{
"NDC": [
{
"NDCCode": "49288-0201-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0201-3)",
"NDC11Code": "49288-0201-03",
"ProductNDC": "49288-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flaxseed",
"NonProprietaryName": "Flaxseed",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "FLAX SEED",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are \"For Diagnostic Use Only\": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.",
"Description": "Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following \"For Diagnostic Use Only\" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. 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%. USP 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."
},
{
"NDCCode": "49288-0201-1",
"PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0201-1)",
"NDC11Code": "49288-0201-01",
"ProductNDC": "49288-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flaxseed",
"NonProprietaryName": "Flaxseed",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "FLAX SEED",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are \"For Diagnostic Use Only\": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.",
"Description": "Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following \"For Diagnostic Use Only\" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. 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%. USP 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."
},
{
"NDCCode": "49288-0201-2",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0201-2)",
"NDC11Code": "49288-0201-02",
"ProductNDC": "49288-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flaxseed",
"NonProprietaryName": "Flaxseed",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "FLAX SEED",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are \"For Diagnostic Use Only\": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.",
"Description": "Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following \"For Diagnostic Use Only\" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. 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%. USP 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."
},
{
"NDCCode": "49288-0201-4",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0201-4)",
"NDC11Code": "49288-0201-04",
"ProductNDC": "49288-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flaxseed",
"NonProprietaryName": "Flaxseed",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "FLAX SEED",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are \"For Diagnostic Use Only\": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.",
"Description": "Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following \"For Diagnostic Use Only\" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. 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%. USP 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."
},
{
"NDCCode": "49288-0201-5",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0201-5)",
"NDC11Code": "49288-0201-05",
"ProductNDC": "49288-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flaxseed",
"NonProprietaryName": "Flaxseed",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "FLAX SEED",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are \"For Diagnostic Use Only\": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.",
"Description": "Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following \"For Diagnostic Use Only\" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. 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%. USP 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."
},
{
"NDCCode": "0135-0201-03",
"PackageDescription": "1 TUBE in 1 CARTON (0135-0201-03) > 281.3 g in 1 TUBE",
"NDC11Code": "00135-0201-03",
"ProductNDC": "0135-0201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aquafresh",
"ProprietaryNameSuffix": "Ultimate White",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE",
"RouteName": "DENTAL",
"StartMarketingDate": "20110325",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "GlaxoSmithKline Consumer Healthcare Holdings (US) LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.1",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2018-05-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0201-4008-21",
"PackageDescription": "6.3 g in 1 TUBE (0201-4008-21)",
"NDC11Code": "00201-4008-21",
"ProductNDC": "0201-4008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calendula Diaper Rash",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171127",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Weleda AG",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "12",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-11-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "0363-0201-05",
"PackageDescription": "3 CONTAINER in 1 CARTON (0363-0201-05) / 24 LOZENGE in 1 CONTAINER (0363-0201-03) ",
"NDC11Code": "00363-0201-05",
"ProductNDC": "0363-0201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20100112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090821",
"LabelerName": "Walgreen Company",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100112",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "0487-0201-01",
"PackageDescription": "30 POUCH in 1 CARTON (0487-0201-01) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00487-0201-01",
"ProductNDC": "0487-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"NonProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20071231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076749",
"LabelerName": "Nephron Pharmaceuticals Corporation",
"SubstanceName": "IPRATROPIUM BROMIDE; ALBUTEROL SULFATE",
"StrengthNumber": ".5; 3",
"StrengthUnit": "mg/3mL; mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20071231",
"SamplePackage": "N",
"IndicationAndUsage": "Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.",
"Description": "The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP are albuterol sulfate, USP and ipratropium bromide, USP. Albuterol sulfate is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α 1-[( tert-Butylamino) methyl]-4-hydroxy- m-xylene- α,α′-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13H 21NO 3) 2 H 2SO 4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo,syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20H 30BrNO 3 H 2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP contains 3 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride and hydrochloric acid to adjust to pH 4. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION)."
