RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "0044-0175-99",
      "PackageDescription": "50 kg in 1 DRUM (0044-0175-99)",
      "NDC11Code": "00044-0175-99",
      "ProductNDC": "0044-0175",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Divalproex Sodium",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20130101",
      "EndMarketingDate": "20171215",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Abbott Laboratories",
      "SubstanceName": "DIVALPROEX SODIUM",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171215"
    },
    {
      "NDCCode": "0044-1800-99",
      "PackageDescription": "100 kg in 1 DRUM (0044-1800-99)",
      "NDC11Code": "00044-1800-99",
      "ProductNDC": "0044-1800",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Choline Fenofibrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20140701",
      "EndMarketingDate": "20150904",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Abbott Laboratories",
      "SubstanceName": "CHOLINE FENOFIBRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20150904"
    },
    {
      "NDCCode": "0044-3699-99",
      "PackageDescription": "100 kg in 1 DRUM (0044-3699-99)",
      "NDC11Code": "00044-3699-99",
      "ProductNDC": "0044-3699",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Clarithromycin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20130101",
      "EndMarketingDate": "20171110",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Abbott Laboratories",
      "SubstanceName": "CLARITHROMYCIN",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171110"
    },
    {
      "NDCCode": "13107-044-99",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (13107-044-99) ",
      "NDC11Code": "13107-0044-99",
      "ProductNDC": "13107-044",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130715",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201972",
      "LabelerName": "Aurolife Pharma, LLC",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-12-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130715",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
      "Description": "Oxycodone hydrochloride and acetaminophen is available in tablets for oral administration. Each tablet, for oral administration, contains: Oxycodone Hydrochloride, USP……………...2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone) Acetaminophen, USP ……………..............    325 mg Oxycodone Hydrochloride, USP……………... 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...7.5 mg*  (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone)  Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...10 mg* (* 10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone) Acetaminophen, USP  ……………..................325 mg All strengths of Oxycodone Hydrochloride and Acetaminophen Tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white to off- white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
    },
    {
      "NDCCode": "65862-044-99",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (65862-044-99) ",
      "NDC11Code": "65862-0044-99",
      "ProductNDC": "65862-044",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lisinopril And Hydrochlorothiazide",
      "NonProprietaryName": "Lisinopril And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060314",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077606",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "LISINOPRIL; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "20; 12.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20060314",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lisinopril and Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using Lisinopril and Hydrochlorothiazide Tablets, USP consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS). In considering use of Lisinopril and Hydrochlorothiazide Tablets, USP it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks. (See WARNINGS, Head and Neck Angioedema).",
      "Description": "Lisinopril and Hydrochlorothiazide Tablets combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its molecular formula is C21H31N3O5  2H2O and its structural formula is. Lisinopril USP is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is:. Hydrochlorothiazide USP is a white, or practically white, crystalline powder with a molecular weight of 297.73, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and Hydrochlorothiazide Tablets are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg containing 10 mg lisinopril USP and 12.5 mg hydrochlorothiazide USP; Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg containing 20 mg lisinopril USP and 12.5 mg hydrochlorothiazide USP; and, Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg containing 20 mg lisinopril USP and 25 mg hydrochlorothiazide USP. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch (maize starch) and starch. Lisinopril and hydrochlorothiazide 10 mg/12.5 mg and 20 mg/25 mg also contains ferric oxide red and ferric oxide yellow. Lisinopril and hydrochlorothiazide 20 mg/12.5 mg also contains ferric oxide yellow."
    },
    {
      "NDCCode": "0363-0175-99",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0363-0175-99)  > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00363-0175-99",
      "ProductNDC": "0363-0175",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pain Reliever",
      "ProprietaryNameSuffix": "Extra Strength",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930402",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Walgreen Company",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-02-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "19930402",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "47682-175-99",
      "PackageDescription": "2 TABLET, FILM COATED in 1 PACKET (47682-175-99) ",
      "NDC11Code": "47682-0175-99",
      "ProductNDC": "47682-175",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Medique Apap Extra Strength",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20081230",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "Unifirst First Aid Corporation",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-09-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20081230",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. temporarily relieves minor aches and pains due to: 1 headache, 2 muscular aches, 3 minor pain of arthritis , 4 backahe, 5 the common cold, 6 toothache, 7 premenstrual and menstrual cramps."
    },
    {
      "NDCCode": "65862-175-99",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-175-99) ",
      "NDC11Code": "65862-0175-99",
      "ProductNDC": "65862-175",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Penicillin V Potassium",
      "NonProprietaryName": "Penicillin V Potassium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080429",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065435",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "PENICILLIN V POTASSIUM",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
      "Status": "Active",
      "LastUpdate": "2022-02-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20080429",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium and other antibacterial drugs, penicillin V potassium 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.Penicillin V potassium tablets are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriologic studies (including sensitivity tests) and by clinical response.NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following infections will usually respond to adequate dosage of penicillin V.Streptococcal Infections (without bacteremia)Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant.Pneumococcal Infections Mild to moderately severe infections of the respiratory tract.Staphylococcal infections – penicillin G-sensitive Mild infections of the skin and soft tissues.NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections.Fusospirochetosis (Vincent’s gingivitis and pharyngitis)  Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue.Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract1. Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association1.",
      "Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V potassium tablets, for oral administration, contain 250 mg (400,000 units) or 500 mg (800,000 units). The 250 mg tablet is equivalent to 250 mg (400,000 units) penicillin V and the 500 mg tablet is equivalent to 500 mg (800,000 units) penicillin V. In addition, each tablet contains the following inactive ingredients: povidone, microcrystalline cellulose, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide."
    },
    {
      "NDCCode": "70720-175-99",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (70720-175-99)  > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
      "NDC11Code": "70720-0175-99",
      "ProductNDC": "70720-175",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Qmiiz Odt",
      "NonProprietaryName": "Meloxicam",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190221",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA211210",
      "LabelerName": "TerSera Therapeutics LLC",
      "SubstanceName": "MELOXICAM",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2021-09-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190221",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "80479-175-99",
      "PackageDescription": "100 POUCH in 1 BAG (80479-175-99)  > 3 mL in 1 POUCH",
      "NDC11Code": "80479-0175-99",
      "ProductNDC": "80479-175",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Bernal Premium Alcohol Wipe",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201020",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Newport MFG LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20201020",
      "SamplePackage": "N",
      "IndicationAndUsage": "to decrease bacteria on skin. recommended for repeated use."
