{
"NDC": [
{
"NDCCode": "0220-9000-65",
"PackageDescription": "1 TUBE in 1 PACKAGE (0220-9000-65) / 14 g in 1 TUBE",
"NDC11Code": "00220-9000-65",
"ProductNDC": "0220-9000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnicare",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070109",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoires Boiron",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/g",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070109",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*. temporarily relieves muscle pain and stiffness due to: 1 minor injuries, 2 overexertion, 3 falls."
},
{
"NDCCode": "49614-220-65",
"PackageDescription": "1 BOTTLE in 1 CARTON (49614-220-65) > 30 TABLET in 1 BOTTLE",
"NDC11Code": "49614-0220-65",
"ProductNDC": "49614-220",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acid Reducer",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076760",
"LabelerName": "Medicine Shoppe International Inc",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "0220-9000-54",
"PackageDescription": "1 TUBE in 1 PACKAGE (0220-9000-54) / 45 g in 1 TUBE",
"NDC11Code": "00220-9000-54",
"ProductNDC": "0220-9000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnicare",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070109",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoires Boiron",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/g",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20070109",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*. temporarily relieves muscle pain and stiffness due to: 1 minor injuries, 2 overexertion, 3 falls."
},
{
"NDCCode": "0220-9000-59",
"PackageDescription": "1 TUBE in 1 PACKAGE (0220-9000-59) / 75 g in 1 TUBE",
"NDC11Code": "00220-9000-59",
"ProductNDC": "0220-9000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnicare",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070109",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoires Boiron",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/g",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070109",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*. temporarily relieves muscle pain and stiffness due to: 1 minor injuries, 2 overexertion, 3 falls."
},
{
"NDCCode": "0220-9000-66",
"PackageDescription": "1 TUBE in 1 PACKAGE (0220-9000-66) / 120 g in 1 TUBE",
"NDC11Code": "00220-9000-66",
"ProductNDC": "0220-9000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnicare",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070109",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoires Boiron",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/g",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070109",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*. temporarily relieves muscle pain and stiffness due to: 1 minor injuries, 2 overexertion, 3 falls."
},
{
"NDCCode": "0220-9000-84",
"PackageDescription": "1 TUBE in 1 PACKAGE (0220-9000-84) / 45 g in 1 TUBE",
"NDC11Code": "00220-9000-84",
"ProductNDC": "0220-9000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnicare",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070109",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoires Boiron",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/g",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*. temporarily relieves muscle pain and stiffness due to: 1 minor injuries, 2 overexertion, 3 falls."
},
{
"NDCCode": "0220-9000-85",
"PackageDescription": "2 TUBE in 1 PACKAGE (0220-9000-85) / 120 g in 1 TUBE",
"NDC11Code": "00220-9000-85",
"ProductNDC": "0220-9000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnicare",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070109",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoires Boiron",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/g",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250721",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*. temporarily relieves muscle pain and stiffness due to: 1 minor injuries, 2 overexertion, 3 falls."
},
{
"NDCCode": "0220-9000-86",
"PackageDescription": "2 TUBE in 1 PACKAGE (0220-9000-86) / 45 g in 1 TUBE",
"NDC11Code": "00220-9000-86",
"ProductNDC": "0220-9000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnicare",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070109",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoires Boiron",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/g",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*. temporarily relieves muscle pain and stiffness due to: 1 minor injuries, 2 overexertion, 3 falls."
},
{
"NDCCode": "0220-9000-94",
"PackageDescription": "5 g in 1 POUCH (0220-9000-94) ",
"NDC11Code": "00220-9000-94",
"ProductNDC": "0220-9000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnicare",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070109",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoires Boiron",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/g",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230609",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*. temporarily relieves muscle pain and stiffness due to: 1 minor injuries, 2 overexertion, 3 falls."
