{
"NDC": [
{
"NDCCode": "0555-0788-02",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0555-0788-02) ",
"NDC11Code": "00555-0788-02",
"ProductNDC": "0555-0788",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090402",
"EndMarketingDate": "20200731",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021303",
"LabelerName": "Barr Laboratories Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "5; 5; 5; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2020-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090402",
"EndMarketingDatePackage": "20200731",
"SamplePackage": "N"
},
{
"NDCCode": "37662-0788-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-0788-2) ",
"NDC11Code": "37662-0788-02",
"ProductNDC": "37662-0788",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Graphites",
"NonProprietaryName": "Graphites",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220708",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "GRAPHITE",
"StrengthNumber": "100",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220708",
"SamplePackage": "N"
},
{
"NDCCode": "50991-788-02",
"PackageDescription": "12 TABLET in 1 BLISTER PACK (50991-788-02) ",
"NDC11Code": "50991-0788-02",
"ProductNDC": "50991-788",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alahist Pe",
"NonProprietaryName": "Dexbrompheniramine Maleate, Phenylephrine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200824",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Poly Pharmaceuticals, Inc.",
"SubstanceName": "DEXBROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "2; 7.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200824",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, water eyes, 5 nasal congestion, 6 reduces swelling of nasal passages."
},
{
"NDCCode": "61786-788-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (61786-788-02) ",
"NDC11Code": "61786-0788-02",
"ProductNDC": "61786-788",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077745",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160726",
"SamplePackage": "N"
},
{
"NDCCode": "65044-0788-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0788-2) ",
"NDC11Code": "65044-0788-02",
"ProductNDC": "65044-0788",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Ryegrass",
"NonProprietaryName": "Standardized Grass Pollen, Ryegrass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103877",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "LOLIUM PERENNE POLLEN",
"StrengthNumber": "100000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "69968-0788-2",
"PackageDescription": "1500 mL in 1 BOTTLE, PLASTIC (69968-0788-2) ",
"NDC11Code": "69968-0788-02",
"ProductNDC": "69968-0788",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Listerine Ultraclean Antiseptic",
"ProprietaryNameSuffix": "Cool Mint",
"NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "20230205",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "THYMOL; EUCALYPTOL; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE",
"StrengthNumber": ".64; .92; .42; .6",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230205",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent and reduce: 1 plaque, 2 gingivitis."
},
{
"NDCCode": "71335-0788-2",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-0788-2) ",
"NDC11Code": "71335-0788-02",
"ProductNDC": "71335-0788",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyoscyamine",
"ProprietaryNameSuffix": "Sl",
"NonProprietaryName": "Hyoscyamine Sulfate",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20160415",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "HYOSCYAMINE SULFATE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180424",
"SamplePackage": "N",
"IndicationAndUsage": "Hyoscyamine sulfate sublingual tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine sulfate sublingual tablets are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.",
"Description": "Hyoscyamine sulfate sublingual tablets contain 0.125 mg hyoscyamine sulfate formulated for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2H2SO42H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure. Each tablet also contains as inactive ingredients: FD&C blue #1, lactose monohydrate, magnesium stearate, mannitol, starch and stearic acid."
},
{
"NDCCode": "76420-788-02",
"PackageDescription": "2 TABLET in 1 BOTTLE (76420-788-02) ",
"NDC11Code": "76420-0788-02",
"ProductNDC": "76420-788",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212517",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240319",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Tablets are indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis, 5 tendonitis, 6 bursitis, 7 acute gout.",
"Description": "Naproxen tablets, USP are nonsteroidal anti-inflammatory drugs and available as follows: Naproxen tablets, USP are available as light yellow round shaped tablets containing 250 mg naproxen, light yellow capsule shaped tablets containing 375 mg naproxen, and light yellow oblong shaped tablets containing 500 mg naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. It has the following structural formula:. Naproxen is white or almost white crystalline powder. It is insoluble in water, soluble in chloroform, dehydrated ethanol and methanol. Sparingly soluble in ether. The octanol/water partition coefficient of Naproxen at pH < 2.18 is 3.18. Each naproxen tablet, USP contains the following inactive ingredients: croscarmellose sodium, yellow iron oxide, povidone and magnesium stearate."
},
{
"NDCCode": "0009-0555-02",
"PackageDescription": "10 mL in 1 VIAL (0009-0555-02) ",
"NDC11Code": "00009-0555-02",
"ProductNDC": "0009-0555",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lincocin",
"NonProprietaryName": "Lincomycin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL",
"StartMarketingDate": "19641229",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050317",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "LINCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-07-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19641229",
"SamplePackage": "N"
},
{
"NDCCode": "0555-0033-02",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0555-0033-02) ",
"NDC11Code": "00555-0033-02",
"ProductNDC": "0555-0033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlordiazepoxide Hydrochloride",
"NonProprietaryName": "Chlordiazepoxide Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083116",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CHLORDIAZEPOXIDE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19900930",
"SamplePackage": "N",
"IndicationAndUsage": "Chlordiazepoxide HCl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide HCl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Chlordiazepoxide hydrochloride, USP is the prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety. Chlordiazepoxide hydrochloride, USP is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence. Chlordiazepoxide hydrochloride, USP is 7-chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A white to practically white crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The structural formula is. C16H14ClN3O HCl M.W. 336.22. Each capsule, for oral administration, contains either 5 mg, 10 mg or 25 mg of chlordiazepoxide hydrochloride, USP and has the following inactive ingredients: anhydrous lactose, D&C yellow no. 10, FD&C blue no. 1, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, pharmaceutical glaze, and titanium dioxide. The 5 mg and 25 mg also contain D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and synthetic black iron oxide. In addition, the 5 mg contains D&C red no. 33 and the 10 mg also contains FD&C red no. 40, povidone, propylene glycol, and sodium hydroxide. The 5 mg and 25 mg may also contain propylene glycol."
