{
"NDC": [
{
"NDCCode": "68071-2309-3",
"PackageDescription": "1 TUBE in 1 CARTON (68071-2309-3) > 30 g in 1 TUBE",
"NDC11Code": "68071-2309-03",
"ProductNDC": "68071-2309",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketoconazole",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075581",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201207",
"SamplePackage": "N",
"IndicationAndUsage": "Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); and in the treatment of cutaneous candidiasis caused by Candida spp.",
"Description": "Ketoconazole Cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%. Each gram, for topical administration, contains ketoconazole 20 mg and is formulated in an aqueous cream vehicle consisting of propylene glycol, purified water, cetyl alcohol, stearyl alcohol, isopropyl myristate, sorbitan monostearate, polysorbate 60, polysorbate 80, and sodium sulfite, anhydrous. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1 H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula:. C 26H 28Cl 2N 4O 4 M.W. 531.44."
},
{
"NDCCode": "15631-2309-3",
"PackageDescription": "1 CONTAINER in 1 CONTAINER (15631-2309-3) > 500 g in 1 CONTAINER",
"NDC11Code": "15631-2309-03",
"ProductNDC": "15631-2309",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Flour",
"NonProprietaryName": "Calcarea Flour",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160330",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "CALCIUM FLUORIDE",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "36987-2309-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-2309-3)",
"NDC11Code": "36987-2309-03",
"ProductNDC": "36987-2309",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Corn Grass",
"NonProprietaryName": "Corn Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ZEA MAYS POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Cell-mediated Immunity [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-2309-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-2309-3) ",
"NDC11Code": "37662-2309-03",
"ProductNDC": "37662-2309",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thiosinaminum",
"NonProprietaryName": "Thiosinaminum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230111",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "ALLYLTHIOUREA",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230111",
"SamplePackage": "N"
},
{
"NDCCode": "64942-2309-3",
"PackageDescription": "45 g in 1 CONTAINER (64942-2309-3) ",
"NDC11Code": "64942-2309-03",
"ProductNDC": "64942-2309",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dove",
"NonProprietaryName": "Powder 48h Antiperspirant Deodorant",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Conopco Inc. d/b/a/ Unilever",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "15.2",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2024-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240801",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness. 48 Hour Protection."
},
{
"NDCCode": "64942-2309-4",
"PackageDescription": "2 CONTAINER in 1 CONTAINER (64942-2309-4) / 45 g in 1 CONTAINER (64942-2309-3) ",
"NDC11Code": "64942-2309-04",
"ProductNDC": "64942-2309",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dove",
"NonProprietaryName": "Powder 48h Antiperspirant Deodorant",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Conopco Inc. d/b/a/ Unilever",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "15.2",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2024-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240801",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness. 48 Hour Protection."
},
{
"NDCCode": "71335-2309-3",
"PackageDescription": "90 TABLET in 1 BOTTLE (71335-2309-3) ",
"NDC11Code": "71335-2309-03",
"ProductNDC": "71335-2309",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202202",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231214",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: : 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). , 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement. , 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. .",
"Description": "Crystalline warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its empirical formula is C19H15NaO4, and its structural formula is represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Warfarin sodium tablets, USP (Crystalline) for oral use also contain. All strengths: Hydroxypropyl Cellulose, Lactose Monohydrate, Magnesium Stearate and Pregelatinized Starch. 1 mg: D&C Red No. 6 Barium Lake. 2 mg: FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. 2-1/2 mg: D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. 3 mg: FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. 4 mg: FD&C Blue No. 1 Aluminum Lake. 5 mg: FD&C Yellow No. 6 Aluminum Lake. 6 mg: FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. 7-1/2 mg: D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. 10 mg: Dye-free."
},
{
"NDCCode": "0480-2309-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-2309-56) ",
"NDC11Code": "00480-2309-56",
"ProductNDC": "0480-2309",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240116",
"EndMarketingDate": "20270228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205885",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240116",
"EndMarketingDatePackage": "20270228",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).",
"Description": "Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as oval-shaped film-coated tablets for oral administration. Each tablet contains 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, pregelatinized corn starch, and sodium lauryl sulfate. The film coating contains hypromellose 2910, lactose monohydrate, red iron oxide, talc, titanium dioxide, triacetin, and yellow iron oxide."
},
{
"NDCCode": "0480-2309-65",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0480-2309-65) / 15 TABLET, FILM COATED in 1 BLISTER PACK (0480-2309-30) ",
"NDC11Code": "00480-2309-65",
"ProductNDC": "0480-2309",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205885",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241106",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).",
"Description": "Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as oval-shaped film-coated tablets for oral administration. Each tablet contains 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, pregelatinized corn starch, and sodium lauryl sulfate. The film coating contains hypromellose 2910, lactose monohydrate, red iron oxide, talc, titanium dioxide, triacetin, and yellow iron oxide."
