{
"NDC": [
{
"NDCCode": "0378-2474-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2474-01) ",
"NDC11Code": "00378-2474-01",
"ProductNDC": "0378-2474",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Potassium",
"NonProprietaryName": "Diclofenac Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19990917",
"EndMarketingDate": "20240229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075463",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DICLOFENAC POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19990917",
"EndMarketingDatePackage": "20240229",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: 1 For treatment of primary dysmenorrhea, 2 For relief of mild to moderate pain, 3 For relief of the signs and symptoms of osteoarthritis, 4 For relief of the signs and symptoms of rheumatoid arthritis.",
"Description": "Diclofenac potassium tablets, USP are a benzeneacetic acid derivative. Diclofenac potassium tablets are available for oral administration. Diclofenac potassium, USP is a white to off-white or slightly yellowish crystalline powder and is sparingly soluble in water at 25ºC. The chemical name is Potassium [o-(2,6-dichloroanilino)phenyl] acetate. The molecular weight is 334.24. Its molecular formula is C14H10C12KNO2, and it has the following structural formula. The inactive ingredients in diclofenac potassium tablets include: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, glyceryl triacetate, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide."
},
{
"NDCCode": "0378-2474-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2474-05)",
"NDC11Code": "00378-2474-05",
"ProductNDC": "0378-2474",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Potassium",
"NonProprietaryName": "Diclofenac Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120813",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075463",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DICLOFENAC POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-12-25"
},
{
"NDCCode": "0591-2474-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0591-2474-01) ",
"NDC11Code": "00591-2474-01",
"ProductNDC": "0591-2474",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracycline Hydrochloride",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061837",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110815",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible., 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.)., 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis caused by Chlamydophila psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Klebsiella granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful. .",
"Description": "Tetracycline, USP is a yellow, odorless, crystalline powder. Tetracycline, USP is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline, USP is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. Each capsule, for oral administration, contains tetracycline hydrochloride USP, 250 mg or 500 mg. Inactive Ingredients: Anhydrous lactose, magnesium stearate, and sodium lauryl sulfate. The 250 mg capsule shell contains D&C Red No. 22, D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, and titanium dioxide. The imprinting ink for the 250 mg capsule contains ammonium hydroxide, black iron oxide, propylene glycol, shellac glaze. The 500 mg capsule shell contains D&C Yellow No. 10, FD&C Blue No.1, FD&C Red No. 40, gelatin, and titanium dioxide. The imprinting ink for the 500 mg capsule contains propylene glycol, shellac glaze, titanium dioxide."
},
{
"NDCCode": "36987-2474-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-2474-1)",
"NDC11Code": "36987-2474-01",
"ProductNDC": "36987-2474",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "White Alder",
"NonProprietaryName": "White Alder",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ALNUS RHOMBIFOLIA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"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": "37662-2474-1",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-2474-1) ",
"NDC11Code": "37662-2474-01",
"ProductNDC": "37662-2474",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Manganum Bromatum",
"NonProprietaryName": "Manganum Bromatum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230124",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "MANGANESE BROMIDE",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230124",
"SamplePackage": "N"
},
{
"NDCCode": "55714-2474-1",
"PackageDescription": "28 g in 1 BOTTLE, GLASS (55714-2474-1) ",
"NDC11Code": "55714-2474-01",
"ProductNDC": "55714-2474",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leg Cramps-swelling",
"NonProprietaryName": "Echinacea, Argentum Nitricum, Bryonia, Calcarea Carbonica, Colocynthis, Convallaria Majalis, Crotalus Horridus, Cuprum Metallicum, Digitalis , Gelsemium Sempervirens, Hypericum Perforatum, Kali Carbonicum, Lachesis Mutus, Lathyrus Sativus, Lilium Tigrinum, Magnesia Phosphorica, Nux Vomica, Rhus Toxicodendron, Silicea, Stramonium, Veratrum Viride, Elaps",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ECHINACEA, UNSPECIFIED; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CITRULLUS COLOCYNTHIS FRUIT PULP; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; COPPER; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LATHYRUS SATIVAS SEED; LILIUM LANCIFOLIUM WHOLE FLOWERING; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; DATURA STRAMONIUM; VERATRUM VIRIDE ROOT; MICRURUS CORALLINUS VENOM; SILVER NITRATE",
"StrengthNumber": "6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 30; 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",
"Pharm_Classes": "Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2023-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Formulated for associated symptoms such as pain, cramping, swelling, inflammation and stiffness in the legs and feet."