},
{
"NDCCode": "43353-034-09",
"PackageDescription": "9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-034-09) ",
"NDC11Code": "43353-0034-09",
"ProductNDC": "43353-034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitriol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076917",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": ".25",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130703",
"SamplePackage": "N",
"IndicationAndUsage": "Calcitriol Capsules are indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥100 pg/mL is strongly suggestive of secondary hyperparathyroidism.",
"Description": "Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Cacitriol is available as capsules containing 0.25 mcg. Calcitriol Capsules contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain a fractionated triglyceride of coconut oil. Gelatin capsule shells contain gelatin, glycerin (anhydrous), and titanium dioxide, with the following dyes: FD&C Yellow No. 5 and FD&C Yellow No. 6. In addition to the ingredients listed above, each tablet contains Opacode (Black) monogramming ink, Opacode (Black) contains ammonium hydroxide, iron oxide black, isopropyl alcohol, macrogol, polyvinyl acetate phthalate, propylene glycol, purified water, and SDA 35A alcohol. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula:. The other names frequently used for calcitriol are 1α, 25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3,1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC."
},
{
"NDCCode": "43353-138-09",
"PackageDescription": "9000 CAPSULE in 1 BOTTLE (43353-138-09)",
"NDC11Code": "43353-0138-09",
"ProductNDC": "43353-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitriol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090826",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018044",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": ".25",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"IndicationAndUsage": "Predialysis Patients. Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients. Calcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients. Calcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.",
"Description": "Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol and as an oral solution containing 1 mcg/mL of calcitriol. All dosage forms contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain a fractionated triglyceride of coconut oil, and the oral solution contains a fractionated triglyceride of palm seed oil. Gelatin capsule shells contain glycerin, and sorbitol, with the following dye systems: 0.25 mcg — FD&C Yellow No. 6 and titanium dioxide; 0.5 mcg — FD&C Red No. 3, FD&C Yellow No. 6 and titanium dioxide. The oral solution contains no additional adjuvants or coloring principles. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9,10- seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula:. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC."
},
{
"NDCCode": "43353-998-09",
"PackageDescription": "9000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-998-09)",
"NDC11Code": "43353-0998-09",
"ProductNDC": "43353-998",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitriol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20130529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091174",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": ".25",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Calcitriol capsules are indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism.",
"Description": "Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol Capsules contain 0.25 mcg or 0.5 mcg calcitriol, fractionated triglyceride of coconut oil, butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. Gelatin capsule shells contain glycerin, water, sorbitol, sorbitan, mannitol, water, FD&C Yellow No. 6, FD&C Red #40, titanium dioxide and iron oxide black. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9,10- seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC."
},
{
"NDCCode": "59617-0010-1",
"PackageDescription": "1 BLISTER PACK in 1 BOX (59617-0010-1) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "59617-0010-01",
"ProductNDC": "59617-0010",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Oralair",
"ProprietaryNameSuffix": "100 Ir",
"NonProprietaryName": "Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20140430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125471",
"LabelerName": "Stallergenes",
"SubstanceName": "POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN",
"StrengthNumber": "100; 100; 100; 100; 100",
"StrengthUnit": "[IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140430",
"SamplePackage": "N",
"IndicationAndUsage": "ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.",
"Description": "ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU."
},
{
"NDCCode": "59617-0015-2",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59617-0015-2) ",
"NDC11Code": "59617-0015-02",
"ProductNDC": "59617-0015",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Oralair",
"ProprietaryNameSuffix": "300 Ir",
"NonProprietaryName": "Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20140430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125471",
"LabelerName": "Stallergenes",
"SubstanceName": "DACTYLIS GLOMERATA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN",
"StrengthNumber": "300; 300; 300; 300; 300",
"StrengthUnit": "[IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140430",
"SamplePackage": "N",
"IndicationAndUsage": "ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.",
"Description": "ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU."
