{
"NDC": [
{
"NDCCode": "49643-346-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-346-05) ",
"NDC11Code": "49643-0346-05",
"ProductNDC": "49643-346",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Russian Olive Pollen",
"NonProprietaryName": "Elaeagnus Angustifolia",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "ELAEAGNUS ANGUSTIFOLIA POLLEN",
"StrengthNumber": ".05",
"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": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-346-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49643-346-10) ",
"NDC11Code": "49643-0346-10",
"ProductNDC": "49643-346",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Russian Olive Pollen",
"NonProprietaryName": "Elaeagnus Angustifolia",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "ELAEAGNUS ANGUSTIFOLIA POLLEN",
"StrengthNumber": ".05",
"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": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-346-30",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49643-346-30) ",
"NDC11Code": "49643-0346-30",
"ProductNDC": "49643-346",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Russian Olive Pollen",
"NonProprietaryName": "Elaeagnus Angustifolia",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "ELAEAGNUS ANGUSTIFOLIA POLLEN",
"StrengthNumber": ".05",
"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": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-346-50",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49643-346-50) ",
"NDC11Code": "49643-0346-50",
"ProductNDC": "49643-346",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Russian Olive Pollen",
"NonProprietaryName": "Elaeagnus Angustifolia",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "ELAEAGNUS ANGUSTIFOLIA POLLEN",
"StrengthNumber": ".05",
"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": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "41520-346-05",
"PackageDescription": "170 g in 1 CAN (41520-346-05) ",
"NDC11Code": "41520-0346-05",
"ProductNDC": "41520-346",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sport Sunscreen Spf 30",
"NonProprietaryName": "Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2% Oxybenzone 4%",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180413",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Care One",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "3; 10; 5; 2; 4",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180413",
"SamplePackage": "N",
"IndicationAndUsage": "Uses helps prevent sunburn higher SPF gives more sunburn protection retains SPF after 80 minutes of activity in the water or sweating provides highprotection against sunburn."
},
{
"NDCCode": "49967-346-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (49967-346-05) / 50 mL in 1 BOTTLE",
"NDC11Code": "49967-0346-05",
"ProductNDC": "49967-346",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cerave Facial Moisturizing With Sunscreen Broad Spectrum Spf 30",
"NonProprietaryName": "Homosalate, Octinoxate, Octisalate, Octocrylene And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240919",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "L�Oreal USA Products Inc",
"SubstanceName": "HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE",
"StrengthNumber": "100; 50; 50; 20; 80",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240919",
"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": "50419-346-05",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (50419-346-05) / 50 mL in 1 VIAL, GLASS",
"NDC11Code": "50419-0346-05",
"ProductNDC": "50419-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultravist",
"NonProprietaryName": "Iopromide",
"DosageFormName": "INJECTION",
"RouteName": "INTRA-ARTERIAL; INTRAVENOUS",
"StartMarketingDate": "20091230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020220",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "IOPROMIDE",
"StrengthNumber": "370",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091230",
"SamplePackage": "N",
"IndicationAndUsage": "ULTRAVIST® Injection is an iodinated contrast agent indicated for.",
"Description": "ULTRAVIST(iopromide) injection is a nonionic radiographic contrast agent for intra-arterial or intravenous administration. The chemical name for iopromide is N,N'-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methyl- 1,3- benzenedicarboxamide. Iopromide has a molecular weight of 791.12 (iodine content 48.12%). Iopromide has the following structural formula. Each mL contains 623.4 mg or 768.86 mg iopromide (300 mg or 370 mg iodine, respectively) and the following inactive ingredients: 0.1 mg edetate calcium disodium as a stabilizer and 2.42 mg tromethamine as a buffer. It may also contain sodium hydroxide or hydrochloric acid to adjust pH to 7.4 (6.5–8) at 25± 2°C and contains no preservatives. ULTRAVIST is a sterile (sterilized by autoclaving), clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution and has the following physicochemical properties. ULTRAVIST 300 mg Iodine per mL and 370 mg Iodine per mL have osmolalities respectively 2.1 and 2.7 times that of plasma (285 mOsmol/kg water)."
