{
"NDC": [
{
"NDCCode": "63083-9302-1",
"PackageDescription": "29.5 mL in 1 BOTTLE, DROPPER (63083-9302-1) ",
"NDC11Code": "63083-9302-01",
"ProductNDC": "63083-9302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Large Ring Combination",
"ProprietaryNameSuffix": "9302",
"NonProprietaryName": "Large Ring Combination",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; SODIUM CARBONATE; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAF; ANTHRACENE; BENZO(A)PYRENE; 3-METHYLCHOLANTHRENE",
"StrengthNumber": "3; 3; 3; 12; 12; 14; 30; 30",
"StrengthUnit": "[hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "0031-9302-01",
"PackageDescription": "18 CAPSULE, LIQUID FILLED in 1 BOTTLE (0031-9302-01) ",
"NDC11Code": "00031-9302-01",
"ProductNDC": "0031-9302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Robitussin Direct Cough",
"NonProprietaryName": "Dextromethorphan Hydrobromide",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20220715",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220715",
"SamplePackage": "N",
"IndicationAndUsage": "Use. temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold."
},
{
"NDCCode": "0409-9302-20",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9302-20) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-9302-21) ",
"NDC11Code": "00409-9302-20",
"ProductNDC": "0409-9302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; PERINEURAL",
"StartMarketingDate": "20140923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090194",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140923",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine Hydrochloride Injection, USP is indicated for the production of local or regional anesthesia for surgery and for acute pain management.",
"Description": "Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection, USP is administered parenterally by infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n‑octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.12 mg, 5.3 mg, 7.95 mg, or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg, or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg, 7.5 mg, or 7.1 mg of sodium chloride, respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "0420-9302-01",
"PackageDescription": "1440 TRAY in 1 BOX (0420-9302-01) / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE",
"NDC11Code": "00420-9302-01",
"ProductNDC": "0420-9302",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Semaglutide",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20260428",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Novo Nordisk A/S",
"SubstanceName": "SEMAGLUTIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/.5mL",
"Status": "Unfinished",
"LastUpdate": "2026-04-29",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "28-APR-26"
},
{
"NDCCode": "0517-9302-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9302-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-9302-01) ",
"NDC11Code": "00517-9302-25",
"ProductNDC": "0517-9302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multrys",
"NonProprietaryName": "Trace Elements Injection 4",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209376",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "ZINC SULFATE; CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID",
"StrengthNumber": "2470; 150; 8.22; 9.8",
"StrengthUnit": "ug/mL; ug/mL; ug/mL; ug/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210901",
"SamplePackage": "N",
"IndicationAndUsage": "Multrys is indicated in neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "Multrys (trace elements injection 4*, USP) is a sterile, non-pyrogenic, clear, and colorless to slightly blue solution, intended for use as a combination of four trace elements and an additive to intravenous solutions for parenteral nutrition. It contains no preservative. Each single-dose vial contains 1 mL. *Each mL contains zinc 1,000 mcg (equivalent to zinc sulfate 2,470 mcg), copper 60 mcg (equivalent to cupric sulfate 150 mcg), manganese 3 mcg (equivalent to manganese sulfate 8.22 mcg), selenium 6 mcg (equivalent to selenious acid 9.8 mcg), and water for injection. Sulfuric acid may be added to adjust pH between 1.5 and 3.5. Zinc sulfate exists as a heptahydrate. The structural formula is. Molecular formula: ZnSO4 7H2O.Molecular weight: 287.54 g/mol. Cupric sulfate exists as a pentahydrate. The structural formula is. Molecular formula: CuSO4 5H2O.Molecular weight: 249.69 g/mol. Manganese sulfate exists as a monohydrate. The structural formula is. Molecular formula: MnSO4 H2O. Molecular weight: 169.02 g/mol. The structural formula of selenious acid is. Molecular formula: H2SeO3.Molecular weight: 128.97 g/mol. Multrys contains no more than 1,500 mcg/L of aluminum."