},
{
"NDCCode": "0555-0059-02",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0555-0059-02)",
"NDC11Code": "00555-0059-02",
"ProductNDC": "0555-0059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diphenhydramine Hydrochloride",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19720901",
"EndMarketingDate": "20140731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080738",
"LabelerName": "Barr Laboratories Inc.",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-08-08"
},
{
"NDCCode": "0555-0066-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (0555-0066-02) ",
"NDC11Code": "00555-0066-02",
"ProductNDC": "0555-0066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isoniazid",
"NonProprietaryName": "Isoniazid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19720901",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080936",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ISONIAZID",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimycobacterial [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19720901",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy. Isoniazid tablets, USP are recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis): 1 Persons with human immunodeficiency virus (HIV) infection (greater than or equal to 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy., 2 Close contacts of persons with newly diagnosed infectious tuberculosis (greater than or equal to 5 mm). In addition, tuberculin-negative (less than 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (greater than 5 mm), therapy should be continued., 3 Recent converters, as indicated by a tuberculin skin test (greater than or equal to 10 mm increase within a 2-year period for those less than 35 years old; greater than or equal to 15 mm increase for those greater than or equal to 35 years of age). All infants and children younger than 4 years of age with a greater than 10 mm skin test are included in this category., 4 Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (greater than or equal to 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly., 5 Intravenous drug users known to be HIV-seronegative (greater than 10 mm)., 6 Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (greater than or equal to 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin’s disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state [with or without weight loss], chronic peptic ulcer disease, chronic malabsorption syndromes and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly.",
"Description": "Isoniazid, USP is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil, microcrystalline cellulose, pregelatinized corn starch and talc. Isoniazid, USP is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has the following structural formula. C6H7N3O M.W. 137.14. Isoniazid, USP is odorless, and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol and slightly soluble in chloroform and in ether. Isoniazid, USP is slowly affected by exposure to air and light."
},
{
"NDCCode": "0555-0071-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (0555-0071-02) ",
"NDC11Code": "00555-0071-02",
"ProductNDC": "0555-0071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isoniazid",
"NonProprietaryName": "Isoniazid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19720901",
"EndMarketingDate": "20270630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080937",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ISONIAZID",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimycobacterial [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19720901",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N",
"IndicationAndUsage": "Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy. Isoniazid tablets, USP are recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis): 1 Persons with human immunodeficiency virus (HIV) infection (greater than or equal to 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy., 2 Close contacts of persons with newly diagnosed infectious tuberculosis (greater than or equal to 5 mm). In addition, tuberculin-negative (less than 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (greater than 5 mm), therapy should be continued., 3 Recent converters, as indicated by a tuberculin skin test (greater than or equal to 10 mm increase within a 2-year period for those less than 35 years old; greater than or equal to 15 mm increase for those greater than or equal to 35 years of age). All infants and children younger than 4 years of age with a greater than 10 mm skin test are included in this category., 4 Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (greater than or equal to 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly., 5 Intravenous drug users known to be HIV-seronegative (greater than 10 mm)., 6 Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (greater than or equal to 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin’s disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state [with or without weight loss], chronic peptic ulcer disease, chronic malabsorption syndromes and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly.",
"Description": "Isoniazid, USP is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil, microcrystalline cellulose, pregelatinized corn starch and talc. Isoniazid, USP is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has the following structural formula. C6H7N3O M.W. 137.14. Isoniazid, USP is odorless, and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol and slightly soluble in chloroform and in ether. Isoniazid, USP is slowly affected by exposure to air and light."
},
{
"NDCCode": "0555-0158-02",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0555-0158-02) ",
"NDC11Code": "00555-0158-02",
"ProductNDC": "0555-0158",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlordiazepoxide Hydrochloride",
"NonProprietaryName": "Chlordiazepoxide Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19760701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084768",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CHLORDIAZEPOXIDE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19760701",
"SamplePackage": "N",
"IndicationAndUsage": "Chlordiazepoxide HCl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide HCl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Chlordiazepoxide hydrochloride, USP is the prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety. Chlordiazepoxide hydrochloride, USP is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence. Chlordiazepoxide hydrochloride, USP is 7-chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A white to practically white crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The structural formula is. C16H14ClN3O HCl M.W. 336.22. Each capsule, for oral administration, contains either 5 mg, 10 mg or 25 mg of chlordiazepoxide hydrochloride, USP and has the following inactive ingredients: anhydrous lactose, D&C yellow no. 10, FD&C blue no. 1, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, pharmaceutical glaze, and titanium dioxide. The 5 mg and 25 mg also contain D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and synthetic black iron oxide. In addition, the 5 mg contains D&C red no. 33 and the 10 mg also contains FD&C red no. 40, povidone, propylene glycol, and sodium hydroxide. The 5 mg and 25 mg may also contain propylene glycol."