},
{
"NDCCode": "51079-346-05",
"PackageDescription": "20 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-346-05) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (51079-346-01) ",
"NDC11Code": "51079-0346-05",
"ProductNDC": "51079-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20110610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091537",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110610",
"SamplePackage": "N"
},
{
"NDCCode": "63304-346-05",
"PackageDescription": "500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-346-05)",
"NDC11Code": "63304-0346-05",
"ProductNDC": "63304-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20120110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078602",
"LabelerName": "Rnabaxy Pharmaceuticals Inc.",
"SubstanceName": "ONDANSETRON",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m2. 2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. 3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. 4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron orally disintegrating tablets, USP are recommended even where the incidence of postoperative nausea and/or vomiting is low.",
"Description": "The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following molecular structure:. The molecular formula is C18H19N3O, representing a molecular weight of 293.4. USP disintegration test pending. Does not meet USP Disintegration Time. This product disintegrates in approximately 60 seconds. Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet, USP also contains the inactive ingredients aspartame, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, strawberry guarana flavor, and talc. Ondansetron orally disintegrating tablets, USP are orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing."
},
{
"NDCCode": "67645-346-06",
"PackageDescription": "25 BAG in 1 BOX (67645-346-06) / .454 kg in 1 BAG (67645-346-05) ",
"NDC11Code": "67645-0346-06",
"ProductNDC": "67645-346",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20021103",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Nouryon Chemicals, S.A. de C.V.",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "75",
"StrengthUnit": "kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "01-JUL-19"
},
{
"NDCCode": "68382-346-05",
"PackageDescription": "500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-346-05) ",
"NDC11Code": "68382-0346-05",
"ProductNDC": "68382-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20110511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090175",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110511",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride orally disintegrating tablets are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.",
"Description": "Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has a molecular formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Each donepezil hydrochloride orally disintegrating tablet, USP intended for oral administration contains 5 mg or 10 mg of donepezil hydrochloride. In addition, each tablet contains the following inactive ingredients: ammonium glycyrrhizate, colloidal silicon dioxide, crospovidone, flavor peppermint, flavor strawberry, magnesium stearate, mannitol and sucralose."
},
{
"NDCCode": "68428-346-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-346-05) ",
"NDC11Code": "68428-0346-05",
"ProductNDC": "68428-346",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Croton Tiglium",
"NonProprietaryName": "Croton Tiglium Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CROTON TIGLIUM SEED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "68462-346-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (68462-346-05) ",
"NDC11Code": "68462-0346-05",
"ProductNDC": "68462-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levocetirizine Dihydrochloride",
"NonProprietaryName": "Levocetirizine Dihydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090385",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Levocetirizine dihydrochloride tablets are a histamine H1-receptor antagonist indicated for: 1 The relief of symptoms associated with perennial allergic rhinitis (1.1), 2 The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.2).",
"Description": "Levocetirizine dihydrochloride, USP the active component of Levocetirizine Dihydrochloride Tablets, USP is an orally active H1-receptor antagonist. The chemical name is (-)2-[2-[4-[(4-chlorophenyl) phenyl methyl] piperazin-1-yl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride, USP is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride, USP is C21H25ClN2O32HCl. The molecular weight is 461.81 g/mol and the chemical structure is shown below:. Levocetirizine dihydrochloride, USP is a white to off-white crystalline powder and soluble in methanol and in water. Levocetirizine Dihydrochloride Tablets, USP 5 mg are formulated as immediate release, white, oval, film-coated, biconvex tablets, one side embossed with ‘G’ break line ‘G’ and the other side plain for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, macrogol 400, and titanium dioxide."
},
{
"NDCCode": "69367-346-05",
"PackageDescription": "500 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-346-05) ",
"NDC11Code": "69367-0346-05",
"ProductNDC": "69367-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207057",
"LabelerName": "Westminster Pharmaceuticals, LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211101",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: copovidone, corn starch, macrogol, magnesium stearate, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "75907-346-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (75907-346-05) ",
"NDC11Code": "75907-0346-05",
"ProductNDC": "75907-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078889",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260113",
"SamplePackage": "N",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 95 mg and 190 mg of metoprolol succinate equivalent to 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide."
