{
"NDC": [
{
"NDCCode": "45567-0455-2",
"PackageDescription": "30 VIAL, MULTI-DOSE in 1 KIT (45567-0455-2) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "45567-0455-02",
"ProductNDC": "45567-0455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kit For The Preparation Of Technetium Tc 99m Mebrofenin",
"NonProprietaryName": "Kit For The Preparation Of Technetium Tc 99m Mebrofenin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078242",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "MEBROFENIN",
"StrengthNumber": "45",
"StrengthUnit": "mg/10mL",
"Status": "Active",
"LastUpdate": "2024-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080129",
"SamplePackage": "N",
"IndicationAndUsage": "Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.",
"Description": "Each multidose reaction vial contains a nonradioactive, sterile, nonpyrogenic mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF 22H 2O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF 22H 2O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH is adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7. The structure of mebrofenin (2,2'-[[2-[(3-Bromo-2,4,6-trimethylphenyl)-amino]-2-oxoethyl]imino] bisacetic acid) is shown below. Molecular Weight = 387.23. When sterile, pyrogen-free sodium pertechnetate Tc 99m injection is added to the vial, the diagnostic agent Technetium Tc 99m Mebrofenin is formed for administration by intravenous injection. PHYSICAL CHARACTERISTICS. Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours. 1The principal photon that is useful for detection and imaging studies is listed in Table 1. 1Kocher, David C., \"Radioactive Decay Data Tables\", DOE/TIC-11026, (1981) p. 108. External Radiation. The specific gamma ray constant for Tc 99m is 0.78 R/hour-millicurie at 1 cm. The first half value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000. To correct for physical decay of technetium Tc 99m, the fractions that remain at selected intervals after the time of calibration are shown in Table 3. *Calibration time."
},
{
"NDCCode": "45567-0455-1",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 KIT (45567-0455-1) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "45567-0455-01",
"ProductNDC": "45567-0455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kit For The Preparation Of Technetium Tc 99m Mebrofenin",
"NonProprietaryName": "Kit For The Preparation Of Technetium Tc 99m Mebrofenin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078242",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "MEBROFENIN",
"StrengthNumber": "45",
"StrengthUnit": "mg/10mL",
"Status": "Active",
"LastUpdate": "2024-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080129",
"SamplePackage": "N",
"IndicationAndUsage": "Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.",
"Description": "Each multidose reaction vial contains a nonradioactive, sterile, nonpyrogenic mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF 22H 2O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF 22H 2O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH is adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7. The structure of mebrofenin (2,2'-[[2-[(3-Bromo-2,4,6-trimethylphenyl)-amino]-2-oxoethyl]imino] bisacetic acid) is shown below. Molecular Weight = 387.23. When sterile, pyrogen-free sodium pertechnetate Tc 99m injection is added to the vial, the diagnostic agent Technetium Tc 99m Mebrofenin is formed for administration by intravenous injection. PHYSICAL CHARACTERISTICS. Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours. 1The principal photon that is useful for detection and imaging studies is listed in Table 1. 1Kocher, David C., \"Radioactive Decay Data Tables\", DOE/TIC-11026, (1981) p. 108. External Radiation. The specific gamma ray constant for Tc 99m is 0.78 R/hour-millicurie at 1 cm. The first half value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000. To correct for physical decay of technetium Tc 99m, the fractions that remain at selected intervals after the time of calibration are shown in Table 3. *Calibration time."
},
{
"NDCCode": "45567-0040-2",
"PackageDescription": "30 VIAL, MULTI-DOSE in 1 KIT (45567-0040-2) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "45567-0040-02",
"ProductNDC": "45567-0040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kit For The Preparation Of Technetium Tc 99m Medronate",
"NonProprietaryName": "Tc 99m Medronate",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19790829",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018124",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TECHNETIUM TC-99M MEDRONATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19790829",
"SamplePackage": "N",
"IndicationAndUsage": "Technetium Tc 99m Medronate Injection may be used as a bone imaging agent to delineate areas of altered osteogenesis.",
"Description": "Kit for the Preparation of Technetium Tc 99m Medronate is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Medronate Injection for diagnostic use by Intravenous injection. Each 10mL multidose vial contains: 1 Medronic acid: 20 mg, 2 Ascorbic acid: 1 mg, 3 Stannous fluoride, SnF 2: 0.13 mg (minimum) , 4 Total tin (maximum, as stannous fluoride, SnF 2): 0.38 mg ."
},
{
"NDCCode": "45567-0060-2",
"PackageDescription": "30 VIAL, MULTI-DOSE in 1 KIT (45567-0060-2) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "45567-0060-02",
"ProductNDC": "45567-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kit For The Preparation Of Technetium Tc99m Pyrophosphate",
"NonProprietaryName": "Technetium Tc99m Pyrophosphate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19870630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019039",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TECHNETIUM TC-99M PYROPHOSPHATE",
"StrengthNumber": "12",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19870630",
"SamplePackage": "N",
"IndicationAndUsage": "Technetium Tc 99m Pyrophosphate Injection is a bone imaging agent used to demonstrate areas of altered osteogenesis, and a cardiac imaging agent used as an adjunct in the diagnosis of acute myocardial infarction. Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is a blood pool imaging agent which may be used for gated blood pool imaging and for the detection of sites of gastrointestinal bleeding. When reconstituted with sterile non-pyrogenic isotonic saline and administered intravenously 30 minutes prior to the intravenous administration of Sodium Pertechnetate Tc 99m Injection, approximately 76% of the injected radioactivity remains in the blood pool.",
"Description": "Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Pyrophosphate Injection for diagnostic use by intravenous injection. Each 10 mL vial contains 12.0 mg of sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate; pH is adjusted to 5.3-5.7 with hydrochloric acid prior to lyophilization. No bacteriostatic preservative is present. Sealed under nitrogen. The chemical names are: (1) Diphosphoric acid, Ditin (2 +) salt; (2) Ditin (2 +) pyrophosphate (4 -). The structural formula is:. When a solution of sterile, non-pyrogenic, oxidant-free isotonic Sodium Pertechnetate Tc 99m Injection U.S.P. is added to the vial, Technetium Tc 99m Pyrophosphate Injection is formed for intravenous injection. When a solution of sterile, non-pyrogenic, isotonic saline is added to the vial, it forms a blood pool imaging agent when Sodium Pertechnetate Tc 99m Injection is injected intravenously 30 minutes after the intravenous administration of the non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection. The precise structure of Technetium Tc 99m Pyrophosphate Injection is not known at this time."