    },
    {
      "NDCCode": "49288-0175-1",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0175-1)",
      "NDC11Code": "49288-0175-01",
      "ProductNDC": "49288-0175",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite, Dermatophagoides Farinae",
      "NonProprietaryName": "Standardized Mite, Dermatophagoides Farinae",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19911022",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102224",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES FARINAE",
      "StrengthNumber": "10000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "INDICATIONS AND USAGE    Standardized Mite allergenic extract is indicated for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. An orderly approach to the diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.     Mite mixtures should not be used for diagnostic skin testing. The individual mites should be used. Mite mixtures may be used for immunotherapy to treat patients who demonstrated sensi­tivity to both D. farinae and D. pteronyssinus mites. Patients who react to both D. farinae and D. pteronyssinus have demonstrated a significant cross-reactivity. Caution should be used in esca­lating treatment with mite mixtures.21PRICK-PUNCTURE TESTING: A positive control using Histamine Phosphate is important to identify those patients whose skin may not be reactive due to medications, metabolic or other rea­sons. A diluent control, if negative, would exclude false-positive reactions due to ingredients in the diluent or patients who have dermatographism.     To identify highly sensitive individuals and as a safety precaution, it is recommended that prick-puncture test using a drop of the extract concentrate (10,000 AU/ml) be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. Glycerinated Mite extracts containing 10,000 AU/ml are recommended for prick-puncture testing. Skin reactions are based on size of erythema and wheal. For interpretation of skin reactions, refer to chart below.      Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the mite allergen. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. Hence, the importance of a good patient history. Less sensitive individuals can be tested intra­dermally with an appropriately diluted extract.     A clinical study using the same patients with positive prick-puncture test (10) using the ID50EAL Method, Intradermal Dilution for 50 mm Sum of Erythema D50 Determines the Allergy Unit, has demonstrated the following:     Skin test by prick-puncture test using Standardized D. farinae Mite, 10,000 AU/ml was per­formed in 10 patients. The mean sum of erythema diameter was 76.6 mm (Range 45-104 mm). Skin test by prick-puncture test using Standardized D. pteronyssinus Mite, 10,000 AU/ml in 10 patients, the mean sum of erythema diameter was 74.7 mm (Range 43-109 mm). *C = Concentration. SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Intracutaneous test dilutions should be made with aqueous diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, a prick-puncture test of less than 2+, the initial dilu­tion for skin testing should contain 0.02 to 0.06 AU/ml (see Table I). For very sensitive patients with a prick-puncture of greater than 2+, a further dilution should be made to 0.002 to 0.006 AU/ml (see Table I). If after 20 minutes no skin reaction is obtained, continue the testing using five-fold or ten-fold incre­ments in potency until a reaction of 1+ or until the concentration of 2,000 AU (five-fold) or 1,000 AU (ten-fold) has been tested with a glycerine control. Glycerine may be used at a dilution of 0.5% as long as 0.5% glycerine produces negative control. The diluent should be tested and included in the interpretation of the skin reactions.16 INTRADERMAL TESTING–SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patient's degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving pro­gressive five-fold dilutions of allergenic extracts, prepared and refrigerated at 2-8° C. The critical variable is the size if the wheal and erythema produced by the intracutaneous injection of 0.01 to 0.02 ml of the test allergen producing a 4 mm diameter superficial skin wheal. For patients demon­strating a prick-puncture skin test of less than 2+, an initial screening dilution of 0.02-0.06 AU/ml is safe (see Table I). For patients demonstrating a prick-puncture skin test greater than 2+, an initial screening dilu­tion of 0.002 to 0.006 AU/ml is safe. The skin endpoint is detected by noting the dilution that pro­duces a wheal 2 mm larger than non-reacting dilutions (5 mm negative wheal) until progressive whealing with each five-fold increase in test potency occurs, i.e., a 5 mm (negative), 7 mm, 9 mm, 11 mm is the normal sequence of whealing. The 7 mm wheal would be the endpoint. The endpoint dilution is used as an initial dose concentration for immunotherapy. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each indi­vidual.     Using Standardized D. farinae Mite, 10,000 AU/ml on 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.4). Using Standardized D. pteronyssinus Mite 10,000 AU/ml in 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.7).",
      "Description": "DESCRIPTION     The extract is sterile and intended for dilution prior to skin testing and/or immunotherapy. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. The route of administration for immunotherapy is subcutaneous. The designation AU/ml (Allergy Units per ml) is unitage based upon the relative potency of this standardized mite extract when com­pared by ELISA competition to the F.D.A. Mite Allergenic Reference Standard labeled 10,000 AU/ml assigned on the basis of quantitative skin testing by the ID50EAL Method.1,2,3,4,5,16 Lower con­centrations (e.g. 5,000 AU/ml and 3,000 AU/ml) are prepared by dilution of stock concentrates. Mite mixtures containing equal volumes of D. farinae and D. pteronyssinus are available at 5,000 AU/ml, 2,500 AU/ml and 1,500 AU/ml.     Active allergens are described by common and scientific name on the stock concentrate con­tainer label.     INGREDIENTS: Extract of Standardized Mites contain at least 99.0% adult mites and mite stages. This product may contain trace amounts of yeast and/or pork products; sodium chloride 0.95%; sodium bicarbonate 0.24%; 50% v/v glycerine as stabilizing agent and preservative.     Following is a brief description of the standardized quality procedures applied to these extracts:         1. The source material is carefully selected from whole body adult mites and mite stages cul­tured from a medium containing no material of human origin. The source material is extracted with a saline buffer and 50% v/v glycerine.         2. Several manufacturers submitted intradermal skin test data on Biopol Laboratories mite medium extract using patients who were puncture test positive (erythema greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (erythe­ma greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive to the mite extract and who were also skin test positive to the mite medium extract were also skin tested by the puncture method with an extract of yeast (Saccharomyces sp.) and were positive.         3. A ninhydrin protein analysis is completed to compare with the standard extract.         4. Each lot is standardized against the F.D.A. reference standard extract for total biologic activ­ity by means of ELISA competition.         5. The standardized mite extract is analyzed for glycerine content to insure a minimum of 50% v/v glycerine for optimal stability during the entire dating period."
