RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "35781-0210-9",
      "PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (35781-0210-9)  > 90 mL in 1 BOTTLE, DISPENSING",
      "NDC11Code": "35781-0210-09",
      "ProductNDC": "35781-0210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Speedgel Rx",
      "NonProprietaryName": "Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale",
      "DosageFormName": "GEL",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20111201",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Gensco Laboratories, LLC",
      "SubstanceName": "ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL",
      "StrengthNumber": "1; 3; 1; 3; 1; 1; 1; 3; 3; 1; 1; 1; 1; 1",
      "StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
      "Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS], Allergens [CS], Cell-mediated Immunity [PE], Cytochrome P450 3A4 Inhibitors [MoA], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], P-Glycoprotein Interactions [MoA], Plant Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20111201",
      "SamplePackage": "N",
      "IndicationAndUsage": "SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes.",
      "Description": "SpeedGel Rx® is a prescription transdermal gel that provides relief of pain, inflammation and bruising, utilizing patented Isopeutic Transdermal Technology. The Gensco® patented transdermal drug delivery system used in SpeedGel Rx® carries proprietary formulation of active ingredients, through the skin to the locally affected tissues. SpeedGel Rx® is applied directly to the affected site specifically, minimizing side effects, interactions and comorbidities caused by oral therapies and topical NSAIDs. Furthermore, SpeedGel Rx® is clinically proven to reduce narcotic use. SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes. SpeedGel Rx® is a proprietary combination of 14 active ingredients, 4 of which are prescription, in a patented transdermal delivery system. Among the prescription ingredients is Colchicinum Autumnale also known as Colchicine, which is a well-known, strong and effective anti-inflammatory medication. It contains the following active ingredients: Aconitum Napellus 3X HPUS, Arnica Montana 1X HPUS, Belladonna 3X HPUS, Bellis Perennis 1X HPUS, Calendula Officinalis 1X HPUS, Chamomilla 1X HPUS, Colchicinum 3X HPUS, Echinacea Angustifolia 1X HPUS, Echinacea Purpurea 1X HPUS, Hamamelis Virginiana 1X HPUS, Hypericum Perforatum 1X HPUS, Millefolium 1X HPUS, Symphytum Officinale 3X HPUS, Zingiber Officinale 1X HPUS. It also contains the following inactive ingredients: Docusate sodium, Ethyl Alcohol, Isopropyl myristate, Lecithin, Purified Water & Urea. The patented transdermal gel’s liposomal base comprising of hydrophilic and lipophilic components is designed to suspend the active ingredients and allow for the hydration of the skin barrier and movement of the active ingredients, irrespective of their molecular polarity, across the skin at an enhanced rate. The unique transdermal characteristics in SpeedGel Rx® permit the active ingredients to penetrate to the site of injury, diminishing pain and inflammation, and enhancing bruise resolution. As a topically applied transdermal medication,  SpeedGel Rx® avoids the common concerns of toxicity and drug interactions associated with systemic (oral) medications. SpeedGel Rx® is an amber colored, odorless gel dispensed in a patented metered dose container (MDose) containing either 10ml, 30ml, or 90ml. Gensco’s unique metered dose technology (MDose) which dispenses exactly (0.25 mL of medication per pump) per application, covering a 2”x2” area of skin. MDose provides more accurate dosing, less waste and significant cost savings (Gensco® Pharma Tube vs. Pump Study)."
