{
"NDC": [
{
"NDCCode": "22840-4460-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (22840-4460-1) ",
"NDC11Code": "22840-4460-01",
"ProductNDC": "22840-4460",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Arizona Gambel Oak Pollen",
"NonProprietaryName": "Quercus Gambelii",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "QUERCUS GAMBELII POLLEN",
"StrengthNumber": ".001",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "0264-4460-00",
"PackageDescription": "8 CARTON in 1 CASE (0264-4460-00) / 1 CONTAINER in 1 CARTON / 1000 mL in 1 CONTAINER",
"NDC11Code": "00264-4460-00",
"ProductNDC": "0264-4460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nutrilipid I.v. Fat Emulsion",
"NonProprietaryName": "Soybean Oil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019531",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "SOYBEAN OIL",
"StrengthNumber": "20",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Lipid Emulsion [EPC], Lipids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140630",
"SamplePackage": "N",
"IndicationAndUsage": "Nutrilipid® 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "Nutrilipid 20% is a homogenous white and milky sterile, nonpyrogenic lipid emulsion for intravenous administration. Each 100 mL of Nutrilipid 20% contains: Soybean Oil 20 g; Egg Yolk Phospholipid 1.2 g; Glycerin USP (glycerol) 2.5 g; Sodium Oleate 0.03 g; Water for Injection USP qs. pH adjusted with Sodium Hydroxide NF. pH: 6.8 (6.0-8.9); Osmolality: 390 mOsmol/kg (actual). Contains emulsified fat particles averaging approximately 0.26 micron in diameter, similar to naturally occurring chylomicrons. The total caloric value, including fat, phospholipid, and glycerol is 2.0 Kcal per mL. Soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48% - 58%), oleic (17% - 30%), palmitic (9% -13%), linolenic (4% - 11%), and stearic (2.5% - 5.0%). These fatty acids have the folIowing chemical and structural formulas. Egg yolk phospholipids are a mixture of naturally occurring phospholipids isolated from egg yolk. Glycerol is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It is added to adjust tonicity. Not made with natural rubber latex, PVC or DEHP. Drug product contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0264-4460-10",
"PackageDescription": "12 CARTON in 1 CASE (0264-4460-10) / 1 CONTAINER in 1 CARTON / 500 mL in 1 CONTAINER",
"NDC11Code": "00264-4460-10",
"ProductNDC": "0264-4460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nutrilipid I.v. Fat Emulsion",
"NonProprietaryName": "Soybean Oil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019531",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "SOYBEAN OIL",
"StrengthNumber": "20",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Lipid Emulsion [EPC], Lipids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140630",
"SamplePackage": "N",
"IndicationAndUsage": "Nutrilipid® 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "Nutrilipid 20% is a homogenous white and milky sterile, nonpyrogenic lipid emulsion for intravenous administration. Each 100 mL of Nutrilipid 20% contains: Soybean Oil 20 g; Egg Yolk Phospholipid 1.2 g; Glycerin USP (glycerol) 2.5 g; Sodium Oleate 0.03 g; Water for Injection USP qs. pH adjusted with Sodium Hydroxide NF. pH: 6.8 (6.0-8.9); Osmolality: 390 mOsmol/kg (actual). Contains emulsified fat particles averaging approximately 0.26 micron in diameter, similar to naturally occurring chylomicrons. The total caloric value, including fat, phospholipid, and glycerol is 2.0 Kcal per mL. Soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48% - 58%), oleic (17% - 30%), palmitic (9% -13%), linolenic (4% - 11%), and stearic (2.5% - 5.0%). These fatty acids have the folIowing chemical and structural formulas. Egg yolk phospholipids are a mixture of naturally occurring phospholipids isolated from egg yolk. Glycerol is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It is added to adjust tonicity. Not made with natural rubber latex, PVC or DEHP. Drug product contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0264-4460-20",
"PackageDescription": "12 CARTON in 1 CASE (0264-4460-20) > 1 CONTAINER in 1 CARTON > 500 mL in 1 CONTAINER",
"NDC11Code": "00264-4460-20",
"ProductNDC": "0264-4460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nutrilipid I.v. Fat Emulsion",
"NonProprietaryName": "Soybean Oil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019531",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "SOYBEAN OIL",
"StrengthNumber": "20",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Lipid Emulsion [EPC],Lipids [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140630",
"SamplePackage": "N"
},
{
"NDCCode": "0264-4460-30",
"PackageDescription": "12 CARTON in 1 CASE (0264-4460-30) / 1 CONTAINER in 1 CARTON / 250 mL in 1 CONTAINER",