},
{
"NDCCode": "63629-2474-1",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (63629-2474-1) ",
"NDC11Code": "63629-2474-01",
"ProductNDC": "63629-2474",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170907",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202765",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170907",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate Capsule is indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each Benzonatate Capsules USP contains: Benzonatate, USP 100 mg or 200 mg. Benzonatate Capsules USP also contain: D&C Yellow 10, gelatin, glycerin, methylparaben, propylparaben and titanium dioxide."
},
{
"NDCCode": "64942-2474-1",
"PackageDescription": "74 g in 1 CONTAINER (64942-2474-1) ",
"NDC11Code": "64942-2474-01",
"ProductNDC": "64942-2474",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Degree",
"NonProprietaryName": "Advanced Protection Sport Defense Antiperspirant Deodorant",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260707",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Conopco d/b/a Unilever",
"SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
"StrengthNumber": "16",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260707",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness.",
"Description": "Degree Advanced Protection Sport Defense Antiperspirant Deodorant."
},
{
"NDCCode": "71335-2474-1",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (71335-2474-1) ",
"NDC11Code": "71335-2474-01",
"ProductNDC": "71335-2474",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078384",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240903",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol Tablet is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Mild to severe chronic heart failure (1.1), 2 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 Hypertension (1.3).",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure. Carvedilol is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol Tablet is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5)."
},
{
"NDCCode": "37662-2474-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-2474-2) ",
"NDC11Code": "37662-2474-02",
"ProductNDC": "37662-2474",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Manganum Bromatum",
"NonProprietaryName": "Manganum Bromatum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230124",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "MANGANESE BROMIDE",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230124",
"SamplePackage": "N"
},
{
"NDCCode": "37662-2474-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-2474-3) ",
"NDC11Code": "37662-2474-03",
"ProductNDC": "37662-2474",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Manganum Bromatum",
"NonProprietaryName": "Manganum Bromatum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230124",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "MANGANESE BROMIDE",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230124",
"SamplePackage": "N"
},
{
"NDCCode": "37662-2474-4",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-2474-4) ",
"NDC11Code": "37662-2474-04",
"ProductNDC": "37662-2474",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Manganum Bromatum",
"NonProprietaryName": "Manganum Bromatum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230124",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "MANGANESE BROMIDE",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230124",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0001-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0001-01)",
"NDC11Code": "00378-0001-01",
"ProductNDC": "0378-0001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clorpres",
"NonProprietaryName": "Clonidine Hydrochloride And Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19980313",
"EndMarketingDate": "20180228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071325",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE; CHLORTHALIDONE",
"StrengthNumber": ".1; 15",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0378-0014-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0014-01) ",
"NDC11Code": "00378-0014-01",
"ProductNDC": "0378-0014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methotrexate",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081235",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920518",
"SamplePackage": "N",
"IndicationAndUsage": "Methotrexate tablets are a dihydrofolate reductase inhibitor indicated for the: : 1 Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1) , 2 Treatment of adults with mycosis fungoides (1.1) , 3 Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1) , 4 Treatment of adults with rheumatoid arthritis (1.2) , 5 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3) , 6 Treatment of adults with severe psoriasis (1.4) .",
"Description": "Methotrexate is dihydrofolate reductase inhibitor with the chemical name of N-[4-[[(2,4 diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L glutamic acid. The molecular formula is C20H22N8O5 and the molecular weight is 454.4 g/mol. The structural formula is. Methotrexate Tablets, USP for oral use are available in bottles of 100 tablets. Each methotrexate tablet contains 2.5 mg methotrexate equivalent to 2.74 mg methotrexate sodium and the following inactive ingredients: colloidal silicon dioxide, FD&C Red No. 40 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium carbonate (monohydrate), sodium lauryl sulfate and sodium starch glycolate (potato)."