},
{
"NDCCode": "45567-0475-2",
"PackageDescription": "30 VIAL in 1 KIT (45567-0475-2) > 10 mL in 1 VIAL",
"NDC11Code": "45567-0475-02",
"ProductNDC": "45567-0475",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kit For The Preparation Of Technetium Tc99m Disofenin",
"NonProprietaryName": "Hepatolite",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19820316",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018467",
"LabelerName": "Pharmalucence, Inc.",
"SubstanceName": "TECHNETIUM TC-99M DISOFENIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19820316",
"SamplePackage": "N"
},
{
"NDCCode": "45567-0555-2",
"PackageDescription": "30 VIAL in 1 CARTON (45567-0555-2) / 10 mL in 1 VIAL",
"NDC11Code": "45567-0555-02",
"ProductNDC": "45567-0555",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kit For The Preparation Of Technetium Tc99m Sestamibi",
"NonProprietaryName": "Technetium Tc-99m Sestamibi",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079157",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SESTAMIBI",
"StrengthNumber": "1",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090710",
"SamplePackage": "N",
"IndicationAndUsage": "Myocardial Imaging: Technetium Tc 99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc 99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent’s labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Technetium Tc 99m Sestamibi is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Technetium Tc 99m Sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.",
"Description": "Each 10mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: 1 Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate - 1 mg, 2 Sodium Citrate Dihydrate - 2.6 mg, 3 L-Cysteine Hydrochloride Monohydrate - 1 mg, 4 Mannitol - 20 mg, 5 Stannous Chloride, Dihydrate, minimum (SnCl 22H 2O) - 0.025 mg , 6 Stannous Chloride, Dihydrate (SnCl 22H 2O) - 0.075 mg , 7 Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl 22H 2O) - 0.086 mg ."
},
{
"NDCCode": "15631-0455-2",
"PackageDescription": "400 PELLET in 1 PACKAGE (15631-0455-2) ",
"NDC11Code": "15631-0455-02",
"ProductNDC": "15631-0455",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Veratrum Album",
"NonProprietaryName": "Veratrum Album",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "VERATRUM ALBUM ROOT",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "37662-0455-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-0455-2) ",
"NDC11Code": "37662-0455-02",
"ProductNDC": "37662-0455",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cobaltum Muriaticum",
"NonProprietaryName": "Cobaltum Muriaticum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220609",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "COBALTOUS CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2022-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220609",
"SamplePackage": "N"
},
{
"NDCCode": "49288-0455-1",
"PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0455-1)",
"NDC11Code": "49288-0455-01",
"ProductNDC": "49288-0455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desert Ragweed",
"NonProprietaryName": "Desert Ragweed",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "AMBROSIA DUMOSA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic 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": "49288-0455-2",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0455-2)",
"NDC11Code": "49288-0455-02",
"ProductNDC": "49288-0455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desert Ragweed",
"NonProprietaryName": "Desert Ragweed",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "AMBROSIA DUMOSA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic 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": "70000-0455-2",
"PackageDescription": "2 BOTTLE, DROPPER in 1 BOX (70000-0455-2) / 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "70000-0455-02",
"ProductNDC": "70000-0455",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Long Lasting Lubricant Eye Drops",
"NonProprietaryName": "Polyethylene Glycol 400, Propylene Glycol",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20190219",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Cardinal Health",
"SubstanceName": "POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL",
"StrengthNumber": ".4; .3",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190429",
"SamplePackage": "N",
"IndicationAndUsage": "Uses for the temporary relief of burning and irritation due to dryness of the eye."
},
{
"NDCCode": "70518-0455-2",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (70518-0455-2) ",
"NDC11Code": "70518-0455-02",
"ProductNDC": "70518-0455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091426",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200713",
"SamplePackage": "N",
"IndicationAndUsage": "Spironolactone tablets are an aldosterone antagonist indicated for: 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure. ( 1.1) , 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.2) , 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response. ( 1.3) , 4 Treatment of primary hyperaldosternism for: ( 1.4) .",
"Description": "Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone, USP is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, corn starch, croscarmellose sodium, peppermint flavor, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and triacetin. The 50 mg tablet also contains D&C yellow # 10 and FD&C yellow # 6."
