RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "75920-0464-8",
      "PackageDescription": "12 TABLET, EFFERVESCENT in 1 BOX (75920-0464-8) ",
      "NDC11Code": "75920-0464-08",
      "ProductNDC": "75920-0464",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Blowfish",
      "NonProprietaryName": "Aspirin, Caffeine",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110723",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Rally Labs LLC",
      "SubstanceName": "ASPIRIN; CAFFEINE",
      "StrengthNumber": "500; 60",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110723",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of minor aches and pains associated with a hangover. helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover. also for the temporary relief of headaches or body aches and pains alone."
    },
    {
      "NDCCode": "75920-0464-1",
      "PackageDescription": "2 TABLET, EFFERVESCENT in 1 BOX (75920-0464-1) ",
      "NDC11Code": "75920-0464-01",
      "ProductNDC": "75920-0464",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Blowfish",
      "NonProprietaryName": "Aspirin, Caffeine",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110723",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Rally Labs LLC",
      "SubstanceName": "ASPIRIN; CAFFEINE",
      "StrengthNumber": "500; 60",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110723",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of minor aches and pains associated with a hangover. helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover. also for the temporary relief of headaches or body aches and pains alone."
    },
    {
      "NDCCode": "75920-0464-2",
      "PackageDescription": "20 TABLET, EFFERVESCENT in 1 BAG (75920-0464-2) ",
      "NDC11Code": "75920-0464-02",
      "ProductNDC": "75920-0464",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Blowfish",
      "NonProprietaryName": "Aspirin, Caffeine",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110723",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Rally Labs LLC",
      "SubstanceName": "ASPIRIN; CAFFEINE",
      "StrengthNumber": "500; 60",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20171130",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of minor aches and pains associated with a hangover. helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover. also for the temporary relief of headaches or body aches and pains alone."
    },
    {
      "NDCCode": "75920-0464-4",
      "PackageDescription": "40 TABLET, EFFERVESCENT in 1 BAG (75920-0464-4) ",
      "NDC11Code": "75920-0464-04",
      "ProductNDC": "75920-0464",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Blowfish",
      "NonProprietaryName": "Aspirin, Caffeine",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110723",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Rally Labs LLC",
      "SubstanceName": "ASPIRIN; CAFFEINE",
      "StrengthNumber": "500; 60",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20171130",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of minor aches and pains associated with a hangover. helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover. also for the temporary relief of headaches or body aches and pains alone."
    },
    {
      "NDCCode": "75920-0464-5",
      "PackageDescription": "20 TABLET, EFFERVESCENT in 1 BOX (75920-0464-5) ",
      "NDC11Code": "75920-0464-05",
      "ProductNDC": "75920-0464",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Blowfish",
      "NonProprietaryName": "Aspirin, Caffeine",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110723",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Rally Labs LLC",
      "SubstanceName": "ASPIRIN; CAFFEINE",
      "StrengthNumber": "500; 60",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201228",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of minor aches and pains associated with a hangover. helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover. also for the temporary relief of headaches or body aches and pains alone."
    },
    {
      "NDCCode": "75920-0464-6",
      "PackageDescription": "4 TABLET, EFFERVESCENT in 1 BOX (75920-0464-6) ",
      "NDC11Code": "75920-0464-06",
      "ProductNDC": "75920-0464",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Blowfish",
      "NonProprietaryName": "Aspirin, Caffeine",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110723",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Rally Labs LLC",
      "SubstanceName": "ASPIRIN; CAFFEINE",
      "StrengthNumber": "500; 60",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200201",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of minor aches and pains associated with a hangover. helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover. also for the temporary relief of headaches or body aches and pains alone."
    },
    {
      "NDCCode": "75920-0464-7",
      "PackageDescription": "20 TABLET, EFFERVESCENT in 1 BOX (75920-0464-7) ",
      "NDC11Code": "75920-0464-07",
      "ProductNDC": "75920-0464",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Blowfish",
      "NonProprietaryName": "Aspirin, Caffeine",
      "DosageFormName": "TABLET, EFFERVESCENT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110723",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Rally Labs LLC",
      "SubstanceName": "ASPIRIN; CAFFEINE",
      "StrengthNumber": "500; 60",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201228",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of minor aches and pains associated with a hangover. helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover. also for the temporary relief of headaches or body aches and pains alone."
