{
"NDC": [
{
"NDCCode": "0615-8185-50",
"PackageDescription": "5 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-50) ",
"NDC11Code": "00615-8185-50",
"ProductNDC": "0615-8185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
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"MarketingCategoryName": "ANDA",
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"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate USP is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
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"PackageDescription": "5 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-00) ",
"NDC11Code": "00615-8185-00",
"ProductNDC": "0615-8185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
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"DosageFormName": "TABLET, FILM COATED",
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"ApplicationNumber": "ANDA076183",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate USP is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "0615-8185-05",
"PackageDescription": "15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-05) ",
"NDC11Code": "00615-8185-05",
"ProductNDC": "0615-8185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076183",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20200324",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate USP is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "0615-8185-10",
"PackageDescription": "10 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-10) ",
"NDC11Code": "00615-8185-10",
"ProductNDC": "0615-8185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076183",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-26",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate USP is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "0615-8185-12",
"PackageDescription": "12 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-12) ",
"NDC11Code": "00615-8185-12",
"ProductNDC": "0615-8185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076183",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-26",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate USP is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "0615-8185-39",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-39) ",
"NDC11Code": "00615-8185-39",
"ProductNDC": "0615-8185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076183",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-26",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate USP is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "0268-0615-50",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0615-50) ",
"NDC11Code": "00268-0615-50",
"ProductNDC": "0268-0615",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Canis Lupus Familiaris Skin",
"NonProprietaryName": "Dog Epithelia",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "CANIS LUPUS FAMILIARIS SKIN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-06",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19650101",
"SamplePackage": "N",
"IndicationAndUsage": "Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.",
"Description": "Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety."
},
{
"NDCCode": "15631-0615-2",
"PackageDescription": "50 TABLET in 1 CONTAINER (15631-0615-2)",
"NDC11Code": "15631-0615-02",
"ProductNDC": "15631-0615",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kreosotum",
"NonProprietaryName": "Kreosotum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151218",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "WOOD CREOSOTE",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "16252-615-50",
"PackageDescription": "1 BOTTLE in 1 CARTON (16252-615-50) > 500 TABLET in 1 BOTTLE",
"NDC11Code": "16252-0615-50",
"ProductNDC": "16252-615",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160502",
"EndMarketingDate": "20181130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079167",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160816",
"EndMarketingDatePackage": "20181130",
"SamplePackage": "N"
},
{
"NDCCode": "25021-615-50",
"PackageDescription": "10 BOTTLE in 1 CARTON (25021-615-50) / 50 mL in 1 BOTTLE",
"NDC11Code": "25021-0615-50",
"ProductNDC": "25021-615",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride",
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217308",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240215",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a alpha2-adrenergic receptor agonist indicated for: : 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection by continuous infusion not to exceed 24 hours. (1.1) , 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2) .",
"Description": "Dexmedetomidine hydrochloride in 0.9% sodium chloride injection (4 mcg per mL) is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine. Dexmedetomidine hydrochloride chemical name is 1H-Imidazole, 4-[1-(2,3-dimethylphenyl)ethyl]-, monohydrochloride, (S). Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 HCl and the structural formula is:. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg of sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers."
