) </PackageDescription>
<NDC11Code>58809-0206-60</NDC11Code>
<ProductNDC>58809-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear Homeopathic Allergy Relief</ProprietaryName>
<NonProprietaryName>Over 100 Extracts</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200801</StartMarketingDate>
<EndMarketingDate>20250101</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS RHOMBIFOLIA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA OCCIDENTALIS WHOLE; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HYDRASTIS CANADENSIS WHOLE; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPER BERRY; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS PONDEROSA POLLEN; PINUS STROBUS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALSOLA KALI WHOLE; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; TAXODIUM DISTICHUM POLLEN; THUJA OCCIDENTALIS LEAF; THUJA PLICATA LEAF; TRIADICA SEBIFERA WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30; 6; 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</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], 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], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200801</StartMarketingDatePackage>
<EndMarketingDatePackage>20250101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>this product is a Homeopathic Dilution, formulated to support the body’s immunity for the temporary relief of allergies*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59310-206-06</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (59310-206-06) > 60 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>59310-0206-06</NDC11Code>
<ProductNDC>59310-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Qnasl</ProprietaryName>
<NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20150201</StartMarketingDate>
<EndMarketingDate>20191017</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202813</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>BECLOMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150202</StartMarketingDatePackage>
<EndMarketingDatePackage>20191017</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59310-206-08</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (59310-206-08) > 60 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>59310-0206-08</NDC11Code>
<ProductNDC>59310-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Qnasl</ProprietaryName>
<NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20150201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202813</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>BECLOMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150201</StartMarketingDatePackage>
<EndMarketingDatePackage>20190122</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61748-206-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (61748-206-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>61748-0206-60</NDC11Code>
<ProductNDC>61748-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201005</ApplicationNumber>
<LabelerName>VersaPharm Incorporated</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63187-206-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (63187-206-60) </PackageDescription>
<NDC11Code>63187-0206-60</NDC11Code>
<ProductNDC>63187-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077666</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine tablets, USP in the treatment of major depressive disorder was established in six week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders – 3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effectiveness of mirtazapine tablets, USP in hospitalized depressed patients has not been adequately studied. The efficacy of mirtazapine tablets, USP in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine tablets, USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY).</IndicationAndUsage>
<Description>Mirtazapine tablets, USP are an orally administered drug. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1α] pyrido [2,3-c] [2] benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder, which is sparingly soluble in water. Mirtazapine tablets, USP are supplied for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet also contains the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. In addition, mirtazapine tablets, USP 15 mg and 30 mg contain yellow iron oxide and mirtazapine tablets, USP 30 mg contains red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>63402-206-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (63402-206-60) </PackageDescription>
<NDC11Code>63402-0206-60</NDC11Code>
<ProductNDC>63402-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aptiom</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022416</ApplicationNumber>
<LabelerName>Sumitomo Pharma America, Inc.</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>67544-206-60</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-206-60)</PackageDescription>
<NDC11Code>67544-0206-60</NDC11Code>
<ProductNDC>67544-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040218</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68016-206-60</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (68016-206-60) > 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>68016-0206-60</NDC11Code>
<ProductNDC>68016-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Senna S Stool Softener With Laxative</ProprietaryName>
<NonProprietaryName>Docusate Sodium, Sennosides</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130308</StartMarketingDate>
<EndMarketingDate>20200308</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Chain Drug Consortium, LLC</LabelerName>
<SubstanceName>DOCUSATE SODIUM; SENNOSIDES</SubstanceName>
<StrengthNumber>50; 8.6</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130308</StartMarketingDatePackage>
<EndMarketingDatePackage>20200308</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70625-206-01</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70625-206-01) </PackageDescription>
<NDC11Code>70625-0206-01</NDC11Code>
<ProductNDC>70625-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212781</ApplicationNumber>
<LabelerName>SunGen Pharma LLC</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C 24H 33N 3O 4, a molecular weight of 427.54 g/mole, and the following structural formula:. Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, ethanol, acetonitrile, and acetone;slightly soluble in ethyl acetate, isopropanol, toluene, and ethyl ether; and very slightly soluble in water. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose (5 mPas), hypromellose (6 mPas), lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol 3350, polysorbate 80, sodium lauryl sulfate, titanium dioxide, triacetin, sodium hydroxide. Additional inactive ingredient for the 500 mg tablet includes FD&C yellow #6 and additional inactive ingredients for the 1000 mg tablet include iron oxide yellow and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>71205-206-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71205-206-60) </PackageDescription>