    },
    {
      "NDCCode": "11523-0464-1",
      "PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK (11523-0464-1)  > 9.8 mL in 1 BOTTLE, WITH APPLICATOR",
      "NDC11Code": "11523-0464-01",
      "ProductNDC": "11523-0464",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr. Scholls",
      "ProprietaryNameSuffix": "Corn/callus Remover",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19900814",
      "EndMarketingDate": "20210131",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part358F",
      "LabelerName": "Bayer HealthCare LLC.",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "1.7",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19900814",
      "EndMarketingDatePackage": "20210131",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "33992-0464-8",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (33992-0464-8)  / 12 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "33992-0464-08",
      "ProductNDC": "33992-0464",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Plus Sinus Headache",
      "NonProprietaryName": "Acetaminophen, Diphenhydramine Hcl And Phenylephrine Hcl",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050615",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "GREENBRIER INTERNATIONAL, INC.",
      "SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 12.5; 5",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20050615",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "58118-0464-8",
      "PackageDescription": "30 TABLET in 1 BLISTER PACK (58118-0464-8)",
      "NDC11Code": "58118-0464-08",
      "ProductNDC": "58118-0464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091123",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078558",
      "LabelerName": "Clinical Solutions Wholesale",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "71335-0464-8",
      "PackageDescription": "42 TABLET in 1 BOTTLE (71335-0464-8) ",
      "NDC11Code": "71335-0464-08",
      "ProductNDC": "71335-0464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090803",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088832",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20131029",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prednisone Tablets, USP are indicated in the following conditions. 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 hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic DiseasesPemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory DiseasesSymptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic DisordersIdiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic DiseasesFor palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. 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. Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.",
      "Description": "Each tablet for oral administration contains. Prednisone.................................................5 mg, 10 mg and 20 mg. Inactive Ingredients. Prednisone Tablets, USP of 5 mg and 10 mg strengths contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc. Prednisone Tablets, USP of 20 mg strength contain anhydrous lactose, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Prednisone Tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. C21H26O5 M.W. 358.43Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol."
    },
    {
      "NDCCode": "16714-464-01",
      "PackageDescription": "1 BLISTER PACK in 1 PACKET (16714-464-01)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "16714-0464-01",
      "ProductNDC": "16714-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Juleber",
      "NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20130712",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091234",
      "LabelerName": "Northstar Rx LLC",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130712",
      "SamplePackage": "N",
      "IndicationAndUsage": "JULEBER is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY; Irvington Publishers, 1998. 1Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. JULEBER has not been studied for and is not indicated for use in emergency contraception.",
      "Description": "JULEBER (desogestrel and ethinyl estradiol tablets, USP) provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each \"active\" orange tablet with \"S3\" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitaminE, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each \"inactive\" reminder white, biconvex, round tablets with \"P\" debossed on one side and \"N\" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "16714-464-02",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (16714-464-02)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "16714-0464-02",
      "ProductNDC": "16714-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Juleber",
      "NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20130712",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091234",
      "LabelerName": "Northstar Rx LLC",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130712",
      "SamplePackage": "N",
      "IndicationAndUsage": "JULEBER is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY; Irvington Publishers, 1998. 1Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. JULEBER has not been studied for and is not indicated for use in emergency contraception.",
      "Description": "JULEBER (desogestrel and ethinyl estradiol tablets, USP) provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each \"active\" orange tablet with \"S3\" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitaminE, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each \"inactive\" reminder white, biconvex, round tablets with \"P\" debossed on one side and \"N\" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "16714-464-03",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (16714-464-03)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "16714-0464-03",
      "ProductNDC": "16714-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Juleber",
      "NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20130712",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091234",
      "LabelerName": "Northstar Rx LLC",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130712",
      "SamplePackage": "N",
      "IndicationAndUsage": "JULEBER is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY; Irvington Publishers, 1998. 1Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. JULEBER has not been studied for and is not indicated for use in emergency contraception.",
      "Description": "JULEBER (desogestrel and ethinyl estradiol tablets, USP) provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each \"active\" orange tablet with \"S3\" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitaminE, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each \"inactive\" reminder white, biconvex, round tablets with \"P\" debossed on one side and \"N\" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "16714-464-04",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (16714-464-04)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "16714-0464-04",
      "ProductNDC": "16714-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Juleber",
      "NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20130712",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091234",
      "LabelerName": "Northstar Rx LLC",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130712",
      "SamplePackage": "N",
      "IndicationAndUsage": "JULEBER is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY; Irvington Publishers, 1998. 1Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. JULEBER has not been studied for and is not indicated for use in emergency contraception.",
      "Description": "JULEBER (desogestrel and ethinyl estradiol tablets, USP) provide an oral contraceptive regimen of 21 orange tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17, diol). Each \"active\" orange tablet with \"S3\" debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitaminE, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminium Lake, Iron Oxide Yellow, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each \"inactive\" reminder white, biconvex, round tablets with \"P\" debossed on one side and \"N\" on the other side contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 orange tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "21695-464-07",
      "PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE (21695-464-07)",
      "NDC11Code": "21695-0464-07",
      "ProductNDC": "21695-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levaquin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961220",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020634",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN® and other antibacterial drugs, LEVAQUIN® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. LEVAQUIN® Tablets/Injection and Oral Solution are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. LEVAQUIN® Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).",
      "Description": "LEVAQUIN® is a synthetic broad-spectrum antibacterial agent for oral and intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The empirical formula is C18H20FN3O4  ½ H2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2."