    },
    {
      "NDCCode": "35781-0210-1",
      "PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (35781-0210-1)  > 10 mL in 1 BOTTLE, DISPENSING",
      "NDC11Code": "35781-0210-01",
      "ProductNDC": "35781-0210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Speedgel Rx",
      "NonProprietaryName": "Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale",
      "DosageFormName": "GEL",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20111201",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Gensco Laboratories, LLC",
      "SubstanceName": "ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL",
      "StrengthNumber": "1; 3; 1; 3; 1; 1; 1; 3; 3; 1; 1; 1; 1; 1",
      "StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
      "Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS], Allergens [CS], Cell-mediated Immunity [PE], Cytochrome P450 3A4 Inhibitors [MoA], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], P-Glycoprotein Interactions [MoA], Plant Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20111201",
      "SamplePackage": "N",
      "IndicationAndUsage": "SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes.",
      "Description": "SpeedGel Rx® is a prescription transdermal gel that provides relief of pain, inflammation and bruising, utilizing patented Isopeutic Transdermal Technology. The Gensco® patented transdermal drug delivery system used in SpeedGel Rx® carries proprietary formulation of active ingredients, through the skin to the locally affected tissues. SpeedGel Rx® is applied directly to the affected site specifically, minimizing side effects, interactions and comorbidities caused by oral therapies and topical NSAIDs. Furthermore, SpeedGel Rx® is clinically proven to reduce narcotic use. SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes. SpeedGel Rx® is a proprietary combination of 14 active ingredients, 4 of which are prescription, in a patented transdermal delivery system. Among the prescription ingredients is Colchicinum Autumnale also known as Colchicine, which is a well-known, strong and effective anti-inflammatory medication. It contains the following active ingredients: Aconitum Napellus 3X HPUS, Arnica Montana 1X HPUS, Belladonna 3X HPUS, Bellis Perennis 1X HPUS, Calendula Officinalis 1X HPUS, Chamomilla 1X HPUS, Colchicinum 3X HPUS, Echinacea Angustifolia 1X HPUS, Echinacea Purpurea 1X HPUS, Hamamelis Virginiana 1X HPUS, Hypericum Perforatum 1X HPUS, Millefolium 1X HPUS, Symphytum Officinale 3X HPUS, Zingiber Officinale 1X HPUS. It also contains the following inactive ingredients: Docusate sodium, Ethyl Alcohol, Isopropyl myristate, Lecithin, Purified Water & Urea. The patented transdermal gel’s liposomal base comprising of hydrophilic and lipophilic components is designed to suspend the active ingredients and allow for the hydration of the skin barrier and movement of the active ingredients, irrespective of their molecular polarity, across the skin at an enhanced rate. The unique transdermal characteristics in SpeedGel Rx® permit the active ingredients to penetrate to the site of injury, diminishing pain and inflammation, and enhancing bruise resolution. As a topically applied transdermal medication,  SpeedGel Rx® avoids the common concerns of toxicity and drug interactions associated with systemic (oral) medications. SpeedGel Rx® is an amber colored, odorless gel dispensed in a patented metered dose container (MDose) containing either 10ml, 30ml, or 90ml. Gensco’s unique metered dose technology (MDose) which dispenses exactly (0.25 mL of medication per pump) per application, covering a 2”x2” area of skin. MDose provides more accurate dosing, less waste and significant cost savings (Gensco® Pharma Tube vs. Pump Study)."
    },
    {
      "NDCCode": "35781-0210-2",
      "PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (35781-0210-2)  > 30 mL in 1 BOTTLE, DISPENSING",
      "NDC11Code": "35781-0210-02",
      "ProductNDC": "35781-0210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Speedgel Rx",
      "NonProprietaryName": "Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale",
      "DosageFormName": "GEL",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20111201",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Gensco Laboratories, LLC",
      "SubstanceName": "ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL",
      "StrengthNumber": "1; 3; 1; 3; 1; 1; 1; 3; 3; 1; 1; 1; 1; 1",
      "StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
      "Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS], Allergens [CS], Cell-mediated Immunity [PE], Cytochrome P450 3A4 Inhibitors [MoA], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], P-Glycoprotein Interactions [MoA], Plant Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20111201",
      "SamplePackage": "N",
      "IndicationAndUsage": "SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes.",
      "Description": "SpeedGel Rx® is a prescription transdermal gel that provides relief of pain, inflammation and bruising, utilizing patented Isopeutic Transdermal Technology. The Gensco® patented transdermal drug delivery system used in SpeedGel Rx® carries proprietary formulation of active ingredients, through the skin to the locally affected tissues. SpeedGel Rx® is applied directly to the affected site specifically, minimizing side effects, interactions and comorbidities caused by oral therapies and topical NSAIDs. Furthermore, SpeedGel Rx® is clinically proven to reduce narcotic use. SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes. SpeedGel Rx® is a proprietary combination of 14 active ingredients, 4 of which are prescription, in a patented transdermal delivery system. Among the prescription ingredients is Colchicinum Autumnale also known as Colchicine, which is a well-known, strong and effective anti-inflammatory medication. It contains the following active ingredients: Aconitum Napellus 3X HPUS, Arnica Montana 1X HPUS, Belladonna 3X HPUS, Bellis Perennis 1X HPUS, Calendula Officinalis 1X HPUS, Chamomilla 1X HPUS, Colchicinum 3X HPUS, Echinacea Angustifolia 1X HPUS, Echinacea Purpurea 1X HPUS, Hamamelis Virginiana 1X HPUS, Hypericum Perforatum 1X HPUS, Millefolium 1X HPUS, Symphytum Officinale 3X HPUS, Zingiber Officinale 1X HPUS. It also contains the following inactive ingredients: Docusate sodium, Ethyl Alcohol, Isopropyl myristate, Lecithin, Purified Water & Urea. The patented transdermal gel’s liposomal base comprising of hydrophilic and lipophilic components is designed to suspend the active ingredients and allow for the hydration of the skin barrier and movement of the active ingredients, irrespective of their molecular polarity, across the skin at an enhanced rate. The unique transdermal characteristics in SpeedGel Rx® permit the active ingredients to penetrate to the site of injury, diminishing pain and inflammation, and enhancing bruise resolution. As a topically applied transdermal medication,  SpeedGel Rx® avoids the common concerns of toxicity and drug interactions associated with systemic (oral) medications. SpeedGel Rx® is an amber colored, odorless gel dispensed in a patented metered dose container (MDose) containing either 10ml, 30ml, or 90ml. Gensco’s unique metered dose technology (MDose) which dispenses exactly (0.25 mL of medication per pump) per application, covering a 2”x2” area of skin. MDose provides more accurate dosing, less waste and significant cost savings (Gensco® Pharma Tube vs. Pump Study)."