},
{
"NDCCode": "0487-0201-02",
"PackageDescription": "30 POUCH in 1 CARTON (0487-0201-02) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00487-0201-02",
"ProductNDC": "0487-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"NonProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20071231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076749",
"LabelerName": "Nephron Pharmaceuticals Corporation",
"SubstanceName": "IPRATROPIUM BROMIDE; ALBUTEROL SULFATE",
"StrengthNumber": ".5; 3",
"StrengthUnit": "mg/3mL; mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20071231",
"SamplePackage": "N",
"IndicationAndUsage": "Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.",
"Description": "The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP are albuterol sulfate, USP and ipratropium bromide, USP. Albuterol sulfate is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α 1-[( tert-Butylamino) methyl]-4-hydroxy- m-xylene- α,α′-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13H 21NO 3) 2 H 2SO 4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo,syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20H 30BrNO 3 H 2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP contains 3 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride and hydrochloric acid to adjust to pH 4. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION)."
},
{
"NDCCode": "0487-0201-03",
"PackageDescription": "6 POUCH in 1 CARTON (0487-0201-03) / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00487-0201-03",
"ProductNDC": "0487-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"NonProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20071231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076749",
"LabelerName": "Nephron Pharmaceuticals Corporation",
"SubstanceName": "IPRATROPIUM BROMIDE; ALBUTEROL SULFATE",
"StrengthNumber": ".5; 3",
"StrengthUnit": "mg/3mL; mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20071231",
"SamplePackage": "N",
"IndicationAndUsage": "Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.",
"Description": "The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP are albuterol sulfate, USP and ipratropium bromide, USP. Albuterol sulfate is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α 1-[( tert-Butylamino) methyl]-4-hydroxy- m-xylene- α,α′-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13H 21NO 3) 2 H 2SO 4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo,syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20H 30BrNO 3 H 2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP contains 3 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride and hydrochloric acid to adjust to pH 4. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION)."
},
{
"NDCCode": "0487-0201-60",
"PackageDescription": "12 POUCH in 1 CARTON (0487-0201-60) / 5 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00487-0201-60",
"ProductNDC": "0487-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"NonProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20071231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076749",
"LabelerName": "Nephron Pharmaceuticals Corporation",
"SubstanceName": "IPRATROPIUM BROMIDE; ALBUTEROL SULFATE",
"StrengthNumber": ".5; 3",
"StrengthUnit": "mg/3mL; mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20071231",
"SamplePackage": "N",
"IndicationAndUsage": "Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.",
"Description": "The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP are albuterol sulfate, USP and ipratropium bromide, USP. Albuterol sulfate is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α 1-[( tert-Butylamino) methyl]-4-hydroxy- m-xylene- α,α′-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13H 21NO 3) 2 H 2SO 4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo,syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20H 30BrNO 3 H 2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP contains 3 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride and hydrochloric acid to adjust to pH 4. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION)."
},
{
"NDCCode": "10223-0201-3",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (10223-0201-3) > 20 g in 1 BOTTLE, GLASS",
"NDC11Code": "10223-0201-03",
"ProductNDC": "10223-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cetacaine Anesthetic",
"NonProprietaryName": "Benzocaine, Butamben, And Tetracaine Hydrochloride",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "19580101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Cetylite Industries, Inc.",
"SubstanceName": "BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE",
"StrengthNumber": ".028; .004; .004",
"StrengthUnit": "g/.2g; g/.2g; g/.2g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Ester Local Anesthetic [EPC], Esters [CS], Increased Histamine Release [PE], Local Anesthesia [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2022-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160101",
"SamplePackage": "N",
"IndicationAndUsage": "Cetacaine is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. Cetacaine Spray is indicated for use to control pain or gagging. Cetacaine in all forms is indicated to control pain and for use for surgical or endoscopic or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus. It may also be used for vaginal or rectal procedures when feasible."
