RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "55045-1266-8",
      "PackageDescription": "118 mL in 1 BOTTLE (55045-1266-8)",
      "NDC11Code": "55045-1266-08",
      "ProductNDC": "55045-1266",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Promethazine Vc With Codeine",
      "NonProprietaryName": "Codeine Phosphate, Promethazine Hydrochloride, And Phenylephrine Hydrochloride",
      "DosageFormName": "SYRUP",
      "RouteName": "ORAL",
      "StartMarketingDate": "20061207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040660",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "10; 6.5; 5",
      "StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
      "Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Promethazine HCl, phenylephrine HCl and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.",
      "Description": "Each 5 mL (one teaspoonful), for oral administration contains: Codeine phosphate 10 mg; promethazine hydrochloride 6.25 mg; phenylephrine hydrochloride 5 mg. Alcohol 7%. Inactive Ingredients: Ascorbic acid, citric acid, D&C Red #33, FD&C Yellow #6, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate, strawberry flavor and sucrose. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C18H21NO3  H3PO4  ½H2O and the following structural formula. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2S  HCI and the following structural formula. Phenylephrine hydrochloride is a sympathomimetic amine salt which is chemically indicated as (-)-m-Hydroxy-α-[(methyl-amino)-methyl] benzyl alcohol hydrochloride. It occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride is subject to oxidation and must be protected from light and air. It has a molecular weight of 203.67, a molecular formula of C9H13NO2  HCI and the following structural formula."
    },
    {
      "NDCCode": "71335-1266-8",
      "PackageDescription": "56 TABLET, FILM COATED in 1 BOTTLE (71335-1266-8) ",
      "NDC11Code": "71335-1266-08",
      "ProductNDC": "71335-1266",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208170",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-10-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190711",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C20H21N  HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake."
    },
    {
      "NDCCode": "55045-1167-8",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (55045-1167-8)",
      "NDC11Code": "55045-1167-08",
      "ProductNDC": "55045-1167",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clonidine Hydrochloride",
      "NonProprietaryName": "Clonidine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070309",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077901",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "CLONIDINE HYDROCHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents."
    },
    {
      "NDCCode": "55045-1594-8",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (55045-1594-8)",
      "NDC11Code": "55045-1594-08",
      "ProductNDC": "55045-1594",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Chlorzoxazone",
      "NonProprietaryName": "Chlorzoxazone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110116",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089895",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "CHLORZOXAZONE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Chlorzoxazone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.",
      "Description": "Each tablet contains. Chlorzoxazone…………500 mg. Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium, docusate sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium benzoate, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake HT. 5-chloro-2-benzoxazolinone. The structural formula is as follows."
    },
    {
      "NDCCode": "55045-1715-8",
      "PackageDescription": "30 TABLET in 1 BOTTLE (55045-1715-8)",
      "NDC11Code": "55045-1715-08",
      "ProductNDC": "55045-1715",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Trazodone Hydrochloride",
      "NonProprietaryName": "Trazodone Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110120",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071523",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "TRAZODONE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Trazodone Hydrochloride Tablets USP are indicated for the treatment of depression. The efficacy of Trazodone Hydrochloride Tablets USP has been demonstrated in both inpatient and outpatient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association’s Diagnostic and Statistical Manual, lll.a. Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.",
      "Description": "Trazodone Hydrochloride Tablets USP is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1, 2, 4-triazolo[4, 3-a]-pyridin-3(2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows. Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
    },
    {
      "NDCCode": "55045-2386-8",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (55045-2386-8)",
      "NDC11Code": "55045-2386-08",
      "ProductNDC": "55045-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040143",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
      "StrengthNumber": "10; 650",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
    },
    {
      "NDCCode": "55045-3453-8",
      "PackageDescription": "30 TABLET in 1 BOTTLE (55045-3453-8)",
      "NDC11Code": "55045-3453-08",
      "ProductNDC": "55045-3453",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluconazole",
      "NonProprietaryName": "Fluconazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060125",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077253",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "FLUCONAZOLE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Fluconazole Tablets USP are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 3 Cryptococcal meningitis. Before prescribing fluconazole tablets USP for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .",
      "Description": "Fluconazole USP, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole USP is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline. Fluconazole tablets USP contain 50, 100, 150, or 200 mg of fluconazole USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40 aluminum lake dye, magnesium stearate, microcrystalline cellulose and povidone."