    },
    {
      "NDCCode": "35781-0300-1",
      "PackageDescription": "1 TUBE in 1 CARTON (35781-0300-1)  > 9.5 g in 1 TUBE",
      "NDC11Code": "35781-0300-01",
      "ProductNDC": "35781-0300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lido Rx",
      "NonProprietaryName": "Lidocaine",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130301",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Gensco Laboratories, LLC",
      "SubstanceName": "LIDOCAINE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20150928",
      "SamplePackage": "N",
      "IndicationAndUsage": "Anesthetic for relief of pain at site of injury; relief of musculoskeletal pain  and soreness; pain from neuropathy; local medical procedures,  injections and vaccines; relief of pruritis, pruritic eczema, abrasions,  minor burns, insect bites, pain, soreness and discomfort due to pruritis  ani, pruritis vulvae, hemorrhoids, anal fissures and similar conditions of  the skin and mucous membranes.",
      "Description": "Each gram of LiDORx® 3% contains Lidocaine Hydrochloride USP 3% (30 mg). Lidocaine Hydrochloride USP is chemically designated as acetamide, 2- (diethylamino)-N-(2,6-dimethylphenyl), and has the following structure."
    },
    {
      "NDCCode": "35781-0300-9",
      "PackageDescription": "1 TUBE in 1 CARTON (35781-0300-9)  > 85.5 g in 1 TUBE",
      "NDC11Code": "35781-0300-09",
      "ProductNDC": "35781-0300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lido Rx",
      "NonProprietaryName": "Lidocaine",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130301",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Gensco Laboratories, LLC",
      "SubstanceName": "LIDOCAINE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20150928",
      "SamplePackage": "N",
      "IndicationAndUsage": "Anesthetic for relief of pain at site of injury; relief of musculoskeletal pain  and soreness; pain from neuropathy; local medical procedures,  injections and vaccines; relief of pruritis, pruritic eczema, abrasions,  minor burns, insect bites, pain, soreness and discomfort due to pruritis  ani, pruritis vulvae, hemorrhoids, anal fissures and similar conditions of  the skin and mucous membranes.",
      "Description": "Each gram of LiDORx® 3% contains Lidocaine Hydrochloride USP 3% (30 mg). Lidocaine Hydrochloride USP is chemically designated as acetamide, 2- (diethylamino)-N-(2,6-dimethylphenyl), and has the following structure."
    },
    {
      "NDCCode": "35781-0500-9",
      "PackageDescription": "1 TUBE in 1 CARTON (35781-0500-9)  > 90 g in 1 TUBE",
      "NDC11Code": "35781-0500-09",
      "ProductNDC": "35781-0500",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidocaine Hydrochloride",
      "NonProprietaryName": "Lidocaine",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20090630",
      "MarketingCategoryName": "PREMARKET NOTIFICATION",
      "ApplicationNumber": "K092086",
      "LabelerName": "Gensco Laboratories, LLC",
      "SubstanceName": "LIDOCAINE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-27",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Stage I - IV pressure ulcers. Venous stasis ulcers. Ulcerations caused by mixed vascular etiologies. Diabetic skin ulcers. First and second degree burns. Post-surgical incisions, cuts and abrasions.",
      "Description": "A soothing hydrogel wound dressing that promotes a moist wound environment that is ideal for the healing process. LDO Plus contains Lidocaine HCl USP 4%, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, and has the following structural formula."