},
{
"NDCCode": "79903-346-05",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (79903-346-05) / 15 mL in 1 BOTTLE, PUMP",
"NDC11Code": "79903-0346-05",
"ProductNDC": "79903-346",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate",
"NonProprietaryName": "Oxymetazoline Hcl",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20250401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Walmart Inc",
"SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250401",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves: 1 nasal congestion due to a cold, hay fever, or other upper respiratory allergies, 2 sinus congestion and pressure."
},
{
"NDCCode": "49643-003-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-003-05) ",
"NDC11Code": "49643-0003-05",
"ProductNDC": "49643-003",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Cattle Epithelia",
"NonProprietaryName": "Cattle Epithelia",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "BOS TAURUS SKIN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-004-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-004-05) ",
"NDC11Code": "49643-0004-05",
"ProductNDC": "49643-004",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Cotton Linters",
"NonProprietaryName": "Cotton Linters",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "COTTON FIBER",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Fiber Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-005-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-005-05) ",
"NDC11Code": "49643-0005-05",
"ProductNDC": "49643-005",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Cottonseed",
"NonProprietaryName": "Cottonseed",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "COTTON SEED",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-006-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-006-05) ",
"NDC11Code": "49643-0006-05",
"ProductNDC": "49643-006",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Dog Hair",
"NonProprietaryName": "Dog Hair",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "CANIS LUPUS FAMILIARIS HAIR",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Animal Fur [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Hair Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-008-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-008-05) ",
"NDC11Code": "49643-0008-05",
"ProductNDC": "49643-008",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "House Dust",
"NonProprietaryName": "House Dust",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "HOUSE DUST",
"StrengthNumber": ".02",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], House Dust [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized House Dust Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-010-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-010-05) ",
"NDC11Code": "49643-0010-05",
"ProductNDC": "49643-010",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Flaxseed",
"NonProprietaryName": "Flaxseed",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "FLAX SEED",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-011-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-011-05) ",
"NDC11Code": "49643-0011-05",
"ProductNDC": "49643-011",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Goat Epithelia",
"NonProprietaryName": "Goat Epithelia",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "CAPRA HIRCUS SKIN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-012-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-012-05) ",
"NDC11Code": "49643-0012-05",
"ProductNDC": "49643-012",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Guinea Pig Epithelia",
"NonProprietaryName": "Guinea Pig Epithelia",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "CAVIA PORCELLUS SKIN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-013-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-013-05) ",
"NDC11Code": "49643-0013-05",
"ProductNDC": "49643-013",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Hamster Epithelia",
"NonProprietaryName": "Hamster Epithelia",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "MESOCRICETUS AURATUS SKIN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-014-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-014-05) ",
"NDC11Code": "49643-0014-05",
"ProductNDC": "49643-014",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Hog Epithelia",
"NonProprietaryName": "Hog Epithelia",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "SUS SCROFA SKIN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-015-05",
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"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Horse Epithelia",
"NonProprietaryName": "Horse Epithelia",
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"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-016-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-016-05) ",
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"ProductNDC": "49643-016",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Jute",
"NonProprietaryName": "Jute",
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"SubstanceName": "CORCORUS CAPSULARIS FIBER",
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"StrengthUnit": "g/mL",
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"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-017-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-017-05) ",
"NDC11Code": "49643-0017-05",
"ProductNDC": "49643-017",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
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"StartMarketingDate": "19740312",
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"StrengthUnit": "g/mL",
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"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-018-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-018-05) ",
"NDC11Code": "49643-0018-05",
"ProductNDC": "49643-018",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Karaya Gum",
"NonProprietaryName": "Karaya Gum",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "KARAYA GUM",
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"StrengthUnit": "g/mL",
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"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
}
]
}
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<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
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<NDC>
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<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
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<NDC>
<NDCCode>49643-346-30</NDCCode>
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<NonProprietaryName>Elaeagnus Angustifolia</NonProprietaryName>
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<SamplePackage>N</SamplePackage>