},
{
"NDCCode": "0555-0159-02",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0555-0159-02) ",
"NDC11Code": "00555-0159-02",
"ProductNDC": "0555-0159",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlordiazepoxide Hydrochloride",
"NonProprietaryName": "Chlordiazepoxide Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19760701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084769",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CHLORDIAZEPOXIDE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19760701",
"SamplePackage": "N",
"IndicationAndUsage": "Chlordiazepoxide HCl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide HCl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Chlordiazepoxide hydrochloride, USP is the prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety. Chlordiazepoxide hydrochloride, USP is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence. Chlordiazepoxide hydrochloride, USP is 7-chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A white to practically white crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The structural formula is. C16H14ClN3O HCl M.W. 336.22. Each capsule, for oral administration, contains either 5 mg, 10 mg or 25 mg of chlordiazepoxide hydrochloride, USP and has the following inactive ingredients: anhydrous lactose, D&C yellow no. 10, FD&C blue no. 1, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, pharmaceutical glaze, and titanium dioxide. The 5 mg and 25 mg also contain D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and synthetic black iron oxide. In addition, the 5 mg contains D&C red no. 33 and the 10 mg also contains FD&C red no. 40, povidone, propylene glycol, and sodium hydroxide. The 5 mg and 25 mg may also contain propylene glycol."
},
{
"NDCCode": "0555-0252-02",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0555-0252-02) ",
"NDC11Code": "00555-0252-02",
"ProductNDC": "0555-0252",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dipyridamole",
"NonProprietaryName": "Dipyridamole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19801001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087184",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "DIPYRIDAMOLE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-01-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19801001",
"SamplePackage": "N"
},
{
"NDCCode": "0555-0285-02",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0555-0285-02) ",
"NDC11Code": "00555-0285-02",
"ProductNDC": "0555-0285",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dipyridamole",
"NonProprietaryName": "Dipyridamole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19820101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087716",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "DIPYRIDAMOLE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-01-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19820101",
"SamplePackage": "N"
},
{
"NDCCode": "0555-0286-02",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0555-0286-02) ",
"NDC11Code": "00555-0286-02",
"ProductNDC": "0555-0286",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dipyridamole",
"NonProprietaryName": "Dipyridamole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19820101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087717",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "DIPYRIDAMOLE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-01-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19820101",
"SamplePackage": "N"
},
{
"NDCCode": "0555-0302-02",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0555-0302-02) ",
"NDC11Code": "00555-0302-02",
"ProductNDC": "0555-0302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Pamoate",
"NonProprietaryName": "Hydroxyzine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19840701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088487",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "HYDROXYZINE PAMOATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19840701",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine pamoate, USP is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1′-methylene bis (2 hydroxy-3-naphthalene carboxylic acid). It has the following structural formula. C21H27ClN2O2C23H16O6 M.W. 763.27. Hydroxyzine pamoate capsules, USP are administered in doses equivalent to 25 mg, 50 mg or 100 mg of hydroxyzine hydrochloride. In addition, each capsule contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, and pregelatinized corn starch. The 25 mg also contains anhydrous lactose. The 50 mg and 100 mg also contain lactose monohydrate. The capsule shell ingredients for the 25 mg capsule are D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 50 mg capsule shell contains D&C Red No. 33, D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 100 mg capsule shell contains D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The edible imprinting ink on the 25 mg, 50 mg and 100 mg capsules contains black iron oxide, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, propylene glycol, and shellac glaze."
},
{
"NDCCode": "0555-0323-02",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0555-0323-02) ",
"NDC11Code": "00555-0323-02",
"ProductNDC": "0555-0323",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Pamoate",
"NonProprietaryName": "Hydroxyzine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19840701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088496",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "HYDROXYZINE PAMOATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19840701",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine pamoate, USP is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1′-methylene bis (2 hydroxy-3-naphthalene carboxylic acid). It has the following structural formula. C21H27ClN2O2C23H16O6 M.W. 763.27. Hydroxyzine pamoate capsules, USP are administered in doses equivalent to 25 mg, 50 mg or 100 mg of hydroxyzine hydrochloride. In addition, each capsule contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, and pregelatinized corn starch. The 25 mg also contains anhydrous lactose. The 50 mg and 100 mg also contain lactose monohydrate. The capsule shell ingredients for the 25 mg capsule are D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 50 mg capsule shell contains D&C Red No. 33, D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 100 mg capsule shell contains D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The edible imprinting ink on the 25 mg, 50 mg and 100 mg capsules contains black iron oxide, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, propylene glycol, and shellac glaze."
},
{
"NDCCode": "0555-0324-02",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0555-0324-02) ",
"NDC11Code": "00555-0324-02",
"ProductNDC": "0555-0324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Pamoate",
"NonProprietaryName": "Hydroxyzine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19840701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088488",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "HYDROXYZINE PAMOATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19840701",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine pamoate, USP is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1′-methylene bis (2 hydroxy-3-naphthalene carboxylic acid). It has the following structural formula. C21H27ClN2O2C23H16O6 M.W. 763.27. Hydroxyzine pamoate capsules, USP are administered in doses equivalent to 25 mg, 50 mg or 100 mg of hydroxyzine hydrochloride. In addition, each capsule contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, and pregelatinized corn starch. The 25 mg also contains anhydrous lactose. The 50 mg and 100 mg also contain lactose monohydrate. The capsule shell ingredients for the 25 mg capsule are D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 50 mg capsule shell contains D&C Red No. 33, D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 100 mg capsule shell contains D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The edible imprinting ink on the 25 mg, 50 mg and 100 mg capsules contains black iron oxide, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, propylene glycol, and shellac glaze."