},
{
"NDCCode": "45567-0030-1",
"PackageDescription": "1 KIT in 1 PACKAGE (45567-0030-1) * 3 mL in 1 VIAL * 3 mL in 1 VIAL * 10 mL in 1 VIAL",
"NDC11Code": "45567-0030-01",
"ProductNDC": "45567-0030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kit For The Prepartion Of Technetium Tc99m Sulfur Colloid",
"NonProprietaryName": "Technetium Tc 99m Sulfur Colloid",
"DosageFormName": "KIT",
"StartMarketingDate": "19780419",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017858",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"Status": "Active",
"LastUpdate": "2024-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19780419",
"SamplePackage": "N",
"IndicationAndUsage": "Technetium Tc 99m Sulfur Colloid Injection is indicated. In adults, to assist in the: : 1 localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter., 2 evaluation of peritoneo-venous (LeVeen) shunt patency.",
"Description": "Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection contains a multi-dose Reaction Vial, a Solution A vial and a Solution B vial which contain the sterile non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Sulfur Colloid Injection for diagnostic use by subcutaneous, intraperitoneal, or intravenous injection or by oral administration. Each 10 mL multi-dose Reaction Vial contains, in lyophilized form 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin; a Solution A vial contains 1.8 mL of 0.148 N hydrochloric acid solution and a Solution B vial contains 1.8 mL aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide. When a solution of sterile and non-pyrogenic Sodium Pertechnetate Tc 99m Injection in isotonic saline is mixed with these components, following the instructions provided with the kit, Technetium Tc 99m Sulfur Colloid Injection is formed. The product is intended for subcutaneous, intraperitoneal, or intravenous injection or for oral administration. The precise structure of Technetium Tc 99m Sulfur Colloid Injection is not known at this time."
},
{
"NDCCode": "45567-0040-1",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 KIT (45567-0040-1) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "45567-0040-01",
"ProductNDC": "45567-0040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kit For The Preparation Of Technetium Tc 99m Medronate",
"NonProprietaryName": "Tc 99m Medronate",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19790829",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018124",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TECHNETIUM TC-99M MEDRONATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19790829",
"SamplePackage": "N",
"IndicationAndUsage": "Technetium Tc 99m Medronate Injection may be used as a bone imaging agent to delineate areas of altered osteogenesis.",
"Description": "Kit for the Preparation of Technetium Tc 99m Medronate is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Medronate Injection for diagnostic use by Intravenous injection. Each 10mL multidose vial contains: 1 Medronic acid: 20 mg, 2 Ascorbic acid: 1 mg, 3 Stannous fluoride, SnF 2: 0.13 mg (minimum) , 4 Total tin (maximum, as stannous fluoride, SnF 2): 0.38 mg ."
},
{
"NDCCode": "45567-0060-1",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 KIT (45567-0060-1) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "45567-0060-01",
"ProductNDC": "45567-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kit For The Preparation Of Technetium Tc99m Pyrophosphate",
"NonProprietaryName": "Technetium Tc99m Pyrophosphate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19870630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019039",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TECHNETIUM TC-99M PYROPHOSPHATE",
"StrengthNumber": "12",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19870630",
"SamplePackage": "N",
"IndicationAndUsage": "Technetium Tc 99m Pyrophosphate Injection is a bone imaging agent used to demonstrate areas of altered osteogenesis, and a cardiac imaging agent used as an adjunct in the diagnosis of acute myocardial infarction. Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is a blood pool imaging agent which may be used for gated blood pool imaging and for the detection of sites of gastrointestinal bleeding. When reconstituted with sterile non-pyrogenic isotonic saline and administered intravenously 30 minutes prior to the intravenous administration of Sodium Pertechnetate Tc 99m Injection, approximately 76% of the injected radioactivity remains in the blood pool.",
"Description": "Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Pyrophosphate Injection for diagnostic use by intravenous injection. Each 10 mL vial contains 12.0 mg of sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate; pH is adjusted to 5.3-5.7 with hydrochloric acid prior to lyophilization. No bacteriostatic preservative is present. Sealed under nitrogen. The chemical names are: (1) Diphosphoric acid, Ditin (2 +) salt; (2) Ditin (2 +) pyrophosphate (4 -). The structural formula is:. When a solution of sterile, non-pyrogenic, oxidant-free isotonic Sodium Pertechnetate Tc 99m Injection U.S.P. is added to the vial, Technetium Tc 99m Pyrophosphate Injection is formed for intravenous injection. When a solution of sterile, non-pyrogenic, isotonic saline is added to the vial, it forms a blood pool imaging agent when Sodium Pertechnetate Tc 99m Injection is injected intravenously 30 minutes after the intravenous administration of the non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection. The precise structure of Technetium Tc 99m Pyrophosphate Injection is not known at this time."
},
{
"NDCCode": "45567-0555-1",
"PackageDescription": "5 VIAL in 1 CARTON (45567-0555-1) / 10 mL in 1 VIAL",
"NDC11Code": "45567-0555-01",
"ProductNDC": "45567-0555",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kit For The Preparation Of Technetium Tc99m Sestamibi",
"NonProprietaryName": "Technetium Tc-99m Sestamibi",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079157",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SESTAMIBI",
"StrengthNumber": "1",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090710",
"SamplePackage": "N",
"IndicationAndUsage": "Myocardial Imaging: Technetium Tc 99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc 99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent’s labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Technetium Tc 99m Sestamibi is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Technetium Tc 99m Sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.",
"Description": "Each 10mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: 1 Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate - 1 mg, 2 Sodium Citrate Dihydrate - 2.6 mg, 3 L-Cysteine Hydrochloride Monohydrate - 1 mg, 4 Mannitol - 20 mg, 5 Stannous Chloride, Dihydrate, minimum (SnCl 22H 2O) - 0.025 mg , 6 Stannous Chloride, Dihydrate (SnCl 22H 2O) - 0.075 mg , 7 Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl 22H 2O) - 0.086 mg ."