},
{
"NDCCode": "0781-9302-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0781-9302-01)",
"NDC11Code": "00781-9302-01",
"ProductNDC": "0781-9302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065461",
"LabelerName": "Sandoz Inc",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-11-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "10157-9302-3",
"PackageDescription": "1 TUBE in 1 CARTON (10157-9302-3) / 14 g in 1 TUBE",
"NDC11Code": "10157-9302-03",
"ProductNDC": "10157-9302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blistex",
"ProprietaryNameSuffix": "Foille Medicated First Aid",
"NonProprietaryName": "Benzocaine And Chloroxylenol",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130305",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Blistex Inc.",
"SubstanceName": "BENZOCAINE; CHLOROXYLENOL",
"StrengthNumber": "5; .1",
"StrengthUnit": "g/100g; g/100g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160923",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. First aid to help prevent infection in minor cuts, scrapes and burns."
},
{
"NDCCode": "10157-9302-4",
"PackageDescription": "1 TUBE in 1 CARTON (10157-9302-4) / 28 g in 1 TUBE",
"NDC11Code": "10157-9302-04",
"ProductNDC": "10157-9302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blistex",
"ProprietaryNameSuffix": "Foille Medicated First Aid",
"NonProprietaryName": "Benzocaine And Chloroxylenol",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130305",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Blistex Inc.",
"SubstanceName": "BENZOCAINE; CHLOROXYLENOL",
"StrengthNumber": "5; .1",
"StrengthUnit": "g/100g; g/100g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130305",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. First aid to help prevent infection in minor cuts, scrapes and burns."
},
{
"NDCCode": "22840-9302-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-9302-2) ",
"NDC11Code": "22840-9302-02",
"ProductNDC": "22840-9302",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "3 Weed Mix",
"NonProprietaryName": "Xanthium Strumarium, Chenopodium Album, Amaranthus Retroflexus",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; XANTHIUM STRUMARIUM POLLEN",
"StrengthNumber": ".03333; .03333; .03333",
"StrengthUnit": "g/mL; g/mL; g/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"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": "22840-9302-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-9302-4) ",
"NDC11Code": "22840-9302-04",
"ProductNDC": "22840-9302",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "3 Weed Mix",
"NonProprietaryName": "Xanthium Strumarium, Chenopodium Album, Amaranthus Retroflexus",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; XANTHIUM STRUMARIUM POLLEN",
"StrengthNumber": ".03333; .03333; .03333",
"StrengthUnit": "g/mL; g/mL; g/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"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": "48951-9302-1",
"PackageDescription": "8 AMPULE in 1 BOX (48951-9302-1) / 1 mL in 1 AMPULE",
"NDC11Code": "48951-9302-01",
"ProductNDC": "48951-9302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viscum Abietis 5",
"NonProprietaryName": "Viscum Abietis 5",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140801",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "2",
"StrengthUnit": "[hp_X]/mL",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140801",
"SamplePackage": "N",
"IndicationAndUsage": "FOR ORAL USE ONLY."
},
{
"NDCCode": "61589-9302-7",
"PackageDescription": "1 TUBE in 1 CARTON (61589-9302-7) / 5 g in 1 TUBE",
"NDC11Code": "61589-9302-07",
"ProductNDC": "61589-9302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No7 Future Renew Defense Shield Spf 50",
"NonProprietaryName": "Avobenzone, Octinoxate, Octisalate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250722",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "BCMC",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE",
"StrengthNumber": "3; 6.993; 4.5",
"StrengthUnit": "g/50g; g/50g; g/50g",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251104",
"SamplePackage": "N",
"IndicationAndUsage": "Uses - helps prevent sunburn."