},
{
"NDCCode": "59617-0015-3",
"PackageDescription": "1 BLISTER PACK in 1 BOX (59617-0015-3) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "59617-0015-03",
"ProductNDC": "59617-0015",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Oralair",
"ProprietaryNameSuffix": "300 Ir",
"NonProprietaryName": "Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20140430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125471",
"LabelerName": "Stallergenes",
"SubstanceName": "DACTYLIS GLOMERATA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN",
"StrengthNumber": "300; 300; 300; 300; 300",
"StrengthUnit": "[IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140430",
"SamplePackage": "N",
"IndicationAndUsage": "ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.",
"Description": "ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU."
},
{
"NDCCode": "59617-0016-1",
"PackageDescription": "1 BLISTER PACK in 1 BOX (59617-0016-1) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "59617-0016-01",
"ProductNDC": "59617-0016",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Oralair",
"ProprietaryNameSuffix": "300 Ir",
"NonProprietaryName": "Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20140430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125471",
"LabelerName": "Stallergenes",
"SubstanceName": "POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN",
"StrengthNumber": "300; 300; 300; 300; 300",
"StrengthUnit": "[IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140430",
"SamplePackage": "N",
"IndicationAndUsage": "ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.",
"Description": "ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU."
},
{
"NDCCode": "59617-0020-1",
"PackageDescription": "1 KIT in 1 CARTON (59617-0020-1) * 1 TABLET, ORALLY DISINTEGRATING in 1 BOX * 2 TABLET, ORALLY DISINTEGRATING in 1 BOX",
"NDC11Code": "59617-0020-01",
"ProductNDC": "59617-0020",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Oralair",
"NonProprietaryName": "Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phelum Pratense Pollen, And Poa Pratensis Pollen",
"DosageFormName": "KIT",
"StartMarketingDate": "20140430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125471",
"LabelerName": "Stallergenes",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140430",
"SamplePackage": "N",
"IndicationAndUsage": "ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.",
"Description": "ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU."
},
{
"NDCCode": "59617-0025-1",
"PackageDescription": "1 KIT in 1 CARTON (59617-0025-1) * 1 TABLET, ORALLY DISINTEGRATING in 1 BOX * 2 TABLET, ORALLY DISINTEGRATING in 1 BOX",
"NDC11Code": "59617-0025-01",
"ProductNDC": "59617-0025",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Oralair",
"NonProprietaryName": "Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phelum Pratense Pollen, And Poa Pratensis Pollen",
"DosageFormName": "KIT",
"StartMarketingDate": "20140430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125471",
"LabelerName": "Stallergenes",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140430",
"SamplePackage": "N",
"IndicationAndUsage": "ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.",
"Description": "ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU."
},
{
"NDCCode": "71610-468-09",
"PackageDescription": "9000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71610-468-09) ",
"NDC11Code": "71610-0468-09",
"ProductNDC": "71610-468",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitriol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20130524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091174",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": ".25",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200921",
"SamplePackage": "N",
"IndicationAndUsage": "Calcitriol capsules are indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism.",
"Description": "Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol Capsules contain 0.25 mcg or 0.5 mcg calcitriol, fractionated triglyceride of coconut oil, butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. Gelatin capsule shells contain glycerin, water, sorbitol, sorbitan, mannitol, water, FD&C Yellow No. 6, FD&C Red #40, titanium dioxide and iron oxide black. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9,10- seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D 3, 1,25-DHCC, 1,25(OH) 2D 3 and 1,25-diOHC."