},
{
"NDCCode": "45567-0655-1",
"PackageDescription": "5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (45567-0655-1) ",
"NDC11Code": "45567-0655-01",
"ProductNDC": "45567-0655",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kit For The Preparation Of Technetium Tc99m Mertiatide",
"NonProprietaryName": "Betiatide",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190902",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208994",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "BETIATIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190902",
"SamplePackage": "N",
"IndicationAndUsage": "Technetium Tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (See Pediatric Use.) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.",
"Description": "Kit for the Preparation of Technetium Tc99m Mertiatide is used for the preparation of technetium Tc 99m mertiatide, a diagnostic radiopharmaceutical. It is supplied as a sterile, nonpyrogenic, lyophilized powder. Each vial contains betiatide (N-[N-[N-[(benzoylthio) acetyl]glycyl]glycyl]-glycine). After reconstitution with sterile sodium pertechnetate Tc 99m injection, the technetium Tc 99m mertiatide (disodium[N-[N-[N-(mercaptoacetyl) glycyl]glycyl] glycinato (2-) - N,N′,N″,S′]oxotechnetate (2-)) which is formed is suitable for intravenous administration. Each 10 milliliter vial contains 1 milligram betiatide, 0.05 milligram (minimum) stannous chloride dihydrate (SnCl 2∙2H 2O) and 0.2 milligram (maximum) total tin expressed as stannous chloride dihydrate (SnCl 2∙2H 2O), 40 milligrams sodium tartrate dihydrate (Na 2C 4H 2O 6∙2H 2O), and 20 milligrams lactose monohydrate. Prior to lyophilization, sodium hydroxide or hydrochloric acid may be added for pH adjustment. The pH of the reconstituted drug is between 5.0 and 6.0. No bacteriostatic preservative is present. The contents are sealed under argon. Betiatide is light sensitive and must be protected from light. Betiatide and technetium Tc 99m mertiatide have the following structural formulas:."
},
{
"NDCCode": "45567-0755-3",
"PackageDescription": "1 KIT in 1 KIT (45567-0755-3) * 1 mL in 1 VIAL (45567-0752-1) * 1 mL in 1 VIAL (45567-0753-1) ",
"NDC11Code": "45567-0755-03",
"ProductNDC": "45567-0755",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kit For The Preparation Of Indium In 111 Pentetreotide",
"NonProprietaryName": "Indium In-111 Pentetreotide",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212785",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"Status": "Deprecated",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250325",
"SamplePackage": "N",
"IndicationAndUsage": "Indium In 111 pentetreotide injection, after radiolabeling is an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.",
"Description": "Indium In 111 pentetreotide is the kit for the preparation of indium In 111 pentetreotide injection, a radioactive diagnostic agent. It is a kit consisting of two components. 1). A 10-mL Pentetreotide Reaction Vial which contains a lyophilized mixture of. (i) 10 mcg pentetreotide [N-(diethylenetriamine-N,N,N',N”-tetraacetic acid-N”-acetyl)-D-phenylalanyl-L- hemicystyl-L-phenylalanyl-D- tryptophyl-L-lysyl-L-threonyl-L-hemicystyl-L-threoninol cyclic (2→7) disulfide], (also known as octreotide DTPA). (ii) 2 mg gentisic acid [2, 5-dihydroxybenzoic acid]. (iii) 4.9 mg trisodium citrate, anhydrous. (iv) 0.37 mg citric acid, anhydrous, and. (v) 10 mg inositol. Pentetreotide has the following structural formula. Prior to lyophilization, sodium hydroxide or hydrochloric acid may have been added for pH adjustment. The vial contents are sterile and nonpyrogenic. No bacteriostatic preservative is present. 2). A 10-mL vial of Indium In 111 Chloride Solution, which contains: 1.1 mL of 111 MBq/mL (3 mCi/mL) indium In 111 chloride in 0.02N HCl at time of calibration. The vial also contains ferric chloride at a concentration of 3.5 mcg/mL (ferric ion, 1.2 mcg/mL). The vial contents are sterile and nonpyrogenic. No bacteriostatic preservative is present. Indium In 111 pentetreotide injection is prepared by combining the two kit components ( see INSTRUCTIONS FOR THE PREPARATION OF INDIUM In 111 PENTETREOTIDE INJECTION). Indium In 111 reacts with the diethylenetriaminetetraacetic acid portion of the pentetreotide molecule to form indium In 111 pentetreotide. The pH of the resultant indium In 111 pentetreotide injection is between 3.8 and 4.3. No bacteriostatic preservative is present. The indium In 111 pentetreotide injection is suitable for intravenous administration as is, or it may be diluted to a maximum volume of 3 mL with 0.9% Sodium Chloride Injection, USP, immediately before intravenous administration. In either case, the radiolabeling yield of indium In 111 pentetreotide injection should be determined before administration to the patient. A method recommended for determining the labeling yield is presented at the end of this package insert (see RECOMMENDED METHOD FOR DETERMINATION OF RADIOLABELING YIELD OF INDIUM In 111 PENTETREOTIDE INJECTION)."
},
{
"NDCCode": "0168-0455-30",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0455-30) > 30 g in 1 TUBE",
"NDC11Code": "00168-0455-30",
"ProductNDC": "0168-0455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tazarotene Cream",
"NonProprietaryName": "Tazarotene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211175",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "TAZAROTENE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC],Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190128",
"SamplePackage": "N",
"IndicationAndUsage": "Tazarotene cream, 0.1% is indicated as an adjunctive agent for use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs.",
"Description": "Tazarotene cream, 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene cream, 0.1% contains 1 mg of tazarotene in a white cream base. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[2-(4,4-dimethylthiochroman-6-yl)ethynyl] nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. Tazarotene cream contains the following inactive ingredients: benzyl alcohol 1%, carbomer 974P; carbomer 1342, edetate disodium, medium chain triglycerides, mineral oil, purified water, sodium thiosulfate, sorbitan monooleate, and sodium hydroxide to adjust pH."