},
{
"NDCCode": "15631-2309-0",
"PackageDescription": "1 CONTAINER in 1 CONTAINER (15631-2309-0) > 50 g in 1 CONTAINER",
"NDC11Code": "15631-2309-00",
"ProductNDC": "15631-2309",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Flour",
"NonProprietaryName": "Calcarea Flour",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160330",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "CALCIUM FLUORIDE",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-2309-1",
"PackageDescription": "1 CONTAINER in 1 CONTAINER (15631-2309-1) > 100 g in 1 CONTAINER",
"NDC11Code": "15631-2309-01",
"ProductNDC": "15631-2309",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Flour",
"NonProprietaryName": "Calcarea Flour",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160330",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "CALCIUM FLUORIDE",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-2309-2",
"PackageDescription": "1 CONTAINER in 1 CONTAINER (15631-2309-2) > 200 g in 1 CONTAINER",
"NDC11Code": "15631-2309-02",
"ProductNDC": "15631-2309",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Flour",
"NonProprietaryName": "Calcarea Flour",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160330",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "CALCIUM FLUORIDE",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "50090-2309-0",
"PackageDescription": "18 BLISTER PACK in 1 CARTON (50090-2309-0) > 18 LOZENGE in 1 BLISTER PACK",
"NDC11Code": "50090-2309-00",
"ProductNDC": "50090-2309",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sore Throat Logenzes",
"ProprietaryNameSuffix": "Sore Throat",
"NonProprietaryName": "Benzocaine And Menthol",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20121228",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BENZOCAINE; MENTHOL",
"StrengthNumber": "15; 3.6",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55714-2309-0",
"PackageDescription": "7 g in 1 BOTTLE, GLASS (55714-2309-0)",
"NDC11Code": "55714-2309-00",
"ProductNDC": "55714-2309",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pollen Weeds",
"NonProprietaryName": "Xerophyllum Asphodeloides, Adrenalinum, Alfalfa, Aletris Farinosa, Artemisia Vulgaris, Bellis Perennis, Dysphania Ambrosioides, Lycopus Virginicus, Phytolacca American Root, Populus Tremuloides, Ptelea Trifoliata, Sambusus Nigra, Trillium Erectum Root, Elymus Repens Root, Urtica Urens, Wyethia Helenioides, Yucca Filamentosa, Avena Sativa Pollen, Cynosurus Cristatus Pollen. Echinochloa Crus-galli Pollen, Poa Pratensis Pollen, Anthoxanthum Odoratum Pollen, Agrostis Gigantea Pollen, Bromus Secalinus Pollen",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "XEROPHYLLUM ASPHODELOIDES; EPINEPHRINE; ALFALFA; ALETRIS FARINOSA ROOT; ARTEMISIA VULGARIS ROOT; BELLIS PERENNIS; DYSPHANIA AMBROSIOIDES; LYCOPUS VIRGINICUS; PHYTOLACCA AMERICANA ROOT; POPULUS TREMULOIDES LEAF; POPULUS TREMULOIDES BARK; PTELEA TRIFOLIATA BARK; SAMBUCUS NIGRA FLOWERING TOP; TRILLIUM ERECTUM ROOT; ELYMUS REPENS ROOT; URTICA URENS; WYETHIA HELENIOIDES ROOT; YUCCA FILAMENTOSA; AVENA SATIVA POLLEN; CYNOSURUS CRISTATUS POLLEN; ECHINOCHLOA CRUS-GALLI POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; BROMUS SECALINUS POLLEN; ALOPECURUS PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; FAGUS SYLVATICA POLLEN; BETULA PENDULA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS EXCELSIOR POLLEN; CORYLUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; PLATANUS ORIENTALIS POLLEN; ULMUS GLABRA POLLEN; SALIX ALBA POLLEN; NARCISSUS PSEUDONARCISSUS; ROSA CANINA FLOWER; LILIUM CANDIDUM FLOWER; PRIMULA VULGARIS; DIANTHUS CARYOPHYLLUS FLOWER; ULEX EUROPAEUS FLOWER; CYTISUS SCOPARIUS POLLEN; CALLUNA VULGARIS POLLEN; CRATAEGUS MONOGYNA POLLEN; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POPULUS BALSAMIFERA LEAF BUD; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER; USTILAGO MAYDIS; ONION; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; DIOSCOREA VILLOSA TUBER; GINKGO; GOLDENSEAL; TARAXACUM OFFICINALE; ANTHOXANTHUM ODORATUM POLLEN",
"StrengthNumber": "30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 15",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Formulated for associated symptoms of Spring and early Summer pollens such as itchy eyes, sneezing, post-nasal drip, sore throat and sinus pressure."
},
{
"NDCCode": "55714-2309-1",
"PackageDescription": "28 g in 1 BOTTLE, GLASS (55714-2309-1)",
"NDC11Code": "55714-2309-01",
"ProductNDC": "55714-2309",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pollen Weeds",
"NonProprietaryName": "Xerophyllum Asphodeloides, Adrenalinum, Alfalfa, Aletris Farinosa, Artemisia Vulgaris, Bellis Perennis, Dysphania Ambrosioides, Lycopus Virginicus, Phytolacca American Root, Populus Tremuloides, Ptelea Trifoliata, Sambusus Nigra, Trillium Erectum Root, Elymus Repens Root, Urtica Urens, Wyethia Helenioides, Yucca Filamentosa, Avena Sativa Pollen, Cynosurus Cristatus Pollen. Echinochloa Crus-galli Pollen, Poa Pratensis Pollen, Anthoxanthum Odoratum Pollen, Agrostis Gigantea Pollen, Bromus Secalinus Pollen",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "XEROPHYLLUM ASPHODELOIDES; EPINEPHRINE; ALFALFA; ALETRIS FARINOSA ROOT; ARTEMISIA VULGARIS ROOT; BELLIS PERENNIS; DYSPHANIA AMBROSIOIDES; LYCOPUS VIRGINICUS; PHYTOLACCA AMERICANA ROOT; POPULUS TREMULOIDES LEAF; POPULUS TREMULOIDES BARK; PTELEA TRIFOLIATA BARK; SAMBUCUS NIGRA FLOWERING TOP; TRILLIUM ERECTUM ROOT; ELYMUS REPENS ROOT; URTICA URENS; WYETHIA HELENIOIDES ROOT; YUCCA FILAMENTOSA; AVENA SATIVA POLLEN; CYNOSURUS CRISTATUS POLLEN; ECHINOCHLOA CRUS-GALLI POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; BROMUS SECALINUS POLLEN; ALOPECURUS PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; FAGUS SYLVATICA POLLEN; BETULA PENDULA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS EXCELSIOR POLLEN; CORYLUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; PLATANUS ORIENTALIS POLLEN; ULMUS GLABRA POLLEN; SALIX ALBA POLLEN; NARCISSUS PSEUDONARCISSUS; ROSA CANINA FLOWER; LILIUM CANDIDUM FLOWER; PRIMULA VULGARIS; DIANTHUS CARYOPHYLLUS FLOWER; ULEX EUROPAEUS FLOWER; CYTISUS SCOPARIUS POLLEN; CALLUNA VULGARIS POLLEN; CRATAEGUS MONOGYNA POLLEN; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POPULUS BALSAMIFERA LEAF BUD; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER; USTILAGO MAYDIS; ONION; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; DIOSCOREA VILLOSA TUBER; GINKGO; GOLDENSEAL; TARAXACUM OFFICINALE; ANTHOXANTHUM ODORATUM POLLEN",
"StrengthNumber": "30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 15",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Formulated for associated symptoms of Spring and early Summer pollens such as itchy eyes, sneezing, post-nasal drip, sore throat and sinus pressure."