    },
    {
      "NDCCode": "11014-0210-1",
      "PackageDescription": "24 BOX in 1 CARTON (11014-0210-1)  > 36 VIAL in 1 BOX > .9 mL in 1 VIAL",
      "NDC11Code": "11014-0210-01",
      "ProductNDC": "11014-0210",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Genteal Tears Liquid Drops",
      "DosageFormName": "SOLUTION",
      "StartMarketingDate": "20160401",
      "EndMarketingDate": "20180425",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Catalent Pharma Solutions, LLC",
      "SubstanceName": "GLYCERIN; DEXTRAN 70; HYPROMELLOSES",
      "StrengthNumber": "2; 1; 3",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20180425"
    },
    {
      "NDCCode": "51552-0210-9",
      "PackageDescription": "180 mg in 1 CONTAINER (51552-0210-9) ",
      "NDC11Code": "51552-0210-09",
      "ProductNDC": "51552-0210",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Methylcellulose 4000 Cps",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20040901",
      "EndMarketingDate": "20241014",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Fagron Inc",
      "SubstanceName": "METHYLCELLULOSE (4000 MPA.S)",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "StartMarketingDatePackage": "01-SEP-04",
      "EndMarketingDatePackage": "14-OCT-24"
    },
    {
      "NDCCode": "60505-0210-9",
      "PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-0210-9)",
      "NDC11Code": "60505-0210-09",
      "ProductNDC": "60505-0210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diltzac",
      "NonProprietaryName": "Diltiazem Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090203",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076395",
      "LabelerName": "Apotex Corp.",
      "SubstanceName": "DILTIAZEM HYDROCHLORIDE",
      "StrengthNumber": "120",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-03-20"
    },
    {
      "NDCCode": "69968-0163-9",
      "PackageDescription": "1 KIT in 1 CARTON (69968-0163-9)  *  177 mL in 1 BOTTLE, PUMP (58232-0210-2)  *  1 BOTTLE, PUMP in 1 CARTON (58232-0208-1)  > 118 mL in 1 BOTTLE, PUMP",
      "NDC11Code": "69968-0163-09",
      "ProductNDC": "69968-0163",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aveeno Favorites From Clear Complexion",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20151202",
      "EndMarketingDate": "20210428",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "Johnson & Johnson Consumer Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2021-04-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20151202",
      "EndMarketingDatePackage": "20210428",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71335-0210-9",
      "PackageDescription": "45 TABLET, FILM COATED in 1 BOTTLE (71335-0210-9) ",
      "NDC11Code": "71335-0210-09",
      "ProductNDC": "71335-0210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline Hydrochloride",
      "NonProprietaryName": "Sertraline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070206",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077206",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-08-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211227",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].",
      "Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
    },
    {
      "NDCCode": "90107-0210-1",
      "PackageDescription": ".9 g in 1 PACKET (90107-0210-1) ",
      "NDC11Code": "90107-0210-01",
      "ProductNDC": "90107-0210",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Easy Care First Aid Afterburn",
      "NonProprietaryName": "Benzalkonium Chloride, Lidocaine",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190901",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Adventure Ready Brands",
      "SubstanceName": "BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": ".13; .5",
      "StrengthUnit": "g/100g; g/100g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20201201",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporary relief of pain associated with minor burns. helps protect against harmful bacteria in minor burns."
    },
    {
      "NDCCode": "90107-0210-2",
      "PackageDescription": "6 PACKET in 1 BOX (90107-0210-2)  > .9 g in 1 PACKET",
      "NDC11Code": "90107-0210-02",
      "ProductNDC": "90107-0210",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Easy Care First Aid Afterburn",
      "NonProprietaryName": "Benzalkonium Chloride, Lidocaine",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190901",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Adventure Ready Brands",
      "SubstanceName": "BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": ".13; .5",
      "StrengthUnit": "g/100g; g/100g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20201201",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporary relief of pain associated with minor burns. helps protect against harmful bacteria in minor burns."
    },
    {
      "NDCCode": "90107-0210-3",
      "PackageDescription": "100 PACKET in 1 CARTON (90107-0210-3)  > .9 g in 1 PACKET",
      "NDC11Code": "90107-0210-03",
      "ProductNDC": "90107-0210",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Easy Care First Aid Afterburn",
      "NonProprietaryName": "Benzalkonium Chloride, Lidocaine",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190901",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Adventure Ready Brands",
      "SubstanceName": "BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": ".13; .5",
      "StrengthUnit": "g/100g; g/100g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20201201",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporary relief of pain associated with minor burns. helps protect against harmful bacteria in minor burns."
    },
    {
      "NDCCode": "13630-0210-4",
      "PackageDescription": "205 mL in 1 CAN (13630-0210-4) ",
      "NDC11Code": "13630-0210-04",
      "ProductNDC": "13630-0210",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Soleil Toujours",
      "ProprietaryNameSuffix": "Spf 30 Sheer Sunscreen Mist",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210426",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Prime Packaging Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE",
      "StrengthNumber": "24.9; 62.25; 41.5",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-09-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210426",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
    },
    {
      "NDCCode": "13733-210-01",
      "PackageDescription": "11 g in 1 CONTAINER (13733-210-01)",
      "NDC11Code": "13733-0210-01",
      "ProductNDC": "13733-210",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Missha M Radiance Two Way Pact Spf27 No23",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide, Octinoxate",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160601",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Able C&C Co., Ltd.",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "3.5; 9.05; 3.92",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2017-11-22"
    },
    {
      "NDCCode": "14141-210-01",
      "PackageDescription": "9 g in 1 CASE (14141-210-01) ",
      "NDC11Code": "14141-0210-01",
      "ProductNDC": "14141-210",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Clarite Makeup Foundation For A Clearer Appearance Spf 30 230-n",
      "NonProprietaryName": "Octinoxate, Zinc Oxide",
      "DosageFormName": "PASTE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201109",
      "EndMarketingDate": "20251231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "BEL STAR S A",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "7.5; 7.84",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20201109",
      "EndMarketingDatePackage": "20251231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Stop use and ask a doctorif rash occurs."