    },
    {
      "NDCCode": "55045-1259-9",
      "PackageDescription": "21 TABLET in 1 BOTTLE, PLASTIC (55045-1259-9)",
      "NDC11Code": "55045-1259-09",
      "ProductNDC": "55045-1259",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylprednisolone",
      "NonProprietaryName": "Methylprednisolone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19981222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040183",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "METHYLPREDNISOLONE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "MethylPREDNISolone Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).Congenital adrenal hyperplasiaHypercalcemia associated with cancerNonsuppurative thyroiditis, 2 Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisSynovitis of osteoarthritisAcute nonspecific tenosynovitisPsoriatic arthritisEpicondylitisAcute gouty arthritisPost-traumatic osteoarthritis, 3 Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusAcute rheumatic carditisSystemic dermatomyositis (polymyositis), 4 Dermatologic DiseasesBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Severe seborrheic dermatitisExfoliative dermatitisMycosis fungoidesPemphigusSevere psoriasis, 5 Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisSerum sicknessContact dermatitisDrug hypersensitivity reactionsBronchial asthmaAtopic dermatitis, 6 Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersAnterior segment inflammationSympathetic ophthalmiaKeratitisOptic neuritisIritis and iridocyclitisHerpes zoster ophthalmicusDiffuse posterior uveitis and choroiditisAllergic conjunctivitisChorioretinitis, 7 Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitisBerylliosis, 8 Hematologic DisordersIdiopathic thrombocytopenia purpura in adultsAcquired (autoimmune) hemolytic anemiaCongenital (erythroid) hypoplastic anemiaSecondary thrombocytopenia in adultsErythroblastopenia (RBC anemia), 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus., 11 Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 Nervous SystemAcute exacerbations of multiple sclerosis, 13 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.Trichinosis with neurologic or myocardial involvement.",
      "Description": "Methylprednisolone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-, and the molecular weight is 374.48. The structural formula is represented below. Each MethylPREDNISolone Tablet for oral administration contains 4 mg methylprednisolone."
    },
    {
      "NDCCode": "55045-1580-5",
      "PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (55045-1580-5)",
      "NDC11Code": "55045-1580-05",
      "ProductNDC": "55045-1580",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetaminophen And Codeine Phosphate",
      "NonProprietaryName": "Acetaminophen And Codeine Phosphate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110706",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040419",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
      "StrengthNumber": "300; 15",
      "StrengthUnit": "mg/1; mg/1",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.",
      "Description": "Acetaminophen and codeine phosphate is supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains: 1  Acetaminophen USP . . . . . . . . . . . . . 300 mg, 2  Codeine Phosphate USP . . . . . . . . . . . . . 15 mg."
    },
    {
      "NDCCode": "55045-1755-5",
      "PackageDescription": "5 mL in 1 BOTTLE, PLASTIC (55045-1755-5)",
      "NDC11Code": "55045-1755-05",
      "ProductNDC": "55045-1755",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexamethasone Sodium Phosphate",
      "NonProprietaryName": "Dexamethasone Sodium Phosphate",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20040701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088771",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "DEXAMETHASONE SODIUM PHOSPHATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "For the treatment of the following conditions. Ophthalmic: Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctuate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical or thermal burns, or penetration of foreign bodies. Otic: Steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and nonpurulent infective otitis externa when the hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.",
      "Description": "Dexamethasone sodium phosphate ophthalmic solution is a clear, colorless to pale yellow topical steroid solution for ophthalmic or otic administration. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic. Dexamethasone is a synthetic analog of naturally occurring glucocorticoids (hydrocortisone and cortisone). Dexamethasone sodium phosphate is a water soluble, inorganic ester of dexamethasone. It is approximately three thousand times more soluble in water at 25°C than hydrocortisone. Dexamethasone sodium phosphate is 9-fluoro-11 β, 17-dihydroxy-16 -methyl-21-(phosphonooxy)pregna-1,4-diene-3, 20-dione disodium salt and has the following structural formula. Each mL contains: Active: dexamethasone sodium phosphate equivalent to 1mg (0.1%) dexamethasone phosphate. Preservative: benzalkonium chloride 0.01%. Inactives: monobasic sodium phosphate, sodium chloride, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate and/or dibasic sodium phosphate to adjust pH (6.6 to 7.8) and water for injection."