},
{
"NDCCode": "55714-2309-2",
"PackageDescription": "57 g in 1 BOTTLE, GLASS (55714-2309-2)",
"NDC11Code": "55714-2309-02",
"ProductNDC": "55714-2309",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pollen Weeds",
"NonProprietaryName": "Xerophyllum Asphodeloides, Adrenalinum, Alfalfa, Aletris Farinosa, Artemisia Vulgaris, Bellis Perennis, Dysphania Ambrosioides, Lycopus Virginicus, Phytolacca American Root, Populus Tremuloides, Ptelea Trifoliata, Sambusus Nigra, Trillium Erectum Root, Elymus Repens Root, Urtica Urens, Wyethia Helenioides, Yucca Filamentosa, Avena Sativa Pollen, Cynosurus Cristatus Pollen. Echinochloa Crus-galli Pollen, Poa Pratensis Pollen, Anthoxanthum Odoratum Pollen, Agrostis Gigantea Pollen, Bromus Secalinus Pollen",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "XEROPHYLLUM ASPHODELOIDES; EPINEPHRINE; ALFALFA; ALETRIS FARINOSA ROOT; ARTEMISIA VULGARIS ROOT; BELLIS PERENNIS; DYSPHANIA AMBROSIOIDES; LYCOPUS VIRGINICUS; PHYTOLACCA AMERICANA ROOT; POPULUS TREMULOIDES LEAF; POPULUS TREMULOIDES BARK; PTELEA TRIFOLIATA BARK; SAMBUCUS NIGRA FLOWERING TOP; TRILLIUM ERECTUM ROOT; ELYMUS REPENS ROOT; URTICA URENS; WYETHIA HELENIOIDES ROOT; YUCCA FILAMENTOSA; AVENA SATIVA POLLEN; CYNOSURUS CRISTATUS POLLEN; ECHINOCHLOA CRUS-GALLI POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; BROMUS SECALINUS POLLEN; ALOPECURUS PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; FAGUS SYLVATICA POLLEN; BETULA PENDULA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS EXCELSIOR POLLEN; CORYLUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; PLATANUS ORIENTALIS POLLEN; ULMUS GLABRA POLLEN; SALIX ALBA POLLEN; NARCISSUS PSEUDONARCISSUS; ROSA CANINA FLOWER; LILIUM CANDIDUM FLOWER; PRIMULA VULGARIS; DIANTHUS CARYOPHYLLUS FLOWER; ULEX EUROPAEUS FLOWER; CYTISUS SCOPARIUS POLLEN; CALLUNA VULGARIS POLLEN; CRATAEGUS MONOGYNA POLLEN; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POPULUS BALSAMIFERA LEAF BUD; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER; USTILAGO MAYDIS; ONION; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; DIOSCOREA VILLOSA TUBER; GINKGO; GOLDENSEAL; TARAXACUM OFFICINALE; ANTHOXANTHUM ODORATUM POLLEN",
"StrengthNumber": "30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 15",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Formulated for associated symptoms of Spring and early Summer pollens such as itchy eyes, sneezing, post-nasal drip, sore throat and sinus pressure."
},
{
"NDCCode": "45861-107-01",
"PackageDescription": "1 KIT in 1 PACKAGE (45861-107-01) * 1 TABLET in 1 PACKAGE (68071-097-01) * 3 mL in 1 PACKET * 1 in 1 PACKAGE",
"NDC11Code": "45861-0107-01",
"ProductNDC": "45861-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Active-medicated Specimen Collection Kit",
"NonProprietaryName": "Urine Specimen Collection Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20131031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078010",
"LabelerName": "Pharmaceutica North America, Inc",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "68071-1026-3",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (68071-1026-3) ",
"NDC11Code": "68071-1026-03",
"ProductNDC": "68071-1026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benazepril Hydrochloride",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076118",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N",
"IndicationAndUsage": "Benazepril hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.",
"Description": "Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril hydrochloride is supplied as film-coated tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide, and triacetin. The 10 mg tablet also contains FD&C Red No. 40 aluminum lake. The 20 mg tablet also contains black iron oxide and yellow iron oxide. The 40 mg tablet also contains FD&C Blue No. 2 aluminum lake. Benazepril hydrochloride tablets USP, 5 mg, 10 mg, 20 mg and 40 mg meet USP Dissolution Test 2."