},
{
"NDCCode": "10544-455-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (10544-455-30)",
"NDC11Code": "10544-0455-30",
"ProductNDC": "10544-455",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076471",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "16714-455-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (16714-455-01) ",
"NDC11Code": "16714-0455-01",
"ProductNDC": "16714-455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151201",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202152",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151201",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f ] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablet, USP is supplied for oral administration as 25 mg (round, pink), 50 mg (round, white to off white), 100 mg (round, yellow), 200 mg (round, white to off white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow. Each 25 mg tablet contains quetiapine fumarate, USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains quetiapine fumarate, USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains quetiapine fumarate, USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains quetiapine fumarate, USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains quetiapine fumarate, USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains quetiapine fumarate, USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "16729-455-15",
"PackageDescription": "90 TABLET in 1 BOTTLE (16729-455-15) ",
"NDC11Code": "16729-0455-15",
"ProductNDC": "16729-455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212399",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201203",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7."
},
{
"NDCCode": "16729-455-17",
"PackageDescription": "1000 TABLET in 1 BOTTLE (16729-455-17) ",
"NDC11Code": "16729-0455-17",
"ProductNDC": "16729-455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212399",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201125",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7."
},
{
"NDCCode": "17856-0455-1",
"PackageDescription": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0455-1) > 5 mL in 1 CUP, UNIT-DOSE",
"NDC11Code": "17856-0455-01",
"ProductNDC": "17856-0455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
"NonProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088008",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE",
"StrengthNumber": "1.5; 5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210407",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is a combination of hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist, indicated for the symptomatic relief of cough in patients 18 years of age and older. Important Limitations of Use. : 1 Not indicated for pediatric patients under 18 years of age., 2 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.",
"Description": "Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL contains hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist. Each spoonful (5 mL) of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP, for oral administration. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL also contains the following inactive ingredients: Alcohol (less than 0.1%), Caramel, NF; Cherry Flavor; D&C Red No. 33; Glycerin, USP; Liquid Sugar; Methylparaben, NF; Propylene Glycol, USP; Propylparaben, NF and Sorbitol Solution, USP. Citric Acid, USP or Sodium Citrate, USP may be added for pH adjustment. Hydrocodone Bitartrate. The chemical name for hydrocodone is bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]- 2,3 dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α -Epoxy-3- methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.50 and has the following chemical structure. Homatropine Methylbromide. The chemical name for homatropine methylbromide is 8-Azoniabicyclo [3.2.1] octane, 3[(hydroxyphenylacetyl)-oxy]-8,8-dimethyl-, bromide,endo-. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure."
},
{
"NDCCode": "21695-455-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-455-30)",
"NDC11Code": "21695-0455-30",
"ProductNDC": "21695-455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invega",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20061219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021999",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "INVEGA® is an atypical antipsychotic agent indicated for the : 1 acute and maintenance treatment of schizophrenia (1.1), 2 acute treatment of schizoaffective disorder as monotherapy (1.2), 3 acute treatment of schizoaffective disorder as an adjunct to mood stabilizers and/or antidepressants (1.2) .",
"Description": "Paliperidone, the active ingredient in INVEGA® Extended-Release Tablets, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. INVEGA® contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.49. The structural formula is. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. INVEGA® (paliperidone) Extended-Release Tablets are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. INVEGA® utilizes OROS® osmotic drug-release technology [see Description (11.1)]. Inactive ingredients are carnauba wax, cellulose acetate, hydroxyethyl cellulose, propylene glycol, polyethylene glycol, polyethylene oxides, povidone, sodium chloride, stearic acid, butylated hydroxytoluene, hypromellose, titanium dioxide, and iron oxides. The 3 mg tablets also contain lactose monohydrate and triacetin."
},
{
"NDCCode": "30142-455-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (30142-455-26) / 118 mL in 1 BOTTLE",
"NDC11Code": "30142-0455-26",
"ProductNDC": "30142-455",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Pain And Fever",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20131214",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Kroger Company",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20131214",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache, 6 sore throat, 7 toothache."
},
{
"NDCCode": "30698-455-01",
"PackageDescription": "300 mL in 1 BOTTLE (30698-455-01) ",
"NDC11Code": "30698-0455-01",
"ProductNDC": "30698-455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Raldesy",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Trazodone Hydrochloride Oral",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20241126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218637",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241126",
"SamplePackage": "N",
"IndicationAndUsage": "RALDESY TMis indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "RALDESY contains trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1- piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2 H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. Molecular Formula: C 19H 22CIN 5O HCL. Molecular Weight:408.33. RALDESY Oral Solution: Each mL contains 10 mg of Trazodone Hydrochloride, USP equivalent to 9.1 mg of trazodone base. The following inactive ingredients: disodium edetate, glycerin, ortho phosphoric acid, propyl gallate, propylene glycol, purified water, sodium benzoate,sorbitol, and sucralose. The pH of the oral solution is 3.8 to 4.8."
},
{
"NDCCode": "30698-455-02",
"PackageDescription": "150 mL in 1 BOTTLE (30698-455-02) ",
"NDC11Code": "30698-0455-02",
"ProductNDC": "30698-455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Raldesy",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Trazodone Hydrochloride Oral",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20241126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218637",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241126",
"SamplePackage": "N",
"IndicationAndUsage": "RALDESY TMis indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "RALDESY contains trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1- piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2 H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. Molecular Formula: C 19H 22CIN 5O HCL. Molecular Weight:408.33. RALDESY Oral Solution: Each mL contains 10 mg of Trazodone Hydrochloride, USP equivalent to 9.1 mg of trazodone base. The following inactive ingredients: disodium edetate, glycerin, ortho phosphoric acid, propyl gallate, propylene glycol, purified water, sodium benzoate,sorbitol, and sucralose. The pH of the oral solution is 3.8 to 4.8."