    },
    {
      "NDCCode": "24979-210-04",
      "PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (24979-210-04) ",
      "NDC11Code": "24979-0210-04",
      "ProductNDC": "24979-210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Topiramate",
      "NonProprietaryName": "Topiramate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231205",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217694",
      "LabelerName": "Upsher-Smith Laboratories, LLC",
      "SubstanceName": "TOPIRAMATE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231205",
      "SamplePackage": "N",
      "IndicationAndUsage": "Topiramate capsules are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
      "Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate capsules, USP are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5­-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate capsules, USP contain topiramate-coated beads in a hard gelatin capsule. The inactive ingredients are black ink, cellulose acetate, gelatin, mannitol, povidone, sodium lauryl sulfate, sugar spheres (sucrose and starch) and titanium dioxide. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "31722-210-10",
      "PackageDescription": "10 VIAL in 1 CARTON (31722-210-10)  > 10 mL in 1 VIAL (31722-210-33) ",
      "NDC11Code": "31722-0210-10",
      "ProductNDC": "31722-210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vancomycin Hydrochloride",
      "NonProprietaryName": "Vancomycin Hydrochloride",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20220706",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216591",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/10mL",
      "Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
      "Status": "Active",
      "LastUpdate": "2022-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220706",
      "SamplePackage": "N",
      "IndicationAndUsage": "Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, and skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin hydrochloride for injection, USP has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP 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. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
      "Description": "Vancomycin Hydrochloride for Injection, USP, is a white to tan lyophilized cake or powder, for preparing intravenous infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base is equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE.Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is [3S-[3 R*, 6S* (S*), 7S*, 22S*, 23R*, 26R*, 36S*, 38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-l-lyxo hexopyranosyl)-β-d-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H[1,6,9] oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. Vancomycin hydrochloride has the following structural formula:. C 66H 75Cl 2N 9O 24 HCl                          M.W. 1485.71."
    },
    {
      "NDCCode": "31722-210-32",
      "PackageDescription": "25 VIAL in 1 CARTON (31722-210-32)  > 10 mL in 1 VIAL (31722-210-33) ",
      "NDC11Code": "31722-0210-32",
      "ProductNDC": "31722-210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vancomycin Hydrochloride",
      "NonProprietaryName": "Vancomycin Hydrochloride",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20220706",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216591",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/10mL",
      "Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
      "Status": "Active",
      "LastUpdate": "2022-07-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220706",
      "SamplePackage": "N",
      "IndicationAndUsage": "Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, and skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin hydrochloride for injection, USP has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP 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. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
      "Description": "Vancomycin Hydrochloride for Injection, USP, is a white to tan lyophilized cake or powder, for preparing intravenous infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base is equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE.Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is [3S-[3 R*, 6S* (S*), 7S*, 22S*, 23R*, 26R*, 36S*, 38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-l-lyxo hexopyranosyl)-β-d-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H[1,6,9] oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. Vancomycin hydrochloride has the following structural formula:. C 66H 75Cl 2N 9O 24 HCl                          M.W. 1485.71."
    },
    {
      "NDCCode": "46708-210-10",
      "PackageDescription": "100 TABLET in 1 CARTON (46708-210-10) ",
      "NDC11Code": "46708-0210-10",
      "ProductNDC": "46708-210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Telmisartan And Hydrochlorothiazide",
      "NonProprietaryName": "Telmisartan And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140314",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203010",
      "LabelerName": "Alembic Pharmaceuticals Limited",
      "SubstanceName": "TELMISARTAN; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "80; 12.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2023-02-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140314",
      "SamplePackage": "N",
      "IndicationAndUsage": "Telmisartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).",
      "Description": "Telmisartan and hydrochlorothiazide. tablets, USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.Telmisartan, a non-peptide molecule, is chemically described as 4’-[(1,4’-dimethyl-2’-propyl[2,6’-bi-1H-benzimidazol]-1’-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H. -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively.  The tablets contain the following inactive ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate, lactose monohydrate, magnesium stearate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. Telmisartan and hydrochlorothiazide tablets are hygroscopic and require protection from moisture."
