{
"NDC": [
{
"NDCCode": "22840-3412-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (22840-3412-1) ",
"NDC11Code": "22840-3412-01",
"ProductNDC": "22840-3412",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "White Oak Pollen",
"NonProprietaryName": "Quercus Alba",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "QUERCUS ALBA POLLEN",
"StrengthNumber": ".001",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "0378-3412-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3412-01) ",
"NDC11Code": "00378-3412-01",
"ProductNDC": "0378-3412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100409",
"EndMarketingDate": "20191231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090325",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100409",
"EndMarketingDatePackage": "20191231",
"SamplePackage": "N"
},
{
"NDCCode": "0378-3412-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3412-05) ",
"NDC11Code": "00378-3412-05",
"ProductNDC": "0378-3412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100409",
"EndMarketingDate": "20191231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090325",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100409",
"EndMarketingDatePackage": "20191031",
"SamplePackage": "N"
},
{
"NDCCode": "0378-3412-91",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3412-91)",
"NDC11Code": "00378-3412-91",
"ProductNDC": "0378-3412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100409",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090325",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-10-31"
},
{
"NDCCode": "0409-3412-10",
"PackageDescription": "10 VIAL in 1 CARTON (0409-3412-10) / 20 mL in 1 VIAL (0409-3412-01) ",
"NDC11Code": "00409-3412-10",
"ProductNDC": "0409-3412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meropenem",
"NonProprietaryName": "Meropenem",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20221206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091404",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MEROPENEM",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Carbapenems [CS], Penem Antibacterial [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221206",
"SamplePackage": "N",
"IndicationAndUsage": "Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: 1 4.Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1), 2 5.Complicated intra-abdominal infections (adult and pediatric patients). (1.2), 3 6.Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3).",
"Description": "Meropenem for injection, USP (I.V.) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection, USP (I.V.) is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 500 mg Meropenem for injection, USP (I.V.) vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq). Each 1 gram Meropenem for injection, USP (I.V.) vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq) [see Dosage and Administration (2.4)]."
},
{
"NDCCode": "0781-3412-92",
"PackageDescription": "10 VIAL, GLASS in 1 PACKAGE (0781-3412-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (0781-3412-15) ",
"NDC11Code": "00781-3412-92",
"ProductNDC": "0781-3412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19870219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062738",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2025-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19870219",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by Streptococcus pneumoniae. Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.",
"Description": "Ampicillin for Injection, USP, the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a white to cream-tinged, crystalline powder. The reconstituted solution is clear, colorless and free from visible particulates. Each ADD-Vantage® vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 2.9 milliequivalents of sodium per gram of ampicillin. It has the following molecular structure. The molecular formula is C16H18N3NaO4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
},
{
"NDCCode": "36987-3412-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-3412-1)",
"NDC11Code": "36987-3412-01",
"ProductNDC": "36987-3412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Common Sagebrush",
"NonProprietaryName": "Common Sagebrush",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ARTEMISIA TRIDENTATA POLLEN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-3412-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-3412-2)",
"NDC11Code": "36987-3412-02",
"ProductNDC": "36987-3412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Common Sagebrush",
"NonProprietaryName": "Common Sagebrush",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ARTEMISIA TRIDENTATA POLLEN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-3412-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-3412-3)",
"NDC11Code": "36987-3412-03",
"ProductNDC": "36987-3412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Common Sagebrush",
"NonProprietaryName": "Common Sagebrush",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ARTEMISIA TRIDENTATA POLLEN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-3412-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-3412-4)",
"NDC11Code": "36987-3412-04",
"ProductNDC": "36987-3412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Common Sagebrush",
"NonProprietaryName": "Common Sagebrush",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ARTEMISIA TRIDENTATA POLLEN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-3412-1",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-3412-1) ",
"NDC11Code": "37662-3412-01",