    },
    {
      "NDCCode": "49288-0175-2",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0175-2)",
      "NDC11Code": "49288-0175-02",
      "ProductNDC": "49288-0175",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite, Dermatophagoides Farinae",
      "NonProprietaryName": "Standardized Mite, Dermatophagoides Farinae",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19911022",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102224",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES FARINAE",
      "StrengthNumber": "10000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "INDICATIONS AND USAGE    Standardized Mite allergenic extract is indicated for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. An orderly approach to the diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.     Mite mixtures should not be used for diagnostic skin testing. The individual mites should be used. Mite mixtures may be used for immunotherapy to treat patients who demonstrated sensi­tivity to both D. farinae and D. pteronyssinus mites. Patients who react to both D. farinae and D. pteronyssinus have demonstrated a significant cross-reactivity. Caution should be used in esca­lating treatment with mite mixtures.21PRICK-PUNCTURE TESTING: A positive control using Histamine Phosphate is important to identify those patients whose skin may not be reactive due to medications, metabolic or other rea­sons. A diluent control, if negative, would exclude false-positive reactions due to ingredients in the diluent or patients who have dermatographism.     To identify highly sensitive individuals and as a safety precaution, it is recommended that prick-puncture test using a drop of the extract concentrate (10,000 AU/ml) be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. Glycerinated Mite extracts containing 10,000 AU/ml are recommended for prick-puncture testing. Skin reactions are based on size of erythema and wheal. For interpretation of skin reactions, refer to chart below.      Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the mite allergen. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. Hence, the importance of a good patient history. Less sensitive individuals can be tested intra­dermally with an appropriately diluted extract.     A clinical study using the same patients with positive prick-puncture test (10) using the ID50EAL Method, Intradermal Dilution for 50 mm Sum of Erythema D50 Determines the Allergy Unit, has demonstrated the following:     Skin test by prick-puncture test using Standardized D. farinae Mite, 10,000 AU/ml was per­formed in 10 patients. The mean sum of erythema diameter was 76.6 mm (Range 45-104 mm). Skin test by prick-puncture test using Standardized D. pteronyssinus Mite, 10,000 AU/ml in 10 patients, the mean sum of erythema diameter was 74.7 mm (Range 43-109 mm). *C = Concentration. SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Intracutaneous test dilutions should be made with aqueous diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, a prick-puncture test of less than 2+, the initial dilu­tion for skin testing should contain 0.02 to 0.06 AU/ml (see Table I). For very sensitive patients with a prick-puncture of greater than 2+, a further dilution should be made to 0.002 to 0.006 AU/ml (see Table I). If after 20 minutes no skin reaction is obtained, continue the testing using five-fold or ten-fold incre­ments in potency until a reaction of 1+ or until the concentration of 2,000 AU (five-fold) or 1,000 AU (ten-fold) has been tested with a glycerine control. Glycerine may be used at a dilution of 0.5% as long as 0.5% glycerine produces negative control. The diluent should be tested and included in the interpretation of the skin reactions.16 INTRADERMAL TESTING–SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patient's degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving pro­gressive five-fold dilutions of allergenic extracts, prepared and refrigerated at 2-8° C. The critical variable is the size if the wheal and erythema produced by the intracutaneous injection of 0.01 to 0.02 ml of the test allergen producing a 4 mm diameter superficial skin wheal. For patients demon­strating a prick-puncture skin test of less than 2+, an initial screening dilution of 0.02-0.06 AU/ml is safe (see Table I). For patients demonstrating a prick-puncture skin test greater than 2+, an initial screening dilu­tion of 0.002 to 0.006 AU/ml is safe. The skin endpoint is detected by noting the dilution that pro­duces a wheal 2 mm larger than non-reacting dilutions (5 mm negative wheal) until progressive whealing with each five-fold increase in test potency occurs, i.e., a 5 mm (negative), 7 mm, 9 mm, 11 mm is the normal sequence of whealing. The 7 mm wheal would be the endpoint. The endpoint dilution is used as an initial dose concentration for immunotherapy. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each indi­vidual.     Using Standardized D. farinae Mite, 10,000 AU/ml on 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.4). Using Standardized D. pteronyssinus Mite 10,000 AU/ml in 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.7).",
      "Description": "DESCRIPTION     The extract is sterile and intended for dilution prior to skin testing and/or immunotherapy. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. The route of administration for immunotherapy is subcutaneous. The designation AU/ml (Allergy Units per ml) is unitage based upon the relative potency of this standardized mite extract when com­pared by ELISA competition to the F.D.A. Mite Allergenic Reference Standard labeled 10,000 AU/ml assigned on the basis of quantitative skin testing by the ID50EAL Method.1,2,3,4,5,16 Lower con­centrations (e.g. 5,000 AU/ml and 3,000 AU/ml) are prepared by dilution of stock concentrates. Mite mixtures containing equal volumes of D. farinae and D. pteronyssinus are available at 5,000 AU/ml, 2,500 AU/ml and 1,500 AU/ml.     Active allergens are described by common and scientific name on the stock concentrate con­tainer label.     INGREDIENTS: Extract of Standardized Mites contain at least 99.0% adult mites and mite stages. This product may contain trace amounts of yeast and/or pork products; sodium chloride 0.95%; sodium bicarbonate 0.24%; 50% v/v glycerine as stabilizing agent and preservative.     Following is a brief description of the standardized quality procedures applied to these extracts:         1. The source material is carefully selected from whole body adult mites and mite stages cul­tured from a medium containing no material of human origin. The source material is extracted with a saline buffer and 50% v/v glycerine.         2. Several manufacturers submitted intradermal skin test data on Biopol Laboratories mite medium extract using patients who were puncture test positive (erythema greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (erythe­ma greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive to the mite extract and who were also skin test positive to the mite medium extract were also skin tested by the puncture method with an extract of yeast (Saccharomyces sp.) and were positive.         3. A ninhydrin protein analysis is completed to compare with the standard extract.         4. Each lot is standardized against the F.D.A. reference standard extract for total biologic activ­ity by means of ELISA competition.         5. The standardized mite extract is analyzed for glycerine content to insure a minimum of 50% v/v glycerine for optimal stability during the entire dating period."