},
{
"NDCCode": "0378-0018-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0018-01) ",
"NDC11Code": "00378-0018-01",
"ProductNDC": "0378-0018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076704",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040223",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, 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. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "0378-0023-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0023-01) ",
"NDC11Code": "00378-0023-01",
"ProductNDC": "0378-0023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19920316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072838",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19920316",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0027-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0027-01)",
"NDC11Code": "00378-0027-01",
"ProductNDC": "0378-0027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clorpres",
"NonProprietaryName": "Clonidine Hydrochloride And Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19980313",
"EndMarketingDate": "20180228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071325",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE; CHLORTHALIDONE",
"StrengthNumber": ".2; 15",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0378-0028-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0378-0028-01) ",
"NDC11Code": "00378-0028-01",
"ProductNDC": "0378-0028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nadolol",
"NonProprietaryName": "Nadolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19931031",
"EndMarketingDate": "20231130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074172",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "NADOLOL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19931031",
"EndMarketingDatePackage": "20231130",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0030-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0030-01) ",
"NDC11Code": "00378-0030-01",
"ProductNDC": "0378-0030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clorazepate Dipotassium",
"NonProprietaryName": "Clorazepate Dipotassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19870717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071858",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CLORAZEPATE DIPOTASSIUM",
"StrengthNumber": "3.75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19870717",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0032-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0032-01) ",
"NDC11Code": "00378-0032-01",
"ProductNDC": "0378-0032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076704",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19931223",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, 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. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "0378-0040-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0040-01) ",
"NDC11Code": "00378-0040-01",
"ProductNDC": "0378-0040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clorazepate Dipotassium",
"NonProprietaryName": "Clorazepate Dipotassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19870717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071858",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CLORAZEPATE DIPOTASSIUM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19870717",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0042-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0042-01) ",
"NDC11Code": "00378-0042-01",
"ProductNDC": "0378-0042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perphenazine And Amitriptyline Hydrochloride",
"NonProprietaryName": "Perphenazine And Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19881110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071443",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PERPHENAZINE; AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "4; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS], Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19881110",
"SamplePackage": "N",
"IndicationAndUsage": "Perphenazine and amitriptyline hydrochloride tablets are recommended for treatment of (1) patients with moderate to severe anxiety and/or agitation and depressed mood, (2) patients with depression in whom anxiety and/or agitation are severe, and (3) patients with depression and anxiety in association with chronic physical disease. In many of these patients, anxiety masks the depressive state so that, although therapy with a tranquilizer appears to be indicated, the administration of a tranquilizer alone will not be adequate. Schizophrenic patients who have associated depressive symptoms should be considered for therapy with perphenazine and amitriptyline hydrochloride tablets.",
"Description": "Perphenazine and amitriptyline hydrochloride, a broad spectrum psychotherapeutic agent for the management of outpatients and hospitalized patients with psychoses or neuroses characterized by mixtures of anxiety or agitation with symptoms of depression, is a combination of perphenazine and amitriptyline hydrochloride. Since such mixed syndromes can occur in patients with various degrees of intensity of mental illness, perphenazine and amitriptyline hydrochloride tablets are provided in multiple combinations to afford dosage flexibility for optimum management. Perphenazine is a phenothiazine derivative. The formula is 4-[3-(2-chloro-10H-phenothiazin-10yl) propyl]-piperazineethanol. Perphenazine, USP is a white, odorless, bitter tasting powder that is insoluble in water. The molecular weight is 403.97. Its structural formula is. Amitriptyline is a dibenzocycloheptadiene derivative. The formula is 10,11-dihydro-N,N-dimethyl-5H-dibenzo[a,d]cycloheptene-∆5,γ -propylamine hydrochloride. Amitriptyline hydrochloride, USP is a white, odorless, crystalline compound which is freely soluble in water. The molecular weight is 313.87. Its structural formula is. Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide. The following additional product specific inactive ingredients are employed. 2 mg/10 mg - hydroxypropyl cellulose2 mg/25 mg - hydroxypropyl cellulose4 mg/10 mg - polysorbate 804 mg/25 mg - hydroxypropyl cellulose4 mg/50 mg - hydroxypropyl cellulose. The following product specific coloring agents are employed. 2 mg/10 mg - calcium sulfate, talc2 mg/25 mg - D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake4 mg/10 mg - FD&C Blue No. 1 Aluminum Lake4 mg/25 mg - FD&C Yellow No. 6 Aluminum Lake4 mg/50 mg - D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake."