    },
    {
      "NDCCode": "55045-3197-6",
      "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55045-3197-6)",
      "NDC11Code": "55045-3197-06",
      "ProductNDC": "55045-3197",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupropion Hydrochloride",
      "NonProprietaryName": "Bupropion Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "OCCLUSIVE DRESSING TECHNIQUE",
      "StartMarketingDate": "20090702",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079095",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "BUPROPION HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-10",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets (SR) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
      "Description": "Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1- dimethylethyl)amino]-1 -propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100 mg, 150 mg, and 200 mg white to off-white, film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the following inactive ingredients:  hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate, and diluted hydrochloric acid. The film coating contains lactose monohydrate, hydroxypropyl cellulose, titanium dioxide, and polyethylene glycol."
    },
    {
      "NDCCode": "55045-3207-2",
      "PackageDescription": "1 CONTAINER in 1 CARTON (55045-3207-2)  > 1 SYRINGE, GLASS in 1 CONTAINER > .3 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "55045-3207-02",
      "ProductNDC": "55045-3207",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Epipen",
      "NonProprietaryName": "Epinephrine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19871222",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019430",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "EPINEPHRINE",
      "StrengthNumber": ".3",
      "StrengthUnit": "mg/.3mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "EpiPen® and EpiPen® Jr Auto-Injectors are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitos), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. EpiPen® and EpiPen® Jr Auto-Injectors are intended for immediate administration in patients, who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Selection of the appropriate dosage strength is determined according to patient body weight (see DOSAGE AND ADMINISTRATION section). Such reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. EpiPen® and EpiPen® Jr Auto-Injectors are intended for immediate self-administration as emergency supportive therapy only and are not a substitute for immediate medical care.",
      "Description": "Each EpiPen® Auto-Injector delivers a single dose of 0.3 mg epinephrine injection, USP, 1:1000 (0.3 mL) in a sterile solution. Each EpiPen® Jr Auto-Injector delivers a single dose of 0.15 mg epinephrine injection, USP, 1:2000 (0.3 mL) in a sterile solution. The EpiPen® and EpiPen® Jr Auto-Injectors each contain 2 mL epinephrine solution. Approximately 1.7 mL remains in the auto-injector after activation and cannot be used. Each 0.3 mL in the EpiPen® Auto-Injector contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection.The pH range is 2.2-5.0. Each 0.3 mL in the EpiPen® Jr Auto-Injector contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is B-(3, 4-dihydroxyphenyl)-a-methyl-aminoethanol, with the following structure:. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace EpiPen® and EpiPen® Jr Auto-Injectors if the epinephrine solution appears discolored. EpiPen® and EpiPen® Jr Auto-Injectors do not contain latex."
    },
    {
      "NDCCode": "55045-3259-3",
      "PackageDescription": "20 g in 1 TUBE, WITH APPLICATOR (55045-3259-3)",
      "NDC11Code": "55045-3259-03",
      "ProductNDC": "55045-3259",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Terconazole",
      "NonProprietaryName": "Terconazole",
      "DosageFormName": "CREAM",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20040401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019964",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "TERCONAZOLE",
      "StrengthNumber": "8",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Azole Antifungal [EPC],Azoles [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Terconazole Vaginal Cream is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As this product is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.",
      "Description": "Terconazole Vaginal Cream 0.4% is a white to off-white, water washable cream for intravaginal administration containing 0.4% of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water. Terconazole Vaginal Cream 0.8% is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water. The structural formula of terconazole is as follows. Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol."