},
{
"NDCCode": "0555-0381-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (0555-0381-02) ",
"NDC11Code": "00555-0381-02",
"ProductNDC": "0555-0381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meperidine Hydrochloride",
"NonProprietaryName": "Meperidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970203",
"EndMarketingDate": "20210228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088639",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "MEPERIDINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2021-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19970203",
"EndMarketingDatePackage": "20210228",
"SamplePackage": "N"
},
{
"NDCCode": "0555-0382-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (0555-0382-02)",
"NDC11Code": "00555-0382-02",
"ProductNDC": "0555-0382",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meperidine Hydrochloride",
"NonProprietaryName": "Meperidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961011",
"EndMarketingDate": "20160731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088640",
"LabelerName": "Barr Laboratories Inc.",
"SubstanceName": "MEPERIDINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0555-0392-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (0555-0392-02) ",
"NDC11Code": "00555-0392-02",
"ProductNDC": "0555-0392",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meperidine Hydrochloride",
"NonProprietaryName": "Meperidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150224",
"EndMarketingDate": "20210228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088640",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "MEPERIDINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2021-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150224",
"EndMarketingDatePackage": "20210228",
"SamplePackage": "N"
},
{
"NDCCode": "0555-0483-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (0555-0483-02) ",
"NDC11Code": "00555-0483-02",
"ProductNDC": "0555-0483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amiloride Hydrochloride And Hydrochlorothiazide",
"NonProprietaryName": "Amiloride Hydrochloride And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19891201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071111",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "5; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2023-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19891201",
"SamplePackage": "N",
"IndicationAndUsage": "Amiloride hydrochloride and hydrochlorothiazide tablets are indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic diuretics are used alone, or in whom maintenance of normal serum potassium levels is considered to be clinically important, e.g., digitalized patients, or patients with significant cardiac arrhythmias. The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet. Amiloride hydrochloride and hydrochlorothiazide tablets may be used alone or as an adjunct to other antihypertensive drugs, such as methyldopa or beta blockers. Since amiloride hydrochloride and hydrochlorothiazide enhances the action of these agents, dosage adjustments may be necessary to avoid an excessive fall in blood pressure and other unwanted side effects. The fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.",
"Description": "Amiloride hydrochloride and hydrochlorothiazide tablets, USP combine the potassium-conserving action of amiloride hydrochloride with the natriuretic action of hydrochlorothiazide. Amiloride HCl, USP is designated chemically as N-amidino-3,5,-diamino-6-chloropyrazine-carboxamide monohydrochloride dihydrate and its structural formula is. C6H8CIN7OHCl2H2O M.W. 302.12. Hydrochlorothiazide, USP is designated chemically as 6-chloro-3,4-dihydro-2H-1, 2, 4-benzo-thiadiazine-7-sulfonamide 1, 1-dioxide. Its structural formula is. C7H8CIN3O4S2 M.W. 297.74. It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Each tablet, for oral administration, contains 5 mg of amiloride hydrochloride, USP (calculated on the anhydrous basis) and 50 mg of hydrochlorothiazide, USP. Inactive Ingredients: Croscarmellose sodium, D&C yellow no. 10 (aluminum lake), lactose monohydrate, magnesium oxide, magnesium stearate, microcrystalline cellulose."
},
{
"NDCCode": "0555-0484-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (0555-0484-02) ",
"NDC11Code": "00555-0484-02",
"ProductNDC": "0555-0484",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leucovorin Calcium",
"NonProprietaryName": "Leucovorin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071198",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "LEUCOVORIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2026-04-21",
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"StartMarketingDatePackage": "19900630",
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"IndicationAndUsage": "Leucovorin calcium tablets are a folate analog indicated: 1 To reduce the toxicity of: Methotrexate in adult patients with impaired methotrexate elimination, andFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1), 2 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2).",
"Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8- hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.5 g/mol. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg tablet contains 5 mg of leucovorin (equivalent to 5.4 mg of leucovorin calcium, USP), and each 25 mg tablet contains 25 mg of leucovorin (equivalent to 27.01 mg of leucovorin calcium, USP). The 5 mg and 25 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Additionally, the 25 mg tablet contains D&C yellow no.10 aluminum lake and FD&C blue no.1 aluminum lake."
},
{
"NDCCode": "0555-0513-02",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0555-0513-02) ",
"NDC11Code": "00555-0513-02",
"ProductNDC": "0555-0513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetazolamide",
"NonProprietaryName": "Acetazolamide",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20000222",
"EndMarketingDate": "20190630",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA012945",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ACETAZOLAMIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20000222",
"EndMarketingDatePackage": "20190630",
"SamplePackage": "N"
},
{
"NDCCode": "0555-0572-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (0555-0572-02) ",
"NDC11Code": "00555-0572-02",
"ProductNDC": "0555-0572",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methotrexate",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19901101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081099",
"LabelerName": "Teva Pharmaceuticals USA, 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": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19901101",
"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, USP is dihydrofolate reductase inhibitor with the chemical name of L-glutamic acid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]. The molecular formula is C20H22N8O5 and the molecular weight is 454.45 g/mol. The structural formula is. Methotrexate tablets, USP for oral use are available in bottles of 36 and 100 tablets. Each tablet contains 2.5 mg methotrexate, USP equivalent to 2.74 mg methotrexate sodium. Inactive Ingredients: Anhydrous lactose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, propylene glycol, sodium carbonate monohydrate, and talc."