},
{
"NDCCode": "0378-0045-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0045-01) ",
"NDC11Code": "00378-0045-01",
"ProductNDC": "0378-0045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19920316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072838",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19920316",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0047-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0047-01) ",
"NDC11Code": "00378-0047-01",
"ProductNDC": "0378-0047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076704",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19931223",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, 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. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "0378-0052-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0052-01) ",
"NDC11Code": "00378-0052-01",
"ProductNDC": "0378-0052",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pindolol",
"NonProprietaryName": "Pindolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920903",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074019",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PINDOLOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19920903",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Pindolol tablets are indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.",
"Description": "Pindolol, a synthetic beta-adrenergic receptor blocking agent with intrinsic sympathomimetic activity is 1-(Indol-4-yloxy)-3-(isopropylamino)-2-propanol. Pindolol, USP is a white to off-white, crystalline powder having a faint odor which is practically insoluble in water; slightly soluble in methanol; and very slightly soluble in chloroform. Each tablet for oral administration contains pindolol, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and sodium lauryl sulfate."
},
{
"NDCCode": "0378-0053-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0053-01) ",
"NDC11Code": "00378-0053-01",
"ProductNDC": "0378-0053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cimetidine",
"NonProprietaryName": "Cimetidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19940517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074246",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CIMETIDINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19940517",
"SamplePackage": "N",
"IndicationAndUsage": "Cimetidine tablets are indicated in. 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION: Duodenal Ulcer). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine tablets 400 mg at bedtime for periods of up to 5 years. 3. Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks. 4. Erosive gastroesophageal reflux (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine tablets beyond 12 weeks has not been established (see DOSAGE AND ADMINISTRATION: GERD). 5. The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).",
"Description": "Cimetidine is a histamine H2-receptor antagonist. Chemically it is N\"-cyano-N-methyl-N'-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]thio]-ethyl]guanidine. Its structural formula is. Cimetidine contains an imidazole ring, and is chemically related to histamine. Cimetidine has a bitter taste and characteristic odor."
},
{
"NDCCode": "0378-0055-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0055-01) ",
"NDC11Code": "00378-0055-01",
"ProductNDC": "0378-0055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900608",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072668",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19900608",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "Timolol maleate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.",
"Description": "Timolol maleate is a nonselective beta-adrenergic receptor blocking agent. The chemical name for timolol maleate is (S)-1-[(1,1-dimethylethyl)amino]-3-[[4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]oxy]-2-propanol (Z)-2-butenedioate (1:1) salt. It possesses an asymmetric carbon atom in its structure and is provided as the levo isomer. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is supplied as tablets containing 5 mg, 10 mg and 20 mg timolol maleate for oral administration. Inactive ingredients are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium lauryl sulfate, FD&C Blue No. 2 aluminum lake, and D&C Yellow No. 10 aluminum lake."
},
{
"NDCCode": "0378-0060-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0060-01) ",
"NDC11Code": "00378-0060-01",
"ProductNDC": "0378-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Maprotiline Hydrochloride",
"NonProprietaryName": "Maprotiline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19881003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072285",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "MAPROTILINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19881003",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0069-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0069-01) ",
"NDC11Code": "00378-0069-01",
"ProductNDC": "0378-0069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indapamide",
"NonProprietaryName": "Indapamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19970326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074461",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "INDAPAMIDE",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19970326",
"SamplePackage": "N",
"IndicationAndUsage": "Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure.",
"Description": "Indapamide is an oral antihypertensive/diuretic. Its molecule contains both a polar sulfamoyl chlorobenzamide moiety and a lipid-soluble methylindoline moiety. It differs chemically from the thiazides in that it does not possess the thiazide ring system and contains only one sulfonamide group. The chemical name of indapamide is 4-Chloro-N-(2-methyl-1-indolinyl)-3-Sulfamoylbenzamide, and its molecular weight is 365.84. The compound is a weak acid, pKa=8.8, and is soluble in aqueous solutions of strong bases. It is a white to yellow-white crystalline (tetragonal) powder. C16H16ClN3O3S. Each tablet, for oral administration, contains 1.25 mg or 2.5 mg of indapamide, USP and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide. Additionally, the 1.25 mg product contains glyceryl triacetate and D&C Red No. 30 Aluminum Lake and the 2.5 mg product contains triacetin."