},
{
"NDCCode": "11822-0201-0",
"PackageDescription": "3 CONTAINER in 1 CARTON (11822-0201-0) / 24 LOZENGE in 1 CONTAINER (11822-0201-1) ",
"NDC11Code": "11822-0201-00",
"ProductNDC": "11822-0201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20201211",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090821",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201211",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "15631-0201-3",
"PackageDescription": "750 PELLET in 1 PACKAGE (15631-0201-3) ",
"NDC11Code": "15631-0201-03",
"ProductNDC": "15631-0201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gallicum Acidum",
"NonProprietaryName": "Gallicum Acidum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151002",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "GALLIC ACID MONOHYDRATE",
"StrengthNumber": "2",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "17856-0201-3",
"PackageDescription": "48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0201-3) > 5 mL in 1 SYRINGE",
"NDC11Code": "17856-0201-03",
"ProductNDC": "17856-0201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20140409",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20211011",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache, 6 sore throat, 7 toothache."
},
{
"NDCCode": "26509-0201-3",
"PackageDescription": "3785 mL in 1 BOTTLE (26509-0201-3) ",
"NDC11Code": "26509-0201-03",
"ProductNDC": "26509-0201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clorox Healthcare Aloeguard Antimicrobial",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190710",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "The Clorox Company",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190710",
"SamplePackage": "N",
"IndicationAndUsage": "for hand-washing to decrease microbes on the skin. ideal for daily repeated washings."
},
{
"NDCCode": "37662-0201-3",
"PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (37662-0201-3) ",
"NDC11Code": "37662-0201-03",
"ProductNDC": "37662-0201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Castoreum",
"NonProprietaryName": "Castoreum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220526",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "CASTOR FIBER SCENT GLAND SECRETION",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220526",
"SamplePackage": "N"
},
{
"NDCCode": "50332-0201-3",
"PackageDescription": "30 mL in 1 BOTTLE (50332-0201-3) ",
"NDC11Code": "50332-0201-03",
"ProductNDC": "50332-0201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eye Clean",
"NonProprietaryName": "Eye Wash",
"DosageFormName": "LIQUID",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19000101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M",
"LabelerName": "HART Health",
"SubstanceName": "WATER",
"StrengthNumber": "98.3",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19000101",
"SamplePackage": "N",
"IndicationAndUsage": "Use: For cleansing the eye to help relieve irritation or burning by removing loose foreign material."
},
{
"NDCCode": "58118-0201-3",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (58118-0201-3)",
"NDC11Code": "58118-0201-03",
"ProductNDC": "58118-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090066",
"LabelerName": "Clinical Solutions Wholesale",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "60659-0201-3",
"PackageDescription": "3 PACKAGE in 1 CARTON (60659-0201-3) > 3 g in 1 PACKAGE (60659-0201-1)",
"NDC11Code": "60659-0201-03",
"ProductNDC": "60659-0201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bang Lie An High-efficiency Anti-bacteria Monomer Silver Gel For Prostatitis",
"NonProprietaryName": "High-efficiency Anti-bacteria Monomer Silver Gel For Prostatitis",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "RECTAL",
"StartMarketingDate": "20160108",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Bang An Bao Medical Equipment Co., Ltd.",
"SubstanceName": "SILVER; WATER",
"StrengthNumber": "1050; 2980950",
"StrengthUnit": "ug/3g; ug/3g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indication to bacterial diseases; and frequent micturition, odynuria, urine waiting, urine be unable completely, aching pain of waist and knees, bearing-down pain of local perineum due to chronic prostatitis.Topical use: Apply in the rectum."
},
{
"NDCCode": "69817-0201-1",
"PackageDescription": "1 KIT in 1 BOX (69817-0201-1) * 3 g in 1 BOTTLE, PLASTIC * 54 g in 1 JAR * 3 g in 1 BOTTLE, PLASTIC",
"NDC11Code": "69817-0201-01",
"ProductNDC": "69817-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopax",
"NonProprietaryName": "Levocetirizine Dihydrochloride 5%, Loratadine 5%",
"DosageFormName": "KIT",
"StartMarketingDate": "20150630",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PharmaGenetico LLC",
"Status": "Deprecated",
"LastUpdate": "2017-07-27"
},
{
"NDCCode": "70000-0201-3",
"PackageDescription": "1 BOTTLE in 1 CARTON (70000-0201-3) / 100 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "70000-0201-03",
"ProductNDC": "70000-0201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader All Day Pain Relief",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074661",
"LabelerName": "Cardinal Health 110, LLC. dba Leader",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170216",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:. minor pain of arthritis. muscular aches. backache. menstrual cramps. headache. toothache. the common cold. temporarily reduces fever."