},
{
"NDCCode": "0555-0594-02",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0555-0594-02)",
"NDC11Code": "00555-0594-02",
"ProductNDC": "0555-0594",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protriptyline Hydrochloride",
"NonProprietaryName": "Protriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073645",
"LabelerName": "Barr Laboratories Inc.",
"SubstanceName": "PROTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-01-30"
},
{
"NDCCode": "0555-0595-02",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0555-0595-02)",
"NDC11Code": "00555-0595-02",
"ProductNDC": "0555-0595",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protriptyline Hydrochloride",
"NonProprietaryName": "Protriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073644",
"LabelerName": "Barr Laboratories Inc.",
"SubstanceName": "PROTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-01-30"
}
]
}
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<NDC>
<NDCCode>0555-0788-02</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0555-0788-02) </PackageDescription>
<NDC11Code>00555-0788-02</NDC11Code>
<ProductNDC>0555-0788</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090402</StartMarketingDate>
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<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021303</ApplicationNumber>
<LabelerName>Barr Laboratories Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
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<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090402</StartMarketingDatePackage>
<EndMarketingDatePackage>20200731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-0788-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-0788-2) </PackageDescription>
<NDC11Code>37662-0788-02</NDC11Code>
<ProductNDC>37662-0788</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Graphites</ProprietaryName>
<NonProprietaryName>Graphites</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220708</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>GRAPHITE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50991-788-02</NDCCode>
<PackageDescription>12 TABLET in 1 BLISTER PACK (50991-788-02) </PackageDescription>
<NDC11Code>50991-0788-02</NDC11Code>
<ProductNDC>50991-788</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alahist Pe</ProprietaryName>
<NonProprietaryName>Dexbrompheniramine Maleate, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200824</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Poly Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DEXBROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, water eyes, 5 nasal congestion, 6 reduces swelling of nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61786-788-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (61786-788-02) </PackageDescription>
<NDC11Code>61786-0788-02</NDC11Code>
<ProductNDC>61786-788</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine</ProprietaryName>
<NonProprietaryName>Quetiapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077745</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65044-0788-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0788-2) </PackageDescription>
<NDC11Code>65044-0788-02</NDC11Code>
<ProductNDC>65044-0788</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Ryegrass</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Ryegrass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103877</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>LOLIUM PERENNE POLLEN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>69968-0788-2</NDCCode>
<PackageDescription>1500 mL in 1 BOTTLE, PLASTIC (69968-0788-2) </PackageDescription>
<NDC11Code>69968-0788-02</NDC11Code>
<ProductNDC>69968-0788</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Listerine Ultraclean Antiseptic</ProprietaryName>
<ProprietaryNameSuffix>Cool Mint</ProprietaryNameSuffix>
<NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230205</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>THYMOL; EUCALYPTOL; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>.64; .92; .42; .6</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent and reduce: 1 plaque, 2 gingivitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-0788-2</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-0788-2) </PackageDescription>
<NDC11Code>71335-0788-02</NDC11Code>
<ProductNDC>71335-0788</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyoscyamine</ProprietaryName>
<ProprietaryNameSuffix>Sl</ProprietaryNameSuffix>
<NonProprietaryName>Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160415</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyoscyamine sulfate sublingual tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine sulfate sublingual tablets are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.</IndicationAndUsage>
<Description>Hyoscyamine sulfate sublingual tablets contain 0.125 mg hyoscyamine sulfate formulated for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2H2SO42H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure. Each tablet also contains as inactive ingredients: FD&C blue #1, lactose monohydrate, magnesium stearate, mannitol, starch and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>76420-788-02</NDCCode>
<PackageDescription>2 TABLET in 1 BOTTLE (76420-788-02) </PackageDescription>
<NDC11Code>76420-0788-02</NDC11Code>
<ProductNDC>76420-788</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212517</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>375</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen Tablets are indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis, 5 tendonitis, 6 bursitis, 7 acute gout.</IndicationAndUsage>
<Description>Naproxen tablets, USP are nonsteroidal anti-inflammatory drugs and available as follows: Naproxen tablets, USP are available as light yellow round shaped tablets containing 250 mg naproxen, light yellow capsule shaped tablets containing 375 mg naproxen, and light yellow oblong shaped tablets containing 500 mg naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. It has the following structural formula:. Naproxen is white or almost white crystalline powder. It is insoluble in water, soluble in chloroform, dehydrated ethanol and methanol. Sparingly soluble in ether. The octanol/water partition coefficient of Naproxen at pH < 2.18 is 3.18. Each naproxen tablet, USP contains the following inactive ingredients: croscarmellose sodium, yellow iron oxide, povidone and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0009-0555-02</NDCCode>
<PackageDescription>10 mL in 1 VIAL (0009-0555-02) </PackageDescription>
<NDC11Code>00009-0555-02</NDC11Code>
<ProductNDC>0009-0555</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lincocin</ProprietaryName>
<NonProprietaryName>Lincomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL</RouteName>
<StartMarketingDate>19641229</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050317</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>LINCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-07-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19641229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0555-0033-02</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0555-0033-02) </PackageDescription>
<NDC11Code>00555-0033-02</NDC11Code>
<ProductNDC>0555-0033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlordiazepoxide Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlordiazepoxide Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083116</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>CHLORDIAZEPOXIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlordiazepoxide HCl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide HCl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Chlordiazepoxide hydrochloride, USP is the prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety. Chlordiazepoxide hydrochloride, USP is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence. Chlordiazepoxide hydrochloride, USP is 7-chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A white to practically white crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The structural formula is. C16H14ClN3O HCl M.W. 336.22. Each capsule, for oral administration, contains either 5 mg, 10 mg or 25 mg of chlordiazepoxide hydrochloride, USP and has the following inactive ingredients: anhydrous lactose, D&C yellow no. 10, FD&C blue no. 1, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, pharmaceutical glaze, and titanium dioxide. The 5 mg and 25 mg also contain D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and synthetic black iron oxide. In addition, the 5 mg contains D&C red no. 33 and the 10 mg also contains FD&C red no. 40, povidone, propylene glycol, and sodium hydroxide. The 5 mg and 25 mg may also contain propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0555-0059-02</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0555-0059-02)</PackageDescription>