},
{
"NDCCode": "0378-0070-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0070-01) ",
"NDC11Code": "00378-0070-01",
"ProductNDC": "0378-0070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clorazepate Dipotassium",
"NonProprietaryName": "Clorazepate Dipotassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19870717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071858",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CLORAZEPATE DIPOTASSIUM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19870717",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0378-2474-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2474-01) </PackageDescription>
<NDC11Code>00378-2474-01</NDC11Code>
<ProductNDC>0378-2474</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Potassium</ProprietaryName>
<NonProprietaryName>Diclofenac Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990917</StartMarketingDate>
<EndMarketingDate>20240229</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075463</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DICLOFENAC POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19990917</StartMarketingDatePackage>
<EndMarketingDatePackage>20240229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: 1 For treatment of primary dysmenorrhea, 2 For relief of mild to moderate pain, 3 For relief of the signs and symptoms of osteoarthritis, 4 For relief of the signs and symptoms of rheumatoid arthritis.</IndicationAndUsage>
<Description>Diclofenac potassium tablets, USP are a benzeneacetic acid derivative. Diclofenac potassium tablets are available for oral administration. Diclofenac potassium, USP is a white to off-white or slightly yellowish crystalline powder and is sparingly soluble in water at 25ºC. The chemical name is Potassium [o-(2,6-dichloroanilino)phenyl] acetate. The molecular weight is 334.24. Its molecular formula is C14H10C12KNO2, and it has the following structural formula. The inactive ingredients in diclofenac potassium tablets include: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, glyceryl triacetate, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0378-2474-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2474-05)</PackageDescription>
<NDC11Code>00378-2474-05</NDC11Code>
<ProductNDC>0378-2474</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Potassium</ProprietaryName>
<NonProprietaryName>Diclofenac Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120813</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075463</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DICLOFENAC POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-12-25</LastUpdate>
</NDC>
<NDC>
<NDCCode>0591-2474-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0591-2474-01) </PackageDescription>
<NDC11Code>00591-2474-01</NDC11Code>
<ProductNDC>0591-2474</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061837</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible., 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.)., 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis caused by Chlamydophila psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Klebsiella granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful. .</IndicationAndUsage>
<Description>Tetracycline, USP is a yellow, odorless, crystalline powder. Tetracycline, USP is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline, USP is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. Each capsule, for oral administration, contains tetracycline hydrochloride USP, 250 mg or 500 mg. Inactive Ingredients: Anhydrous lactose, magnesium stearate, and sodium lauryl sulfate. The 250 mg capsule shell contains D&C Red No. 22, D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, and titanium dioxide. The imprinting ink for the 250 mg capsule contains ammonium hydroxide, black iron oxide, propylene glycol, shellac glaze. The 500 mg capsule shell contains D&C Yellow No. 10, FD&C Blue No.1, FD&C Red No. 40, gelatin, and titanium dioxide. The imprinting ink for the 500 mg capsule contains propylene glycol, shellac glaze, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>36987-2474-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-2474-1)</PackageDescription>
<NDC11Code>36987-2474-01</NDC11Code>
<ProductNDC>36987-2474</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>White Alder</ProprietaryName>
<NonProprietaryName>White Alder</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ALNUS RHOMBIFOLIA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</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>37662-2474-1</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-2474-1) </PackageDescription>
<NDC11Code>37662-2474-01</NDC11Code>
<ProductNDC>37662-2474</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Manganum Bromatum</ProprietaryName>
<NonProprietaryName>Manganum Bromatum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230124</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>MANGANESE BROMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55714-2474-1</NDCCode>
<PackageDescription>28 g in 1 BOTTLE, GLASS (55714-2474-1) </PackageDescription>
<NDC11Code>55714-2474-01</NDC11Code>
<ProductNDC>55714-2474</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leg Cramps-swelling</ProprietaryName>
<NonProprietaryName>Echinacea, Argentum Nitricum, Bryonia, Calcarea Carbonica, Colocynthis, Convallaria Majalis, Crotalus Horridus, Cuprum Metallicum, Digitalis , Gelsemium Sempervirens, Hypericum Perforatum, Kali Carbonicum, Lachesis Mutus, Lathyrus Sativus, Lilium Tigrinum, Magnesia Phosphorica, Nux Vomica, Rhus Toxicodendron, Silicea, Stramonium, Veratrum Viride, Elaps</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ECHINACEA, UNSPECIFIED; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CITRULLUS COLOCYNTHIS FRUIT PULP; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; COPPER; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LATHYRUS SATIVAS SEED; LILIUM LANCIFOLIUM WHOLE FLOWERING; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; DATURA STRAMONIUM; VERATRUM VIRIDE ROOT; MICRURUS CORALLINUS VENOM; SILVER NITRATE</SubstanceName>
<StrengthNumber>6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 30; 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</StrengthUnit>