"NDC11Code": "00264-4460-30",
"ProductNDC": "0264-4460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nutrilipid I.v. Fat Emulsion",
"NonProprietaryName": "Soybean Oil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019531",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "SOYBEAN OIL",
"StrengthNumber": "20",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Lipid Emulsion [EPC], Lipids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140630",
"SamplePackage": "N",
"IndicationAndUsage": "Nutrilipid® 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "Nutrilipid 20% is a homogenous white and milky sterile, nonpyrogenic lipid emulsion for intravenous administration. Each 100 mL of Nutrilipid 20% contains: Soybean Oil 20 g; Egg Yolk Phospholipid 1.2 g; Glycerin USP (glycerol) 2.5 g; Sodium Oleate 0.03 g; Water for Injection USP qs. pH adjusted with Sodium Hydroxide NF. pH: 6.8 (6.0-8.9); Osmolality: 390 mOsmol/kg (actual). Contains emulsified fat particles averaging approximately 0.26 micron in diameter, similar to naturally occurring chylomicrons. The total caloric value, including fat, phospholipid, and glycerol is 2.0 Kcal per mL. Soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48% - 58%), oleic (17% - 30%), palmitic (9% -13%), linolenic (4% - 11%), and stearic (2.5% - 5.0%). These fatty acids have the folIowing chemical and structural formulas. Egg yolk phospholipids are a mixture of naturally occurring phospholipids isolated from egg yolk. Glycerol is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It is added to adjust tonicity. Not made with natural rubber latex, PVC or DEHP. Drug product contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "53002-4460-0",
"PackageDescription": "100 TABLET in 1 BOTTLE (53002-4460-0) ",
"NDC11Code": "53002-4460-00",
"ProductNDC": "53002-4460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074550",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, corn starch, silicon dioxide, stearic acid. Glipizide Tablets, USP 5 mg and 10 mg meet USP Dissolution Test 2."
},
{
"NDCCode": "53002-4460-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (53002-4460-3) ",
"NDC11Code": "53002-4460-03",
"ProductNDC": "53002-4460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074550",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, corn starch, silicon dioxide, stearic acid. Glipizide Tablets, USP 5 mg and 10 mg meet USP Dissolution Test 2."
},
{
"NDCCode": "53002-4460-6",
"PackageDescription": "60 TABLET in 1 BOTTLE (53002-4460-6) ",
"NDC11Code": "53002-4460-06",
"ProductNDC": "53002-4460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074550",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, corn starch, silicon dioxide, stearic acid. Glipizide Tablets, USP 5 mg and 10 mg meet USP Dissolution Test 2."
},
{
"NDCCode": "55714-4460-1",
"PackageDescription": "29.57 mL in 1 BOTTLE, GLASS (55714-4460-1)",
"NDC11Code": "55714-4460-01",
"ProductNDC": "55714-4460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nervousness - Anxiety",
"NonProprietaryName": "Aconitum Nap., Ambra, Anacardium Orientale, Arg.nit., Asafoetida, Bryonia, Chamomilla, Cimicifuga, Coffea Cruda, Cypripedium, Gelsemium, Hyoscyamus, Hypericum, Ignatia, Kali Phos., Nux Vom., Sambucus Nig., Strychninum, Theridion, Valeriana, Passiflora",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ASAFETIDA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; BLACK COHOSH; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; THERIDION CURASSAVICUM; VALERIAN; PASSIFLORA INCARNATA FLOWERING TOP",
"StrengthNumber": "20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Nervousness - Anxiety Formulated for symptoms associated with generalized anxiety disorder, post-traumatic stress disorder, panic attacks and other related conditions."
},
{
"NDCCode": "55714-4460-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-4460-2)",
"NDC11Code": "55714-4460-02",
"ProductNDC": "55714-4460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nervousness - Anxiety",
"NonProprietaryName": "Aconitum Nap., Ambra, Anacardium Orientale, Arg.nit., Asafoetida, Bryonia, Chamomilla, Cimicifuga, Coffea Cruda, Cypripedium, Gelsemium, Hyoscyamus, Hypericum, Ignatia, Kali Phos., Nux Vom., Sambucus Nig., Strychninum, Theridion, Valeriana, Passiflora",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ASAFETIDA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; BLACK COHOSH; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; THERIDION CURASSAVICUM; VALERIAN; PASSIFLORA INCARNATA FLOWERING TOP",
"StrengthNumber": "20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Nervousness - Anxiety Formulated for symptoms associated with generalized anxiety disorder, post-traumatic stress disorder, panic attacks and other related conditions."