    },
    {
      "NDCCode": "55045-3598-1",
      "PackageDescription": "2 CONTAINER in 1 CARTON (55045-3598-1)  > 1 SYRINGE, GLASS in 1 CONTAINER > .3 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "55045-3598-01",
      "ProductNDC": "55045-3598",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Epipen Jr",
      "NonProprietaryName": "Epinephrine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "19871222",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019430",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "EPINEPHRINE",
      "StrengthNumber": ".15",
      "StrengthUnit": "mg/.3mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "EpiPen® and EpiPen® Jr Auto-Injectors are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitos), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. EpiPen® and EpiPen® Jr Auto-Injectors are intended for immediate administration in patients, who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Selection of the appropriate dosage strength is determined according to patient body weight (see DOSAGE AND ADMINISTRATION section). Such reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. EpiPen® and EpiPen® Jr Auto-Injectors are intended for immediate self-administration as emergency supportive therapy only and are not a substitute for immediate medical care.",
      "Description": "Each EpiPen® Auto-Injector delivers a single dose of 0.3 mg epinephrine injection, USP, 1:1000 (0.3 mL) in a sterile solution. Each EpiPen® Jr Auto-Injector delivers a single dose of 0.15 mg epinephrine injection, USP, 1:2000 (0.3 mL) in a sterile solution. The EpiPen® and EpiPen® Jr Auto-Injectors each contain 2 mL epinephrine solution. Approximately 1.7 mL remains in the auto-injector after activation and cannot be used. Each 0.3 mL in the EpiPen® Auto-Injector contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection.The pH range is 2.2-5.0. Each 0.3 mL in the EpiPen® Jr Auto-Injector contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is B-(3, 4-dihydroxyphenyl)-a-methyl-aminoethanol, with the following structure:. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace EpiPen® and EpiPen® Jr Auto-Injectors if the epinephrine solution appears discolored. EpiPen® and EpiPen® Jr Auto-Injectors do not contain latex."
    },
    {
      "NDCCode": "55045-3602-1",
      "PackageDescription": "1 VIAL in 1 CARTON (55045-3602-1)  > 10 mL in 1 VIAL",
      "NDC11Code": "55045-3602-01",
      "ProductNDC": "55045-3602",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Humalog",
      "NonProprietaryName": "Insulin Lispro",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "19960724",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020563",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "INSULIN LISPRO",
      "StrengthNumber": "100",
      "StrengthUnit": "[iU]/mL",
      "Pharm_Classes": "Insulin [Chemical/Ingredient],Insulin Analog [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "HUMALOG is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.",
      "Description": "HUMALOG® (insulin lispro injection, USP [rDNA origin]) is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808, both identical to that of human insulin. HUMALOG has the following primary structure:. HUMALOG is a sterile, aqueous, clear, and colorless solution. Each milliliter of HUMALOG contains insulin lispro 100 units, 16 mg glycerin, 1.88 mg dibasic sodium phosphate, 3.15 mg Metacresol, zinc oxide content adjusted to provide 0.0197 mg zinc ion, trace amounts of phenol, and Water for Injection. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid 10% and/or sodium hydroxide 10%."
    },
    {
      "NDCCode": "55045-3729-3",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55045-3729-3)",
      "NDC11Code": "55045-3729-03",
      "ProductNDC": "55045-3729",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron Hydrochloride",
      "NonProprietaryName": "Ondansetron Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070625",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077050",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "ONDANSETRON HYDROCHLORIDE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. 2. Prevention of nausea and vomiting associated with initial and repeat course of moderately emetogenic cancer chemotherapy. 3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. 4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low.",
      "Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch, hypromellose, magnesium stearate, titanium dioxide, and polyethylene glycol 400. Ondansetron tablet 8 mg also contains polysorbate 80 and iron oxide yellow."
    },
    {
      "NDCCode": "55045-3817-3",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55045-3817-3)",
      "NDC11Code": "55045-3817-03",
      "ProductNDC": "55045-3817",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron Hydrochloride",
      "NonProprietaryName": "Ondansetron Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070625",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077050",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "ONDANSETRON HYDROCHLORIDE",
      "StrengthNumber": "8",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. 2. Prevention of nausea and vomiting associated with initial and repeat course of moderately emetogenic cancer chemotherapy. 3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. 4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low.",
      "Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch, hypromellose, magnesium stearate, titanium dioxide, and polyethylene glycol 400. Ondansetron tablet 8 mg also contains polysorbate 80 and iron oxide yellow."