<NDC11Code>00555-0059-02</NDC11Code>
<ProductNDC>0555-0059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diphenhydramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19720901</StartMarketingDate>
<EndMarketingDate>20140731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080738</ApplicationNumber>
<LabelerName>Barr Laboratories Inc.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-08-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>0555-0066-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0555-0066-02) </PackageDescription>
<NDC11Code>00555-0066-02</NDC11Code>
<ProductNDC>0555-0066</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isoniazid</ProprietaryName>
<NonProprietaryName>Isoniazid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19720901</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080936</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ISONIAZID</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19720901</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy. Isoniazid tablets, USP are recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis): 1 Persons with human immunodeficiency virus (HIV) infection (greater than or equal to 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy., 2 Close contacts of persons with newly diagnosed infectious tuberculosis (greater than or equal to 5 mm). In addition, tuberculin-negative (less than 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (greater than 5 mm), therapy should be continued., 3 Recent converters, as indicated by a tuberculin skin test (greater than or equal to 10 mm increase within a 2-year period for those less than 35 years old; greater than or equal to 15 mm increase for those greater than or equal to 35 years of age). All infants and children younger than 4 years of age with a greater than 10 mm skin test are included in this category., 4 Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (greater than or equal to 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly., 5 Intravenous drug users known to be HIV-seronegative (greater than 10 mm)., 6 Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (greater than or equal to 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin’s disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state [with or without weight loss], chronic peptic ulcer disease, chronic malabsorption syndromes and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly.</IndicationAndUsage>
<Description>Isoniazid, USP is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil, microcrystalline cellulose, pregelatinized corn starch and talc. Isoniazid, USP is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has the following structural formula. C6H7N3O M.W. 137.14. Isoniazid, USP is odorless, and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol and slightly soluble in chloroform and in ether. Isoniazid, USP is slowly affected by exposure to air and light.</Description>
</NDC>
<NDC>
<NDCCode>0555-0071-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0555-0071-02) </PackageDescription>
<NDC11Code>00555-0071-02</NDC11Code>
<ProductNDC>0555-0071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isoniazid</ProprietaryName>
<NonProprietaryName>Isoniazid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19720901</StartMarketingDate>
<EndMarketingDate>20270630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080937</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ISONIAZID</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19720901</StartMarketingDatePackage>
<EndMarketingDatePackage>20270630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy. Isoniazid tablets, USP are recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis): 1 Persons with human immunodeficiency virus (HIV) infection (greater than or equal to 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy., 2 Close contacts of persons with newly diagnosed infectious tuberculosis (greater than or equal to 5 mm). In addition, tuberculin-negative (less than 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (greater than 5 mm), therapy should be continued., 3 Recent converters, as indicated by a tuberculin skin test (greater than or equal to 10 mm increase within a 2-year period for those less than 35 years old; greater than or equal to 15 mm increase for those greater than or equal to 35 years of age). All infants and children younger than 4 years of age with a greater than 10 mm skin test are included in this category., 4 Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (greater than or equal to 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly., 5 Intravenous drug users known to be HIV-seronegative (greater than 10 mm)., 6 Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (greater than or equal to 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin’s disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state [with or without weight loss], chronic peptic ulcer disease, chronic malabsorption syndromes and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly.</IndicationAndUsage>
<Description>Isoniazid, USP is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil, microcrystalline cellulose, pregelatinized corn starch and talc. Isoniazid, USP is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has the following structural formula. C6H7N3O M.W. 137.14. Isoniazid, USP is odorless, and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol and slightly soluble in chloroform and in ether. Isoniazid, USP is slowly affected by exposure to air and light.</Description>
</NDC>
<NDC>
<NDCCode>0555-0158-02</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0555-0158-02) </PackageDescription>
<NDC11Code>00555-0158-02</NDC11Code>
<ProductNDC>0555-0158</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlordiazepoxide Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlordiazepoxide Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19760701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084768</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>CHLORDIAZEPOXIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19760701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlordiazepoxide HCl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide HCl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Chlordiazepoxide hydrochloride, USP is the prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety. Chlordiazepoxide hydrochloride, USP is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence. Chlordiazepoxide hydrochloride, USP is 7-chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A white to practically white crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The structural formula is. C16H14ClN3O HCl M.W. 336.22. Each capsule, for oral administration, contains either 5 mg, 10 mg or 25 mg of chlordiazepoxide hydrochloride, USP and has the following inactive ingredients: anhydrous lactose, D&C yellow no. 10, FD&C blue no. 1, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, pharmaceutical glaze, and titanium dioxide. The 5 mg and 25 mg also contain D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and synthetic black iron oxide. In addition, the 5 mg contains D&C red no. 33 and the 10 mg also contains FD&C red no. 40, povidone, propylene glycol, and sodium hydroxide. The 5 mg and 25 mg may also contain propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0555-0159-02</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0555-0159-02) </PackageDescription>