"ProductNDC": "37662-3412",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oleum Santali",
"NonProprietaryName": "Oleum Santali",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230623",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "SANDALWOOD OIL",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230623",
"SamplePackage": "N"
},
{
"NDCCode": "37662-3412-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-3412-2) ",
"NDC11Code": "37662-3412-02",
"ProductNDC": "37662-3412",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oleum Santali",
"NonProprietaryName": "Oleum Santali",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230623",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "SANDALWOOD OIL",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230623",
"SamplePackage": "N"
},
{
"NDCCode": "37662-3412-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-3412-3) ",
"NDC11Code": "37662-3412-03",
"ProductNDC": "37662-3412",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oleum Santali",
"NonProprietaryName": "Oleum Santali",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230623",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "SANDALWOOD OIL",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230623",
"SamplePackage": "N"
},
{
"NDCCode": "37662-3412-4",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-3412-4) ",
"NDC11Code": "37662-3412-04",
"ProductNDC": "37662-3412",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oleum Santali",
"NonProprietaryName": "Oleum Santali",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230623",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "SANDALWOOD OIL",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230623",
"SamplePackage": "N"
},
{
"NDCCode": "49580-3412-4",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (49580-3412-4)",
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"ProductNDC": "49580-3412",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tussin Cough Long Acting",
"NonProprietaryName": "Robitussin Cough Long Acting",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100113",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Aaron Industries Inc",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2017-01-13"
},
{
"NDCCode": "58666-3412-7",
"PackageDescription": "99 g in 1 BOX (58666-3412-7)",
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"ProductNDC": "58666-3412",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "African Black Facial Cleansing Bar Anti-acne Clarifying",
"NonProprietaryName": "Fucus Vesiculosus, Centella Asiatica, Melissa Officinalis, Aloe",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160615",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sundial Group LLC",
"SubstanceName": "ALOE; CENTELLA ASIATICA; FUCUS VESICULOSUS; MELISSA OFFICINALIS",
"StrengthNumber": "1; 1; 1; 1",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"IndicationAndUsage": "Uses: Homeopathic facial cleansing bar for acne prone skin."
},
{
"NDCCode": "61957-3412-0",
"PackageDescription": "1 BOTTLE in 1 CARTON (61957-3412-0) / 30 mL in 1 BOTTLE",
"NDC11Code": "61957-3412-00",
"ProductNDC": "61957-3412",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dior Forever Skin Wear Flawless Skin True Foundation Spf 20 2,5n Neutral",
"NonProprietaryName": "Octisalate, Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Parfums Christian Dior",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "35; 37.6",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260301",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
"NDCCode": "61957-3412-1",
"PackageDescription": "1 BOTTLE in 1 CARTON (61957-3412-1) / 20 mL in 1 BOTTLE",
"NDC11Code": "61957-3412-01",
"ProductNDC": "61957-3412",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dior Forever Skin Wear Flawless Skin True Foundation Spf 20 2,5n Neutral",
"NonProprietaryName": "Octisalate, Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Parfums Christian Dior",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "35; 37.6",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260301",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
"NDCCode": "68071-3412-3",
"PackageDescription": "1 BOTTLE in 1 CARTON (68071-3412-3) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "68071-3412-03",
"ProductNDC": "68071-3412",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076301",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230523",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 itchy, watery eyes , 3 sneezing , 4 itching of the nose or throat ."
},
{
"NDCCode": "70518-3412-0",
"PackageDescription": "100 POUCH in 1 BOX (70518-3412-0) / 1 TABLET in 1 POUCH (70518-3412-1) ",
"NDC11Code": "70518-3412-00",
"ProductNDC": "70518-3412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methimazole",
"NonProprietaryName": "Methimazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220415",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040350",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220415",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "Methimazole is indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option, 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
"Description": "Methimazole (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 or 10 mg (43.8 or 87.6 μmol) methimazole, an orally administered antithyroid drug. Each tablet also contains lactose monohydrate, magnesium stearate, corn starch, and talc. The molecular weight is 114.17, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:."