    },
    {
      "NDCCode": "55045-3848-9",
      "PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (55045-3848-9)",
      "NDC11Code": "55045-3848-09",
      "ProductNDC": "55045-3848",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron",
      "NonProprietaryName": "Ondansetron",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070627",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078152",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "ONDANSETRON",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. . Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. . Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. . Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets USP and ondansetron orally disintegrating tablets USP are recommended even where the incidence of postoperative nausea and/or vomiting is low. .",
      "Description": "The active ingredient in ondansetron tablets USP is ondansetron hydrochloride (HCl) USP as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula:. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron HCl USP dihydrate is a white to off-white powder that is soluble in water and normal saline. The active ingredient in ondansetron orally disintegrating tablets USP is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula:. The empirical formula is C18H19N3O representing a molecular weight of 293.4. Each 4-mg ondansetron tablet USP for oral administration contains ondansetron HCl USP dihydrate equivalent to 4 mg of ondansetron. Each 8-mg ondansetron tablet USP for oral administration contains ondansetron HCl USP dihydrate equivalent to 8 mg of ondansetron. Each 24-mg ondansetron tablet USP for oral administration contains ondansetron HCl USP dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose, iron oxide yellow (8 mg tablet only), iron oxide red (24 mg tablet only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide and triacetin. Each 4-mg ondansetron orally disintegrating tablet USP for oral administration contains 4 mg ondansetron base. Each 8-mg ondansetron orally disintegrating tablet USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet USP also contains the inactive ingredients aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, sodium stearyl fumarate and strawberry flavor. Ondansetron orally disintegrating tablets USP are an orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. This product disintegrates in approximately 60 seconds."
    },
    {
      "NDCCode": "0536-1266-59",
      "PackageDescription": "237 mL in 1 BOTTLE (0536-1266-59) ",
      "NDC11Code": "00536-1266-59",
      "ProductNDC": "0536-1266",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Senna Liquid",
      "NonProprietaryName": "Sennosides",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190501",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "RUGBY LABORATORIES",
      "SubstanceName": "SENNOSIDES",
      "StrengthNumber": "8.8",
      "StrengthUnit": "mg/5mL",
      "Status": "Active",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 relieves occasional constipation (irregularity), 2 generally causes bowel movment in 6 to 12 hours."
    },
    {
      "NDCCode": "43742-1266-1",
      "PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-1266-1) ",
      "NDC11Code": "43742-1266-01",
      "ProductNDC": "43742-1266",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Candida Plus",
      "NonProprietaryName": "Echinacea (angustifolia), Allium Sativum, Asafoetida, Hydrastis Canadensis, Berberis Vulgaris, Borax, Saccharum Officinale, Caffeinum, Gallicum Acidum, Indolum, Acetaldehyde, Folliculinum, Lycopodium Clavatum, Phytolacca Decandra, Pulsatilla (pratensis), Sepia, Ustilago Maidis, Torula Cerevisiae",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180629",
      "EndMarketingDate": "20240218",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Deseret Biologicals, Inc.",
      "SubstanceName": "ACETALDEHYDE; ANEMONE PRATENSIS; BERBERIS VULGARIS ROOT BARK; CAFFEINE; ECHINACEA ANGUSTIFOLIA; ESTRONE; FERULA ASSA-FOETIDA RESIN; GALLIC ACID MONOHYDRATE; GARLIC; GOLDENSEAL; INDOLE; LYCOPODIUM CLAVATUM SPORE; PHYTOLACCA AMERICANA ROOT; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE; SODIUM BORATE; SUCROSE; USTILAGO MAYDIS",
      "StrengthNumber": "8; 12; 6; 6; 3; 12; 3; 6; 3; 5; 6; 12; 12; 60; 12; 6; 6; 12",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Dietary Proteins [CS], Dietary Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Methylxanthine [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Plant Proteins [CS], Xanthines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-02-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180629",
      "EndMarketingDatePackage": "20240218",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary relief of symptoms related to Candida albicans infection such as nausea, drowsiness, lethargy, confusion, vaginal discharge, sensitivities to foods and mucous congestion.**. **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration."
    },
    {
      "NDCCode": "48951-1266-3",
      "PackageDescription": "60 mL in 1 BOTTLE, DROPPER (48951-1266-3) ",
      "NDC11Code": "48951-1266-03",
      "ProductNDC": "48951-1266",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aurum Stibium Special Order",
      "NonProprietaryName": "Aurum Stibium Special Order",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090901",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Uriel Pharmacy Inc.",
      "SubstanceName": "ANTIMONY; GOLD",
      "StrengthNumber": "8; 10",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20090901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions: FOR ORAL USE ONLY."