    },
    {
      "NDCCode": "46708-210-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (46708-210-30) ",
      "NDC11Code": "46708-0210-30",
      "ProductNDC": "46708-210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Telmisartan And Hydrochlorothiazide",
      "NonProprietaryName": "Telmisartan And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140314",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203010",
      "LabelerName": "Alembic Pharmaceuticals Limited",
      "SubstanceName": "TELMISARTAN; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "80; 12.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2023-02-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140314",
      "SamplePackage": "N",
      "IndicationAndUsage": "Telmisartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).",
      "Description": "Telmisartan and hydrochlorothiazide. tablets, USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.Telmisartan, a non-peptide molecule, is chemically described as 4’-[(1,4’-dimethyl-2’-propyl[2,6’-bi-1H-benzimidazol]-1’-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H. -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively.  The tablets contain the following inactive ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate, lactose monohydrate, magnesium stearate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. Telmisartan and hydrochlorothiazide tablets are hygroscopic and require protection from moisture."
    },
    {
      "NDCCode": "46708-210-91",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (46708-210-91) ",
      "NDC11Code": "46708-0210-91",
      "ProductNDC": "46708-210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Telmisartan And Hydrochlorothiazide",
      "NonProprietaryName": "Telmisartan And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140314",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203010",
      "LabelerName": "Alembic Pharmaceuticals Limited",
      "SubstanceName": "TELMISARTAN; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "80; 12.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2023-02-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140314",
      "SamplePackage": "N",
      "IndicationAndUsage": "Telmisartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).",
      "Description": "Telmisartan and hydrochlorothiazide. tablets, USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.Telmisartan, a non-peptide molecule, is chemically described as 4’-[(1,4’-dimethyl-2’-propyl[2,6’-bi-1H-benzimidazol]-1’-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H. -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2, and its structural formula is. Telmisartan and hydrochlorothiazide tablets are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively.  The tablets contain the following inactive ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate, lactose monohydrate, magnesium stearate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. Telmisartan and hydrochlorothiazide tablets are hygroscopic and require protection from moisture."
    },
    {
      "NDCCode": "47469-210-02",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (47469-210-02)  > 300 mL in 1 BOTTLE, PLASTIC (47469-210-01) ",
      "NDC11Code": "47469-0210-02",
      "ProductNDC": "47469-210",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hanskin Hyaluron Skin Essence",
      "NonProprietaryName": "Glycerin",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160701",
      "EndMarketingDate": "20181201",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Celltrion Skincure Co.,Ltd.",
      "SubstanceName": "GLYCERIN",
      "StrengthNumber": "9",
      "StrengthUnit": "g/300mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160701",
      "EndMarketingDatePackage": "20181201",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49288-0210-1",
      "PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0210-1)",
      "NDC11Code": "49288-0210-01",
      "ProductNDC": "49288-0210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Number Four Mold Mixture",
      "NonProprietaryName": "Number Four Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA; ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI",
      "StrengthNumber": ".0125; .0031; .0031; .0031; .0031; .0125; .0021; .0021; .0021; .0021; .0021; .0021",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used 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. 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.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0210-2",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0210-2)",
      "NDC11Code": "49288-0210-02",
      "ProductNDC": "49288-0210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Number Four Mold Mixture",
      "NonProprietaryName": "Number Four Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA; ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI",
      "StrengthNumber": ".0125; .0031; .0031; .0031; .0031; .0125; .0021; .0021; .0021; .0021; .0021; .0021",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used 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. 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.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0210-3",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0210-3)",
      "NDC11Code": "49288-0210-03",