},
{
"NDCCode": "61941-9302-5",
"PackageDescription": "2500 LOZENGE in 1 CASE (61941-9302-5) ",
"NDC11Code": "61941-9302-05",
"ProductNDC": "61941-9302",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOZENGE",
"StartMarketingDate": "20041101",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Pharmaloz Manufacturing Inc.",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "7",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-01-10",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-NOV-04"
},
{
"NDCCode": "68788-9302-1",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (68788-9302-1) ",
"NDC11Code": "68788-9302-01",
"ProductNDC": "68788-9302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076765",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150326",
"SamplePackage": "N"
},
{
"NDCCode": "68788-9302-2",
"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (68788-9302-2) ",
"NDC11Code": "68788-9302-02",
"ProductNDC": "68788-9302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076765",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150326",
"SamplePackage": "N"
},
{
"NDCCode": "68788-9302-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68788-9302-3) ",
"NDC11Code": "68788-9302-03",
"ProductNDC": "68788-9302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076765",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150326",
"SamplePackage": "N"
},
{
"NDCCode": "68788-9302-6",
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"StartMarketingDate": "19840815",
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"ProductNdcExcludeFlag": "N",
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"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
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"ProductTypeName": "HUMAN OTC DRUG",
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"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
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<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0031-9302-01</NDCCode>
<PackageDescription>18 CAPSULE, LIQUID FILLED in 1 BOTTLE (0031-9302-01) </PackageDescription>
<NDC11Code>00031-9302-01</NDC11Code>
<ProductNDC>0031-9302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Robitussin Direct Cough</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide</NonProprietaryName>
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<StartMarketingDate>20220715</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0409-9302-20</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9302-20) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-9302-21) </PackageDescription>
<NDC11Code>00409-9302-20</NDC11Code>
<ProductNDC>0409-9302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; PERINEURAL</RouteName>
<StartMarketingDate>20140923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090194</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
<NDCCode>0420-9302-01</NDCCode>
<PackageDescription>1440 TRAY in 1 BOX (0420-9302-01) / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00420-9302-01</NDC11Code>
<ProductNDC>0420-9302</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Semaglutide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20260428</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Novo Nordisk A/S</LabelerName>
<SubstanceName>SEMAGLUTIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-04-29</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>28-APR-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0517-9302-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9302-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-9302-01) </PackageDescription>
<NDC11Code>00517-9302-25</NDC11Code>
<ProductNDC>0517-9302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multrys</ProprietaryName>
<NonProprietaryName>Trace Elements Injection 4</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209376</ApplicationNumber>
<LabelerName>American Regent, Inc.</LabelerName>
<SubstanceName>ZINC SULFATE; CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID</SubstanceName>
<StrengthNumber>2470; 150; 8.22; 9.8</StrengthNumber>
<StrengthUnit>ug/mL; ug/mL; ug/mL; ug/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Multrys is indicated in neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>Multrys (trace elements injection 4*, USP) is a sterile, non-pyrogenic, clear, and colorless to slightly blue solution, intended for use as a combination of four trace elements and an additive to intravenous solutions for parenteral nutrition. It contains no preservative. Each single-dose vial contains 1 mL. *Each mL contains zinc 1,000 mcg (equivalent to zinc sulfate 2,470 mcg), copper 60 mcg (equivalent to cupric sulfate 150 mcg), manganese 3 mcg (equivalent to manganese sulfate 8.22 mcg), selenium 6 mcg (equivalent to selenious acid 9.8 mcg), and water for injection. Sulfuric acid may be added to adjust pH between 1.5 and 3.5. Zinc sulfate exists as a heptahydrate. The structural formula is. Molecular formula: ZnSO4 7H2O.Molecular weight: 287.54 g/mol. Cupric sulfate exists as a pentahydrate. The structural formula is. Molecular formula: CuSO4 5H2O.Molecular weight: 249.69 g/mol. Manganese sulfate exists as a monohydrate. The structural formula is. Molecular formula: MnSO4 H2O. Molecular weight: 169.02 g/mol. The structural formula of selenious acid is. Molecular formula: H2SeO3.Molecular weight: 128.97 g/mol. Multrys contains no more than 1,500 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0781-9302-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0781-9302-01)</PackageDescription>
<NDC11Code>00781-9302-01</NDC11Code>
<ProductNDC>0781-9302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065461</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10157-9302-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10157-9302-3) / 14 g in 1 TUBE</PackageDescription>
<NDC11Code>10157-9302-03</NDC11Code>
<ProductNDC>10157-9302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blistex</ProprietaryName>
<ProprietaryNameSuffix>Foille Medicated First Aid</ProprietaryNameSuffix>
<NonProprietaryName>Benzocaine And Chloroxylenol</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130305</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Blistex Inc.</LabelerName>
<SubstanceName>BENZOCAINE; CHLOROXYLENOL</SubstanceName>