<NDC11Code>00555-0159-02</NDC11Code>
<ProductNDC>0555-0159</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlordiazepoxide Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlordiazepoxide Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19760701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084769</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>CHLORDIAZEPOXIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19760701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlordiazepoxide HCl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide HCl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Chlordiazepoxide hydrochloride, USP is the prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety. Chlordiazepoxide hydrochloride, USP is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence. Chlordiazepoxide hydrochloride, USP is 7-chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A white to practically white crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The structural formula is. C16H14ClN3O HCl M.W. 336.22. Each capsule, for oral administration, contains either 5 mg, 10 mg or 25 mg of chlordiazepoxide hydrochloride, USP and has the following inactive ingredients: anhydrous lactose, D&C yellow no. 10, FD&C blue no. 1, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, pharmaceutical glaze, and titanium dioxide. The 5 mg and 25 mg also contain D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and synthetic black iron oxide. In addition, the 5 mg contains D&C red no. 33 and the 10 mg also contains FD&C red no. 40, povidone, propylene glycol, and sodium hydroxide. The 5 mg and 25 mg may also contain propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0555-0252-02</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0555-0252-02) </PackageDescription>
<NDC11Code>00555-0252-02</NDC11Code>
<ProductNDC>0555-0252</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dipyridamole</ProprietaryName>
<NonProprietaryName>Dipyridamole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19801001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087184</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>DIPYRIDAMOLE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19801001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0555-0285-02</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0555-0285-02) </PackageDescription>
<NDC11Code>00555-0285-02</NDC11Code>
<ProductNDC>0555-0285</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dipyridamole</ProprietaryName>
<NonProprietaryName>Dipyridamole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19820101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087716</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>DIPYRIDAMOLE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19820101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0555-0286-02</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0555-0286-02) </PackageDescription>
<NDC11Code>00555-0286-02</NDC11Code>
<ProductNDC>0555-0286</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dipyridamole</ProprietaryName>
<NonProprietaryName>Dipyridamole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19820101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087717</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>DIPYRIDAMOLE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19820101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0555-0302-02</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0555-0302-02) </PackageDescription>
<NDC11Code>00555-0302-02</NDC11Code>
<ProductNDC>0555-0302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Pamoate</ProprietaryName>
<NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088487</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>HYDROXYZINE PAMOATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine pamoate, USP is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1′-methylene bis (2 hydroxy-3-naphthalene carboxylic acid). It has the following structural formula. C21H27ClN2O2C23H16O6 M.W. 763.27. Hydroxyzine pamoate capsules, USP are administered in doses equivalent to 25 mg, 50 mg or 100 mg of hydroxyzine hydrochloride. In addition, each capsule contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, and pregelatinized corn starch. The 25 mg also contains anhydrous lactose. The 50 mg and 100 mg also contain lactose monohydrate. The capsule shell ingredients for the 25 mg capsule are D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 50 mg capsule shell contains D&C Red No. 33, D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 100 mg capsule shell contains D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The edible imprinting ink on the 25 mg, 50 mg and 100 mg capsules contains black iron oxide, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, propylene glycol, and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>0555-0323-02</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0555-0323-02) </PackageDescription>
<NDC11Code>00555-0323-02</NDC11Code>
<ProductNDC>0555-0323</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Pamoate</ProprietaryName>
<NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088496</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>HYDROXYZINE PAMOATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine pamoate, USP is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1′-methylene bis (2 hydroxy-3-naphthalene carboxylic acid). It has the following structural formula. C21H27ClN2O2C23H16O6 M.W. 763.27. Hydroxyzine pamoate capsules, USP are administered in doses equivalent to 25 mg, 50 mg or 100 mg of hydroxyzine hydrochloride. In addition, each capsule contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, and pregelatinized corn starch. The 25 mg also contains anhydrous lactose. The 50 mg and 100 mg also contain lactose monohydrate. The capsule shell ingredients for the 25 mg capsule are D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 50 mg capsule shell contains D&C Red No. 33, D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 100 mg capsule shell contains D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The edible imprinting ink on the 25 mg, 50 mg and 100 mg capsules contains black iron oxide, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, propylene glycol, and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>0555-0324-02</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0555-0324-02) </PackageDescription>
<NDC11Code>00555-0324-02</NDC11Code>
<ProductNDC>0555-0324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Pamoate</ProprietaryName>
<NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088488</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>HYDROXYZINE PAMOATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine pamoate, USP is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1′-methylene bis (2 hydroxy-3-naphthalene carboxylic acid). It has the following structural formula. C21H27ClN2O2C23H16O6 M.W. 763.27. Hydroxyzine pamoate capsules, USP are administered in doses equivalent to 25 mg, 50 mg or 100 mg of hydroxyzine hydrochloride. In addition, each capsule contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, and pregelatinized corn starch. The 25 mg also contains anhydrous lactose. The 50 mg and 100 mg also contain lactose monohydrate. The capsule shell ingredients for the 25 mg capsule are D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 50 mg capsule shell contains D&C Red No. 33, D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 100 mg capsule shell contains D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The edible imprinting ink on the 25 mg, 50 mg and 100 mg capsules contains black iron oxide, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, propylene glycol, and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>0555-0381-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0555-0381-02) </PackageDescription>
<NDC11Code>00555-0381-02</NDC11Code>
<ProductNDC>0555-0381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meperidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meperidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970203</StartMarketingDate>