},
{
"NDCCode": "68071-1146-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68071-1146-3) ",
"NDC11Code": "68071-1146-03",
"ProductNDC": "68071-1146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benazepril Hydrochloride",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076820",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170517",
"SamplePackage": "N",
"IndicationAndUsage": "Benazepril hydrochloride (HCl) tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.",
"Description": "Benazepril HCl, USP is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril HCl tablets, USP are supplied as white, round, biconvex tablets containing either 5 mg, 10 mg, 20 mg, or 40 mg of benazepril hydrochloride, USP for oral administration. The inactive ingredients are crospovidone, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch and talc."
},
{
"NDCCode": "68071-1212-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (68071-1212-3) ",
"NDC11Code": "68071-1212-03",
"ProductNDC": "68071-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .",
"Description": "The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide."
},
{
"NDCCode": "68071-1230-3",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-1230-3) ",
"NDC11Code": "68071-1230-03",
"ProductNDC": "68071-1230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20141031",
"EndMarketingDate": "20180801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091672",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180222",
"EndMarketingDatePackage": "20180801",
"SamplePackage": "N"
},
{
"NDCCode": "68071-1255-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (68071-1255-3)",
"NDC11Code": "68071-1255-03",
"ProductNDC": "68071-1255",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090510",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"IndicationAndUsage": "Hydrochlorothiazide capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide capsules may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.",
"Description": "Hydrochlorothiazide is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-Chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C 7H 8ClN 3O 4S 2; its molecular weight is 297.74; and its structural formula is:. It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. Inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, gelatin, titanium dioxide, sodium lauryl sulfate and black iron oxide."
},
{
"NDCCode": "68071-1288-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68071-1288-3) ",
"NDC11Code": "68071-1288-03",
"ProductNDC": "68071-1288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077739",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170517",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets, USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.",
"Description": "Metoprolol tartrate USP is a selective beta 1-adrenoreceptor blocking agent, available as 25, 50 and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt. Its structural formula is:. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of metoprolol tartrate. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents."
},
{
"NDCCode": "68071-1292-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68071-1292-3) ",
"NDC11Code": "68071-1292-03",
"ProductNDC": "68071-1292",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077662",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170222",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin tablets USP are indicated for: 1 Management of postherpetic neuralgia in adults , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .",
"Description": "The active ingredient in gabapentin tablets USP is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablet USP contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients: corn starch, copovidone, poloxamer 407, magnesium stearate, polyethylene glycol, talc, hypromellose, titanium dioxide, macrogol, polysorbate 80 and purified water."
},
{
"NDCCode": "68071-1311-3",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1311-3) ",
"NDC11Code": "68071-1311-03",
"ProductNDC": "68071-1311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210497",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20221123",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) ( 1.1) , 2 prevention of seasonal affective disorder (SAD) ( 1.2) .",
"Description": "Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg creamy- white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: povidone, cysteine hydrochloride monohydrate, colloidal anhydrous silica, glycerol dibehanate, magnesium stearate, ethyl cellulose, polyethylene glycol, colloidal hydrated silica, triethyl citrate, methacrylic acid - ethyl acrylate copolymer , shellac, iron oxide black and propylene glycol. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test pending."
},
{
"NDCCode": "68071-1395-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (68071-1395-3) ",
"NDC11Code": "68071-1395-03",
"ProductNDC": "68071-1395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206948",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191004",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate capsules, USP are indicated for the symptomatic relief of cough.",
"Description": "Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink."
},
{
"NDCCode": "68071-1419-3",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-3) ",
"NDC11Code": "68071-1419-03",
"ProductNDC": "68071-1419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201991",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170329",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended release tablets USP are 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 is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride ( N,N-dimethylimidodicar- bonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:. 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. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of 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 of metformin hydrochloride USP as the active ingredient. Metformin hydrochloride extended release tablets USP 500 mg contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose and magnesium stearate. Metformin hydrochloride extended release tablets USP 500 mg meets USP dissolution Test 3. System Components and Performance- Metformin hydrochloride extended release tablets USP comprises a swellable matrix system. In the aqueous gastrointestinal (GI) environment, the dosage form swells remarkably thereby increasing in size and geometry from where drug is released slowly by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass."
},
{
"NDCCode": "68071-1513-5",
"PackageDescription": "3.5 g in 1 BOX (68071-1513-5) ",
"NDC11Code": "68071-1513-05",
"ProductNDC": "68071-1513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gentak",
"NonProprietaryName": "Gentamicin Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20060508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064093",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "GENTAMICIN SULFATE",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190205",
"SamplePackage": "N",
"IndicationAndUsage": "Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis: acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: : 1 Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.",
"Description": "GENTAK ® Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group. Gentamicin sulfate ophthalmic ointment is a sterile ointment for ophthalmic use. Each gram contains gentamicin sulfate equivalent to 3 mg gentamicin in a base of white petrolatum and mineral oil, with methylparaben and propylparaben as preservatives. Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C 1 C 2, and C 1A. All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:."