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<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
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<NDC>
<NDCCode>49643-346-50</NDCCode>
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<ProprietaryName>Russian Olive Pollen</ProprietaryName>
<NonProprietaryName>Elaeagnus Angustifolia</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
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<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>ELAEAGNUS ANGUSTIFOLIA POLLEN</SubstanceName>
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<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>41520-346-05</NDCCode>
<PackageDescription>170 g in 1 CAN (41520-346-05) </PackageDescription>
<NDC11Code>41520-0346-05</NDC11Code>
<ProductNDC>41520-346</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sport Sunscreen Spf 30</ProprietaryName>
<NonProprietaryName>Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2% Oxybenzone 4%</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180413</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Care One</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>3; 10; 5; 2; 4</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses helps prevent sunburn higher SPF gives more sunburn protection retains SPF after 80 minutes of activity in the water or sweating provides highprotection against sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49967-346-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49967-346-05) / 50 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>49967-0346-05</NDC11Code>
<ProductNDC>49967-346</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cerave Facial Moisturizing With Sunscreen Broad Spectrum Spf 30</ProprietaryName>
<NonProprietaryName>Homosalate, Octinoxate, Octisalate, Octocrylene And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240919</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>L�Oreal USA Products Inc</LabelerName>
<SubstanceName>HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE</SubstanceName>
<StrengthNumber>100; 50; 50; 20; 80</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240919</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>50419-346-05</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (50419-346-05) / 50 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>50419-0346-05</NDC11Code>
<ProductNDC>50419-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultravist</ProprietaryName>
<NonProprietaryName>Iopromide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20091230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020220</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IOPROMIDE</SubstanceName>
<StrengthNumber>370</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ULTRAVIST® Injection is an iodinated contrast agent indicated for.</IndicationAndUsage>
<Description>ULTRAVIST(iopromide) injection is a nonionic radiographic contrast agent for intra-arterial or intravenous administration. The chemical name for iopromide is N,N'-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methyl- 1,3- benzenedicarboxamide. Iopromide has a molecular weight of 791.12 (iodine content 48.12%). Iopromide has the following structural formula. Each mL contains 623.4 mg or 768.86 mg iopromide (300 mg or 370 mg iodine, respectively) and the following inactive ingredients: 0.1 mg edetate calcium disodium as a stabilizer and 2.42 mg tromethamine as a buffer. It may also contain sodium hydroxide or hydrochloric acid to adjust pH to 7.4 (6.5–8) at 25± 2°C and contains no preservatives. ULTRAVIST is a sterile (sterilized by autoclaving), clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution and has the following physicochemical properties. ULTRAVIST 300 mg Iodine per mL and 370 mg Iodine per mL have osmolalities respectively 2.1 and 2.7 times that of plasma (285 mOsmol/kg water).</Description>
</NDC>
<NDC>
<NDCCode>51079-346-05</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-346-05) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (51079-346-01) </PackageDescription>
<NDC11Code>51079-0346-05</NDC11Code>
<ProductNDC>51079-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091537</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63304-346-05</NDCCode>
<PackageDescription>500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-346-05)</PackageDescription>
<NDC11Code>63304-0346-05</NDC11Code>
<ProductNDC>63304-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078602</ApplicationNumber>
<LabelerName>Rnabaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ONDANSETRON</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m2. 2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. 3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. 4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron orally disintegrating tablets, USP are recommended even where the incidence of postoperative nausea and/or vomiting is low.</IndicationAndUsage>
<Description>The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following molecular structure:. The molecular formula is C18H19N3O, representing a molecular weight of 293.4. USP disintegration test pending. Does not meet USP Disintegration Time. This product disintegrates in approximately 60 seconds. Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet, USP also contains the inactive ingredients aspartame, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, strawberry guarana flavor, and talc. Ondansetron orally disintegrating tablets, USP are orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing.</Description>
</NDC>
<NDC>
<NDCCode>67645-346-06</NDCCode>
<PackageDescription>25 BAG in 1 BOX (67645-346-06) / .454 kg in 1 BAG (67645-346-05) </PackageDescription>
<NDC11Code>67645-0346-06</NDC11Code>
<ProductNDC>67645-346</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20021103</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Nouryon Chemicals, S.A. de C.V.</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JUL-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68382-346-05</NDCCode>
<PackageDescription>500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-346-05) </PackageDescription>
<NDC11Code>68382-0346-05</NDC11Code>
<ProductNDC>68382-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090175</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride orally disintegrating tablets are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has a molecular formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Each donepezil hydrochloride orally disintegrating tablet, USP intended for oral administration contains 5 mg or 10 mg of donepezil hydrochloride. In addition, each tablet contains the following inactive ingredients: ammonium glycyrrhizate, colloidal silicon dioxide, crospovidone, flavor peppermint, flavor strawberry, magnesium stearate, mannitol and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>68428-346-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-346-05) </PackageDescription>