<EndMarketingDate>20210228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088639</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>MEPERIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970203</StartMarketingDatePackage>
<EndMarketingDatePackage>20210228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0555-0382-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0555-0382-02)</PackageDescription>
<NDC11Code>00555-0382-02</NDC11Code>
<ProductNDC>0555-0382</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meperidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meperidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961011</StartMarketingDate>
<EndMarketingDate>20160731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088640</ApplicationNumber>
<LabelerName>Barr Laboratories Inc.</LabelerName>
<SubstanceName>MEPERIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0555-0392-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0555-0392-02) </PackageDescription>
<NDC11Code>00555-0392-02</NDC11Code>
<ProductNDC>0555-0392</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meperidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meperidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150224</StartMarketingDate>
<EndMarketingDate>20210228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088640</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>MEPERIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150224</StartMarketingDatePackage>
<EndMarketingDatePackage>20210228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0555-0483-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0555-0483-02) </PackageDescription>
<NDC11Code>00555-0483-02</NDC11Code>
<ProductNDC>0555-0483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amiloride Hydrochloride And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Amiloride Hydrochloride And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19891201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071111</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>5; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19891201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amiloride hydrochloride and hydrochlorothiazide tablets are indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic diuretics are used alone, or in whom maintenance of normal serum potassium levels is considered to be clinically important, e.g., digitalized patients, or patients with significant cardiac arrhythmias. The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet. Amiloride hydrochloride and hydrochlorothiazide tablets may be used alone or as an adjunct to other antihypertensive drugs, such as methyldopa or beta blockers. Since amiloride hydrochloride and hydrochlorothiazide enhances the action of these agents, dosage adjustments may be necessary to avoid an excessive fall in blood pressure and other unwanted side effects. The fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.</IndicationAndUsage>
<Description>Amiloride hydrochloride and hydrochlorothiazide tablets, USP combine the potassium-conserving action of amiloride hydrochloride with the natriuretic action of hydrochlorothiazide. Amiloride HCl, USP is designated chemically as N-amidino-3,5,-diamino-6-chloropyrazine-carboxamide monohydrochloride dihydrate and its structural formula is. C6H8CIN7OHCl2H2O M.W. 302.12. Hydrochlorothiazide, USP is designated chemically as 6-chloro-3,4-dihydro-2H-1, 2, 4-benzo-thiadiazine-7-sulfonamide 1, 1-dioxide. Its structural formula is. C7H8CIN3O4S2 M.W. 297.74. It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Each tablet, for oral administration, contains 5 mg of amiloride hydrochloride, USP (calculated on the anhydrous basis) and 50 mg of hydrochlorothiazide, USP. Inactive Ingredients: Croscarmellose sodium, D&C yellow no. 10 (aluminum lake), lactose monohydrate, magnesium oxide, magnesium stearate, microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>0555-0484-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0555-0484-02) </PackageDescription>
<NDC11Code>00555-0484-02</NDC11Code>
<ProductNDC>0555-0484</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Leucovorin Calcium</ProprietaryName>
<NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071198</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Leucovorin calcium tablets are a folate analog indicated: 1 To reduce the toxicity of: Methotrexate in adult patients with impaired methotrexate elimination, andFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1), 2 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2).</IndicationAndUsage>
<Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8- hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.5 g/mol. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg tablet contains 5 mg of leucovorin (equivalent to 5.4 mg of leucovorin calcium, USP), and each 25 mg tablet contains 25 mg of leucovorin (equivalent to 27.01 mg of leucovorin calcium, USP). The 5 mg and 25 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Additionally, the 25 mg tablet contains D&C yellow no.10 aluminum lake and FD&C blue no.1 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>0555-0513-02</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0555-0513-02) </PackageDescription>
<NDC11Code>00555-0513-02</NDC11Code>
<ProductNDC>0555-0513</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetazolamide</ProprietaryName>
<NonProprietaryName>Acetazolamide</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000222</StartMarketingDate>
<EndMarketingDate>20190630</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA012945</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ACETAZOLAMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20000222</StartMarketingDatePackage>
<EndMarketingDatePackage>20190630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0555-0572-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0555-0572-02) </PackageDescription>
<NDC11Code>00555-0572-02</NDC11Code>
<ProductNDC>0555-0572</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methotrexate</ProprietaryName>
<NonProprietaryName>Methotrexate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19901101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081099</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, 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>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19901101</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, USP is dihydrofolate reductase inhibitor with the chemical name of L-glutamic acid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]. The molecular formula is C20H22N8O5 and the molecular weight is 454.45 g/mol. The structural formula is. Methotrexate tablets, USP for oral use are available in bottles of 36 and 100 tablets. Each tablet contains 2.5 mg methotrexate, USP equivalent to 2.74 mg methotrexate sodium. Inactive Ingredients: Anhydrous lactose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, propylene glycol, sodium carbonate monohydrate, and talc.</Description>
</NDC>
<NDC>
<NDCCode>0555-0594-02</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0555-0594-02)</PackageDescription>
<NDC11Code>00555-0594-02</NDC11Code>
<ProductNDC>0555-0594</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Protriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Protriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073645</ApplicationNumber>
<LabelerName>Barr Laboratories Inc.</LabelerName>
<SubstanceName>PROTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>0555-0595-02</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0555-0595-02)</PackageDescription>
<NDC11Code>00555-0595-02</NDC11Code>
<ProductNDC>0555-0595</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Protriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Protriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073644</ApplicationNumber>
<LabelerName>Barr Laboratories Inc.</LabelerName>
<SubstanceName>PROTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-01-30</LastUpdate>
</NDC>
</NDCList>