},
{
"NDCCode": "68071-1516-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68071-1516-3)",
"NDC11Code": "68071-1516-03",
"ProductNDC": "68071-1516",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090467",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "68071-1518-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68071-1518-3) ",
"NDC11Code": "68071-1518-03",
"ProductNDC": "68071-1518",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090467",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170725",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68071-2309-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68071-2309-3) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>68071-2309-03</NDC11Code>
<ProductNDC>68071-2309</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketoconazole</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075581</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); and in the treatment of cutaneous candidiasis caused by Candida spp.</IndicationAndUsage>
<Description>Ketoconazole Cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%. Each gram, for topical administration, contains ketoconazole 20 mg and is formulated in an aqueous cream vehicle consisting of propylene glycol, purified water, cetyl alcohol, stearyl alcohol, isopropyl myristate, sorbitan monostearate, polysorbate 60, polysorbate 80, and sodium sulfite, anhydrous. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1 H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula:. C 26H 28Cl 2N 4O 4 M.W. 531.44.</Description>
</NDC>
<NDC>
<NDCCode>15631-2309-3</NDCCode>
<PackageDescription>1 CONTAINER in 1 CONTAINER (15631-2309-3) > 500 g in 1 CONTAINER</PackageDescription>
<NDC11Code>15631-2309-03</NDC11Code>
<ProductNDC>15631-2309</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcarea Flour</ProprietaryName>
<NonProprietaryName>Calcarea Flour</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160330</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>CALCIUM FLUORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36987-2309-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-2309-3)</PackageDescription>
<NDC11Code>36987-2309-03</NDC11Code>
<ProductNDC>36987-2309</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Corn Grass</ProprietaryName>
<NonProprietaryName>Corn Grass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ZEA MAYS POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Cell-mediated Immunity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-2309-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-2309-3) </PackageDescription>
<NDC11Code>37662-2309-03</NDC11Code>
<ProductNDC>37662-2309</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thiosinaminum</ProprietaryName>
<NonProprietaryName>Thiosinaminum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230111</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>ALLYLTHIOUREA</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64942-2309-3</NDCCode>
<PackageDescription>45 g in 1 CONTAINER (64942-2309-3) </PackageDescription>
<NDC11Code>64942-2309-03</NDC11Code>
<ProductNDC>64942-2309</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dove</ProprietaryName>
<NonProprietaryName>Powder 48h Antiperspirant Deodorant</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Conopco Inc. d/b/a/ Unilever</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>15.2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness. 48 Hour Protection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64942-2309-4</NDCCode>
<PackageDescription>2 CONTAINER in 1 CONTAINER (64942-2309-4) / 45 g in 1 CONTAINER (64942-2309-3) </PackageDescription>
<NDC11Code>64942-2309-04</NDC11Code>
<ProductNDC>64942-2309</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dove</ProprietaryName>
<NonProprietaryName>Powder 48h Antiperspirant Deodorant</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Conopco Inc. d/b/a/ Unilever</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>15.2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness. 48 Hour Protection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-2309-3</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71335-2309-3) </PackageDescription>
<NDC11Code>71335-2309-03</NDC11Code>
<ProductNDC>71335-2309</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202202</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: : 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). , 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement. , 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. .</IndicationAndUsage>
<Description>Crystalline warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its empirical formula is C19H15NaO4, and its structural formula is represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Warfarin sodium tablets, USP (Crystalline) for oral use also contain. All strengths: Hydroxypropyl Cellulose, Lactose Monohydrate, Magnesium Stearate and Pregelatinized Starch. 1 mg: D&C Red No. 6 Barium Lake. 2 mg: FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. 2-1/2 mg: D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. 3 mg: FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. 4 mg: FD&C Blue No. 1 Aluminum Lake. 5 mg: FD&C Yellow No. 6 Aluminum Lake. 6 mg: FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. 7-1/2 mg: D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. 10 mg: Dye-free.</Description>
</NDC>
<NDC>
<NDCCode>0480-2309-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-2309-56) </PackageDescription>
<NDC11Code>00480-2309-56</NDC11Code>
<ProductNDC>0480-2309</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240116</StartMarketingDate>
<EndMarketingDate>20270228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205885</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240116</StartMarketingDatePackage>
<EndMarketingDatePackage>20270228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
<Description>Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as oval-shaped film-coated tablets for oral administration. Each tablet contains 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, pregelatinized corn starch, and sodium lauryl sulfate. The film coating contains hypromellose 2910, lactose monohydrate, red iron oxide, talc, titanium dioxide, triacetin, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0480-2309-65</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0480-2309-65) / 15 TABLET, FILM COATED in 1 BLISTER PACK (0480-2309-30) </PackageDescription>
<NDC11Code>00480-2309-65</NDC11Code>