},
{
"NDCCode": "22840-0033-6",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-0033-6) ",
"NDC11Code": "22840-0033-06",
"ProductNDC": "22840-0033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
"NonProprietaryName": "Dermatophagoides Farinae",
"DosageFormName": "CONCENTRATE",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19870202",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101834",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "DERMATOPHAGOIDES FARINAE",
"StrengthNumber": "5000",
"StrengthUnit": "[AU]/mL",
"Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19870202",
"SamplePackage": "N",
"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
{
"NDCCode": "22840-0033-8",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (22840-0033-8) ",
"NDC11Code": "22840-0033-08",
"ProductNDC": "22840-0033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
"NonProprietaryName": "Dermatophagoides Farinae",
"DosageFormName": "CONCENTRATE",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19870202",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101834",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "DERMATOPHAGOIDES FARINAE",
"StrengthNumber": "5000",
"StrengthUnit": "[AU]/mL",
"Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19870202",
"SamplePackage": "N",
"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
{
"NDCCode": "22840-0033-9",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0033-9) ",
"NDC11Code": "22840-0033-09",
"ProductNDC": "22840-0033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
"NonProprietaryName": "Dermatophagoides Farinae",
"DosageFormName": "CONCENTRATE",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19870202",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101834",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "DERMATOPHAGOIDES FARINAE",
"StrengthNumber": "5000",
"StrengthUnit": "[AU]/mL",
"Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19870202",
"SamplePackage": "N",
"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
{
"NDCCode": "22840-0034-3",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (22840-0034-3) ",
"NDC11Code": "22840-0034-03",
"ProductNDC": "22840-0034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
"NonProprietaryName": "Dermatophagoides Farinae",
"DosageFormName": "CONCENTRATE",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19870202",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101834",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "DERMATOPHAGOIDES FARINAE",
"StrengthNumber": "10000",
"StrengthUnit": "[AU]/mL",
"Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19870202",
"SamplePackage": "N",
"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
{
"NDCCode": "22840-0034-6",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-0034-6) ",
"NDC11Code": "22840-0034-06",
"ProductNDC": "22840-0034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
"NonProprietaryName": "Dermatophagoides Farinae",
"DosageFormName": "CONCENTRATE",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19870202",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101834",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "DERMATOPHAGOIDES FARINAE",
"StrengthNumber": "10000",
"StrengthUnit": "[AU]/mL",
"Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19870202",
"SamplePackage": "N",
"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
{
"NDCCode": "22840-0034-8",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (22840-0034-8) ",
"NDC11Code": "22840-0034-08",
"ProductNDC": "22840-0034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
"NonProprietaryName": "Dermatophagoides Farinae",
"DosageFormName": "CONCENTRATE",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19870202",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101834",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "DERMATOPHAGOIDES FARINAE",
"StrengthNumber": "10000",
"StrengthUnit": "[AU]/mL",
"Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19870202",
"SamplePackage": "N",
"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
{
"NDCCode": "22840-0034-9",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0034-9) ",
"NDC11Code": "22840-0034-09",
"ProductNDC": "22840-0034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite Dermatophagoides Farinae",
"NonProprietaryName": "Dermatophagoides Farinae",
"DosageFormName": "CONCENTRATE",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19870202",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101834",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "DERMATOPHAGOIDES FARINAE",
"StrengthNumber": "10000",
"StrengthUnit": "[AU]/mL",
"Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19870202",
"SamplePackage": "N",
"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
{
"NDCCode": "22840-0035-6",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-0035-6) ",
"NDC11Code": "22840-0035-06",
"ProductNDC": "22840-0035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite Dermatophagoides Pteronyssinus",
"NonProprietaryName": "Dermatophagoides Pteronyssinus",
"DosageFormName": "CONCENTRATE",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19890627",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101835",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
"StrengthNumber": "5000",
"StrengthUnit": "[AU]/mL",
"Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19890627",
"SamplePackage": "N",
"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
{
"NDCCode": "22840-0035-8",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (22840-0035-8) ",
"NDC11Code": "22840-0035-08",
"ProductNDC": "22840-0035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite Dermatophagoides Pteronyssinus",
"NonProprietaryName": "Dermatophagoides Pteronyssinus",
"DosageFormName": "CONCENTRATE",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19890627",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101835",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
"StrengthNumber": "5000",
"StrengthUnit": "[AU]/mL",
"Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19890627",
"SamplePackage": "N",
"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
{
"NDCCode": "22840-0035-9",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0035-9) ",
"NDC11Code": "22840-0035-09",
"ProductNDC": "22840-0035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite Dermatophagoides Pteronyssinus",
"NonProprietaryName": "Dermatophagoides Pteronyssinus",
"DosageFormName": "CONCENTRATE",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19890627",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101835",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
"StrengthNumber": "5000",
"StrengthUnit": "[AU]/mL",
"Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19890627",