},
{
"NDCCode": "49260-615-50",
"PackageDescription": "50 TABLET in 1 BOTTLE (49260-615-50)",
"NDC11Code": "49260-0615-50",
"ProductNDC": "49260-615",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Help I Have An Aching Body",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075139",
"LabelerName": "Help Remedies, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49288-0615-5",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0615-5)",
"NDC11Code": "49288-0615-05",
"ProductNDC": "49288-0615",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Washington/oregon Inland Weed Mixture",
"NonProprietaryName": "Washington/oregon Inland Weed Mixture",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19960711",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "IVA XANTHIFOLIA POLLEN; ARTEMISIA VULGARIS POLLEN; ARTEMISIA TRIDENTATA POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA TRIFIDA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ATRIPLEX CANESCENS POLLEN",
"StrengthNumber": ".0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "51769-615-50",
"PackageDescription": "50 g in 1 JAR (51769-615-50)",
"NDC11Code": "51769-0615-50",
"ProductNDC": "51769-615",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ponds",
"ProprietaryNameSuffix": "Clarant B3",
"NonProprietaryName": "Anti-dark Moisturizing Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120629",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ALL NATURAL DYNAMICS",
"SubstanceName": "AVOBENZONE",
"StrengthNumber": "3",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "69772-615-50",
"PackageDescription": "50 g in 1 JAR (69772-615-50)",
"NDC11Code": "69772-0615-50",
"ProductNDC": "69772-615",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ponds Clarant B3",
"NonProprietaryName": "Avobenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150526",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Teresa Cecena DBA Genesis",
"SubstanceName": "AVOBENZONE",
"StrengthNumber": "100",
"StrengthUnit": "g/3g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "84448-615-50",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (84448-615-50) / 50 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "84448-0615-50",
"ProductNDC": "84448-615",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Perricone Md Hypoallergenic Cbd Sensitive Skin Therapy Ultra-lightweight Calming Spf 35 Veil",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210427",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "THG Beauty USA LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "15.45",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210427",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "0185-0615-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0185-0615-01) ",
"NDC11Code": "00185-0615-01",
"ProductNDC": "0185-0615",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Pamoate",
"NonProprietaryName": "Hydroxyzine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19811214",
"EndMarketingDate": "20260531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086183",
"LabelerName": "Sandoz Inc",
"SubstanceName": "HYDROXYZINE PAMOATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19811214",
"EndMarketingDatePackage": "20260531",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine pamoate is a light yellow, practically odorless powder practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4’-methylenebis[3-hydroxy-2-naphthoate] (1:1) [10246-75-0] and can be structurally represented as follows. C21H27CIN2O2C23H16O6. M.W. 763.27. Each capsule, for oral administration, contains hydroxyzine pamoate equivalent to hydroxyzine hydrochloride 25 mg or 50 mg. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate (potato), and sodium lauryl sulfate. The capsule shell contains the following ingredients: D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, gelatin, and titanium dioxide. The edible imprinting ink contains the following ingredients: black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, propylene glycol, and shellac glaze."
},
{
"NDCCode": "0185-0615-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (0185-0615-05) ",
"NDC11Code": "00185-0615-05",
"ProductNDC": "0185-0615",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Pamoate",
"NonProprietaryName": "Hydroxyzine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19811214",
"EndMarketingDate": "20260531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086183",
"LabelerName": "Sandoz Inc",
"SubstanceName": "HYDROXYZINE PAMOATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19811214",
"EndMarketingDatePackage": "20260531",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine pamoate is a light yellow, practically odorless powder practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4’-methylenebis[3-hydroxy-2-naphthoate] (1:1) [10246-75-0] and can be structurally represented as follows. C21H27CIN2O2C23H16O6. M.W. 763.27. Each capsule, for oral administration, contains hydroxyzine pamoate equivalent to hydroxyzine hydrochloride 25 mg or 50 mg. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate (potato), and sodium lauryl sulfate. The capsule shell contains the following ingredients: D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, gelatin, and titanium dioxide. The edible imprinting ink contains the following ingredients: black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, propylene glycol, and shellac glaze."