    },
    {
      "NDCCode": "43063-464-08",
      "PackageDescription": "8 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-464-08)",
      "NDC11Code": "43063-0464-08",
      "ProductNDC": "43063-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenazopyridine Hydrochloride",
      "NonProprietaryName": "Phenazopyridine Hydrochloride",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110802",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-07-14"
    },
    {
      "NDCCode": "43857-0464-1",
      "PackageDescription": "30 mL in 1 BOTTLE, SPRAY (43857-0464-1) ",
      "NDC11Code": "43857-0464-01",
      "ProductNDC": "43857-0464",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bio Biological Detox",
      "NonProprietaryName": "Echinacea (angustifolia), Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Propolis, Tabebuia Impetiginosa, Hydrastis Canadensis, Thymus Serpyllum, Glandula Suprarenalis Suis, Lymph Node (suis), Spleen (suis), Thyroidinum (suis), Belladonna, Hypericum Perforatum, Phosphorus, Pyrogenium, Anthracinum, Arsenicum Album, Carbolicum Acidum, Hepar Sulphuris Calcareum, Tarentula Cubensis, Variolinum, Botulinum, Bacillus Dysentery, Gaertner Bacillus, Mutabile Bacillus, Francisella Tularensis, Coxiella Burnetii,",
      "DosageFormName": "SPRAY",
      "RouteName": "ORAL",
      "StartMarketingDate": "20171102",
      "EndMarketingDate": "20260722",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "BioActive Nutritional, Inc.",
      "SubstanceName": "ECHINACEA ANGUSTIFOLIA WHOLE; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM OFFICINALE; PROPOLIS WAX; TABEBUIA IMPETIGINOSA BARK; GOLDENSEAL; THYMUS SERPYLLUM WHOLE; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; THYROID; ATROPA BELLADONNA; HYPERICUM PERFORATUM WHOLE; PHOSPHORUS; RANCID BEEF; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ARSENIC TRIOXIDE; PHENOL; CALCIUM SULFIDE; CITHARACANTHUS SPINICRUS; VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN; BOTULINUM TOXIN TYPE A; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; FRANCISELLA TULARENSIS; COXIELLA BURNETII; CANIS LUPUS FAMILIARIS MILK; PLASMODIUM MALARIAE; ESCHERICHIA COLI; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; YERSINIA PESTIS; SULFUR",
      "StrengthNumber": "12; 12; 12; 15; 12; 30; 12; 30; 3; 30; 30; 5; 30; 12; 3; 3; 3; 12; 12; 30; 3; 12; 12; 12; 30; 8; 8; 8; 3; 5; 8; 12; 30",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
      "Pharm_Classes": "Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Actively Acquired Immunity [PE], Live Vaccinia Virus Vaccine [EPC], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC], Smallpox Vaccine [CS], Vaccines, Live, Unattenuated [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20171102",
      "EndMarketingDatePackage": "20260722",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of weakness, burning pain, fever, pustules."