<Pharm_Classes>Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Formulated for associated symptoms such as pain, cramping, swelling, inflammation and stiffness in the legs and feet.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63629-2474-1</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (63629-2474-1) </PackageDescription>
<NDC11Code>63629-2474-01</NDC11Code>
<ProductNDC>63629-2474</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170907</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202765</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170907</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate Capsule is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each Benzonatate Capsules USP contains: Benzonatate, USP 100 mg or 200 mg. Benzonatate Capsules USP also contain: D&C Yellow 10, gelatin, glycerin, methylparaben, propylparaben and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>64942-2474-1</NDCCode>
<PackageDescription>74 g in 1 CONTAINER (64942-2474-1) </PackageDescription>
<NDC11Code>64942-2474-01</NDC11Code>
<ProductNDC>64942-2474</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Degree</ProprietaryName>
<NonProprietaryName>Advanced Protection Sport Defense Antiperspirant Deodorant</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260707</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Conopco d/b/a Unilever</LabelerName>
<SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
<Description>Degree Advanced Protection Sport Defense Antiperspirant Deodorant.</Description>
</NDC>
<NDC>
<NDCCode>71335-2474-1</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (71335-2474-1) </PackageDescription>
<NDC11Code>71335-2474-01</NDC11Code>
<ProductNDC>71335-2474</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078384</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol Tablet is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Mild to severe chronic heart failure (1.1), 2 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 Hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure. Carvedilol is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol Tablet is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5).</Description>
</NDC>
<NDC>
<NDCCode>37662-2474-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-2474-2) </PackageDescription>
<NDC11Code>37662-2474-02</NDC11Code>
<ProductNDC>37662-2474</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Manganum Bromatum</ProprietaryName>
<NonProprietaryName>Manganum Bromatum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230124</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>MANGANESE BROMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-2474-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-2474-3) </PackageDescription>
<NDC11Code>37662-2474-03</NDC11Code>
<ProductNDC>37662-2474</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Manganum Bromatum</ProprietaryName>
<NonProprietaryName>Manganum Bromatum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230124</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>MANGANESE BROMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-2474-4</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-2474-4) </PackageDescription>
<NDC11Code>37662-2474-04</NDC11Code>
<ProductNDC>37662-2474</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Manganum Bromatum</ProprietaryName>
<NonProprietaryName>Manganum Bromatum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230124</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>MANGANESE BROMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0001-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-0001-01)</PackageDescription>
<NDC11Code>00378-0001-01</NDC11Code>
<ProductNDC>0378-0001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clorpres</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride And Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980313</StartMarketingDate>
<EndMarketingDate>20180228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071325</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE; CHLORTHALIDONE</SubstanceName>
<StrengthNumber>.1; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0378-0014-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-0014-01) </PackageDescription>
<NDC11Code>00378-0014-01</NDC11Code>
<ProductNDC>0378-0014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methotrexate</ProprietaryName>
<NonProprietaryName>Methotrexate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081235</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METHOTREXATE SODIUM</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methotrexate tablets are a dihydrofolate reductase inhibitor indicated for the: : 1 Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1) , 2 Treatment of adults with mycosis fungoides (1.1) , 3 Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1) , 4 Treatment of adults with rheumatoid arthritis (1.2) , 5 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3) , 6 Treatment of adults with severe psoriasis (1.4) .</IndicationAndUsage>
<Description>Methotrexate is dihydrofolate reductase inhibitor with the chemical name of N-[4-[[(2,4 diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L glutamic acid. The molecular formula is C20H22N8O5 and the molecular weight is 454.4 g/mol. The structural formula is. Methotrexate Tablets, USP for oral use are available in bottles of 100 tablets. Each methotrexate tablet contains 2.5 mg methotrexate equivalent to 2.74 mg methotrexate sodium and the following inactive ingredients: colloidal silicon dioxide, FD&C Red No. 40 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium carbonate (monohydrate), sodium lauryl sulfate and sodium starch glycolate (potato).</Description>
</NDC>
<NDC>
<NDCCode>0378-0018-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0018-01) </PackageDescription>
<NDC11Code>00378-0018-01</NDC11Code>
<ProductNDC>0378-0018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076704</ApplicationNumber>
<LabelerName>Mylan 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>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, 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. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0378-0023-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0023-01) </PackageDescription>