},
{
"NDCCode": "0185-0615-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (0185-0615-10) ",
"NDC11Code": "00185-0615-10",
"ProductNDC": "0185-0615",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Pamoate",
"NonProprietaryName": "Hydroxyzine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19811214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086183",
"LabelerName": "Eon Labs, Inc.",
"SubstanceName": "HYDROXYZINE PAMOATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19811214",
"SamplePackage": "N"
},
{
"NDCCode": "0615-0332-39",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (0615-0332-39)",
"NDC11Code": "00615-0332-39",
"ProductNDC": "0615-0332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Pamoate",
"NonProprietaryName": "Hydroxyzine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19811214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086183",
"LabelerName": "NCS HealthCare of KY, Inc dba Vangard Labs",
"SubstanceName": "HYDROXYZINE PAMOATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0615-0532-39",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (0615-0532-39)",
"NDC11Code": "00615-0532-39",
"ProductNDC": "0615-0532",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19800227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086962",
"LabelerName": "NCS HealthCare of KY, Inc dba Vangard Labs",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0615-0536-05",
"PackageDescription": "15 TABLET in 1 BLISTER PACK (0615-0536-05) ",
"NDC11Code": "00615-0536-05",
"ProductNDC": "0615-0536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19720421",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080352",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181024",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets and solutions are indicated in the following conditions.",
"Description": "Prednisone Tablets USP are available for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and stearic acid (1 mg, 2.5 mg, and 5 mg only). Prednisone Oral Solution USP is formulated for oral administration containing 5 mg per 5 mL of prednisone USP and alcohol 5%. The oral solution contains the following inactive ingredients: anhydrous citric acid, edetate disodium, fructose, hydrochloric acid, maltol, peppermint oil, polysorbate 80, propylene glycol, saccharin sodium, sodium benzoate, vanilla flavor and purified water. Prednisone Intensol Oral Solution (Concentrate) is formulated for oral administration containing 5 mg per mL of prednisone USP and alcohol 30%. In addition, the oral solution contains the following inactive ingredients: anhydrous citric acid, poloxamer 188, propylene glycol and purified water. Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below: 1 , 2 C21H26O5 M.W. 358.44."
},
{
"NDCCode": "0615-0536-30",
"PackageDescription": "6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-0536-30) > 5 TABLET in 1 BLISTER PACK",
"NDC11Code": "00615-0536-30",
"ProductNDC": "0615-0536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19720421",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080352",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141104",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets and solutions are indicated in the following conditions.",
"Description": "Prednisone Tablets USP are available for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and stearic acid (1 mg, 2.5 mg, and 5 mg only). Prednisone Oral Solution USP is formulated for oral administration containing 5 mg per 5 mL of prednisone USP and alcohol 5%. The oral solution contains the following inactive ingredients: anhydrous citric acid, edetate disodium, fructose, hydrochloric acid, maltol, peppermint oil, polysorbate 80, propylene glycol, saccharin sodium, sodium benzoate, vanilla flavor and purified water. Prednisone Intensol Oral Solution (Concentrate) is formulated for oral administration containing 5 mg per mL of prednisone USP and alcohol 30%. In addition, the oral solution contains the following inactive ingredients: anhydrous citric acid, poloxamer 188, propylene glycol and purified water. Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below: 1 , 2 C21H26O5 M.W. 358.44."
},
{
"NDCCode": "0615-0536-39",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (0615-0536-39) ",
"NDC11Code": "00615-0536-39",
"ProductNDC": "0615-0536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19720421",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080352",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130109",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets and solutions are indicated in the following conditions.",
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<NDC>
<NDCCode>0615-8185-39</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-39) </PackageDescription>
<NDC11Code>00615-8185-39</NDC11Code>
<ProductNDC>0615-8185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076183</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 ., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy., 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate USP is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0268-0615-50</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (0268-0615-50) </PackageDescription>
<NDC11Code>00268-0615-50</NDC11Code>
<ProductNDC>0268-0615</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Canis Lupus Familiaris Skin</ProprietaryName>
<NonProprietaryName>Dog Epithelia</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19650101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>CANIS LUPUS FAMILIARIS SKIN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19650101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.</IndicationAndUsage>