    },
    {
      "NDCCode": "49288-0175-3",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0175-3)",
      "NDC11Code": "49288-0175-03",
      "ProductNDC": "49288-0175",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite, Dermatophagoides Farinae",
      "NonProprietaryName": "Standardized Mite, Dermatophagoides Farinae",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19911022",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102224",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES FARINAE",
      "StrengthNumber": "10000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "INDICATIONS AND USAGE    Standardized Mite allergenic extract is indicated for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. An orderly approach to the diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.     Mite mixtures should not be used for diagnostic skin testing. The individual mites should be used. Mite mixtures may be used for immunotherapy to treat patients who demonstrated sensi­tivity to both D. farinae and D. pteronyssinus mites. Patients who react to both D. farinae and D. pteronyssinus have demonstrated a significant cross-reactivity. Caution should be used in esca­lating treatment with mite mixtures.21PRICK-PUNCTURE TESTING: A positive control using Histamine Phosphate is important to identify those patients whose skin may not be reactive due to medications, metabolic or other rea­sons. A diluent control, if negative, would exclude false-positive reactions due to ingredients in the diluent or patients who have dermatographism.     To identify highly sensitive individuals and as a safety precaution, it is recommended that prick-puncture test using a drop of the extract concentrate (10,000 AU/ml) be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. Glycerinated Mite extracts containing 10,000 AU/ml are recommended for prick-puncture testing. Skin reactions are based on size of erythema and wheal. For interpretation of skin reactions, refer to chart below.      Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the mite allergen. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. Hence, the importance of a good patient history. Less sensitive individuals can be tested intra­dermally with an appropriately diluted extract.     A clinical study using the same patients with positive prick-puncture test (10) using the ID50EAL Method, Intradermal Dilution for 50 mm Sum of Erythema D50 Determines the Allergy Unit, has demonstrated the following:     Skin test by prick-puncture test using Standardized D. farinae Mite, 10,000 AU/ml was per­formed in 10 patients. The mean sum of erythema diameter was 76.6 mm (Range 45-104 mm). Skin test by prick-puncture test using Standardized D. pteronyssinus Mite, 10,000 AU/ml in 10 patients, the mean sum of erythema diameter was 74.7 mm (Range 43-109 mm). *C = Concentration. SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Intracutaneous test dilutions should be made with aqueous diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, a prick-puncture test of less than 2+, the initial dilu­tion for skin testing should contain 0.02 to 0.06 AU/ml (see Table I). For very sensitive patients with a prick-puncture of greater than 2+, a further dilution should be made to 0.002 to 0.006 AU/ml (see Table I). If after 20 minutes no skin reaction is obtained, continue the testing using five-fold or ten-fold incre­ments in potency until a reaction of 1+ or until the concentration of 2,000 AU (five-fold) or 1,000 AU (ten-fold) has been tested with a glycerine control. Glycerine may be used at a dilution of 0.5% as long as 0.5% glycerine produces negative control. The diluent should be tested and included in the interpretation of the skin reactions.16 INTRADERMAL TESTING–SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patient's degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving pro­gressive five-fold dilutions of allergenic extracts, prepared and refrigerated at 2-8° C. The critical variable is the size if the wheal and erythema produced by the intracutaneous injection of 0.01 to 0.02 ml of the test allergen producing a 4 mm diameter superficial skin wheal. For patients demon­strating a prick-puncture skin test of less than 2+, an initial screening dilution of 0.02-0.06 AU/ml is safe (see Table I). For patients demonstrating a prick-puncture skin test greater than 2+, an initial screening dilu­tion of 0.002 to 0.006 AU/ml is safe. The skin endpoint is detected by noting the dilution that pro­duces a wheal 2 mm larger than non-reacting dilutions (5 mm negative wheal) until progressive whealing with each five-fold increase in test potency occurs, i.e., a 5 mm (negative), 7 mm, 9 mm, 11 mm is the normal sequence of whealing. The 7 mm wheal would be the endpoint. The endpoint dilution is used as an initial dose concentration for immunotherapy. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each indi­vidual.     Using Standardized D. farinae Mite, 10,000 AU/ml on 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.4). Using Standardized D. pteronyssinus Mite 10,000 AU/ml in 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.7).",
      "Description": "DESCRIPTION     The extract is sterile and intended for dilution prior to skin testing and/or immunotherapy. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. The route of administration for immunotherapy is subcutaneous. The designation AU/ml (Allergy Units per ml) is unitage based upon the relative potency of this standardized mite extract when com­pared by ELISA competition to the F.D.A. Mite Allergenic Reference Standard labeled 10,000 AU/ml assigned on the basis of quantitative skin testing by the ID50EAL Method.1,2,3,4,5,16 Lower con­centrations (e.g. 5,000 AU/ml and 3,000 AU/ml) are prepared by dilution of stock concentrates. Mite mixtures containing equal volumes of D. farinae and D. pteronyssinus are available at 5,000 AU/ml, 2,500 AU/ml and 1,500 AU/ml.     Active allergens are described by common and scientific name on the stock concentrate con­tainer label.     INGREDIENTS: Extract of Standardized Mites contain at least 99.0% adult mites and mite stages. This product may contain trace amounts of yeast and/or pork products; sodium chloride 0.95%; sodium bicarbonate 0.24%; 50% v/v glycerine as stabilizing agent and preservative.     Following is a brief description of the standardized quality procedures applied to these extracts:         1. The source material is carefully selected from whole body adult mites and mite stages cul­tured from a medium containing no material of human origin. The source material is extracted with a saline buffer and 50% v/v glycerine.         2. Several manufacturers submitted intradermal skin test data on Biopol Laboratories mite medium extract using patients who were puncture test positive (erythema greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (erythe­ma greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive to the mite extract and who were also skin test positive to the mite medium extract were also skin tested by the puncture method with an extract of yeast (Saccharomyces sp.) and were positive.         3. A ninhydrin protein analysis is completed to compare with the standard extract.         4. Each lot is standardized against the F.D.A. reference standard extract for total biologic activ­ity by means of ELISA competition.         5. The standardized mite extract is analyzed for glycerine content to insure a minimum of 50% v/v glycerine for optimal stability during the entire dating period."