},
{
"NDCCode": "77101-9000-0",
"PackageDescription": "3785 mL in 1 JUG (77101-9000-0) ",
"NDC11Code": "77101-9000-00",
"ProductNDC": "77101-9000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prolab Scented Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200724",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Prolab Health & Beauty Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "65",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200724",
"SamplePackage": "N"
},
{
"NDCCode": "77101-9000-6",
"PackageDescription": "60 mL in 1 TUBE (77101-9000-6) ",
"NDC11Code": "77101-9000-06",
"ProductNDC": "77101-9000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prolab Scented Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200724",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Prolab Health & Beauty Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "65",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200724",
"SamplePackage": "N"
},
{
"NDCCode": "82454-0015-2",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (82454-0015-2) ",
"NDC11Code": "82454-0015-02",
"ProductNDC": "82454-0015",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Oralair",
"ProprietaryNameSuffix": "300 Ir",
"NonProprietaryName": "Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20140430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125471",
"LabelerName": "CENEXI HSC",
"SubstanceName": "DACTYLIS GLOMERATA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN",
"StrengthNumber": "300; 300; 300; 300; 300",
"StrengthUnit": "[IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140430",
"SamplePackage": "N",
"IndicationAndUsage": "ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.",
"Description": "ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU."
},
{
"NDCCode": "82454-0015-3",
"PackageDescription": "1 BLISTER PACK in 1 BOX (82454-0015-3) > 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "82454-0015-03",
"ProductNDC": "82454-0015",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Oralair",
"ProprietaryNameSuffix": "300 Ir",
"NonProprietaryName": "Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20140430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125471",
"LabelerName": "CENEXI HSC",
"SubstanceName": "DACTYLIS GLOMERATA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN",
"StrengthNumber": "300; 300; 300; 300; 300",
"StrengthUnit": "[IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140430",
"SamplePackage": "N",
"IndicationAndUsage": "ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.",
"Description": "ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU."
},
{
"NDCCode": "82454-0020-1",
"PackageDescription": "1 KIT in 1 CARTON (82454-0020-1) * 1 TABLET, ORALLY DISINTEGRATING in 1 BOX * 2 TABLET, ORALLY DISINTEGRATING in 1 BOX",
"NDC11Code": "82454-0020-01",
"ProductNDC": "82454-0020",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Oralair",
"NonProprietaryName": "Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phelum Pratense Pollen, And Poa Pratensis Pollen",
"DosageFormName": "KIT",
"StartMarketingDate": "20140430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125471",
"LabelerName": "CENEXI HSC",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140430",
"SamplePackage": "N",
"IndicationAndUsage": "ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.",
"Description": "ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU."
},
{
"NDCCode": "82454-0025-1",
"PackageDescription": "1 KIT in 1 CARTON (82454-0025-1) * 1 TABLET, ORALLY DISINTEGRATING in 1 BOX * 2 TABLET, ORALLY DISINTEGRATING in 1 BOX",
"NDC11Code": "82454-0025-01",
"ProductNDC": "82454-0025",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Oralair",
"NonProprietaryName": "Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phelum Pratense Pollen, And Poa Pratensis Pollen",
"DosageFormName": "KIT",
"StartMarketingDate": "20140430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125471",
"LabelerName": "CENEXI HSC",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140430",
"SamplePackage": "N",
"IndicationAndUsage": "ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.",
"Description": "ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU."
},
{
"NDCCode": "14789-220-10",
"PackageDescription": "10 BAG in 1 CARTON (14789-220-10) / 100 mL in 1 BAG (14789-220-08) ",
"NDC11Code": "14789-0220-10",
"ProductNDC": "14789-220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam In Sodium Chloride",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213532",
"LabelerName": "Nexus Pharmaceuticals LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200720",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible: : 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures (1.3) .",
"Description": "Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an aluminum over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1000 mg/100 mL: One 100 mL bag contains 1000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1500 mg/100 mL: One 100 mL bag contains 1500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate."