<Description>Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety.</Description>
</NDC>
<NDC>
<NDCCode>15631-0615-2</NDCCode>
<PackageDescription>50 TABLET in 1 CONTAINER (15631-0615-2)</PackageDescription>
<NDC11Code>15631-0615-02</NDC11Code>
<ProductNDC>15631-0615</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kreosotum</ProprietaryName>
<NonProprietaryName>Kreosotum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151218</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>WOOD CREOSOTE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16252-615-50</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (16252-615-50) > 500 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>16252-0615-50</NDC11Code>
<ProductNDC>16252-615</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160502</StartMarketingDate>
<EndMarketingDate>20181130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079167</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160816</StartMarketingDatePackage>
<EndMarketingDatePackage>20181130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>25021-615-50</NDCCode>
<PackageDescription>10 BOTTLE in 1 CARTON (25021-615-50) / 50 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>25021-0615-50</NDC11Code>
<ProductNDC>25021-615</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride</ProprietaryName>
<NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217308</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a alpha2-adrenergic receptor agonist indicated for: : 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection by continuous infusion not to exceed 24 hours. (1.1) , 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2) .</IndicationAndUsage>
<Description>Dexmedetomidine hydrochloride in 0.9% sodium chloride injection (4 mcg per mL) is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine. Dexmedetomidine hydrochloride chemical name is 1H-Imidazole, 4-[1-(2,3-dimethylphenyl)ethyl]-, monohydrochloride, (S). Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 HCl and the structural formula is:. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg of sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers.</Description>
</NDC>
<NDC>
<NDCCode>49260-615-50</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE (49260-615-50)</PackageDescription>
<NDC11Code>49260-0615-50</NDC11Code>
<ProductNDC>49260-615</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Help I Have An Aching Body</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075139</ApplicationNumber>
<LabelerName>Help Remedies, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49288-0615-5</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0615-5)</PackageDescription>
<NDC11Code>49288-0615-05</NDC11Code>
<ProductNDC>49288-0615</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Washington/oregon Inland Weed Mixture</ProprietaryName>
<NonProprietaryName>Washington/oregon Inland Weed Mixture</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19960711</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>IVA XANTHIFOLIA POLLEN; ARTEMISIA VULGARIS POLLEN; ARTEMISIA TRIDENTATA POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA TRIFIDA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ATRIPLEX CANESCENS POLLEN</SubstanceName>
<StrengthNumber>.0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>51769-615-50</NDCCode>
<PackageDescription>50 g in 1 JAR (51769-615-50)</PackageDescription>
<NDC11Code>51769-0615-50</NDC11Code>
<ProductNDC>51769-615</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ponds</ProprietaryName>
<ProprietaryNameSuffix>Clarant B3</ProprietaryNameSuffix>
<NonProprietaryName>Anti-dark Moisturizing Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120629</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ALL NATURAL DYNAMICS</LabelerName>
<SubstanceName>AVOBENZONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69772-615-50</NDCCode>
<PackageDescription>50 g in 1 JAR (69772-615-50)</PackageDescription>
<NDC11Code>69772-0615-50</NDC11Code>
<ProductNDC>69772-615</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ponds Clarant B3</ProprietaryName>
<NonProprietaryName>Avobenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150526</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Teresa Cecena DBA Genesis</LabelerName>
<SubstanceName>AVOBENZONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>g/3g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>84448-615-50</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (84448-615-50) / 50 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>84448-0615-50</NDC11Code>
<ProductNDC>84448-615</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Perricone Md Hypoallergenic Cbd Sensitive Skin Therapy Ultra-lightweight Calming Spf 35 Veil</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210427</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>THG Beauty USA LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>15.45</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0185-0615-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0185-0615-01) </PackageDescription>
<NDC11Code>00185-0615-01</NDC11Code>
<ProductNDC>0185-0615</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Pamoate</ProprietaryName>
<NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811214</StartMarketingDate>
<EndMarketingDate>20260531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086183</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>HYDROXYZINE PAMOATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19811214</StartMarketingDatePackage>