},
{
"NDCCode": "30698-455-05",
"PackageDescription": "150 mL in 1 BOTTLE (30698-455-05) ",
"NDC11Code": "30698-0455-05",
"ProductNDC": "30698-455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Raldesy",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Trazodone Hydrochloride Oral",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20241126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218637",
"LabelerName": "Validus Pharmaceuticals LLC",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250221",
"SamplePackage": "Y",
"IndicationAndUsage": "RALDESY TMis indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "RALDESY contains trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1- piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2 H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. Molecular Formula: C 19H 22CIN 5O HCL. Molecular Weight:408.33. RALDESY Oral Solution: Each mL contains 10 mg of Trazodone Hydrochloride, USP equivalent to 9.1 mg of trazodone base. The following inactive ingredients: disodium edetate, glycerin, ortho phosphoric acid, propyl gallate, propylene glycol, purified water, sodium benzoate,sorbitol, and sucralose. The pH of the oral solution is 3.8 to 4.8."
},
{
"NDCCode": "31722-455-31",
"PackageDescription": "25 VIAL in 1 CARTON (31722-455-31) / 5 mL in 1 VIAL (31722-455-32) ",
"NDC11Code": "31722-0455-31",
"ProductNDC": "31722-455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zinc Sulfate",
"NonProprietaryName": "Zinc Sulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219585",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ZINC SULFATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250501",
"SamplePackage": "N",
"IndicationAndUsage": "Zinc sulfate injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "Zinc Sulfate Injection, USP is a sterile, non-pyrogenic, clear, colorless, and odorless solution intended for use as a trace element and an additive to intravenous solutions for parenteral nutrition. 10 mg/10 mL Pharmacy Bulk Package vial: Each mL contains 1 mg of zinc present as 2.46 mg of zinc sulfate and water for injection q.s. 30 mg/10 mL Pharmacy Bulk Package vial: Each mL contains 3 mg of zinc present as 7.41 mg of zinc sulfate and water for injection q.s. 25 mg/5 mL Pharmacy Bulk Package vial: Each mL contains 5 mg of zinc present as 12.32 mg of zinc sulfate and water for injection q.s. All presentations do not contain preservatives. The pH range is 2 to 4; pH may be adjusted with sulfuric acid. 1 mg/mL of zinc sulfate injection contains no more than 1,500 mcg/L of aluminum and has a calculated osmolarity of 33 mOsmol/L. 3 mg/mL of zinc sulfate injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 96.5 mOsmol/L. 5 mg/mL of zinc sulfate injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 157.2 mOsmol/L. Zinc sulfate heptahydrate USP has a molecular weight of 287.54 g/mol and a formula of ZnSO 4·7H 2O."
}
]
}
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<NDCList>
<NDC>
<NDCCode>45567-0455-2</NDCCode>
<PackageDescription>30 VIAL, MULTI-DOSE in 1 KIT (45567-0455-2) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>45567-0455-02</NDC11Code>
<ProductNDC>45567-0455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kit For The Preparation Of Technetium Tc 99m Mebrofenin</ProprietaryName>
<NonProprietaryName>Kit For The Preparation Of Technetium Tc 99m Mebrofenin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078242</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>MEBROFENIN</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.</IndicationAndUsage>
<Description>Each multidose reaction vial contains a nonradioactive, sterile, nonpyrogenic mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF 22H 2O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF 22H 2O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH is adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7. The structure of mebrofenin (2,2'-[[2-[(3-Bromo-2,4,6-trimethylphenyl)-amino]-2-oxoethyl]imino] bisacetic acid) is shown below. Molecular Weight = 387.23. When sterile, pyrogen-free sodium pertechnetate Tc 99m injection is added to the vial, the diagnostic agent Technetium Tc 99m Mebrofenin is formed for administration by intravenous injection. PHYSICAL CHARACTERISTICS. Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours. 1The principal photon that is useful for detection and imaging studies is listed in Table 1. 1Kocher, David C., "Radioactive Decay Data Tables", DOE/TIC-11026, (1981) p. 108. External Radiation. The specific gamma ray constant for Tc 99m is 0.78 R/hour-millicurie at 1 cm. The first half value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000. To correct for physical decay of technetium Tc 99m, the fractions that remain at selected intervals after the time of calibration are shown in Table 3. *Calibration time.</Description>
</NDC>
<NDC>
<NDCCode>45567-0455-1</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 KIT (45567-0455-1) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>45567-0455-01</NDC11Code>
<ProductNDC>45567-0455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kit For The Preparation Of Technetium Tc 99m Mebrofenin</ProprietaryName>
<NonProprietaryName>Kit For The Preparation Of Technetium Tc 99m Mebrofenin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078242</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>MEBROFENIN</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.</IndicationAndUsage>
<Description>Each multidose reaction vial contains a nonradioactive, sterile, nonpyrogenic mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF 22H 2O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF 22H 2O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH is adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7. The structure of mebrofenin (2,2'-[[2-[(3-Bromo-2,4,6-trimethylphenyl)-amino]-2-oxoethyl]imino] bisacetic acid) is shown below. Molecular Weight = 387.23. When sterile, pyrogen-free sodium pertechnetate Tc 99m injection is added to the vial, the diagnostic agent Technetium Tc 99m Mebrofenin is formed for administration by intravenous injection. PHYSICAL CHARACTERISTICS. Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours. 1The principal photon that is useful for detection and imaging studies is listed in Table 1. 1Kocher, David C., "Radioactive Decay Data Tables", DOE/TIC-11026, (1981) p. 108. External Radiation. The specific gamma ray constant for Tc 99m is 0.78 R/hour-millicurie at 1 cm. The first half value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000. To correct for physical decay of technetium Tc 99m, the fractions that remain at selected intervals after the time of calibration are shown in Table 3. *Calibration time.</Description>
</NDC>
<NDC>
<NDCCode>45567-0040-2</NDCCode>