},
{
"NDCCode": "63730-220-01",
"PackageDescription": "75 mL in 1 TUBE (63730-220-01)",
"NDC11Code": "63730-0220-01",
"ProductNDC": "63730-220",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Luminous Shield",
"ProprietaryNameSuffix": "Spf 50",
"NonProprietaryName": "Ensulizole, Octinoxate, Octocreylene, Oxybensone, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100419",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Natura Bisse International, S.A.",
"SubstanceName": "ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE",
"StrengthNumber": "1.65; 4.9; 7.85; 2.47; 10.14",
"StrengthUnit": "g/75mL; mL/75mL; mL/75mL; g/75mL; g/75mL",
"Status": "Deprecated",
"LastUpdate": "2016-01-29"
},
{
"NDCCode": "63730-220-02",
"PackageDescription": "2 mL in 1 TUBE (63730-220-02)",
"NDC11Code": "63730-0220-02",
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"IndicationAndUsage": "Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.",
"Description": "Ampicillin for Injection, USP the monosodium salt of [2S-[2α, 5α, 6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
}
]
}
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<SubstanceName>ARNICA MONTANA</SubstanceName>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SubstanceName>ARNICA MONTANA</SubstanceName>
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<StrengthUnit>[hp_X]/g</StrengthUnit>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Uses*. temporarily relieves muscle pain and stiffness due to: 1 minor injuries, 2 overexertion, 3 falls.</IndicationAndUsage>
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<NDC>
<NDCCode>0220-9000-94</NDCCode>
<PackageDescription>5 g in 1 POUCH (0220-9000-94) </PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<StrengthUnit>[hp_X]/g</StrengthUnit>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses*. temporarily relieves muscle pain and stiffness due to: 1 minor injuries, 2 overexertion, 3 falls.</IndicationAndUsage>
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<PackageDescription>9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-034-09) </PackageDescription>
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<ProductNDC>43353-034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitriol</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076917</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcitriol Capsules are indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥100 pg/mL is strongly suggestive of secondary hyperparathyroidism.</IndicationAndUsage>
<Description>Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Cacitriol is available as capsules containing 0.25 mcg. Calcitriol Capsules contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain a fractionated triglyceride of coconut oil. Gelatin capsule shells contain gelatin, glycerin (anhydrous), and titanium dioxide, with the following dyes: FD&C Yellow No. 5 and FD&C Yellow No. 6. In addition to the ingredients listed above, each tablet contains Opacode (Black) monogramming ink, Opacode (Black) contains ammonium hydroxide, iron oxide black, isopropyl alcohol, macrogol, polyvinyl acetate phthalate, propylene glycol, purified water, and SDA 35A alcohol. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula:. The other names frequently used for calcitriol are 1α, 25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3,1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC.</Description>
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<PackageDescription>9000 CAPSULE in 1 BOTTLE (43353-138-09)</PackageDescription>
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<ProductNDC>43353-138</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitriol</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018044</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Predialysis Patients. Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients. Calcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients. Calcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.</IndicationAndUsage>
<Description>Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol and as an oral solution containing 1 mcg/mL of calcitriol. All dosage forms contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain a fractionated triglyceride of coconut oil, and the oral solution contains a fractionated triglyceride of palm seed oil. Gelatin capsule shells contain glycerin, and sorbitol, with the following dye systems: 0.25 mcg — FD&C Yellow No. 6 and titanium dioxide; 0.5 mcg — FD&C Red No. 3, FD&C Yellow No. 6 and titanium dioxide. The oral solution contains no additional adjuvants or coloring principles. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9,10- seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula:. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC.</Description>
</NDC>
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<NDCCode>43353-998-09</NDCCode>
<PackageDescription>9000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-998-09)</PackageDescription>
<NDC11Code>43353-0998-09</NDC11Code>
<ProductNDC>43353-998</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitriol</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20130529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091174</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Calcitriol capsules are indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism.</IndicationAndUsage>