<EndMarketingDatePackage>20260531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine pamoate is a light yellow, practically odorless powder practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4’-methylenebis[3-hydroxy-2-naphthoate] (1:1) [10246-75-0] and can be structurally represented as follows. C21H27CIN2O2C23H16O6. M.W. 763.27. Each capsule, for oral administration, contains hydroxyzine pamoate equivalent to hydroxyzine hydrochloride 25 mg or 50 mg. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate (potato), and sodium lauryl sulfate. The capsule shell contains the following ingredients: D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, gelatin, and titanium dioxide. The edible imprinting ink contains the following ingredients: black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, propylene glycol, and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>0185-0615-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (0185-0615-05) </PackageDescription>
<NDC11Code>00185-0615-05</NDC11Code>
<ProductNDC>0185-0615</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Pamoate</ProprietaryName>
<NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811214</StartMarketingDate>
<EndMarketingDate>20260531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086183</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>HYDROXYZINE PAMOATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19811214</StartMarketingDatePackage>
<EndMarketingDatePackage>20260531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine pamoate is a light yellow, practically odorless powder practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4’-methylenebis[3-hydroxy-2-naphthoate] (1:1) [10246-75-0] and can be structurally represented as follows. C21H27CIN2O2C23H16O6. M.W. 763.27. Each capsule, for oral administration, contains hydroxyzine pamoate equivalent to hydroxyzine hydrochloride 25 mg or 50 mg. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate (potato), and sodium lauryl sulfate. The capsule shell contains the following ingredients: D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, gelatin, and titanium dioxide. The edible imprinting ink contains the following ingredients: black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, propylene glycol, and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>0185-0615-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (0185-0615-10) </PackageDescription>
<NDC11Code>00185-0615-10</NDC11Code>
<ProductNDC>0185-0615</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Pamoate</ProprietaryName>
<NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086183</ApplicationNumber>
<LabelerName>Eon Labs, Inc.</LabelerName>
<SubstanceName>HYDROXYZINE PAMOATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19811214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0615-0332-39</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (0615-0332-39)</PackageDescription>
<NDC11Code>00615-0332-39</NDC11Code>
<ProductNDC>0615-0332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Pamoate</ProprietaryName>
<NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086183</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, Inc dba Vangard Labs</LabelerName>
<SubstanceName>HYDROXYZINE PAMOATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0615-0532-39</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (0615-0532-39)</PackageDescription>
<NDC11Code>00615-0532-39</NDC11Code>
<ProductNDC>0615-0532</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19800227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086962</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, Inc dba Vangard Labs</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0615-0536-05</NDCCode>
<PackageDescription>15 TABLET in 1 BLISTER PACK (0615-0536-05) </PackageDescription>
<NDC11Code>00615-0536-05</NDC11Code>
<ProductNDC>0615-0536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19720421</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080352</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181024</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone tablets and solutions are indicated in the following conditions.</IndicationAndUsage>
<Description>Prednisone Tablets USP are available for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and stearic acid (1 mg, 2.5 mg, and 5 mg only). Prednisone Oral Solution USP is formulated for oral administration containing 5 mg per 5 mL of prednisone USP and alcohol 5%. The oral solution contains the following inactive ingredients: anhydrous citric acid, edetate disodium, fructose, hydrochloric acid, maltol, peppermint oil, polysorbate 80, propylene glycol, saccharin sodium, sodium benzoate, vanilla flavor and purified water. Prednisone Intensol Oral Solution (Concentrate) is formulated for oral administration containing 5 mg per mL of prednisone USP and alcohol 30%. In addition, the oral solution contains the following inactive ingredients: anhydrous citric acid, poloxamer 188, propylene glycol and purified water. Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below: 1 , 2 C21H26O5 M.W. 358.44.</Description>
</NDC>
<NDC>
<NDCCode>0615-0536-30</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-0536-30) > 5 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00615-0536-30</NDC11Code>
<ProductNDC>0615-0536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19720421</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080352</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141104</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone tablets and solutions are indicated in the following conditions.</IndicationAndUsage>