<NDC11Code>00378-0023-01</NDC11Code>
<ProductNDC>0378-0023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072838</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0027-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-0027-01)</PackageDescription>
<NDC11Code>00378-0027-01</NDC11Code>
<ProductNDC>0378-0027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clorpres</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride And Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980313</StartMarketingDate>
<EndMarketingDate>20180228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071325</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE; CHLORTHALIDONE</SubstanceName>
<StrengthNumber>.2; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0378-0028-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0378-0028-01) </PackageDescription>
<NDC11Code>00378-0028-01</NDC11Code>
<ProductNDC>0378-0028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nadolol</ProprietaryName>
<NonProprietaryName>Nadolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931031</StartMarketingDate>
<EndMarketingDate>20231130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074172</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NADOLOL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19931031</StartMarketingDatePackage>
<EndMarketingDatePackage>20231130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0030-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-0030-01) </PackageDescription>
<NDC11Code>00378-0030-01</NDC11Code>
<ProductNDC>0378-0030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clorazepate Dipotassium</ProprietaryName>
<NonProprietaryName>Clorazepate Dipotassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071858</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLORAZEPATE DIPOTASSIUM</SubstanceName>
<StrengthNumber>3.75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0032-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0032-01) </PackageDescription>
<NDC11Code>00378-0032-01</NDC11Code>
<ProductNDC>0378-0032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076704</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19931223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, 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. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0378-0040-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-0040-01) </PackageDescription>
<NDC11Code>00378-0040-01</NDC11Code>
<ProductNDC>0378-0040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clorazepate Dipotassium</ProprietaryName>
<NonProprietaryName>Clorazepate Dipotassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071858</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLORAZEPATE DIPOTASSIUM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0042-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0042-01) </PackageDescription>
<NDC11Code>00378-0042-01</NDC11Code>
<ProductNDC>0378-0042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine And Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Perphenazine And Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071443</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PERPHENAZINE; AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS], Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19881110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perphenazine and amitriptyline hydrochloride tablets are recommended for treatment of (1) patients with moderate to severe anxiety and/or agitation and depressed mood, (2) patients with depression in whom anxiety and/or agitation are severe, and (3) patients with depression and anxiety in association with chronic physical disease. In many of these patients, anxiety masks the depressive state so that, although therapy with a tranquilizer appears to be indicated, the administration of a tranquilizer alone will not be adequate. Schizophrenic patients who have associated depressive symptoms should be considered for therapy with perphenazine and amitriptyline hydrochloride tablets.</IndicationAndUsage>
<Description>Perphenazine and amitriptyline hydrochloride, a broad spectrum psychotherapeutic agent for the management of outpatients and hospitalized patients with psychoses or neuroses characterized by mixtures of anxiety or agitation with symptoms of depression, is a combination of perphenazine and amitriptyline hydrochloride. Since such mixed syndromes can occur in patients with various degrees of intensity of mental illness, perphenazine and amitriptyline hydrochloride tablets are provided in multiple combinations to afford dosage flexibility for optimum management. Perphenazine is a phenothiazine derivative. The formula is 4-[3-(2-chloro-10H-phenothiazin-10yl) propyl]-piperazineethanol. Perphenazine, USP is a white, odorless, bitter tasting powder that is insoluble in water. The molecular weight is 403.97. Its structural formula is. Amitriptyline is a dibenzocycloheptadiene derivative. The formula is 10,11-dihydro-N,N-dimethyl-5H-dibenzo[a,d]cycloheptene-∆5,γ -propylamine hydrochloride. Amitriptyline hydrochloride, USP is a white, odorless, crystalline compound which is freely soluble in water. The molecular weight is 313.87. Its structural formula is. Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide. The following additional product specific inactive ingredients are employed. 2 mg/10 mg - hydroxypropyl cellulose2 mg/25 mg - hydroxypropyl cellulose4 mg/10 mg - polysorbate 804 mg/25 mg - hydroxypropyl cellulose4 mg/50 mg - hydroxypropyl cellulose. The following product specific coloring agents are employed. 2 mg/10 mg - calcium sulfate, talc2 mg/25 mg - D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake4 mg/10 mg - FD&C Blue No. 1 Aluminum Lake4 mg/25 mg - FD&C Yellow No. 6 Aluminum Lake4 mg/50 mg - D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0378-0045-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0045-01) </PackageDescription>
<NDC11Code>00378-0045-01</NDC11Code>
<ProductNDC>0378-0045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072838</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0047-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0047-01) </PackageDescription>
<NDC11Code>00378-0047-01</NDC11Code>