<ProductNDC>0480-2309</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205885</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241106</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
<Description>Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as oval-shaped film-coated tablets for oral administration. Each tablet contains 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, pregelatinized corn starch, and sodium lauryl sulfate. The film coating contains hypromellose 2910, lactose monohydrate, red iron oxide, talc, titanium dioxide, triacetin, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>15631-2309-0</NDCCode>
<PackageDescription>1 CONTAINER in 1 CONTAINER (15631-2309-0) > 50 g in 1 CONTAINER</PackageDescription>
<NDC11Code>15631-2309-00</NDC11Code>
<ProductNDC>15631-2309</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcarea Flour</ProprietaryName>
<NonProprietaryName>Calcarea Flour</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160330</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>CALCIUM FLUORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-2309-1</NDCCode>
<PackageDescription>1 CONTAINER in 1 CONTAINER (15631-2309-1) > 100 g in 1 CONTAINER</PackageDescription>
<NDC11Code>15631-2309-01</NDC11Code>
<ProductNDC>15631-2309</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcarea Flour</ProprietaryName>
<NonProprietaryName>Calcarea Flour</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160330</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>CALCIUM FLUORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-2309-2</NDCCode>
<PackageDescription>1 CONTAINER in 1 CONTAINER (15631-2309-2) > 200 g in 1 CONTAINER</PackageDescription>
<NDC11Code>15631-2309-02</NDC11Code>
<ProductNDC>15631-2309</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcarea Flour</ProprietaryName>
<NonProprietaryName>Calcarea Flour</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160330</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>CALCIUM FLUORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-2309-0</NDCCode>
<PackageDescription>18 BLISTER PACK in 1 CARTON (50090-2309-0) > 18 LOZENGE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50090-2309-00</NDC11Code>
<ProductNDC>50090-2309</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sore Throat Logenzes</ProprietaryName>
<ProprietaryNameSuffix>Sore Throat</ProprietaryNameSuffix>
<NonProprietaryName>Benzocaine And Menthol</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121228</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>BENZOCAINE; MENTHOL</SubstanceName>
<StrengthNumber>15; 3.6</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-2309-0</NDCCode>
<PackageDescription>7 g in 1 BOTTLE, GLASS (55714-2309-0)</PackageDescription>
<NDC11Code>55714-2309-00</NDC11Code>
<ProductNDC>55714-2309</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollen Weeds</ProprietaryName>
<NonProprietaryName>Xerophyllum Asphodeloides, Adrenalinum, Alfalfa, Aletris Farinosa, Artemisia Vulgaris, Bellis Perennis, Dysphania Ambrosioides, Lycopus Virginicus, Phytolacca American Root, Populus Tremuloides, Ptelea Trifoliata, Sambusus Nigra, Trillium Erectum Root, Elymus Repens Root, Urtica Urens, Wyethia Helenioides, Yucca Filamentosa, Avena Sativa Pollen, Cynosurus Cristatus Pollen. Echinochloa Crus-galli Pollen, Poa Pratensis Pollen, Anthoxanthum Odoratum Pollen, Agrostis Gigantea Pollen, Bromus Secalinus Pollen</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>XEROPHYLLUM ASPHODELOIDES; EPINEPHRINE; ALFALFA; ALETRIS FARINOSA ROOT; ARTEMISIA VULGARIS ROOT; BELLIS PERENNIS; DYSPHANIA AMBROSIOIDES; LYCOPUS VIRGINICUS; PHYTOLACCA AMERICANA ROOT; POPULUS TREMULOIDES LEAF; POPULUS TREMULOIDES BARK; PTELEA TRIFOLIATA BARK; SAMBUCUS NIGRA FLOWERING TOP; TRILLIUM ERECTUM ROOT; ELYMUS REPENS ROOT; URTICA URENS; WYETHIA HELENIOIDES ROOT; YUCCA FILAMENTOSA; AVENA SATIVA POLLEN; CYNOSURUS CRISTATUS POLLEN; ECHINOCHLOA CRUS-GALLI POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; BROMUS SECALINUS POLLEN; ALOPECURUS PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; FAGUS SYLVATICA POLLEN; BETULA PENDULA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS EXCELSIOR POLLEN; CORYLUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; PLATANUS ORIENTALIS POLLEN; ULMUS GLABRA POLLEN; SALIX ALBA POLLEN; NARCISSUS PSEUDONARCISSUS; ROSA CANINA FLOWER; LILIUM CANDIDUM FLOWER; PRIMULA VULGARIS; DIANTHUS CARYOPHYLLUS FLOWER; ULEX EUROPAEUS FLOWER; CYTISUS SCOPARIUS POLLEN; CALLUNA VULGARIS POLLEN; CRATAEGUS MONOGYNA POLLEN; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POPULUS BALSAMIFERA LEAF BUD; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER; USTILAGO MAYDIS; ONION; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; DIOSCOREA VILLOSA TUBER; GINKGO; GOLDENSEAL; TARAXACUM OFFICINALE; ANTHOXANTHUM ODORATUM POLLEN</SubstanceName>
<StrengthNumber>30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 15</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Formulated for associated symptoms of Spring and early Summer pollens such as itchy eyes, sneezing, post-nasal drip, sore throat and sinus pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-2309-1</NDCCode>
<PackageDescription>28 g in 1 BOTTLE, GLASS (55714-2309-1)</PackageDescription>
<NDC11Code>55714-2309-01</NDC11Code>
<ProductNDC>55714-2309</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollen Weeds</ProprietaryName>
<NonProprietaryName>Xerophyllum Asphodeloides, Adrenalinum, Alfalfa, Aletris Farinosa, Artemisia Vulgaris, Bellis Perennis, Dysphania Ambrosioides, Lycopus Virginicus, Phytolacca American Root, Populus Tremuloides, Ptelea Trifoliata, Sambusus Nigra, Trillium Erectum Root, Elymus Repens Root, Urtica Urens, Wyethia Helenioides, Yucca Filamentosa, Avena Sativa Pollen, Cynosurus Cristatus Pollen. Echinochloa Crus-galli Pollen, Poa Pratensis Pollen, Anthoxanthum Odoratum Pollen, Agrostis Gigantea Pollen, Bromus Secalinus Pollen</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>XEROPHYLLUM ASPHODELOIDES; EPINEPHRINE; ALFALFA; ALETRIS FARINOSA ROOT; ARTEMISIA VULGARIS ROOT; BELLIS PERENNIS; DYSPHANIA AMBROSIOIDES; LYCOPUS VIRGINICUS; PHYTOLACCA AMERICANA ROOT; POPULUS TREMULOIDES LEAF; POPULUS TREMULOIDES BARK; PTELEA TRIFOLIATA BARK; SAMBUCUS NIGRA FLOWERING TOP; TRILLIUM ERECTUM ROOT; ELYMUS REPENS ROOT; URTICA URENS; WYETHIA HELENIOIDES ROOT; YUCCA FILAMENTOSA; AVENA SATIVA POLLEN; CYNOSURUS CRISTATUS POLLEN; ECHINOCHLOA CRUS-GALLI POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; BROMUS SECALINUS POLLEN; ALOPECURUS PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; FAGUS SYLVATICA POLLEN; BETULA PENDULA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS EXCELSIOR POLLEN; CORYLUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; PLATANUS ORIENTALIS POLLEN; ULMUS GLABRA POLLEN; SALIX ALBA POLLEN; NARCISSUS PSEUDONARCISSUS; ROSA CANINA FLOWER; LILIUM CANDIDUM FLOWER; PRIMULA VULGARIS; DIANTHUS CARYOPHYLLUS FLOWER; ULEX EUROPAEUS FLOWER; CYTISUS SCOPARIUS POLLEN; CALLUNA VULGARIS POLLEN; CRATAEGUS MONOGYNA POLLEN; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POPULUS BALSAMIFERA LEAF BUD; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER; USTILAGO MAYDIS; ONION; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; DIOSCOREA VILLOSA TUBER; GINKGO; GOLDENSEAL; TARAXACUM OFFICINALE; ANTHOXANTHUM ODORATUM POLLEN</SubstanceName>