<PackageDescription>30 VIAL, MULTI-DOSE in 1 KIT (45567-0040-2) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>45567-0040-02</NDC11Code>
<ProductNDC>45567-0040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kit For The Preparation Of Technetium Tc 99m Medronate</ProprietaryName>
<NonProprietaryName>Tc 99m Medronate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19790829</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018124</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M MEDRONATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19790829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Technetium Tc 99m Medronate Injection may be used as a bone imaging agent to delineate areas of altered osteogenesis.</IndicationAndUsage>
<Description>Kit for the Preparation of Technetium Tc 99m Medronate is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Medronate Injection for diagnostic use by Intravenous injection. Each 10mL multidose vial contains: 1 Medronic acid: 20 mg, 2 Ascorbic acid: 1 mg, 3 Stannous fluoride, SnF 2: 0.13 mg (minimum) , 4 Total tin (maximum, as stannous fluoride, SnF 2): 0.38 mg .</Description>
</NDC>
<NDC>
<NDCCode>45567-0060-2</NDCCode>
<PackageDescription>30 VIAL, MULTI-DOSE in 1 KIT (45567-0060-2) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>45567-0060-02</NDC11Code>
<ProductNDC>45567-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kit For The Preparation Of Technetium Tc99m Pyrophosphate</ProprietaryName>
<NonProprietaryName>Technetium Tc99m Pyrophosphate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19870630</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019039</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M PYROPHOSPHATE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Technetium Tc 99m Pyrophosphate Injection is a bone imaging agent used to demonstrate areas of altered osteogenesis, and a cardiac imaging agent used as an adjunct in the diagnosis of acute myocardial infarction. Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is a blood pool imaging agent which may be used for gated blood pool imaging and for the detection of sites of gastrointestinal bleeding. When reconstituted with sterile non-pyrogenic isotonic saline and administered intravenously 30 minutes prior to the intravenous administration of Sodium Pertechnetate Tc 99m Injection, approximately 76% of the injected radioactivity remains in the blood pool.</IndicationAndUsage>
<Description>Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Pyrophosphate Injection for diagnostic use by intravenous injection. Each 10 mL vial contains 12.0 mg of sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate; pH is adjusted to 5.3-5.7 with hydrochloric acid prior to lyophilization. No bacteriostatic preservative is present. Sealed under nitrogen. The chemical names are: (1) Diphosphoric acid, Ditin (2 +) salt; (2) Ditin (2 +) pyrophosphate (4 -). The structural formula is:. When a solution of sterile, non-pyrogenic, oxidant-free isotonic Sodium Pertechnetate Tc 99m Injection U.S.P. is added to the vial, Technetium Tc 99m Pyrophosphate Injection is formed for intravenous injection. When a solution of sterile, non-pyrogenic, isotonic saline is added to the vial, it forms a blood pool imaging agent when Sodium Pertechnetate Tc 99m Injection is injected intravenously 30 minutes after the intravenous administration of the non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection. The precise structure of Technetium Tc 99m Pyrophosphate Injection is not known at this time.</Description>
</NDC>
<NDC>
<NDCCode>45567-0475-2</NDCCode>
<PackageDescription>30 VIAL in 1 KIT (45567-0475-2) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>45567-0475-02</NDC11Code>
<ProductNDC>45567-0475</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kit For The Preparation Of Technetium Tc99m Disofenin</ProprietaryName>
<NonProprietaryName>Hepatolite</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19820316</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018467</ApplicationNumber>
<LabelerName>Pharmalucence, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M DISOFENIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19820316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45567-0555-2</NDCCode>
<PackageDescription>30 VIAL in 1 CARTON (45567-0555-2) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>45567-0555-02</NDC11Code>
<ProductNDC>45567-0555</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kit For The Preparation Of Technetium Tc99m Sestamibi</ProprietaryName>
<NonProprietaryName>Technetium Tc-99m Sestamibi</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079157</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SESTAMIBI</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Myocardial Imaging: Technetium Tc 99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc 99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent’s labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Technetium Tc 99m Sestamibi is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Technetium Tc 99m Sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.</IndicationAndUsage>
<Description>Each 10mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: 1 Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate - 1 mg, 2 Sodium Citrate Dihydrate - 2.6 mg, 3 L-Cysteine Hydrochloride Monohydrate - 1 mg, 4 Mannitol - 20 mg, 5 Stannous Chloride, Dihydrate, minimum (SnCl 22H 2O) - 0.025 mg , 6 Stannous Chloride, Dihydrate (SnCl 22H 2O) - 0.075 mg , 7 Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl 22H 2O) - 0.086 mg .</Description>
</NDC>
<NDC>
<NDCCode>15631-0455-2</NDCCode>
<PackageDescription>400 PELLET in 1 PACKAGE (15631-0455-2) </PackageDescription>
<NDC11Code>15631-0455-02</NDC11Code>
<ProductNDC>15631-0455</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Veratrum Album</ProprietaryName>
<NonProprietaryName>Veratrum Album</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151031</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37662-0455-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-0455-2) </PackageDescription>
<NDC11Code>37662-0455-02</NDC11Code>
<ProductNDC>37662-0455</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cobaltum Muriaticum</ProprietaryName>
<NonProprietaryName>Cobaltum Muriaticum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220609</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>COBALTOUS CHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49288-0455-1</NDCCode>
<PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (49288-0455-1)</PackageDescription>
<NDC11Code>49288-0455-01</NDC11Code>
<ProductNDC>49288-0455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desert Ragweed</ProprietaryName>