"SamplePackage": "N",
"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>22840-3412-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (22840-3412-1) </PackageDescription>
<NDC11Code>22840-3412-01</NDC11Code>
<ProductNDC>22840-3412</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>White Oak Pollen</ProprietaryName>
<NonProprietaryName>Quercus Alba</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>QUERCUS ALBA POLLEN</SubstanceName>
<StrengthNumber>.001</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>0378-3412-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3412-01) </PackageDescription>
<NDC11Code>00378-3412-01</NDC11Code>
<ProductNDC>0378-3412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100409</StartMarketingDate>
<EndMarketingDate>20191231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090325</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100409</StartMarketingDatePackage>
<EndMarketingDatePackage>20191231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-3412-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3412-05) </PackageDescription>
<NDC11Code>00378-3412-05</NDC11Code>
<ProductNDC>0378-3412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100409</StartMarketingDate>
<EndMarketingDate>20191231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090325</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100409</StartMarketingDatePackage>
<EndMarketingDatePackage>20191031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-3412-91</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3412-91)</PackageDescription>
<NDC11Code>00378-3412-91</NDC11Code>
<ProductNDC>0378-3412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100409</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090325</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-10-31</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-3412-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0409-3412-10) / 20 mL in 1 VIAL (0409-3412-01) </PackageDescription>
<NDC11Code>00409-3412-10</NDC11Code>
<ProductNDC>0409-3412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meropenem</ProprietaryName>
<NonProprietaryName>Meropenem</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20221206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091404</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MEROPENEM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: 1 4.Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1), 2 5.Complicated intra-abdominal infections (adult and pediatric patients). (1.2), 3 6.Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3).</IndicationAndUsage>
<Description>Meropenem for injection, USP (I.V.) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection, USP (I.V.) is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 500 mg Meropenem for injection, USP (I.V.) vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq). Each 1 gram Meropenem for injection, USP (I.V.) vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq) [see Dosage and Administration (2.4)].</Description>
</NDC>
<NDC>
<NDCCode>0781-3412-92</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 PACKAGE (0781-3412-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (0781-3412-15) </PackageDescription>
<NDC11Code>00781-3412-92</NDC11Code>
<ProductNDC>0781-3412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19870219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062738</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by Streptococcus pneumoniae. Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Ampicillin for Injection, USP, the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a white to cream-tinged, crystalline powder. The reconstituted solution is clear, colorless and free from visible particulates. Each ADD-Vantage® vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 2.9 milliequivalents of sodium per gram of ampicillin. It has the following molecular structure. The molecular formula is C16H18N3NaO4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10.</Description>
</NDC>
<NDC>
<NDCCode>36987-3412-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-3412-1)</PackageDescription>
<NDC11Code>36987-3412-01</NDC11Code>
<ProductNDC>36987-3412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Common Sagebrush</ProprietaryName>
<NonProprietaryName>Common Sagebrush</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ARTEMISIA TRIDENTATA POLLEN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-3412-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-3412-2)</PackageDescription>
<NDC11Code>36987-3412-02</NDC11Code>
<ProductNDC>36987-3412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Common Sagebrush</ProprietaryName>
<NonProprietaryName>Common Sagebrush</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ARTEMISIA TRIDENTATA POLLEN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-3412-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-3412-3)</PackageDescription>
<NDC11Code>36987-3412-03</NDC11Code>
<ProductNDC>36987-3412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Common Sagebrush</ProprietaryName>
<NonProprietaryName>Common Sagebrush</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ARTEMISIA TRIDENTATA POLLEN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-3412-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-3412-4)</PackageDescription>
<NDC11Code>36987-3412-04</NDC11Code>
<ProductNDC>36987-3412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Common Sagebrush</ProprietaryName>
<NonProprietaryName>Common Sagebrush</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ARTEMISIA TRIDENTATA POLLEN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-3412-1</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-3412-1) </PackageDescription>
<NDC11Code>37662-3412-01</NDC11Code>
<ProductNDC>37662-3412</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oleum Santali</ProprietaryName>
<NonProprietaryName>Oleum Santali</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230623</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>SANDALWOOD OIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-3412-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-3412-2) </PackageDescription>
<NDC11Code>37662-3412-02</NDC11Code>
<ProductNDC>37662-3412</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oleum Santali</ProprietaryName>
<NonProprietaryName>Oleum Santali</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230623</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>SANDALWOOD OIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-3412-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-3412-3) </PackageDescription>
<NDC11Code>37662-3412-03</NDC11Code>
<ProductNDC>37662-3412</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oleum Santali</ProprietaryName>