<ProductNDC>0378-0047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076704</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19931223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, 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. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0378-0052-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-0052-01) </PackageDescription>
<NDC11Code>00378-0052-01</NDC11Code>
<ProductNDC>0378-0052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pindolol</ProprietaryName>
<NonProprietaryName>Pindolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920903</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074019</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PINDOLOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19920903</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pindolol tablets are indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.</IndicationAndUsage>
<Description>Pindolol, a synthetic beta-adrenergic receptor blocking agent with intrinsic sympathomimetic activity is 1-(Indol-4-yloxy)-3-(isopropylamino)-2-propanol. Pindolol, USP is a white to off-white, crystalline powder having a faint odor which is practically insoluble in water; slightly soluble in methanol; and very slightly soluble in chloroform. Each tablet for oral administration contains pindolol, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>0378-0053-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0053-01) </PackageDescription>
<NDC11Code>00378-0053-01</NDC11Code>
<ProductNDC>0378-0053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cimetidine</ProprietaryName>
<NonProprietaryName>Cimetidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074246</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CIMETIDINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19940517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cimetidine tablets are indicated in. 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION: Duodenal Ulcer). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine tablets 400 mg at bedtime for periods of up to 5 years. 3. Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks. 4. Erosive gastroesophageal reflux (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine tablets beyond 12 weeks has not been established (see DOSAGE AND ADMINISTRATION: GERD). 5. The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).</IndicationAndUsage>
<Description>Cimetidine is a histamine H2-receptor antagonist. Chemically it is N"-cyano-N-methyl-N'-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]thio]-ethyl]guanidine. Its structural formula is. Cimetidine contains an imidazole ring, and is chemically related to histamine. Cimetidine has a bitter taste and characteristic odor.</Description>
</NDC>
<NDC>
<NDCCode>0378-0055-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-0055-01) </PackageDescription>
<NDC11Code>00378-0055-01</NDC11Code>
<ProductNDC>0378-0055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900608</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072668</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19900608</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Timolol maleate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.</IndicationAndUsage>
<Description>Timolol maleate is a nonselective beta-adrenergic receptor blocking agent. The chemical name for timolol maleate is (S)-1-[(1,1-dimethylethyl)amino]-3-[[4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]oxy]-2-propanol (Z)-2-butenedioate (1:1) salt. It possesses an asymmetric carbon atom in its structure and is provided as the levo isomer. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is supplied as tablets containing 5 mg, 10 mg and 20 mg timolol maleate for oral administration. Inactive ingredients are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium lauryl sulfate, FD&C Blue No. 2 aluminum lake, and D&C Yellow No. 10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>0378-0060-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0060-01) </PackageDescription>
<NDC11Code>00378-0060-01</NDC11Code>
<ProductNDC>0378-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Maprotiline Hydrochloride</ProprietaryName>
<NonProprietaryName>Maprotiline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072285</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MAPROTILINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19881003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0069-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0069-01) </PackageDescription>
<NDC11Code>00378-0069-01</NDC11Code>
<ProductNDC>0378-0069</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indapamide</ProprietaryName>
<NonProprietaryName>Indapamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074461</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>INDAPAMIDE</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure.</IndicationAndUsage>
<Description>Indapamide is an oral antihypertensive/diuretic. Its molecule contains both a polar sulfamoyl chlorobenzamide moiety and a lipid-soluble methylindoline moiety. It differs chemically from the thiazides in that it does not possess the thiazide ring system and contains only one sulfonamide group. The chemical name of indapamide is 4-Chloro-N-(2-methyl-1-indolinyl)-3-Sulfamoylbenzamide, and its molecular weight is 365.84. The compound is a weak acid, pKa=8.8, and is soluble in aqueous solutions of strong bases. It is a white to yellow-white crystalline (tetragonal) powder. C16H16ClN3O3S. Each tablet, for oral administration, contains 1.25 mg or 2.5 mg of indapamide, USP and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide. Additionally, the 1.25 mg product contains glyceryl triacetate and D&C Red No. 30 Aluminum Lake and the 2.5 mg product contains triacetin.</Description>
</NDC>
<NDC>
<NDCCode>0378-0070-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-0070-01) </PackageDescription>
<NDC11Code>00378-0070-01</NDC11Code>
<ProductNDC>0378-0070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clorazepate Dipotassium</ProprietaryName>
<NonProprietaryName>Clorazepate Dipotassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071858</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLORAZEPATE DIPOTASSIUM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>