    },
    {
      "NDCCode": "49288-0175-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0175-4)",
      "NDC11Code": "49288-0175-04",
      "ProductNDC": "49288-0175",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite, Dermatophagoides Farinae",
      "NonProprietaryName": "Standardized Mite, Dermatophagoides Farinae",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19911022",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102224",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES FARINAE",
      "StrengthNumber": "10000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "INDICATIONS AND USAGE    Standardized Mite allergenic extract is indicated for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. An orderly approach to the diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.     Mite mixtures should not be used for diagnostic skin testing. The individual mites should be used. Mite mixtures may be used for immunotherapy to treat patients who demonstrated sensi­tivity to both D. farinae and D. pteronyssinus mites. Patients who react to both D. farinae and D. pteronyssinus have demonstrated a significant cross-reactivity. Caution should be used in esca­lating treatment with mite mixtures.21PRICK-PUNCTURE TESTING: A positive control using Histamine Phosphate is important to identify those patients whose skin may not be reactive due to medications, metabolic or other rea­sons. A diluent control, if negative, would exclude false-positive reactions due to ingredients in the diluent or patients who have dermatographism.     To identify highly sensitive individuals and as a safety precaution, it is recommended that prick-puncture test using a drop of the extract concentrate (10,000 AU/ml) be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. Glycerinated Mite extracts containing 10,000 AU/ml are recommended for prick-puncture testing. Skin reactions are based on size of erythema and wheal. For interpretation of skin reactions, refer to chart below.      Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the mite allergen. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. Hence, the importance of a good patient history. Less sensitive individuals can be tested intra­dermally with an appropriately diluted extract.     A clinical study using the same patients with positive prick-puncture test (10) using the ID50EAL Method, Intradermal Dilution for 50 mm Sum of Erythema D50 Determines the Allergy Unit, has demonstrated the following:     Skin test by prick-puncture test using Standardized D. farinae Mite, 10,000 AU/ml was per­formed in 10 patients. The mean sum of erythema diameter was 76.6 mm (Range 45-104 mm). Skin test by prick-puncture test using Standardized D. pteronyssinus Mite, 10,000 AU/ml in 10 patients, the mean sum of erythema diameter was 74.7 mm (Range 43-109 mm). *C = Concentration. SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Intracutaneous test dilutions should be made with aqueous diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, a prick-puncture test of less than 2+, the initial dilu­tion for skin testing should contain 0.02 to 0.06 AU/ml (see Table I). For very sensitive patients with a prick-puncture of greater than 2+, a further dilution should be made to 0.002 to 0.006 AU/ml (see Table I). If after 20 minutes no skin reaction is obtained, continue the testing using five-fold or ten-fold incre­ments in potency until a reaction of 1+ or until the concentration of 2,000 AU (five-fold) or 1,000 AU (ten-fold) has been tested with a glycerine control. Glycerine may be used at a dilution of 0.5% as long as 0.5% glycerine produces negative control. The diluent should be tested and included in the interpretation of the skin reactions.16 INTRADERMAL TESTING–SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patient's degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving pro­gressive five-fold dilutions of allergenic extracts, prepared and refrigerated at 2-8° C. The critical variable is the size if the wheal and erythema produced by the intracutaneous injection of 0.01 to 0.02 ml of the test allergen producing a 4 mm diameter superficial skin wheal. For patients demon­strating a prick-puncture skin test of less than 2+, an initial screening dilution of 0.02-0.06 AU/ml is safe (see Table I). For patients demonstrating a prick-puncture skin test greater than 2+, an initial screening dilu­tion of 0.002 to 0.006 AU/ml is safe. The skin endpoint is detected by noting the dilution that pro­duces a wheal 2 mm larger than non-reacting dilutions (5 mm negative wheal) until progressive whealing with each five-fold increase in test potency occurs, i.e., a 5 mm (negative), 7 mm, 9 mm, 11 mm is the normal sequence of whealing. The 7 mm wheal would be the endpoint. The endpoint dilution is used as an initial dose concentration for immunotherapy. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each indi­vidual.     Using Standardized D. farinae Mite, 10,000 AU/ml on 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.4). Using Standardized D. pteronyssinus Mite 10,000 AU/ml in 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.7).",
      "Description": "DESCRIPTION     The extract is sterile and intended for dilution prior to skin testing and/or immunotherapy. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. The route of administration for immunotherapy is subcutaneous. The designation AU/ml (Allergy Units per ml) is unitage based upon the relative potency of this standardized mite extract when com­pared by ELISA competition to the F.D.A. Mite Allergenic Reference Standard labeled 10,000 AU/ml assigned on the basis of quantitative skin testing by the ID50EAL Method.1,2,3,4,5,16 Lower con­centrations (e.g. 5,000 AU/ml and 3,000 AU/ml) are prepared by dilution of stock concentrates. Mite mixtures containing equal volumes of D. farinae and D. pteronyssinus are available at 5,000 AU/ml, 2,500 AU/ml and 1,500 AU/ml.     Active allergens are described by common and scientific name on the stock concentrate con­tainer label.     INGREDIENTS: Extract of Standardized Mites contain at least 99.0% adult mites and mite stages. This product may contain trace amounts of yeast and/or pork products; sodium chloride 0.95%; sodium bicarbonate 0.24%; 50% v/v glycerine as stabilizing agent and preservative.     Following is a brief description of the standardized quality procedures applied to these extracts:         1. The source material is carefully selected from whole body adult mites and mite stages cul­tured from a medium containing no material of human origin. The source material is extracted with a saline buffer and 50% v/v glycerine.         2. Several manufacturers submitted intradermal skin test data on Biopol Laboratories mite medium extract using patients who were puncture test positive (erythema greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (erythe­ma greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive to the mite extract and who were also skin test positive to the mite medium extract were also skin tested by the puncture method with an extract of yeast (Saccharomyces sp.) and were positive.         3. A ninhydrin protein analysis is completed to compare with the standard extract.         4. Each lot is standardized against the F.D.A. reference standard extract for total biologic activ­ity by means of ELISA competition.         5. The standardized mite extract is analyzed for glycerine content to insure a minimum of 50% v/v glycerine for optimal stability during the entire dating period."