    },
    {
      "NDCCode": "71335-1266-0",
      "PackageDescription": "40 TABLET, FILM COATED in 1 BOTTLE (71335-1266-0) ",
      "NDC11Code": "71335-1266-00",
      "ProductNDC": "71335-1266",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208170",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-10-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190711",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C20H21N  HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake."
    },
    {
      "NDCCode": "71335-1266-1",
      "PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (71335-1266-1) ",
      "NDC11Code": "71335-1266-01",
      "ProductNDC": "71335-1266",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208170",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-10-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190711",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C20H21N  HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake."
    },
    {
      "NDCCode": "71335-1266-2",
      "PackageDescription": "84 TABLET, FILM COATED in 1 BOTTLE (71335-1266-2) ",
      "NDC11Code": "71335-1266-02",
      "ProductNDC": "71335-1266",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208170",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-10-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190711",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C20H21N  HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake."
    },
    {
      "NDCCode": "71335-1266-3",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (71335-1266-3) ",
      "NDC11Code": "71335-1266-03",
      "ProductNDC": "71335-1266",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208170",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-10-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190711",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C20H21N  HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake."
    },
    {
      "NDCCode": "71335-1266-4",
      "PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (71335-1266-4) ",
      "NDC11Code": "71335-1266-04",
      "ProductNDC": "71335-1266",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208170",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-10-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190711",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C20H21N  HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake."
    },
    {
      "NDCCode": "71335-1266-5",
      "PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE (71335-1266-5) ",
      "NDC11Code": "71335-1266-05",
      "ProductNDC": "71335-1266",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208170",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-10-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190711",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C20H21N  HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake."
    },
    {
      "NDCCode": "71335-1266-6",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71335-1266-6) ",
      "NDC11Code": "71335-1266-06",
      "ProductNDC": "71335-1266",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208170",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-10-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190711",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C20H21N  HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake."
    },
    {
      "NDCCode": "71335-1266-7",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71335-1266-7) ",
      "NDC11Code": "71335-1266-07",
      "ProductNDC": "71335-1266",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208170",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-10-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190711",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C20H21N  HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake."
    },
    {
      "NDCCode": "71335-1266-9",
      "PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (71335-1266-9) ",
      "NDC11Code": "71335-1266-09",
      "ProductNDC": "71335-1266",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208170",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-10-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190711",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C20H21N  HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake."
    }
  ]
}
                    

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Acetaminophen</ProprietaryName><NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>55045-3453-8</NDCCode><ProprietaryName>Fluconazole</ProprietaryName><NonProprietaryName>Fluconazole</NonProprietaryName></NDC><NDC><NDCCode>55045-1259-9</NDCCode><ProprietaryName>Methylprednisolone</ProprietaryName><NonProprietaryName>Methylprednisolone</NonProprietaryName></NDC><NDC><NDCCode>55045-1580-5</NDCCode><ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName><NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName></NDC><NDC><NDCCode>55045-1755-5</NDCCode><ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName><NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName></NDC><NDC><NDCCode>55045-3197-6</NDCCode><ProprietaryName>Bupropion Hydrochloride</ProprietaryName><NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55045-3207-2</NDCCode><ProprietaryName>Epipen</ProprietaryName><NonProprietaryName>Epinephrine</NonProprietaryName></NDC><NDC><NDCCode>55045-3259-3</NDCCode><ProprietaryName>Terconazole</ProprietaryName><NonProprietaryName>Terconazole</NonProprietaryName></NDC><NDC><NDCCode>55045-3598-1</NDCCode><ProprietaryName>Epipen Jr</ProprietaryName><NonProprietaryName>Epinephrine</NonProprietaryName></NDC><NDC><NDCCode>55045-3602-1</NDCCode><ProprietaryName>Humalog</ProprietaryName><NonProprietaryName>Insulin Lispro</NonProprietaryName></NDC><NDC><NDCCode>55045-3729-3</NDCCode><ProprietaryName>Ondansetron Hydrochloride</ProprietaryName><NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55045-3817-3</NDCCode><ProprietaryName>Ondansetron Hydrochloride</ProprietaryName><NonProprietaryName>Ondansetron 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Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71335-1266-1</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71335-1266-2</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71335-1266-3</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71335-1266-4</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71335-1266-5</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71335-1266-6</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71335-1266-7</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71335-1266-9</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC></NDCList>