<StrengthNumber>30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 15</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Formulated for associated symptoms of Spring and early Summer pollens such as itchy eyes, sneezing, post-nasal drip, sore throat and sinus pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-2309-2</NDCCode>
<PackageDescription>57 g in 1 BOTTLE, GLASS (55714-2309-2)</PackageDescription>
<NDC11Code>55714-2309-02</NDC11Code>
<ProductNDC>55714-2309</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollen Weeds</ProprietaryName>
<NonProprietaryName>Xerophyllum Asphodeloides, Adrenalinum, Alfalfa, Aletris Farinosa, Artemisia Vulgaris, Bellis Perennis, Dysphania Ambrosioides, Lycopus Virginicus, Phytolacca American Root, Populus Tremuloides, Ptelea Trifoliata, Sambusus Nigra, Trillium Erectum Root, Elymus Repens Root, Urtica Urens, Wyethia Helenioides, Yucca Filamentosa, Avena Sativa Pollen, Cynosurus Cristatus Pollen. Echinochloa Crus-galli Pollen, Poa Pratensis Pollen, Anthoxanthum Odoratum Pollen, Agrostis Gigantea Pollen, Bromus Secalinus Pollen</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>XEROPHYLLUM ASPHODELOIDES; EPINEPHRINE; ALFALFA; ALETRIS FARINOSA ROOT; ARTEMISIA VULGARIS ROOT; BELLIS PERENNIS; DYSPHANIA AMBROSIOIDES; LYCOPUS VIRGINICUS; PHYTOLACCA AMERICANA ROOT; POPULUS TREMULOIDES LEAF; POPULUS TREMULOIDES BARK; PTELEA TRIFOLIATA BARK; SAMBUCUS NIGRA FLOWERING TOP; TRILLIUM ERECTUM ROOT; ELYMUS REPENS ROOT; URTICA URENS; WYETHIA HELENIOIDES ROOT; YUCCA FILAMENTOSA; AVENA SATIVA POLLEN; CYNOSURUS CRISTATUS POLLEN; ECHINOCHLOA CRUS-GALLI POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; BROMUS SECALINUS POLLEN; ALOPECURUS PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; FAGUS SYLVATICA POLLEN; BETULA PENDULA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS EXCELSIOR POLLEN; CORYLUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; PLATANUS ORIENTALIS POLLEN; ULMUS GLABRA POLLEN; SALIX ALBA POLLEN; NARCISSUS PSEUDONARCISSUS; ROSA CANINA FLOWER; LILIUM CANDIDUM FLOWER; PRIMULA VULGARIS; DIANTHUS CARYOPHYLLUS FLOWER; ULEX EUROPAEUS FLOWER; CYTISUS SCOPARIUS POLLEN; CALLUNA VULGARIS POLLEN; CRATAEGUS MONOGYNA POLLEN; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POPULUS BALSAMIFERA LEAF BUD; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER; USTILAGO MAYDIS; ONION; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; DIOSCOREA VILLOSA TUBER; GINKGO; GOLDENSEAL; TARAXACUM OFFICINALE; ANTHOXANTHUM ODORATUM POLLEN</SubstanceName>
<StrengthNumber>30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 15</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Formulated for associated symptoms of Spring and early Summer pollens such as itchy eyes, sneezing, post-nasal drip, sore throat and sinus pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45861-107-01</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (45861-107-01) * 1 TABLET in 1 PACKAGE (68071-097-01) * 3 mL in 1 PACKET * 1 in 1 PACKAGE</PackageDescription>
<NDC11Code>45861-0107-01</NDC11Code>
<ProductNDC>45861-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Active-medicated Specimen Collection Kit</ProprietaryName>
<NonProprietaryName>Urine Specimen Collection Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20131031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078010</ApplicationNumber>
<LabelerName>Pharmaceutica North America, Inc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68071-1026-3</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (68071-1026-3) </PackageDescription>
<NDC11Code>68071-1026-03</NDC11Code>
<ProductNDC>68071-1026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076118</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benazepril hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
<Description>Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril hydrochloride is supplied as film-coated tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide, and triacetin. The 10 mg tablet also contains FD&C Red No. 40 aluminum lake. The 20 mg tablet also contains black iron oxide and yellow iron oxide. The 40 mg tablet also contains FD&C Blue No. 2 aluminum lake. Benazepril hydrochloride tablets USP, 5 mg, 10 mg, 20 mg and 40 mg meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68071-1146-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68071-1146-3) </PackageDescription>
<NDC11Code>68071-1146-03</NDC11Code>
<ProductNDC>68071-1146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076820</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benazepril hydrochloride (HCl) tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
<Description>Benazepril HCl, USP is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril HCl tablets, USP are supplied as white, round, biconvex tablets containing either 5 mg, 10 mg, 20 mg, or 40 mg of benazepril hydrochloride, USP for oral administration. The inactive ingredients are crospovidone, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch and talc.</Description>
</NDC>
<NDC>
<NDCCode>68071-1212-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (68071-1212-3) </PackageDescription>
<NDC11Code>68071-1212-03</NDC11Code>
<ProductNDC>68071-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68071-1230-3</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-1230-3) </PackageDescription>
<NDC11Code>68071-1230-03</NDC11Code>
<ProductNDC>68071-1230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141031</StartMarketingDate>
<EndMarketingDate>20180801</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091672</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180222</StartMarketingDatePackage>
<EndMarketingDatePackage>20180801</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68071-1255-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (68071-1255-3)</PackageDescription>