    },
    {
      "NDCCode": "57297-464-03",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (57297-464-03)",
      "NDC11Code": "57297-0464-03",
      "ProductNDC": "57297-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151202",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078103",
      "LabelerName": "LUPIN LIMITED",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (1.1) , 2 Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2) , 3 Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. (1.2) , 4 Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (1.2) , 5 Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2, 1.3).",
      "Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
    },
    {
      "NDCCode": "57297-464-06",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (57297-464-06)",
      "NDC11Code": "57297-0464-06",
      "ProductNDC": "57297-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151202",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078103",
      "LabelerName": "LUPIN LIMITED",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (1.1) , 2 Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2) , 3 Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. (1.2) , 4 Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (1.2) , 5 Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2, 1.3).",
      "Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
    },
    {
      "NDCCode": "57297-464-09",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (57297-464-09)",
      "NDC11Code": "57297-0464-09",
      "ProductNDC": "57297-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151202",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078103",
      "LabelerName": "LUPIN LIMITED",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: 1 Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (1.1) , 2 Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2) , 3 Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. (1.2) , 4 Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (1.2) , 5 Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2, 1.3).",
      "Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
    },
    {
      "NDCCode": "59651-464-28",
      "PackageDescription": "28 CAPSULE in 1 BOTTLE (59651-464-28) ",
      "NDC11Code": "59651-0464-28",
      "ProductNDC": "59651-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sunitinib Malate",
      "NonProprietaryName": "Sunitinib Malate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240314",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218615",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "SUNITINIB MALATE",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-04-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240314",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sunitinib malate is a kinase inhibitor indicated for: : 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.  (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
      "Description": "Sunitinib is a kinase inhibitor present in sunitinib malate capules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.71 mg, 33.41 mg, 50.12 mg, or 66.83 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients:  croscarmellose sodium, magnesium stearate, mannitol, and povidone. The red opaque gelatin capsule shells contain gelatin, iron oxide red, and titanium dioxide; the olive green opaque gelatin capsule shells contain FD&C Blue 2, gelatin, iron oxide red, iron oxide yellow, and titanium dioxide; and the light green opaque gelatin capsule shells contain FD&C Blue 2, gelatin, iron oxide yellow, and titanium dioxide. The white printing ink contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide and the black printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac."
    },
    {
      "NDCCode": "59651-464-29",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (59651-464-29)  / 7 CAPSULE in 1 BLISTER PACK",
      "NDC11Code": "59651-0464-29",
      "ProductNDC": "59651-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sunitinib Malate",
      "NonProprietaryName": "Sunitinib Malate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240314",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218615",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "SUNITINIB MALATE",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-04-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240314",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sunitinib malate is a kinase inhibitor indicated for: : 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.  (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
      "Description": "Sunitinib is a kinase inhibitor present in sunitinib malate capules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C22H27FN4O2 C4H6O5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.71 mg, 33.41 mg, 50.12 mg, or 66.83 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients:  croscarmellose sodium, magnesium stearate, mannitol, and povidone. The red opaque gelatin capsule shells contain gelatin, iron oxide red, and titanium dioxide; the olive green opaque gelatin capsule shells contain FD&C Blue 2, gelatin, iron oxide red, iron oxide yellow, and titanium dioxide; and the light green opaque gelatin capsule shells contain FD&C Blue 2, gelatin, iron oxide yellow, and titanium dioxide. The white printing ink contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide and the black printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac."
    },
    {
      "NDCCode": "61324-464-53",
      "PackageDescription": "8 mL in 1 BOTTLE, SPRAY (61324-464-53)",
      "NDC11Code": "61324-0464-53",
      "ProductNDC": "61324-464",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ausanil",
      "NonProprietaryName": "Capsaicin Ginger",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "NASAL",
      "StartMarketingDate": "20140314",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "VR1 Corporation",
      "SubstanceName": "CAPSICUM SPP.; GINGER",
      "StrengthNumber": "3; 3",
      "StrengthUnit": "[hp_X]/8mL; [hp_X]/8mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-01-02",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "61919-464-10",
      "PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (61919-464-10)",
      "NDC11Code": "61919-0464-10",
      "ProductNDC": "61919-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron",
      "NonProprietaryName": "Ondansetron",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077851",
      "LabelerName": "DIRECT RX",
      "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": "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 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) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT. 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. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride, USP equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride, USP equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). Product meets USP Drug Release Test 3."