    },
    {
      "NDCCode": "49288-0175-5",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0175-5)",
      "NDC11Code": "49288-0175-05",
      "ProductNDC": "49288-0175",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Mite, Dermatophagoides Farinae",
      "NonProprietaryName": "Standardized Mite, Dermatophagoides Farinae",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19911022",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102224",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "DERMATOPHAGOIDES FARINAE",
      "StrengthNumber": "10000",
      "StrengthUnit": "[AU]/mL",
      "Pharm_Classes": "Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "INDICATIONS AND USAGE    Standardized Mite allergenic extract is indicated for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. An orderly approach to the diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.     Mite mixtures should not be used for diagnostic skin testing. The individual mites should be used. Mite mixtures may be used for immunotherapy to treat patients who demonstrated sensi­tivity to both D. farinae and D. pteronyssinus mites. Patients who react to both D. farinae and D. pteronyssinus have demonstrated a significant cross-reactivity. Caution should be used in esca­lating treatment with mite mixtures.21PRICK-PUNCTURE TESTING: A positive control using Histamine Phosphate is important to identify those patients whose skin may not be reactive due to medications, metabolic or other rea­sons. A diluent control, if negative, would exclude false-positive reactions due to ingredients in the diluent or patients who have dermatographism.     To identify highly sensitive individuals and as a safety precaution, it is recommended that prick-puncture test using a drop of the extract concentrate (10,000 AU/ml) be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. Glycerinated Mite extracts containing 10,000 AU/ml are recommended for prick-puncture testing. Skin reactions are based on size of erythema and wheal. For interpretation of skin reactions, refer to chart below.      Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the mite allergen. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. Hence, the importance of a good patient history. Less sensitive individuals can be tested intra­dermally with an appropriately diluted extract.     A clinical study using the same patients with positive prick-puncture test (10) using the ID50EAL Method, Intradermal Dilution for 50 mm Sum of Erythema D50 Determines the Allergy Unit, has demonstrated the following:     Skin test by prick-puncture test using Standardized D. farinae Mite, 10,000 AU/ml was per­formed in 10 patients. The mean sum of erythema diameter was 76.6 mm (Range 45-104 mm). Skin test by prick-puncture test using Standardized D. pteronyssinus Mite, 10,000 AU/ml in 10 patients, the mean sum of erythema diameter was 74.7 mm (Range 43-109 mm). *C = Concentration. SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Intracutaneous test dilutions should be made with aqueous diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, a prick-puncture test of less than 2+, the initial dilu­tion for skin testing should contain 0.02 to 0.06 AU/ml (see Table I). For very sensitive patients with a prick-puncture of greater than 2+, a further dilution should be made to 0.002 to 0.006 AU/ml (see Table I). If after 20 minutes no skin reaction is obtained, continue the testing using five-fold or ten-fold incre­ments in potency until a reaction of 1+ or until the concentration of 2,000 AU (five-fold) or 1,000 AU (ten-fold) has been tested with a glycerine control. Glycerine may be used at a dilution of 0.5% as long as 0.5% glycerine produces negative control. The diluent should be tested and included in the interpretation of the skin reactions.16 INTRADERMAL TESTING–SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patient's degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving pro­gressive five-fold dilutions of allergenic extracts, prepared and refrigerated at 2-8° C. The critical variable is the size if the wheal and erythema produced by the intracutaneous injection of 0.01 to 0.02 ml of the test allergen producing a 4 mm diameter superficial skin wheal. For patients demon­strating a prick-puncture skin test of less than 2+, an initial screening dilution of 0.02-0.06 AU/ml is safe (see Table I). For patients demonstrating a prick-puncture skin test greater than 2+, an initial screening dilu­tion of 0.002 to 0.006 AU/ml is safe. The skin endpoint is detected by noting the dilution that pro­duces a wheal 2 mm larger than non-reacting dilutions (5 mm negative wheal) until progressive whealing with each five-fold increase in test potency occurs, i.e., a 5 mm (negative), 7 mm, 9 mm, 11 mm is the normal sequence of whealing. The 7 mm wheal would be the endpoint. The endpoint dilution is used as an initial dose concentration for immunotherapy. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each indi­vidual.     Using Standardized D. farinae Mite, 10,000 AU/ml on 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.4). Using Standardized D. pteronyssinus Mite 10,000 AU/ml in 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.7).",
      "Description": "DESCRIPTION     The extract is sterile and intended for dilution prior to skin testing and/or immunotherapy. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. The route of administration for immunotherapy is subcutaneous. The designation AU/ml (Allergy Units per ml) is unitage based upon the relative potency of this standardized mite extract when com­pared by ELISA competition to the F.D.A. Mite Allergenic Reference Standard labeled 10,000 AU/ml assigned on the basis of quantitative skin testing by the ID50EAL Method.1,2,3,4,5,16 Lower con­centrations (e.g. 5,000 AU/ml and 3,000 AU/ml) are prepared by dilution of stock concentrates. Mite mixtures containing equal volumes of D. farinae and D. pteronyssinus are available at 5,000 AU/ml, 2,500 AU/ml and 1,500 AU/ml.     Active allergens are described by common and scientific name on the stock concentrate con­tainer label.     INGREDIENTS: Extract of Standardized Mites contain at least 99.0% adult mites and mite stages. This product may contain trace amounts of yeast and/or pork products; sodium chloride 0.95%; sodium bicarbonate 0.24%; 50% v/v glycerine as stabilizing agent and preservative.     Following is a brief description of the standardized quality procedures applied to these extracts:         1. The source material is carefully selected from whole body adult mites and mite stages cul­tured from a medium containing no material of human origin. The source material is extracted with a saline buffer and 50% v/v glycerine.         2. Several manufacturers submitted intradermal skin test data on Biopol Laboratories mite medium extract using patients who were puncture test positive (erythema greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (erythe­ma greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive to the mite extract and who were also skin test positive to the mite medium extract were also skin tested by the puncture method with an extract of yeast (Saccharomyces sp.) and were positive.         3. A ninhydrin protein analysis is completed to compare with the standard extract.         4. Each lot is standardized against the F.D.A. reference standard extract for total biologic activ­ity by means of ELISA competition.         5. The standardized mite extract is analyzed for glycerine content to insure a minimum of 50% v/v glycerine for optimal stability during the entire dating period."
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    {
      "NDCCode": "57337-175-01",
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      "ProprietaryName": "Dry Chivalry 3.5oz",
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      "IndicationAndUsage": "Reduces underarm wetness."
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      "LabelerName": "WALMART INC.",
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      "ListingRecordCertifiedThrough": "20271231",
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      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throat."
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      "LabelerName": "Rejoice International",
      "SubstanceName": "ALCOHOL",
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      "ListingRecordCertifiedThrough": "20271231",
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    {
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      "ProductTypeName": "HUMAN OTC DRUG",
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      "RouteName": "TOPICAL",
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      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "China Ningbo Shangge Cosmetic Technology Corp",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "146",
      "StrengthUnit": "g/236g",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20140124",
      "SamplePackage": "N",
      "IndicationAndUsage": "XtraCare® Hand Sanitizer Antibacterial. Kills 99.9% of Germs. Moisturize with Vitamin E & Aloe. 8 Fl Oz (236 mL)."