<NDC11Code>68428-0346-05</NDC11Code>
<ProductNDC>68428-346</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Croton Tiglium</ProprietaryName>
<NonProprietaryName>Croton Tiglium Seed</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CROTON TIGLIUM SEED</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68462-346-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (68462-346-05) </PackageDescription>
<NDC11Code>68462-0346-05</NDC11Code>
<ProductNDC>68462-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levocetirizine Dihydrochloride</ProprietaryName>
<NonProprietaryName>Levocetirizine Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090385</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>LEVOCETIRIZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levocetirizine dihydrochloride tablets are a histamine H1-receptor antagonist indicated for: 1 The relief of symptoms associated with perennial allergic rhinitis (1.1), 2 The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.2).</IndicationAndUsage>
<Description>Levocetirizine dihydrochloride, USP the active component of Levocetirizine Dihydrochloride Tablets, USP is an orally active H1-receptor antagonist. The chemical name is (-)2-[2-[4-[(4-chlorophenyl) phenyl methyl] piperazin-1-yl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride, USP is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride, USP is C21H25ClN2O32HCl. The molecular weight is 461.81 g/mol and the chemical structure is shown below:. Levocetirizine dihydrochloride, USP is a white to off-white crystalline powder and soluble in methanol and in water. Levocetirizine Dihydrochloride Tablets, USP 5 mg are formulated as immediate release, white, oval, film-coated, biconvex tablets, one side embossed with ‘G’ break line ‘G’ and the other side plain for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, macrogol 400, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69367-346-05</NDCCode>
<PackageDescription>500 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-346-05) </PackageDescription>
<NDC11Code>69367-0346-05</NDC11Code>
<ProductNDC>69367-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207057</ApplicationNumber>
<LabelerName>Westminster Pharmaceuticals, LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: copovidone, corn starch, macrogol, magnesium stearate, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>75907-346-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (75907-346-05) </PackageDescription>
<NDC11Code>75907-0346-05</NDC11Code>
<ProductNDC>75907-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078889</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 95 mg and 190 mg of metoprolol succinate equivalent to 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>79903-346-05</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (79903-346-05) / 15 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>79903-0346-05</NDC11Code>
<ProductNDC>79903-346</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate</ProprietaryName>
<NonProprietaryName>Oxymetazoline Hcl</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20250401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Walmart Inc</LabelerName>
<SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: 1 nasal congestion due to a cold, hay fever, or other upper respiratory allergies, 2 sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49643-003-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49643-003-05) </PackageDescription>
<NDC11Code>49643-0003-05</NDC11Code>
<ProductNDC>49643-003</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Cattle Epithelia</ProprietaryName>
<NonProprietaryName>Cattle Epithelia</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>BOS TAURUS SKIN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>49643-004-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49643-004-05) </PackageDescription>
<NDC11Code>49643-0004-05</NDC11Code>
<ProductNDC>49643-004</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Cotton Linters</ProprietaryName>
<NonProprietaryName>Cotton Linters</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>COTTON FIBER</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Fiber Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>49643-005-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49643-005-05) </PackageDescription>
<NDC11Code>49643-0005-05</NDC11Code>
<ProductNDC>49643-005</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Cottonseed</ProprietaryName>
<NonProprietaryName>Cottonseed</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>COTTON SEED</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>49643-006-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49643-006-05) </PackageDescription>
<NDC11Code>49643-0006-05</NDC11Code>
<ProductNDC>49643-006</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Dog Hair</ProprietaryName>
<NonProprietaryName>Dog Hair</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>CANIS LUPUS FAMILIARIS HAIR</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Animal Fur [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Hair Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
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<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
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<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
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<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
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<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
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<ProprietaryName>Guinea Pig Epithelia</ProprietaryName>
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<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
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<NDC>
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<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
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<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>49643-014-05</NDCCode>
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<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
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<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
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<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
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<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
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<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
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