<NDC11Code>68071-1255-03</NDC11Code>
<ProductNDC>68071-1255</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090510</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrochlorothiazide capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide capsules may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.</IndicationAndUsage>
<Description>Hydrochlorothiazide is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-Chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C 7H 8ClN 3O 4S 2; its molecular weight is 297.74; and its structural formula is:. It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. Inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, gelatin, titanium dioxide, sodium lauryl sulfate and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>68071-1288-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68071-1288-3) </PackageDescription>
<NDC11Code>68071-1288-03</NDC11Code>
<ProductNDC>68071-1288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077739</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets, USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Metoprolol tartrate USP is a selective beta 1-adrenoreceptor blocking agent, available as 25, 50 and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt. Its structural formula is:. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of metoprolol tartrate. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents.</Description>
</NDC>
<NDC>
<NDCCode>68071-1292-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68071-1292-3) </PackageDescription>
<NDC11Code>68071-1292-03</NDC11Code>
<ProductNDC>68071-1292</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077662</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin tablets USP are indicated for: 1 Management of postherpetic neuralgia in adults , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets USP is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablet USP contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients: corn starch, copovidone, poloxamer 407, magnesium stearate, polyethylene glycol, talc, hypromellose, titanium dioxide, macrogol, polysorbate 80 and purified water.</Description>
</NDC>
<NDC>
<NDCCode>68071-1311-3</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1311-3) </PackageDescription>
<NDC11Code>68071-1311-03</NDC11Code>
<ProductNDC>68071-1311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190325</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210497</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) ( 1.1) , 2 prevention of seasonal affective disorder (SAD) ( 1.2) .</IndicationAndUsage>
<Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg creamy- white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: povidone, cysteine hydrochloride monohydrate, colloidal anhydrous silica, glycerol dibehanate, magnesium stearate, ethyl cellulose, polyethylene glycol, colloidal hydrated silica, triethyl citrate, methacrylic acid - ethyl acrylate copolymer , shellac, iron oxide black and propylene glycol. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test pending.</Description>
</NDC>
<NDC>
<NDCCode>68071-1395-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (68071-1395-3) </PackageDescription>
<NDC11Code>68071-1395-03</NDC11Code>
<ProductNDC>68071-1395</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206948</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules, USP are indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink.</Description>
</NDC>
<NDC>
<NDCCode>68071-1419-3</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-3) </PackageDescription>
<NDC11Code>68071-1419-03</NDC11Code>
<ProductNDC>68071-1419</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201991</ApplicationNumber>
<LabelerName>NuCare 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>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended release tablets USP are 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 is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride ( N,N-dimethylimidodicar- bonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:. 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. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of 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 of metformin hydrochloride USP as the active ingredient. Metformin hydrochloride extended release tablets USP 500 mg contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose and magnesium stearate. Metformin hydrochloride extended release tablets USP 500 mg meets USP dissolution Test 3. System Components and Performance- Metformin hydrochloride extended release tablets USP comprises a swellable matrix system. In the aqueous gastrointestinal (GI) environment, the dosage form swells remarkably thereby increasing in size and geometry from where drug is released slowly by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.</Description>
</NDC>
<NDC>
<NDCCode>68071-1513-5</NDCCode>
<PackageDescription>3.5 g in 1 BOX (68071-1513-5) </PackageDescription>
<NDC11Code>68071-1513-05</NDC11Code>
<ProductNDC>68071-1513</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gentak</ProprietaryName>
<NonProprietaryName>Gentamicin Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20060508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064093</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>GENTAMICIN SULFATE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis: acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: : 1 Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.</IndicationAndUsage>
<Description>GENTAK ® Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group. Gentamicin sulfate ophthalmic ointment is a sterile ointment for ophthalmic use. Each gram contains gentamicin sulfate equivalent to 3 mg gentamicin in a base of white petrolatum and mineral oil, with methylparaben and propylparaben as preservatives. Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C 1 C 2, and C 1A. All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>68071-1516-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68071-1516-3)</PackageDescription>
<NDC11Code>68071-1516-03</NDC11Code>
<ProductNDC>68071-1516</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090467</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68071-1518-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68071-1518-3) </PackageDescription>
<NDC11Code>68071-1518-03</NDC11Code>
<ProductNDC>68071-1518</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090467</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
</NDCList>