<NonProprietaryName>Oleum Santali</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230623</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>SANDALWOOD OIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-3412-4</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-3412-4) </PackageDescription>
<NDC11Code>37662-3412-04</NDC11Code>
<ProductNDC>37662-3412</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oleum Santali</ProprietaryName>
<NonProprietaryName>Oleum Santali</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230623</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>SANDALWOOD OIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49580-3412-4</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, PLASTIC (49580-3412-4)</PackageDescription>
<NDC11Code>49580-3412-04</NDC11Code>
<ProductNDC>49580-3412</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tussin Cough Long Acting</ProprietaryName>
<NonProprietaryName>Robitussin Cough Long Acting</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100113</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Aaron Industries Inc</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>58666-3412-7</NDCCode>
<PackageDescription>99 g in 1 BOX (58666-3412-7)</PackageDescription>
<NDC11Code>58666-3412-07</NDC11Code>
<ProductNDC>58666-3412</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>African Black Facial Cleansing Bar Anti-acne Clarifying</ProprietaryName>
<NonProprietaryName>Fucus Vesiculosus, Centella Asiatica, Melissa Officinalis, Aloe</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160615</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sundial Group LLC</LabelerName>
<SubstanceName>ALOE; CENTELLA ASIATICA; FUCUS VESICULOSUS; MELISSA OFFICINALIS</SubstanceName>
<StrengthNumber>1; 1; 1; 1</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: Homeopathic facial cleansing bar for acne prone skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61957-3412-0</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (61957-3412-0) / 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>61957-3412-00</NDC11Code>
<ProductNDC>61957-3412</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dior Forever Skin Wear Flawless Skin True Foundation Spf 20 2,5n Neutral</ProprietaryName>
<NonProprietaryName>Octisalate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Parfums Christian Dior</LabelerName>
<SubstanceName>OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>35; 37.6</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61957-3412-1</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (61957-3412-1) / 20 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>61957-3412-01</NDC11Code>
<ProductNDC>61957-3412</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dior Forever Skin Wear Flawless Skin True Foundation Spf 20 2,5n Neutral</ProprietaryName>
<NonProprietaryName>Octisalate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Parfums Christian Dior</LabelerName>
<SubstanceName>OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>35; 37.6</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68071-3412-3</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68071-3412-3) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>68071-3412-03</NDC11Code>
<ProductNDC>68071-3412</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076301</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 itchy, watery eyes , 3 sneezing , 4 itching of the nose or throat .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70518-3412-0</NDCCode>
<PackageDescription>100 POUCH in 1 BOX (70518-3412-0) / 1 TABLET in 1 POUCH (70518-3412-1) </PackageDescription>
<NDC11Code>70518-3412-00</NDC11Code>
<ProductNDC>70518-3412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methimazole</ProprietaryName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220415</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040350</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220415</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methimazole is indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option, 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
<Description>Methimazole (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 or 10 mg (43.8 or 87.6 μmol) methimazole, an orally administered antithyroid drug. Each tablet also contains lactose monohydrate, magnesium stearate, corn starch, and talc. The molecular weight is 114.17, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>22840-0033-6</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-0033-6) </PackageDescription>
<NDC11Code>22840-0033-06</NDC11Code>
<ProductNDC>22840-0033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Mite Dermatophagoides Farinae</ProprietaryName>
<NonProprietaryName>Dermatophagoides Farinae</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19870202</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101834</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES FARINAE</SubstanceName>
<StrengthNumber>5000</StrengthNumber>
<StrengthUnit>[AU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.</IndicationAndUsage>
<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
</NDC>
<NDC>
<NDCCode>22840-0033-8</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (22840-0033-8) </PackageDescription>
<NDC11Code>22840-0033-08</NDC11Code>
<ProductNDC>22840-0033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Mite Dermatophagoides Farinae</ProprietaryName>
<NonProprietaryName>Dermatophagoides Farinae</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19870202</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101834</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES FARINAE</SubstanceName>
<StrengthNumber>5000</StrengthNumber>
<StrengthUnit>[AU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.</IndicationAndUsage>
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<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
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<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
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<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
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<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
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<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
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<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
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<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
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<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
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