},
{
"NDCCode": "59762-4460-1",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (59762-4460-1) ",
"NDC11Code": "59762-4460-01",
"ProductNDC": "59762-4460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040317",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020882",
"LabelerName": "Greenstone LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190603",
"SamplePackage": "N"
},
{
"NDCCode": "63931-4460-1",
"PackageDescription": "150000 mL in 1 DRUM (63931-4460-1) ",
"NDC11Code": "63931-4460-01",
"ProductNDC": "63931-4460",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wl-aad-z-w-1060",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210120",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Nanophase Technologies Corporation",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "132",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210120",
"SamplePackage": "N"
},
{
"NDCCode": "68071-4460-4",
"PackageDescription": "45 g in 1 BOX (68071-4460-4) ",
"NDC11Code": "68071-4460-04",
"ProductNDC": "68071-4460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mometasone Furoate",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078571",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
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"LastUpdate": "2023-01-03",
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"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Mometasone furoate ointment USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.",
"Description": "Mometasone furoate ointment USP, 0.1% contains mometasone furoate USP for topical use. Mometasone furoate USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27H 30Cl 2O 6, a molecular weight of 521.43 and the following structural formula:. Mometasone furoate USP is a white to off-white powder, soluble in acetone and methylene chloride. Each gram of mometasone furoate ointment USP, 0.1% contains 1 mg mometasone furoate USP in an ointment base of hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), white wax, white petrolatum, and purified water."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
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"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
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"ProductNDC": "22840-0033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
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"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
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"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
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"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
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"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
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"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
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"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
{
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"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
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"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
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"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
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"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
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},
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"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
}
]
}
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<ProprietaryName>Arizona Gambel Oak Pollen</ProprietaryName>
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<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
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<NDCCode>0264-4460-10</NDCCode>
<PackageDescription>12 CARTON in 1 CASE (0264-4460-10) / 1 CONTAINER in 1 CARTON / 500 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-4460-10</NDC11Code>
<ProductNDC>0264-4460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nutrilipid I.v. Fat Emulsion</ProprietaryName>
<NonProprietaryName>Soybean Oil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140630</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019531</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>SOYBEAN OIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Lipid Emulsion [EPC], Lipids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nutrilipid® 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>Nutrilipid 20% is a homogenous white and milky sterile, nonpyrogenic lipid emulsion for intravenous administration. Each 100 mL of Nutrilipid 20% contains: Soybean Oil 20 g; Egg Yolk Phospholipid 1.2 g; Glycerin USP (glycerol) 2.5 g; Sodium Oleate 0.03 g; Water for Injection USP qs. pH adjusted with Sodium Hydroxide NF. pH: 6.8 (6.0-8.9); Osmolality: 390 mOsmol/kg (actual). Contains emulsified fat particles averaging approximately 0.26 micron in diameter, similar to naturally occurring chylomicrons. The total caloric value, including fat, phospholipid, and glycerol is 2.0 Kcal per mL. Soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48% - 58%), oleic (17% - 30%), palmitic (9% -13%), linolenic (4% - 11%), and stearic (2.5% - 5.0%). These fatty acids have the folIowing chemical and structural formulas. Egg yolk phospholipids are a mixture of naturally occurring phospholipids isolated from egg yolk. Glycerol is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It is added to adjust tonicity. Not made with natural rubber latex, PVC or DEHP. Drug product contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0264-4460-20</NDCCode>
<PackageDescription>12 CARTON in 1 CASE (0264-4460-20) > 1 CONTAINER in 1 CARTON > 500 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-4460-20</NDC11Code>
<ProductNDC>0264-4460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nutrilipid I.v. Fat Emulsion</ProprietaryName>
<NonProprietaryName>Soybean Oil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140630</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019531</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>SOYBEAN OIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Lipid Emulsion [EPC],Lipids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0264-4460-30</NDCCode>
<PackageDescription>12 CARTON in 1 CASE (0264-4460-30) / 1 CONTAINER in 1 CARTON / 250 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-4460-30</NDC11Code>
<ProductNDC>0264-4460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nutrilipid I.v. Fat Emulsion</ProprietaryName>