      "ProductNDC": "49288-0210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Number Four Mold Mixture",
      "NonProprietaryName": "Number Four Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA; ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI",
      "StrengthNumber": ".0125; .0031; .0031; .0031; .0031; .0125; .0021; .0021; .0021; .0021; .0021; .0021",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used 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. 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.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0210-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0210-4)",
      "NDC11Code": "49288-0210-04",
      "ProductNDC": "49288-0210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Number Four Mold Mixture",
      "NonProprietaryName": "Number Four Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA; ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI",
      "StrengthNumber": ".0125; .0031; .0031; .0031; .0031; .0125; .0021; .0021; .0021; .0021; .0021; .0021",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used 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. 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.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "49288-0210-5",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0210-5)",
      "NDC11Code": "49288-0210-05",
      "ProductNDC": "49288-0210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Number Four Mold Mixture",
      "NonProprietaryName": "Number Four Mold Mixture",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "ALTERNARIA ALTERNATA; ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI",
      "StrengthNumber": ".0125; .0031; .0031; .0031; .0031; .0125; .0021; .0021; .0021; .0021; .0021; .0021",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used 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. 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.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "51009-210-55",
      "PackageDescription": "1 TUBE in 1 CARTON (51009-210-55)  > 155.9 g in 1 TUBE",
      "NDC11Code": "51009-0210-55",
      "ProductNDC": "51009-210",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Toms Cavity Protection Spearmint",
      "ProprietaryNameSuffix": "Fights Cavities Fresh Breath",
      "NonProprietaryName": "Sodium Monofluorophosphate",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20141231",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "Tom's of Maine, Inc.",
      "SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
      "StrengthNumber": "1.4",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20141231",
      "SamplePackage": "N"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"35781-0210-9","ProprietaryName":"Speedgel Rx","NonProprietaryName":"Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale"},{"NDCCode":"35781-0210-1","ProprietaryName":"Speedgel Rx","NonProprietaryName":"Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale"},{"NDCCode":"35781-0210-2","ProprietaryName":"Speedgel Rx","NonProprietaryName":"Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale"},{"NDCCode":"35781-0300-1","ProprietaryName":"Lido Rx","NonProprietaryName":"Lidocaine"},{"NDCCode":"35781-0300-9","ProprietaryName":"Lido Rx","NonProprietaryName":"Lidocaine"},{"NDCCode":"35781-0500-9","ProprietaryName":"Lidocaine Hydrochloride","NonProprietaryName":"Lidocaine"},{"NDCCode":"11014-0210-1","NonProprietaryName":"Genteal Tears Liquid Drops"},{"NDCCode":"51552-0210-9","NonProprietaryName":"Methylcellulose 4000 Cps"},{"NDCCode":"60505-0210-9","ProprietaryName":"Diltzac","NonProprietaryName":"Diltiazem Hydrochloride"},{"NDCCode":"69968-0163-9","ProprietaryName":"Aveeno Favorites From Clear Complexion","NonProprietaryName":"Salicylic Acid"},{"NDCCode":"71335-0210-9","ProprietaryName":"Sertraline Hydrochloride","NonProprietaryName":"Sertraline Hydrochloride"},{"NDCCode":"90107-0210-1","ProprietaryName":"Easy Care First Aid Afterburn","NonProprietaryName":"Benzalkonium Chloride, Lidocaine"},{"NDCCode":"90107-0210-2","ProprietaryName":"Easy Care First Aid Afterburn","NonProprietaryName":"Benzalkonium Chloride, Lidocaine"},{"NDCCode":"90107-0210-3","ProprietaryName":"Easy Care First Aid Afterburn","NonProprietaryName":"Benzalkonium Chloride, Lidocaine"},{"NDCCode":"13630-0210-4","ProprietaryName":"Soleil Toujours","NonProprietaryName":"Avobenzone, Homosalate, Octisalate"},{"NDCCode":"13733-210-01","ProprietaryName":"Missha M Radiance Two Way Pact Spf27 No23","NonProprietaryName":"Titanium Dioxide, Zinc Oxide, Octinoxate"},{"NDCCode":"14141-210-01","ProprietaryName":"Clarite Makeup Foundation For A Clearer Appearance Spf 30 230-n","NonProprietaryName":"Octinoxate, Zinc Oxide"},{"NDCCode":"24979-210-04","ProprietaryName":"Topiramate","NonProprietaryName":"Topiramate"},{"NDCCode":"31722-210-10","ProprietaryName":"Vancomycin Hydrochloride","NonProprietaryName":"Vancomycin Hydrochloride"},{"NDCCode":"31722-210-32","ProprietaryName":"Vancomycin Hydrochloride","NonProprietaryName":"Vancomycin Hydrochloride"},{"NDCCode":"46708-210-10","ProprietaryName":"Telmisartan And Hydrochlorothiazide","NonProprietaryName":"Telmisartan And Hydrochlorothiazide"},{"NDCCode":"46708-210-30","ProprietaryName":"Telmisartan And Hydrochlorothiazide","NonProprietaryName":"Telmisartan And Hydrochlorothiazide"},{"NDCCode":"46708-210-91","ProprietaryName":"Telmisartan And