},
{
"NDCCode": "71335-0201-3",
"PackageDescription": "90 TABLET in 1 BOTTLE (71335-0201-3) ",
"NDC11Code": "71335-0201-03",
"ProductNDC": "71335-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19971028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040197",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151204",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol tablets are indicated in the: 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause., 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure., 4 Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease., 5 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only)., 6 Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See CLINICAL PHARMACOLOGY, Clinical Studies.).",
"Description": "Estradiol Tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is. C18H24O2 M.W. 272.38. Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no. 5 (tartrazine) aluminum lake."
},
{
"NDCCode": "80425-0201-3",
"PackageDescription": "90 TABLET, COATED in 1 BOTTLE (80425-0201-3) ",
"NDC11Code": "80425-0201-03",
"ProductNDC": "80425-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20221028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207057",
"LabelerName": "Advanced Rx of Tennessee, LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221028",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: copovidone, corn starch, macrogol, magnesium stearate, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "49288-0001-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0001-3)",
"NDC11Code": "49288-0001-03",
"ProductNDC": "49288-0001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alternaria Alternata",
"NonProprietaryName": "Alternaria Alternata",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19920413",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "ALTERNARIA ALTERNATA",
"StrengthNumber": ".1",
"StrengthUnit": "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]",
"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": "49288-0002-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0002-3)",
"NDC11Code": "49288-0002-03",
"ProductNDC": "49288-0002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alternaria Alternata",
"NonProprietaryName": "Alternaria Alternata",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "ALTERNARIA ALTERNATA",
"StrengthNumber": ".05",
"StrengthUnit": "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]",
"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": "49288-0003-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0003-3)",
"NDC11Code": "49288-0003-03",
"ProductNDC": "49288-0003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alternaria Alternata",
"NonProprietaryName": "Alternaria Alternata",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "ALTERNARIA ALTERNATA",
"StrengthNumber": ".025",
"StrengthUnit": "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]",
"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": "49288-0004-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0004-3)",
"NDC11Code": "49288-0004-03",
"ProductNDC": "49288-0004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "A Mold Mixture",
"NonProprietaryName": "A Mold Mixture",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19920413",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; COCHLIOBOLUS SATIVUS; CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA; MUCOR PLUMBEUS; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE; RHIZOPUS STOLONIFER",
"StrengthNumber": ".0017; .0017; .0017; .0017; .0067; .0067; .0067; .0067; .0067; .0067; .0033; .0033; .0022; .0022; .0011; .0011; .0011; .0011; .0011; .0011; .0067; .0067; .0067; .0067; .0067; .0022",
"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; g/mL; g/mL; 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],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],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],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": "49288-0005-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0005-3)",
"NDC11Code": "49288-0005-03",
"ProductNDC": "49288-0005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "A Mold Mixture",
"NonProprietaryName": "A Mold Mixture",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; COCHLIOBOLUS SATIVUS; CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA; MUCOR PLUMBEUS; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE; RHIZOPUS STOLONIFER",
"StrengthNumber": ".0008; .0008; .0008; .0008; .0033; .0033; .0033; .0033; .0033; .0033; .0017; .0017; .0011; .0011; .0006; .0006; .0006; .0006; .0006; .0006; .0033; .0033; .0033; .0033; .0033; .0011",
"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; g/mL; g/mL; 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],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],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],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."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>49288-0201-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0201-3)</PackageDescription>
<NDC11Code>49288-0201-03</NDC11Code>
<ProductNDC>49288-0201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flaxseed</ProprietaryName>
<NonProprietaryName>Flaxseed</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>FLAX SEED</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. 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%. USP 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.</Description>
</NDC>
<NDC>
<NDCCode>49288-0201-1</NDCCode>
<PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (49288-0201-1)</PackageDescription>
<NDC11Code>49288-0201-01</NDC11Code>
<ProductNDC>49288-0201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flaxseed</ProprietaryName>
<NonProprietaryName>Flaxseed</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>FLAX SEED</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. 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%. USP 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.</Description>
</NDC>
<NDC>
<NDCCode>49288-0201-2</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0201-2)</PackageDescription>