    },
    {
      "NDCCode": "61919-464-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (61919-464-30)",
      "NDC11Code": "61919-0464-30",
      "ProductNDC": "61919-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron",
      "NonProprietaryName": "Ondansetron",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077851",
      "LabelerName": "DIRECT RX",
      "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": "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 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) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT. 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. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride, USP equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride, USP equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). Product meets USP Drug Release Test 3."
    },
    {
      "NDCCode": "63323-464-17",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-464-17)  / 10 mL in 1 VIAL, SINGLE-DOSE (63323-464-01) ",
      "NDC11Code": "63323-0464-17",
      "ProductNDC": "63323-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sensorcaine",
      "ProprietaryNameSuffix": "Mpf",
      "NonProprietaryName": "Bupivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
      "StartMarketingDate": "20101119",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070552",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2023-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20101119",
      "SamplePackage": "N",
      "IndicationAndUsage": "SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of SENSORCAINE / SENSORCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
      "Description": "SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE injections contains bupivacaine hydrochloride, a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000. The route of administration for SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE is parenterally by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE injections are Methyl Paraben Free (MPF). SENSORCAINE/SENSORCAINE WITH EPINEPHRINE injections contains bupivacaine hydrochloride, a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000. The route of administration for SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is parenterally by injection, for infiltration and perineural use. Bupivacaine hydrochloride is a white or almost white, crystalline powder or colorless crystals, soluble in water, freely soluble in alcohol. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Bupivacaine hydrochloride chemical name is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. The molecular formula is C18H28N2O·HCl·H2O, with a molecular weight of 342.9 g/mol. Bupivacaine hydrochloride monohydrate has the following chemical structure:. The pKa of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Epinephrine bitartrate is a white to greyish white or light brownish-grey, odorless, crystalline powder, freely soluble in water, slightly soluble in 96% ethanol and methanol, practically insoluble in chloroform, methylene chloride and ether. Epinephrine bitartrate chemical name is (-)-3,4-Dihydroxy- α [(methylamino)methyl] benzyl alcohol (+) tartrate (1:1) salt. The molecular formula is C9H13NO3·C4H6O6, with a molecular weight of 333.29 g/mol. Epinephrine bitartrate has the following chemical structure:."
    },
    {
      "NDCCode": "63323-464-31",
      "PackageDescription": "5 VIAL, SINGLE-DOSE in 1 BOX (63323-464-31)  / 30 mL in 1 VIAL, SINGLE-DOSE (63323-464-03) ",
      "NDC11Code": "63323-0464-31",
      "ProductNDC": "63323-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sensorcaine",
      "ProprietaryNameSuffix": "Mpf",
      "NonProprietaryName": "Bupivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
      "StartMarketingDate": "20101119",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018304",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-10-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20101119",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are:. (See DOSAGE AND ADMINISTRATION for additional information.). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.",
      "Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2- piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure:. Epinephrine is (-)-3,4-Dihydroxy-α [(methylamino)methyl] benzyl alcohol. It has the following structural formula:. The pK a of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage."
    },
    {
      "NDCCode": "63323-464-37",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-464-37)  / 30 mL in 1 VIAL, SINGLE-DOSE (63323-464-02) ",
      "NDC11Code": "63323-0464-37",
      "ProductNDC": "63323-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sensorcaine",
      "ProprietaryNameSuffix": "Mpf",
      "NonProprietaryName": "Bupivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
      "StartMarketingDate": "20101119",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018304",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-10-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20101119",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are:. (See DOSAGE AND ADMINISTRATION for additional information.). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.",
      "Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2- piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure:. Epinephrine is (-)-3,4-Dihydroxy-α [(methylamino)methyl] benzyl alcohol. It has the following structural formula:. The pK a of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage."
    },
    {
      "NDCCode": "63323-464-38",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-464-38)  / 10 mL in 1 VIAL, SINGLE-DOSE (63323-464-08) ",
      "NDC11Code": "63323-0464-38",
      "ProductNDC": "63323-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sensorcaine",
      "ProprietaryNameSuffix": "Mpf",
      "NonProprietaryName": "Bupivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
      "StartMarketingDate": "20101119",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070552",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220729",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are:. (See DOSAGE AND ADMINISTRATION for additional information.). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.",
      "Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure:. Epinephrine is (-)-3,4-Dihydroxy-α [(methylamino)methyl] benzyl alcohol. It has the following structural formula:. The pKa of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage."
    }
  ]
}
                    

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