<NonProprietaryName>Soybean Oil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140630</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019531</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>SOYBEAN OIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Lipid Emulsion [EPC], Lipids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nutrilipid® 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>Nutrilipid 20% is a homogenous white and milky sterile, nonpyrogenic lipid emulsion for intravenous administration. Each 100 mL of Nutrilipid 20% contains: Soybean Oil 20 g; Egg Yolk Phospholipid 1.2 g; Glycerin USP (glycerol) 2.5 g; Sodium Oleate 0.03 g; Water for Injection USP qs. pH adjusted with Sodium Hydroxide NF. pH: 6.8 (6.0-8.9); Osmolality: 390 mOsmol/kg (actual). Contains emulsified fat particles averaging approximately 0.26 micron in diameter, similar to naturally occurring chylomicrons. The total caloric value, including fat, phospholipid, and glycerol is 2.0 Kcal per mL. Soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48% - 58%), oleic (17% - 30%), palmitic (9% -13%), linolenic (4% - 11%), and stearic (2.5% - 5.0%). These fatty acids have the folIowing chemical and structural formulas. Egg yolk phospholipids are a mixture of naturally occurring phospholipids isolated from egg yolk. Glycerol is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It is added to adjust tonicity. Not made with natural rubber latex, PVC or DEHP. Drug product contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>53002-4460-0</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (53002-4460-0) </PackageDescription>
<NDC11Code>53002-4460-00</NDC11Code>
<ProductNDC>53002-4460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074550</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, corn starch, silicon dioxide, stearic acid. Glipizide Tablets, USP 5 mg and 10 mg meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>53002-4460-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (53002-4460-3) </PackageDescription>
<NDC11Code>53002-4460-03</NDC11Code>
<ProductNDC>53002-4460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074550</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, corn starch, silicon dioxide, stearic acid. Glipizide Tablets, USP 5 mg and 10 mg meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>53002-4460-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (53002-4460-6) </PackageDescription>
<NDC11Code>53002-4460-06</NDC11Code>
<ProductNDC>53002-4460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074550</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, corn starch, silicon dioxide, stearic acid. Glipizide Tablets, USP 5 mg and 10 mg meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55714-4460-1</NDCCode>
<PackageDescription>29.57 mL in 1 BOTTLE, GLASS (55714-4460-1)</PackageDescription>
<NDC11Code>55714-4460-01</NDC11Code>
<ProductNDC>55714-4460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nervousness - Anxiety</ProprietaryName>
<NonProprietaryName>Aconitum Nap., Ambra, Anacardium Orientale, Arg.nit., Asafoetida, Bryonia, Chamomilla, Cimicifuga, Coffea Cruda, Cypripedium, Gelsemium, Hyoscyamus, Hypericum, Ignatia, Kali Phos., Nux Vom., Sambucus Nig., Strychninum, Theridion, Valeriana, Passiflora</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ASAFETIDA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; BLACK COHOSH; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; THERIDION CURASSAVICUM; VALERIAN; PASSIFLORA INCARNATA FLOWERING TOP</SubstanceName>
<StrengthNumber>20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Nervousness - Anxiety Formulated for symptoms associated with generalized anxiety disorder, post-traumatic stress disorder, panic attacks and other related conditions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-4460-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-4460-2)</PackageDescription>
<NDC11Code>55714-4460-02</NDC11Code>
<ProductNDC>55714-4460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nervousness - Anxiety</ProprietaryName>
<NonProprietaryName>Aconitum Nap., Ambra, Anacardium Orientale, Arg.nit., Asafoetida, Bryonia, Chamomilla, Cimicifuga, Coffea Cruda, Cypripedium, Gelsemium, Hyoscyamus, Hypericum, Ignatia, Kali Phos., Nux Vom., Sambucus Nig., Strychninum, Theridion, Valeriana, Passiflora</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ASAFETIDA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; BLACK COHOSH; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; THERIDION CURASSAVICUM; VALERIAN; PASSIFLORA INCARNATA FLOWERING TOP</SubstanceName>
<StrengthNumber>20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Nervousness - Anxiety Formulated for symptoms associated with generalized anxiety disorder, post-traumatic stress disorder, panic attacks and other related conditions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59762-4460-1</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (59762-4460-1) </PackageDescription>
<NDC11Code>59762-4460-01</NDC11Code>
<ProductNDC>59762-4460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040317</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020882</ApplicationNumber>
<LabelerName>Greenstone LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63931-4460-1</NDCCode>
<PackageDescription>150000 mL in 1 DRUM (63931-4460-1) </PackageDescription>
<NDC11Code>63931-4460-01</NDC11Code>
<ProductNDC>63931-4460</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wl-aad-z-w-1060</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Nanophase Technologies Corporation</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>132</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68071-4460-4</NDCCode>
<PackageDescription>45 g in 1 BOX (68071-4460-4) </PackageDescription>
<NDC11Code>68071-4460-04</NDC11Code>
<ProductNDC>68071-4460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mometasone Furoate</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078571</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mometasone furoate ointment USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.</IndicationAndUsage>
<Description>Mometasone furoate ointment USP, 0.1% contains mometasone furoate USP for topical use. Mometasone furoate USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27H 30Cl 2O 6, a molecular weight of 521.43 and the following structural formula:. Mometasone furoate USP is a white to off-white powder, soluble in acetone and methylene chloride. Each gram of mometasone furoate ointment USP, 0.1% contains 1 mg mometasone furoate USP in an ointment base of hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), white wax, white petrolatum, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>22840-0033-6</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-0033-6) </PackageDescription>
<NDC11Code>22840-0033-06</NDC11Code>
<ProductNDC>22840-0033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Mite Dermatophagoides Farinae</ProprietaryName>
<NonProprietaryName>Dermatophagoides Farinae</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19870202</StartMarketingDate>
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<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
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<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
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<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
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