<NDC11Code>49288-0201-02</NDC11Code>
<ProductNDC>49288-0201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flaxseed</ProprietaryName>
<NonProprietaryName>Flaxseed</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>FLAX SEED</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. 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%. USP 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.</Description>
</NDC>
<NDC>
<NDCCode>49288-0201-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0201-4)</PackageDescription>
<NDC11Code>49288-0201-04</NDC11Code>
<ProductNDC>49288-0201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flaxseed</ProprietaryName>
<NonProprietaryName>Flaxseed</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>FLAX SEED</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. 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%. USP 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.</Description>
</NDC>
<NDC>
<NDCCode>49288-0201-5</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0201-5)</PackageDescription>
<NDC11Code>49288-0201-05</NDC11Code>
<ProductNDC>49288-0201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flaxseed</ProprietaryName>
<NonProprietaryName>Flaxseed</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>FLAX SEED</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. 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%. USP 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.</Description>
</NDC>
<NDC>
<NDCCode>0135-0201-03</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0135-0201-03) > 281.3 g in 1 TUBE</PackageDescription>
<NDC11Code>00135-0201-03</NDC11Code>
<ProductNDC>0135-0201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aquafresh</ProprietaryName>
<ProprietaryNameSuffix>Ultimate White</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20110325</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>GlaxoSmithKline Consumer Healthcare Holdings (US) LLC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-05-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0201-4008-21</NDCCode>
<PackageDescription>6.3 g in 1 TUBE (0201-4008-21)</PackageDescription>
<NDC11Code>00201-4008-21</NDC11Code>
<ProductNDC>0201-4008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calendula Diaper Rash</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171127</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Weleda AG</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0363-0201-05</NDCCode>
<PackageDescription>3 CONTAINER in 1 CARTON (0363-0201-05) / 24 LOZENGE in 1 CONTAINER (0363-0201-03) </PackageDescription>
<NDC11Code>00363-0201-05</NDC11Code>
<ProductNDC>0363-0201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090821</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0487-0201-01</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (0487-0201-01) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00487-0201-01</NDC11Code>
<ProductNDC>0487-0201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide And Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20071231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076749</ApplicationNumber>
<LabelerName>Nephron Pharmaceuticals Corporation</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE; ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>.5; 3</StrengthNumber>
<StrengthUnit>mg/3mL; mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.</IndicationAndUsage>
<Description>The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP are albuterol sulfate, USP and ipratropium bromide, USP. Albuterol sulfate is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α 1-[( tert-Butylamino) methyl]-4-hydroxy- m-xylene- α,α′-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13H 21NO 3) 2 H 2SO 4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo,syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20H 30BrNO 3 H 2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP contains 3 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride and hydrochloric acid to adjust to pH 4. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION).</Description>
</NDC>
<NDC>
<NDCCode>0487-0201-02</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (0487-0201-02) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00487-0201-02</NDC11Code>
<ProductNDC>0487-0201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide And Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20071231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076749</ApplicationNumber>
<LabelerName>Nephron Pharmaceuticals Corporation</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE; ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>.5; 3</StrengthNumber>
<StrengthUnit>mg/3mL; mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.</IndicationAndUsage>
<Description>The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP are albuterol sulfate, USP and ipratropium bromide, USP. Albuterol sulfate is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α 1-[( tert-Butylamino) methyl]-4-hydroxy- m-xylene- α,α′-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13H 21NO 3) 2 H 2SO 4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo,syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20H 30BrNO 3 H 2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP contains 3 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride and hydrochloric acid to adjust to pH 4. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION).</Description>
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<IndicationAndUsage>Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.</IndicationAndUsage>
<Description>The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP are albuterol sulfate, USP and ipratropium bromide, USP. Albuterol sulfate is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α 1-[( tert-Butylamino) methyl]-4-hydroxy- m-xylene- α,α′-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13H 21NO 3) 2 H 2SO 4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo,syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20H 30BrNO 3 H 2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP contains 3 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride and hydrochloric acid to adjust to pH 4. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION).</Description>