<NDC11Code>71205-0206-60</NDC11Code>
<ProductNDC>71205-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseltamivir Phosphate</ProprietaryName>
<NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208348</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oseltamivir phosphate capsule is an influenza neuraminidase inhibitor (NAI) indicated for: 1 Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1), 2 Prophylaxis of influenza A and B in patients 1 year and older. (1.2).</IndicationAndUsage>
<Description>Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: 1 Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate.</Description>
</NDC>
<NDC>
<NDCCode>72603-206-01</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (72603-206-01) </PackageDescription>
<NDC11Code>72603-0206-01</NDC11Code>
<ProductNDC>72603-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202726</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I).The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.</IndicationAndUsage>
<Description>Gemfibrozil is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains calcium stearate, colloidal silicon dioxide, hypromellose, low substituted hydroxypropyl cellulose, low viscosity hydroxypropyl cellulose, microcrystalline cellulose, polyethylene glycol, polysorbate, pregelatinized starch (maize), and titanium dioxide. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The molecular formula is C15H22O3 and the molecular weight is 250.35; practically insoluble in water, soluble in alcohol, in methanol and in chloroform. The melting point is 58° to 61°C. Gemfibrozil USP is a white or almost white, waxy crystalline solid.</Description>
</NDC>
<NDC>
<NDCCode>73027-206-01</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (73027-206-01) </PackageDescription>
<NDC11Code>73027-0206-01</NDC11Code>
<ProductNDC>73027-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Better For Daily Use Eaae Disinfectant</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200616</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>JIANGSU HANHE DAILY CHEMICALS CO., LTD.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73828-206-60</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PLASTIC (73828-206-60) </PackageDescription>
<NDC11Code>73828-0206-60</NDC11Code>
<ProductNDC>73828-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200413</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>WSD Labs USA Inc.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76138-206-02</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PLASTIC (76138-206-02)</PackageDescription>
<NDC11Code>76138-0206-02</NDC11Code>
<ProductNDC>76138-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>5298 Sunscreen</ProprietaryName>
<NonProprietaryName>Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Innovation Specialties</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>7.5; 2; 4; 2.5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>84347-206-60</NDCCode>
<PackageDescription>100 g in 1 BOTTLE (84347-206-60) </PackageDescription>
<NDC11Code>84347-0206-60</NDC11Code>
<ProductNDC>84347-206</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Cjc-1295</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20260104</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Shenzhen Alvantis Pharma Co., Ltd.</LabelerName>
<SubstanceName>CJC-1295</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-09-03</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-JAN-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>87063-206-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (87063-206-60) </PackageDescription>
<NDC11Code>87063-0206-60</NDC11Code>
<ProductNDC>87063-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077731</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candidainfections including candidemia, disseminated candidiasis, and pneumonia. , 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIESsection. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α 1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C 13H 12F 2N 6O and molecular weight of 306.3. The structural formula is:. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline. Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>72789-003-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-003-60) </PackageDescription>
<NDC11Code>72789-0003-60</NDC11Code>
<ProductNDC>72789-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091432</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen delayed-release tablets are indicated for. The relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis.</IndicationAndUsage>
<Description>Naproxen delayed-release tablets are nonsteroidal anti-inflammatory drugs available as follows. Naproxen delayed-release tablets USP are available as enteric coated, white tablets containing 375 mg of naproxen or 500 mg of naproxen, USP for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen has the following structural formula:. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen, USP at pH 7.4 is 1.6 to 1.8. The inactive ingredients are croscarmellose sodium, povidone, colloidal silicon dioxide and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer dispersion, talc, titanium dioxide, triethyl citrate and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4.</Description>
</NDC>
<NDC>
<NDCCode>72789-004-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-004-60) </PackageDescription>
<NDC11Code>72789-0004-60</NDC11Code>
<ProductNDC>72789-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090278</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain: 50 mg tablets: iron oxide yellow 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>72789-009-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-60) </PackageDescription>
<NDC11Code>72789-0009-60</NDC11Code>
<ProductNDC>72789-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride Extended Release</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090295</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin Hydrochloride Extended-Release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride.The chemical name of Metformin hydrochloride is N, N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Extended-Release Tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets, 500 mg or 750 mg contains the inactive ingredients colloidal silicon dioxide, hypromellose and magnesium stearate.</Description>
</NDC>
</NDCList>