<Description>Prednisone Tablets USP are available for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and stearic acid (1 mg, 2.5 mg, and 5 mg only). Prednisone Oral Solution USP is formulated for oral administration containing 5 mg per 5 mL of prednisone USP and alcohol 5%. The oral solution contains the following inactive ingredients: anhydrous citric acid, edetate disodium, fructose, hydrochloric acid, maltol, peppermint oil, polysorbate 80, propylene glycol, saccharin sodium, sodium benzoate, vanilla flavor and purified water. Prednisone Intensol Oral Solution (Concentrate) is formulated for oral administration containing 5 mg per mL of prednisone USP and alcohol 30%. In addition, the oral solution contains the following inactive ingredients: anhydrous citric acid, poloxamer 188, propylene glycol and purified water. Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below: 1 , 2 C21H26O5 M.W. 358.44.</Description>
</NDC>
<NDC>
<NDCCode>0615-0536-39</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (0615-0536-39) </PackageDescription>
<NDC11Code>00615-0536-39</NDC11Code>
<ProductNDC>0615-0536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19720421</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080352</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130109</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone tablets and solutions are indicated in the following conditions.</IndicationAndUsage>
<Description>Prednisone Tablets USP are available for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and stearic acid (1 mg, 2.5 mg, and 5 mg only). Prednisone Oral Solution USP is formulated for oral administration containing 5 mg per 5 mL of prednisone USP and alcohol 5%. The oral solution contains the following inactive ingredients: anhydrous citric acid, edetate disodium, fructose, hydrochloric acid, maltol, peppermint oil, polysorbate 80, propylene glycol, saccharin sodium, sodium benzoate, vanilla flavor and purified water. Prednisone Intensol Oral Solution (Concentrate) is formulated for oral administration containing 5 mg per mL of prednisone USP and alcohol 30%. In addition, the oral solution contains the following inactive ingredients: anhydrous citric acid, poloxamer 188, propylene glycol and purified water. Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below: 1 , 2 C21H26O5 M.W. 358.44.</Description>
</NDC>
<NDC>
<NDCCode>0615-0830-39</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (0615-0830-39)</PackageDescription>
<NDC11Code>00615-0830-39</NDC11Code>
<ProductNDC>0615-0830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19771129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085968</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, Inc dba Vangard Labs</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0615-1308-39</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (0615-1308-39) </PackageDescription>
<NDC11Code>00615-1308-39</NDC11Code>
<ProductNDC>0615-1308</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin</ProprietaryName>
<NonProprietaryName>Nitrofurantoin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074967</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, Inc dba Vangard Labs</LabelerName>
<SubstanceName>NITROFURANTOIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrofurans [CS],Nitrofuran Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0615-1527-39</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (0615-1527-39)</PackageDescription>
<NDC11Code>00615-1527-39</NDC11Code>
<ProductNDC>0615-1527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040786</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, Inc dba Vangard Labs</LabelerName>
<SubstanceName>HYDROXYZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0615-1547-39</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (0615-1547-39)</PackageDescription>
<NDC11Code>00615-1547-39</NDC11Code>
<ProductNDC>0615-1547</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorpromazine</ProprietaryName>
<NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19730103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080439</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, Inc dba Vangard Labs</LabelerName>
<SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazines [CS],Phenothiazine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0615-1562-39</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (0615-1562-39)</PackageDescription>
<NDC11Code>00615-1562-39</NDC11Code>
<ProductNDC>0615-1562</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040412</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, Inc dba Vangard Labs</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0615-1573-39</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (0615-1573-39)</PackageDescription>
<NDC11Code>00615-1573-39</NDC11Code>
<ProductNDC>0615-1573</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dipyridamole</ProprietaryName>
<NonProprietaryName>Dipyridamole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087716</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, Inc dba Vangard Labs</LabelerName>
<SubstanceName>DIPYRIDAMOLE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0615-2578-05</NDCCode>
<PackageDescription>15 TABLET in 1 BLISTER PACK (0615-2578-05) </PackageDescription>
<NDC11Code>00615-2578-05</NDC11Code>
<ProductNDC>0615-2578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110120</StartMarketingDate>
<EndMarketingDate>20220630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071523</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110120</StartMarketingDatePackage>
<EndMarketingDatePackage>20220630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>