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    {
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      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Botanic Heal Boh Dual Primer Sun No 2",
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      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170701",
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      "ApplicationNumber": "part352",
      "LabelerName": "Cj Olivenetworks Co., Ltd",
      "SubstanceName": "OCTOCRYLENE; OCTINOXATE; OCTISALATE",
      "StrengthNumber": ".99; .77; .49",
      "StrengthUnit": "g/11g; g/11g; g/11g",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-03",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231"
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    {
      "NDCCode": "72197-044-06",
      "PackageDescription": "170 g in 1 JAR (72197-044-06) ",
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      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pharmacys Prescription Petroleum Jelly",
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      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210615",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "American Consumer Products Corp",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "99.9",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2025-01-24",
      "PackageNdcExcludeFlag": "N",
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      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210615",
      "SamplePackage": "N",
      "IndicationAndUsage": "USE: Helps treat and prevent diaper rash and seal out wetness."
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    {
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      "PackageDescription": "1 TUBE in 1 CARTON (0062-0175-12)  > 20 g in 1 TUBE",
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      "ProductNDC": "0062-0175",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Retin-a",
      "NonProprietaryName": "Tretinoin",
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      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017522",
      "LabelerName": "Ortho-McNeil Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "TRETINOIN",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Retinoid [EPC],Retinoids [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "0062-0175-13",
      "PackageDescription": "1 TUBE in 1 CARTON (0062-0175-13)  > 45 g in 1 TUBE",
      "NDC11Code": "00062-0175-13",
      "ProductNDC": "0062-0175",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Retin-a",
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      "MarketingCategoryName": "NDA",
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      "LabelerName": "Ortho-McNeil Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "TRETINOIN",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Retinoid [EPC],Retinoids [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "0089-0175-40",
      "PackageDescription": "120 AEROSOL, METERED in 1 CANISTER (0089-0175-40)",
      "NDC11Code": "00089-0175-40",
      "ProductNDC": "0089-0175",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Beclomethasone Dipropionate",
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      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "3M Company",
      "SubstanceName": "BECLOMETHASONE DIPROPIONATE",
      "StrengthNumber": "40",
      "StrengthUnit": "ug/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04"
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    {
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      "ProductTypeName": "HUMAN OTC DRUG",
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      "LabelerName": "L. Perrigo Company",
      "SubstanceName": "ACETAMINOPHEN",
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    {
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      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
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      "LabelerName": "L. Perrigo Company",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/5mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-11-08"
    },
    {
      "NDCCode": "0116-0175-16",
      "PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (0116-0175-16) ",
      "NDC11Code": "00116-0175-16",
      "ProductNDC": "0116-0175",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Chlorhexidine Gluconate",
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      "StartMarketingDate": "20090618",
      "EndMarketingDate": "20280131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077789",
      "LabelerName": "Xttrium Laboratories, Inc.",
      "SubstanceName": "CHLORHEXIDINE GLUCONATE",
      "StrengthNumber": "1.2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20090618",
      "EndMarketingDatePackage": "20280131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis; see PRECAUTIONS.",
      "Description": "Chlorhexidine gluconate oral rinse containing 0.12% chlorhexidine gluconate (1,11-hexamethylene bis[5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:."
    },
    {
      "NDCCode": "0179-0175-88",
      "PackageDescription": "2160 TABLET in 1 BOTTLE (0179-0175-88) ",
      "NDC11Code": "00179-0175-88",
      "ProductNDC": "0179-0175",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Finasteride",
      "NonProprietaryName": "Finasteride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150526",
      "EndMarketingDate": "20200731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090061",
      "LabelerName": "KAISER FOUNDATION HOSPITALS",
      "SubstanceName": "FINASTERIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-08-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150526",
      "EndMarketingDatePackage": "20200731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0220-0175-11",
      "PackageDescription": "1 [hp_X] in 1 BOTTLE, GLASS (0220-0175-11)",
      "NDC11Code": "00220-0175-11",
      "ProductNDC": "0220-0175",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Garlic",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20180205",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "BOIRON",
      "SubstanceName": "ALLIUM SATIVUM WHOLE",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_X]/[hp_X]",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "0220-0175-12",
      "PackageDescription": "1 [hp_X] in 1 BOTTLE, GLASS (0220-0175-12)",
      "NDC11Code": "00220-0175-12",
      "ProductNDC": "0220-0175",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Garlic",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20180205",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "BOIRON",