Hydrochlorothiazide","NonProprietaryName":"Telmisartan And Hydrochlorothiazide"},{"NDCCode":"47469-210-02","ProprietaryName":"Hanskin Hyaluron Skin Essence","NonProprietaryName":"Glycerin"},{"NDCCode":"49288-0210-1","ProprietaryName":"Number Four Mold Mixture","NonProprietaryName":"Number Four Mold Mixture"},{"NDCCode":"49288-0210-2","ProprietaryName":"Number Four Mold Mixture","NonProprietaryName":"Number Four Mold Mixture"},{"NDCCode":"49288-0210-3","ProprietaryName":"Number Four Mold Mixture","NonProprietaryName":"Number Four Mold Mixture"},{"NDCCode":"49288-0210-4","ProprietaryName":"Number Four Mold Mixture","NonProprietaryName":"Number Four Mold Mixture"},{"NDCCode":"49288-0210-5","ProprietaryName":"Number Four Mold Mixture","NonProprietaryName":"Number Four Mold Mixture"},{"NDCCode":"51009-210-55","ProprietaryName":"Toms Cavity Protection Spearmint","NonProprietaryName":"Sodium Monofluorophosphate"}]}
                    

<NDCList><NDC><NDCCode>35781-0210-9</NDCCode><ProprietaryName>Speedgel Rx</ProprietaryName><NonProprietaryName>Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale</NonProprietaryName></NDC><NDC><NDCCode>35781-0210-1</NDCCode><ProprietaryName>Speedgel Rx</ProprietaryName><NonProprietaryName>Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale</NonProprietaryName></NDC><NDC><NDCCode>35781-0210-2</NDCCode><ProprietaryName>Speedgel Rx</ProprietaryName><NonProprietaryName>Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale</NonProprietaryName></NDC><NDC><NDCCode>35781-0300-1</NDCCode><ProprietaryName>Lido Rx</ProprietaryName><NonProprietaryName>Lidocaine</NonProprietaryName></NDC><NDC><NDCCode>35781-0300-9</NDCCode><ProprietaryName>Lido Rx</ProprietaryName><NonProprietaryName>Lidocaine</NonProprietaryName></NDC><NDC><NDCCode>35781-0500-9</NDCCode><ProprietaryName>Lidocaine Hydrochloride</ProprietaryName><NonProprietaryName>Lidocaine</NonProprietaryName></NDC><NDC><NDCCode>11014-0210-1</NDCCode><NonProprietaryName>Genteal Tears Liquid Drops</NonProprietaryName></NDC><NDC><NDCCode>51552-0210-9</NDCCode><NonProprietaryName>Methylcellulose 4000 Cps</NonProprietaryName></NDC><NDC><NDCCode>60505-0210-9</NDCCode><ProprietaryName>Diltzac</ProprietaryName><NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69968-0163-9</NDCCode><ProprietaryName>Aveeno Favorites From Clear Complexion</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>71335-0210-9</NDCCode><ProprietaryName>Sertraline Hydrochloride</ProprietaryName><NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>90107-0210-1</NDCCode><ProprietaryName>Easy Care First Aid Afterburn</ProprietaryName><NonProprietaryName>Benzalkonium Chloride, Lidocaine</NonProprietaryName></NDC><NDC><NDCCode>90107-0210-2</NDCCode><ProprietaryName>Easy Care First Aid Afterburn</ProprietaryName><NonProprietaryName>Benzalkonium Chloride, Lidocaine</NonProprietaryName></NDC><NDC><NDCCode>90107-0210-3</NDCCode><ProprietaryName>Easy Care First Aid Afterburn</ProprietaryName><NonProprietaryName>Benzalkonium Chloride, Lidocaine</NonProprietaryName></NDC><NDC><NDCCode>13630-0210-4</NDCCode><ProprietaryName>Soleil Toujours</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate</NonProprietaryName></NDC><NDC><NDCCode>13733-210-01</NDCCode><ProprietaryName>Missha M Radiance Two Way Pact Spf27 No23</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide, Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>14141-210-01</NDCCode><ProprietaryName>Clarite Makeup Foundation For A Clearer Appearance Spf 30 230-n</ProprietaryName><NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>24979-210-04</NDCCode><ProprietaryName>Topiramate</ProprietaryName><NonProprietaryName>Topiramate</NonProprietaryName></NDC><NDC><NDCCode>31722-210-10</NDCCode><ProprietaryName>Vancomycin Hydrochloride</ProprietaryName><NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>31722-210-32</NDCCode><ProprietaryName>Vancomycin Hydrochloride</ProprietaryName><NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>46708-210-10</NDCCode><ProprietaryName>Telmisartan And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>46708-210-30</NDCCode><ProprietaryName>Telmisartan And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>46708-210-91</NDCCode><ProprietaryName>Telmisartan And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>47469-210-02</NDCCode><ProprietaryName>Hanskin Hyaluron Skin Essence</ProprietaryName><NonProprietaryName>Glycerin</NonProprietaryName></NDC><NDC><NDCCode>49288-0210-1</NDCCode><ProprietaryName>Number Four Mold Mixture</ProprietaryName><NonProprietaryName>Number Four Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0210-2</NDCCode><ProprietaryName>Number Four Mold Mixture</ProprietaryName><NonProprietaryName>Number Four Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0210-3</NDCCode><ProprietaryName>Number Four Mold Mixture</ProprietaryName><NonProprietaryName>Number Four Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0210-4</NDCCode><ProprietaryName>Number Four Mold Mixture</ProprietaryName><NonProprietaryName>Number Four Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>49288-0210-5</NDCCode><ProprietaryName>Number Four Mold Mixture</ProprietaryName><NonProprietaryName>Number Four Mold Mixture</NonProprietaryName></NDC><NDC><NDCCode>51009-210-55</NDCCode><ProprietaryName>Toms Cavity Protection Spearmint</ProprietaryName><NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName></NDC></NDCList>