<StrengthNumber>5; .1</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. First aid to help prevent infection in minor cuts, scrapes and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10157-9302-4</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10157-9302-4) / 28 g in 1 TUBE</PackageDescription>
<NDC11Code>10157-9302-04</NDC11Code>
<ProductNDC>10157-9302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blistex</ProprietaryName>
<ProprietaryNameSuffix>Foille Medicated First Aid</ProprietaryNameSuffix>
<NonProprietaryName>Benzocaine And Chloroxylenol</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130305</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Blistex Inc.</LabelerName>
<SubstanceName>BENZOCAINE; CHLOROXYLENOL</SubstanceName>
<StrengthNumber>5; .1</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. First aid to help prevent infection in minor cuts, scrapes and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>22840-9302-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-9302-2) </PackageDescription>
<NDC11Code>22840-9302-02</NDC11Code>
<ProductNDC>22840-9302</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>3 Weed Mix</ProprietaryName>
<NonProprietaryName>Xanthium Strumarium, Chenopodium Album, Amaranthus Retroflexus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; XANTHIUM STRUMARIUM POLLEN</SubstanceName>
<StrengthNumber>.03333; .03333; .03333</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</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>22840-9302-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-9302-4) </PackageDescription>
<NDC11Code>22840-9302-04</NDC11Code>
<ProductNDC>22840-9302</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>3 Weed Mix</ProprietaryName>
<NonProprietaryName>Xanthium Strumarium, Chenopodium Album, Amaranthus Retroflexus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; XANTHIUM STRUMARIUM POLLEN</SubstanceName>
<StrengthNumber>.03333; .03333; .03333</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</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>48951-9302-1</NDCCode>
<PackageDescription>8 AMPULE in 1 BOX (48951-9302-1) / 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>48951-9302-01</NDC11Code>
<ProductNDC>48951-9302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viscum Abietis 5</ProprietaryName>
<NonProprietaryName>Viscum Abietis 5</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOR ORAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61589-9302-7</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (61589-9302-7) / 5 g in 1 TUBE</PackageDescription>
<NDC11Code>61589-9302-07</NDC11Code>
<ProductNDC>61589-9302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No7 Future Renew Defense Shield Spf 50</ProprietaryName>
<NonProprietaryName>Avobenzone, Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250722</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>BCMC</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>3; 6.993; 4.5</StrengthNumber>
<StrengthUnit>g/50g; g/50g; g/50g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses - helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61941-9302-5</NDCCode>
<PackageDescription>2500 LOZENGE in 1 CASE (61941-9302-5) </PackageDescription>
<NDC11Code>61941-9302-05</NDC11Code>
<ProductNDC>61941-9302</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<StartMarketingDate>20041101</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Pharmaloz Manufacturing Inc.</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-10</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-NOV-04</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68788-9302-1</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (68788-9302-1) </PackageDescription>
<NDC11Code>68788-9302-01</NDC11Code>
<ProductNDC>68788-9302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076765</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-9302-2</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE (68788-9302-2) </PackageDescription>
<NDC11Code>68788-9302-02</NDC11Code>
<ProductNDC>68788-9302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076765</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-9302-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68788-9302-3) </PackageDescription>
<NDC11Code>68788-9302-03</NDC11Code>
<ProductNDC>68788-9302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076765</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-9302-6</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (68788-9302-6) </PackageDescription>
<NDC11Code>68788-9302-06</NDC11Code>
<ProductNDC>68788-9302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076765</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-9302-9</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68788-9302-9) </PackageDescription>
<NDC11Code>68788-9302-09</NDC11Code>
<ProductNDC>68788-9302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076765</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63083-1001-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1001-2) </PackageDescription>
<NDC11Code>63083-1001-02</NDC11Code>
<ProductNDC>63083-1001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pets</ProprietaryName>
<ProprietaryNameSuffix>1001</ProprietaryNameSuffix>
<NonProprietaryName>Pets</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CAMELUS BACTRIANUS HAIR; FELIS CATUS HAIR; BOVINE TYPE I COLLAGEN (SKIN); CANIS LUPUS FAMILIARIS HAIR; GALLUS GALLUS FEATHER; BLUEGILL; CAPRA HIRCUS HAIR; CAVIA PORCELLUS WHOLE; SUS SCROFA HAIR; HORSE; RABBIT; SHEEP WOOL</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
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<Status>Deprecated</Status>
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<IndicationAndUsage>For the temporary relief of gas, bloating, diarrhea, and itching of the nose or throat due to sensitivity to sugars and sweeteners.*.</IndicationAndUsage>
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<LastUpdate>2026-01-09</LastUpdate>
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<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
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<SamplePackage>N</SamplePackage>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; ASPARAGUS; LIMA BEAN; BEET; BROCCOLI; CABBAGE; CARROT; CAULIFLOWER; CELERY; CORN; CUCUMBER; GARLIC; KALE; LENTIL; LETTUCE; ONION; PARSNIP; CHICKPEA; PEPPERS; POTATO; RADISH; SOYBEAN; SPINACH; TURNIP</SubstanceName>
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