<Description>Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol Capsules contain 0.25 mcg or 0.5 mcg calcitriol, fractionated triglyceride of coconut oil, butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. Gelatin capsule shells contain glycerin, water, sorbitol, sorbitan, mannitol, water, FD&C Yellow No. 6, FD&C Red #40, titanium dioxide and iron oxide black. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9,10- seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC.</Description>
</NDC>
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<NDCCode>59617-0010-1</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (59617-0010-1) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59617-0010-01</NDC11Code>
<ProductNDC>59617-0010</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Oralair</ProprietaryName>
<ProprietaryNameSuffix>100 Ir</ProprietaryNameSuffix>
<NonProprietaryName>Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen</NonProprietaryName>
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<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20140430</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125471</ApplicationNumber>
<LabelerName>Stallergenes</LabelerName>
<SubstanceName>POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN</SubstanceName>
<StrengthNumber>100; 100; 100; 100; 100</StrengthNumber>
<StrengthUnit>[IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1</StrengthUnit>
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<IndicationAndUsage>ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.</IndicationAndUsage>
<Description>ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU.</Description>
</NDC>
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<ProprietaryNameSuffix>300 Ir</ProprietaryNameSuffix>
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<StrengthUnit>[IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1</StrengthUnit>
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<IndicationAndUsage>ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.</IndicationAndUsage>
<Description>ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU.</Description>
</NDC>
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<IndicationAndUsage>ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.</IndicationAndUsage>
<Description>ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU.</Description>
</NDC>
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<StrengthUnit>[IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1</StrengthUnit>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.</IndicationAndUsage>
<Description>ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU.</Description>
</NDC>
<NDC>
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<IndicationAndUsage>ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.</IndicationAndUsage>
<Description>ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU.</Description>
</NDC>
<NDC>
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<IndicationAndUsage>ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.</IndicationAndUsage>
<Description>ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU.</Description>
</NDC>
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<IndicationAndUsage>Calcitriol capsules are indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism.</IndicationAndUsage>
<Description>Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol Capsules contain 0.25 mcg or 0.5 mcg calcitriol, fractionated triglyceride of coconut oil, butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. Gelatin capsule shells contain glycerin, water, sorbitol, sorbitan, mannitol, water, FD&C Yellow No. 6, FD&C Red #40, titanium dioxide and iron oxide black. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9,10- seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D 3, 1,25-DHCC, 1,25(OH) 2D 3 and 1,25-diOHC.</Description>
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<SamplePackage>N</SamplePackage>
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<NonProprietaryName>Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen</NonProprietaryName>
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<MarketingCategoryName>BLA</MarketingCategoryName>
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<LabelerName>CENEXI HSC</LabelerName>
<SubstanceName>DACTYLIS GLOMERATA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN</SubstanceName>
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<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.</IndicationAndUsage>
<Description>ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU.</Description>
</NDC>
<NDC>
<NDCCode>82454-0015-3</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (82454-0015-3) > 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>82454-0015-03</NDC11Code>
<ProductNDC>82454-0015</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Oralair</ProprietaryName>
<ProprietaryNameSuffix>300 Ir</ProprietaryNameSuffix>
<NonProprietaryName>Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20140430</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125471</ApplicationNumber>
<LabelerName>CENEXI HSC</LabelerName>
<SubstanceName>DACTYLIS GLOMERATA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN</SubstanceName>
<StrengthNumber>300; 300; 300; 300; 300</StrengthNumber>
<StrengthUnit>[IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.</IndicationAndUsage>
<Description>ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU.</Description>
</NDC>
<NDC>
<NDCCode>82454-0020-1</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (82454-0020-1) * 1 TABLET, ORALLY DISINTEGRATING in 1 BOX * 2 TABLET, ORALLY DISINTEGRATING in 1 BOX</PackageDescription>
<NDC11Code>82454-0020-01</NDC11Code>