</NDC>
<NDC>
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<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
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<StartMarketingDatePackage>20071231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.</IndicationAndUsage>
<Description>The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP are albuterol sulfate, USP and ipratropium bromide, USP. Albuterol sulfate is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α 1-[( tert-Butylamino) methyl]-4-hydroxy- m-xylene- α,α′-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13H 21NO 3) 2 H 2SO 4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo,syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20H 30BrNO 3 H 2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP contains 3 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride and hydrochloric acid to adjust to pH 4. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION).</Description>
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<ProprietaryName>Cetacaine Anesthetic</ProprietaryName>
<NonProprietaryName>Benzocaine, Butamben, And Tetracaine Hydrochloride</NonProprietaryName>
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<LastUpdate>2022-01-20</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Cetacaine is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. Cetacaine Spray is indicated for use to control pain or gagging. Cetacaine in all forms is indicated to control pain and for use for surgical or endoscopic or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus. It may also be used for vaginal or rectal procedures when feasible.</IndicationAndUsage>
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<NDC>
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<PackageDescription>3 CONTAINER in 1 CARTON (11822-0201-0) / 24 LOZENGE in 1 CONTAINER (11822-0201-1) </PackageDescription>
<NDC11Code>11822-0201-00</NDC11Code>
<ProductNDC>11822-0201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
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<StartMarketingDate>20201211</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090821</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201211</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
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<NDC>
<NDCCode>15631-0201-3</NDCCode>
<PackageDescription>750 PELLET in 1 PACKAGE (15631-0201-3) </PackageDescription>
<NDC11Code>15631-0201-03</NDC11Code>
<ProductNDC>15631-0201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gallicum Acidum</ProprietaryName>
<NonProprietaryName>Gallicum Acidum</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20151002</StartMarketingDate>
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<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>GALLIC ACID MONOHYDRATE</SubstanceName>
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<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0201-3) > 5 mL in 1 SYRINGE</PackageDescription>
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<ProductNDC>17856-0201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
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<StartMarketingDate>20140409</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache, 6 sore throat, 7 toothache.</IndicationAndUsage>
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<NDC>
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<NDC11Code>26509-0201-03</NDC11Code>
<ProductNDC>26509-0201</ProductNDC>
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<ProprietaryName>Clorox Healthcare Aloeguard Antimicrobial</ProprietaryName>
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<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>The Clorox Company</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for hand-washing to decrease microbes on the skin. ideal for daily repeated washings.</IndicationAndUsage>
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<NDC>
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<PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (37662-0201-3) </PackageDescription>
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<ProprietaryName>Castoreum</ProprietaryName>
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<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>CASTOR FIBER SCENT GLAND SECRETION</SubstanceName>
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<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
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<ProprietaryName>Eye Clean</ProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M</ApplicationNumber>
<LabelerName>HART Health</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>98.3</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use: For cleansing the eye to help relieve irritation or burning by removing loose foreign material.</IndicationAndUsage>
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<NDC>
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<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (58118-0201-3)</PackageDescription>
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<ProprietaryName>Diclofenac Sodium</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090066</ApplicationNumber>
<LabelerName>Clinical Solutions Wholesale</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
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<NDC>
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<ProprietaryName>Bang Lie An High-efficiency Anti-bacteria Monomer Silver Gel For Prostatitis</ProprietaryName>
<NonProprietaryName>High-efficiency Anti-bacteria Monomer Silver Gel For Prostatitis</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Bang An Bao Medical Equipment Co., Ltd.</LabelerName>
<SubstanceName>SILVER; WATER</SubstanceName>
<StrengthNumber>1050; 2980950</StrengthNumber>