      "SubstanceName": "ALLIUM SATIVUM WHOLE",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_X]/[hp_X]",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20191231"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"0044-0175-99","NonProprietaryName":"Divalproex Sodium"},{"NDCCode":"0044-1800-99","NonProprietaryName":"Choline Fenofibrate"},{"NDCCode":"0044-3699-99","NonProprietaryName":"Clarithromycin"},{"NDCCode":"13107-044-99","ProprietaryName":"Oxycodone And Acetaminophen","NonProprietaryName":"Oxycodone And Acetaminophen"},{"NDCCode":"65862-044-99","ProprietaryName":"Lisinopril And Hydrochlorothiazide","NonProprietaryName":"Lisinopril And Hydrochlorothiazide"},{"NDCCode":"0363-0175-99","ProprietaryName":"Pain Reliever","NonProprietaryName":"Acetaminophen"},{"NDCCode":"47682-175-99","ProprietaryName":"Medique Apap Extra Strength","NonProprietaryName":"Acetaminophen"},{"NDCCode":"65862-175-99","ProprietaryName":"Penicillin V Potassium","NonProprietaryName":"Penicillin V Potassium"},{"NDCCode":"70720-175-99","ProprietaryName":"Qmiiz Odt","NonProprietaryName":"Meloxicam"},{"NDCCode":"80479-175-99","ProprietaryName":"Bernal Premium Alcohol Wipe","NonProprietaryName":"Alcohol"},{"NDCCode":"49288-0175-1","ProprietaryName":"Standardized Mite, Dermatophagoides Farinae","NonProprietaryName":"Standardized Mite, Dermatophagoides Farinae"},{"NDCCode":"49288-0175-2","ProprietaryName":"Standardized Mite, Dermatophagoides Farinae","NonProprietaryName":"Standardized Mite, Dermatophagoides Farinae"},{"NDCCode":"49288-0175-3","ProprietaryName":"Standardized Mite, Dermatophagoides Farinae","NonProprietaryName":"Standardized Mite, Dermatophagoides Farinae"},{"NDCCode":"49288-0175-4","ProprietaryName":"Standardized Mite, Dermatophagoides Farinae","NonProprietaryName":"Standardized Mite, Dermatophagoides Farinae"},{"NDCCode":"49288-0175-5","ProprietaryName":"Standardized Mite, Dermatophagoides Farinae","NonProprietaryName":"Standardized Mite, Dermatophagoides Farinae"},{"NDCCode":"57337-175-01","ProprietaryName":"Dry Chivalry 3.5oz","NonProprietaryName":"Aluminum Chlorohydrate"},{"NDCCode":"79903-175-08","ProprietaryName":"Allergy Relief","NonProprietaryName":"Diphenhydramine Hcl"},{"NDCCode":"57337-044-01","ProprietaryName":"Xtracare Hand Sanitizer","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"58503-044-01","ProprietaryName":"Xtracare Hand Sanitizer","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"71596-044-02","ProprietaryName":"Botanic Heal Boh Dual Primer Sun No 2","NonProprietaryName":"Octocrylene, Octinoxate, Octisalate"},{"NDCCode":"72197-044-06","ProprietaryName":"Pharmacys Prescription Petroleum Jelly","NonProprietaryName":"Petrolatum"},{"NDCCode":"0062-0175-12","ProprietaryName":"Retin-a","NonProprietaryName":"Tretinoin"},{"NDCCode":"0062-0175-13","ProprietaryName":"Retin-a","NonProprietaryName":"Tretinoin"},{"NDCCode":"0089-0175-40","NonProprietaryName":"Beclomethasone Dipropionate"},{"NDCCode":"0113-0175-26","ProprietaryName":"Good Sense Pain Relief","NonProprietaryName":"Acetaminophen"},{"NDCCode":"0113-0175-28","ProprietaryName":"Good Sense Pain Relief","NonProprietaryName":"Acetaminophen"},{"NDCCode":"0116-0175-16","ProprietaryName":"Chlorhexidine Gluconate","NonProprietaryName":"Chlorhexidine Gluconate"},{"NDCCode":"0179-0175-88","ProprietaryName":"Finasteride","NonProprietaryName":"Finasteride"},{"NDCCode":"0220-0175-11","NonProprietaryName":"Garlic"},{"NDCCode":"0220-0175-12","NonProprietaryName":"Garlic"}]}
                    

<NDCList><NDC><NDCCode>0044-0175-99</NDCCode><NonProprietaryName>Divalproex Sodium</NonProprietaryName></NDC><NDC><NDCCode>0044-1800-99</NDCCode><NonProprietaryName>Choline Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>0044-3699-99</NDCCode><NonProprietaryName>Clarithromycin</NonProprietaryName></NDC><NDC><NDCCode>13107-044-99</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>65862-044-99</NDCCode><ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>0363-0175-99</NDCCode><ProprietaryName>Pain Reliever</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>47682-175-99</NDCCode><ProprietaryName>Medique Apap Extra Strength</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>65862-175-99</NDCCode><ProprietaryName>Penicillin V Potassium</ProprietaryName><NonProprietaryName>Penicillin V Potassium</NonProprietaryName></NDC><NDC><NDCCode>70720-175-99</NDCCode><ProprietaryName>Qmiiz Odt</ProprietaryName><NonProprietaryName>Meloxicam</NonProprietaryName></NDC><NDC><NDCCode>80479-175-99</NDCCode><ProprietaryName>Bernal Premium Alcohol Wipe</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>49288-0175-1</NDCCode><ProprietaryName>Standardized Mite, Dermatophagoides Farinae</ProprietaryName><NonProprietaryName>Standardized Mite, Dermatophagoides Farinae</NonProprietaryName></NDC><NDC><NDCCode>49288-0175-2</NDCCode><ProprietaryName>Standardized Mite, Dermatophagoides Farinae</ProprietaryName><NonProprietaryName>Standardized Mite, Dermatophagoides Farinae</NonProprietaryName></NDC><NDC><NDCCode>49288-0175-3</NDCCode><ProprietaryName>Standardized Mite, Dermatophagoides Farinae</ProprietaryName><NonProprietaryName>Standardized Mite, Dermatophagoides Farinae</NonProprietaryName></NDC><NDC><NDCCode>49288-0175-4</NDCCode><ProprietaryName>Standardized Mite, Dermatophagoides Farinae</ProprietaryName><NonProprietaryName>Standardized Mite, Dermatophagoides Farinae</NonProprietaryName></NDC><NDC><NDCCode>49288-0175-5</NDCCode><ProprietaryName>Standardized Mite, Dermatophagoides Farinae</ProprietaryName><NonProprietaryName>Standardized Mite, Dermatophagoides Farinae</NonProprietaryName></NDC><NDC><NDCCode>57337-175-01</NDCCode><ProprietaryName>Dry Chivalry 3.5oz</ProprietaryName><NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName></NDC><NDC><NDCCode>79903-175-08</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName></NDC><NDC><NDCCode>57337-044-01</NDCCode><ProprietaryName>Xtracare Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>58503-044-01</NDCCode><ProprietaryName>Xtracare Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>71596-044-02</NDCCode><ProprietaryName>Botanic Heal Boh Dual Primer Sun No 2</ProprietaryName><NonProprietaryName>Octocrylene, Octinoxate, Octisalate</NonProprietaryName></NDC><NDC><NDCCode>72197-044-06</NDCCode><ProprietaryName>Pharmacys Prescription Petroleum Jelly</ProprietaryName><NonProprietaryName>Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>0062-0175-12</NDCCode><ProprietaryName>Retin-a</ProprietaryName><NonProprietaryName>Tretinoin</NonProprietaryName></NDC><NDC><NDCCode>0062-0175-13</NDCCode><ProprietaryName>Retin-a</ProprietaryName><NonProprietaryName>Tretinoin</NonProprietaryName></NDC><NDC><NDCCode>0089-0175-40</NDCCode><NonProprietaryName>Beclomethasone Dipropionate</NonProprietaryName></NDC><NDC><NDCCode>0113-0175-26</NDCCode><ProprietaryName>Good Sense Pain Relief</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>0113-0175-28</NDCCode><ProprietaryName>Good Sense Pain Relief</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>0116-0175-16</NDCCode><ProprietaryName>Chlorhexidine Gluconate</ProprietaryName><NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName></NDC><NDC><NDCCode>0179-0175-88</NDCCode><ProprietaryName>Finasteride</ProprietaryName><NonProprietaryName>Finasteride</NonProprietaryName></NDC><NDC><NDCCode>0220-0175-11</NDCCode><NonProprietaryName>Garlic</NonProprietaryName></NDC><NDC><NDCCode>0220-0175-12</NDCCode><NonProprietaryName>Garlic</NonProprietaryName></NDC></NDCList>