<ProductNDC>82454-0020</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Oralair</ProprietaryName>
<NonProprietaryName>Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phelum Pratense Pollen, And Poa Pratensis Pollen</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20140430</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125471</ApplicationNumber>
<LabelerName>CENEXI HSC</LabelerName>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.</IndicationAndUsage>
<Description>ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU.</Description>
</NDC>
<NDC>
<NDCCode>82454-0025-1</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (82454-0025-1) * 1 TABLET, ORALLY DISINTEGRATING in 1 BOX * 2 TABLET, ORALLY DISINTEGRATING in 1 BOX</PackageDescription>
<NDC11Code>82454-0025-01</NDC11Code>
<ProductNDC>82454-0025</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Oralair</ProprietaryName>
<NonProprietaryName>Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phelum Pratense Pollen, And Poa Pratensis Pollen</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20140430</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125471</ApplicationNumber>
<LabelerName>CENEXI HSC</LabelerName>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. ORALAIR is not indicated for the immediate relief of allergy symptoms.</IndicationAndUsage>
<Description>ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L). ORALAIR is available as a sublingual tablet in the following strengths: 1 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units), 2 300 IR (equivalent to approximately 9000 BAU.</Description>
</NDC>
<NDC>
<NDCCode>14789-220-10</NDCCode>
<PackageDescription>10 BAG in 1 CARTON (14789-220-10) / 100 mL in 1 BAG (14789-220-08) </PackageDescription>
<NDC11Code>14789-0220-10</NDC11Code>
<ProductNDC>14789-220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam In Sodium Chloride</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200720</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213532</ApplicationNumber>
<LabelerName>Nexus Pharmaceuticals LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible: : 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures (1.3) .</IndicationAndUsage>
<Description>Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an aluminum over wrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1000 mg/100 mL: One 100 mL bag contains 1000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1500 mg/100 mL: One 100 mL bag contains 1500 mg of levetiracetam (15 mg/mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate.</Description>
</NDC>
<NDC>
<NDCCode>63730-220-01</NDCCode>
<PackageDescription>75 mL in 1 TUBE (63730-220-01)</PackageDescription>
<NDC11Code>63730-0220-01</NDC11Code>
<ProductNDC>63730-220</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Luminous Shield</ProprietaryName>
<ProprietaryNameSuffix>Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Ensulizole, Octinoxate, Octocreylene, Oxybensone, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100419</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Natura Bisse International, S.A.</LabelerName>
<SubstanceName>ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>1.65; 4.9; 7.85; 2.47; 10.14</StrengthNumber>
<StrengthUnit>g/75mL; mL/75mL; mL/75mL; g/75mL; g/75mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-01-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>63730-220-02</NDCCode>
<PackageDescription>2 mL in 1 TUBE (63730-220-02)</PackageDescription>
<NDC11Code>63730-0220-02</NDC11Code>
<ProductNDC>63730-220</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Luminous Shield</ProprietaryName>
<ProprietaryNameSuffix>Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Ensulizole, Octinoxate, Octocreylene, Oxybensone, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100419</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Natura Bisse International, S.A.</LabelerName>
<SubstanceName>ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>1.65; 4.9; 7.85; 2.47; 10.14</StrengthNumber>
<StrengthUnit>g/75mL; mL/75mL; mL/75mL; g/75mL; g/75mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-01-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>63730-220-03</NDCCode>
<PackageDescription>10 mL in 1 TUBE (63730-220-03)</PackageDescription>
<NDC11Code>63730-0220-03</NDC11Code>
<ProductNDC>63730-220</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Luminous Shield</ProprietaryName>
<ProprietaryNameSuffix>Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Ensulizole, Octinoxate, Octocreylene, Oxybensone, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100419</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Natura Bisse International, S.A.</LabelerName>
<SubstanceName>ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>1.65; 4.9; 7.85; 2.47; 10.14</StrengthNumber>
<StrengthUnit>g/75mL; mL/75mL; mL/75mL; g/75mL; g/75mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-01-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>66794-220-41</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (66794-220-41) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-220-02) </PackageDescription>
<NDC11Code>66794-0220-41</NDC11Code>
<ProductNDC>66794-220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20200309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090583</ApplicationNumber>
<LabelerName>Piramal Critical Care Inc</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Ampicillin for Injection, USP the monosodium salt of [2S-[2α, 5α, 6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10.</Description>
</NDC>
</NDCList>