<StrengthUnit>ug/3g; ug/3g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indication to bacterial diseases; and frequent micturition, odynuria, urine waiting, urine be unable completely, aching pain of waist and knees, bearing-down pain of local perineum due to chronic prostatitis.Topical use: Apply in the rectum.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>1 KIT in 1 BOX (69817-0201-1) * 3 g in 1 BOTTLE, PLASTIC * 54 g in 1 JAR * 3 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69817-0201-01</NDC11Code>
<ProductNDC>69817-0201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopax</ProprietaryName>
<NonProprietaryName>Levocetirizine Dihydrochloride 5%, Loratadine 5%</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150630</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PharmaGenetico LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2017-07-27</LastUpdate>
</NDC>
<NDC>
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<PackageDescription>1 BOTTLE in 1 CARTON (70000-0201-3) / 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
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<ProductNDC>70000-0201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader All Day Pain Relief</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074661</ApplicationNumber>
<LabelerName>Cardinal Health 110, LLC. dba Leader</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:. minor pain of arthritis. muscular aches. backache. menstrual cramps. headache. toothache. the common cold. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-0201-3</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71335-0201-3) </PackageDescription>
<NDC11Code>71335-0201-03</NDC11Code>
<ProductNDC>71335-0201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040197</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol tablets are indicated in the: 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause., 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure., 4 Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease., 5 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only)., 6 Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See CLINICAL PHARMACOLOGY, Clinical Studies.).</IndicationAndUsage>
<Description>Estradiol Tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is. C18H24O2 M.W. 272.38. Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no. 5 (tartrazine) aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>80425-0201-3</NDCCode>
<PackageDescription>90 TABLET, COATED in 1 BOTTLE (80425-0201-3) </PackageDescription>
<NDC11Code>80425-0201-03</NDC11Code>
<ProductNDC>80425-0201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207057</ApplicationNumber>
<LabelerName>Advanced Rx of Tennessee, LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: copovidone, corn starch, macrogol, magnesium stearate, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49288-0001-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0001-3)</PackageDescription>
<NDC11Code>49288-0001-03</NDC11Code>
<ProductNDC>49288-0001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alternaria Alternata</ProprietaryName>
<NonProprietaryName>Alternaria Alternata</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19920413</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>49288-0002-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0002-3)</PackageDescription>
<NDC11Code>49288-0002-03</NDC11Code>
<ProductNDC>49288-0002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alternaria Alternata</ProprietaryName>
<NonProprietaryName>Alternaria Alternata</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>49288-0003-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0003-3)</PackageDescription>
<NDC11Code>49288-0003-03</NDC11Code>
<ProductNDC>49288-0003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alternaria Alternata</ProprietaryName>
<NonProprietaryName>Alternaria Alternata</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA</SubstanceName>
<StrengthNumber>.025</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>49288-0004-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0004-3)</PackageDescription>
<NDC11Code>49288-0004-03</NDC11Code>
<ProductNDC>49288-0004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>A Mold Mixture</ProprietaryName>
<NonProprietaryName>A Mold Mixture</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19920413</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; COCHLIOBOLUS SATIVUS; CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA; MUCOR PLUMBEUS; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE; RHIZOPUS STOLONIFER</SubstanceName>
<StrengthNumber>.0017; .0017; .0017; .0017; .0067; .0067; .0067; .0067; .0067; .0067; .0033; .0033; .0022; .0022; .0011; .0011; .0011; .0011; .0011; .0011; .0067; .0067; .0067; .0067; .0067; .0022</StrengthNumber>
<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; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Pharm_Classes>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],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],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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>49288-0005-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0005-3)</PackageDescription>
<NDC11Code>49288-0005-03</NDC11Code>
<ProductNDC>49288-0005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>A Mold Mixture</ProprietaryName>
<NonProprietaryName>A Mold Mixture</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; COCHLIOBOLUS SATIVUS; CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA; MUCOR PLUMBEUS; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE; RHIZOPUS STOLONIFER</SubstanceName>
<StrengthNumber>.0008; .0008; .0008; .0008; .0033; .0033; .0033; .0033; .0033; .0033; .0017; .0017; .0011; .0011; .0006; .0006; .0006; .0006; .0006; .0006; .0033; .0033; .0033; .0033; .0033; .0011</StrengthNumber>
<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; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Pharm_Classes>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],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],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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
</NDCList>