<NonProprietaryName>Desert Ragweed</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>AMBROSIA DUMOSA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic 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>49288-0455-2</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0455-2)</PackageDescription>
<NDC11Code>49288-0455-02</NDC11Code>
<ProductNDC>49288-0455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desert Ragweed</ProprietaryName>
<NonProprietaryName>Desert Ragweed</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>AMBROSIA DUMOSA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic 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>70000-0455-2</NDCCode>
<PackageDescription>2 BOTTLE, DROPPER in 1 BOX (70000-0455-2) / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>70000-0455-02</NDC11Code>
<ProductNDC>70000-0455</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Long Lasting Lubricant Eye Drops</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 400, Propylene Glycol</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20190219</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL</SubstanceName>
<StrengthNumber>.4; .3</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses for the temporary relief of burning and irritation due to dryness of the eye.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70518-0455-2</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (70518-0455-2) </PackageDescription>
<NDC11Code>70518-0455-02</NDC11Code>
<ProductNDC>70518-0455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone</ProprietaryName>
<NonProprietaryName>Spironolactone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091426</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>SPIRONOLACTONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Spironolactone tablets are an aldosterone antagonist indicated for: 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure. ( 1.1) , 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.2) , 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response. ( 1.3) , 4 Treatment of primary hyperaldosternism for: ( 1.4) .</IndicationAndUsage>
<Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone, USP is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, corn starch, croscarmellose sodium, peppermint flavor, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and triacetin. The 50 mg tablet also contains D&C yellow # 10 and FD&C yellow # 6.</Description>
</NDC>
<NDC>
<NDCCode>45567-0030-1</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (45567-0030-1) * 3 mL in 1 VIAL * 3 mL in 1 VIAL * 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>45567-0030-01</NDC11Code>
<ProductNDC>45567-0030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kit For The Prepartion Of Technetium Tc99m Sulfur Colloid</ProprietaryName>
<NonProprietaryName>Technetium Tc 99m Sulfur Colloid</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19780419</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017858</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19780419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Technetium Tc 99m Sulfur Colloid Injection is indicated. In adults, to assist in the: : 1 localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter., 2 evaluation of peritoneo-venous (LeVeen) shunt patency.</IndicationAndUsage>
<Description>Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection contains a multi-dose Reaction Vial, a Solution A vial and a Solution B vial which contain the sterile non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Sulfur Colloid Injection for diagnostic use by subcutaneous, intraperitoneal, or intravenous injection or by oral administration. Each 10 mL multi-dose Reaction Vial contains, in lyophilized form 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin; a Solution A vial contains 1.8 mL of 0.148 N hydrochloric acid solution and a Solution B vial contains 1.8 mL aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide. When a solution of sterile and non-pyrogenic Sodium Pertechnetate Tc 99m Injection in isotonic saline is mixed with these components, following the instructions provided with the kit, Technetium Tc 99m Sulfur Colloid Injection is formed. The product is intended for subcutaneous, intraperitoneal, or intravenous injection or for oral administration. The precise structure of Technetium Tc 99m Sulfur Colloid Injection is not known at this time.</Description>
</NDC>
<NDC>
<NDCCode>45567-0040-1</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 KIT (45567-0040-1) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>45567-0040-01</NDC11Code>
<ProductNDC>45567-0040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kit For The Preparation Of Technetium Tc 99m Medronate</ProprietaryName>
<NonProprietaryName>Tc 99m Medronate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19790829</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018124</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M MEDRONATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19790829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Technetium Tc 99m Medronate Injection may be used as a bone imaging agent to delineate areas of altered osteogenesis.</IndicationAndUsage>
<Description>Kit for the Preparation of Technetium Tc 99m Medronate is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Medronate Injection for diagnostic use by Intravenous injection. Each 10mL multidose vial contains: 1 Medronic acid: 20 mg, 2 Ascorbic acid: 1 mg, 3 Stannous fluoride, SnF 2: 0.13 mg (minimum) , 4 Total tin (maximum, as stannous fluoride, SnF 2): 0.38 mg .</Description>
</NDC>
<NDC>
<NDCCode>45567-0060-1</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 KIT (45567-0060-1) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>45567-0060-01</NDC11Code>
<ProductNDC>45567-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kit For The Preparation Of Technetium Tc99m Pyrophosphate</ProprietaryName>
<NonProprietaryName>Technetium Tc99m Pyrophosphate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19870630</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019039</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M PYROPHOSPHATE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Technetium Tc 99m Pyrophosphate Injection is a bone imaging agent used to demonstrate areas of altered osteogenesis, and a cardiac imaging agent used as an adjunct in the diagnosis of acute myocardial infarction. Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is a blood pool imaging agent which may be used for gated blood pool imaging and for the detection of sites of gastrointestinal bleeding. When reconstituted with sterile non-pyrogenic isotonic saline and administered intravenously 30 minutes prior to the intravenous administration of Sodium Pertechnetate Tc 99m Injection, approximately 76% of the injected radioactivity remains in the blood pool.</IndicationAndUsage>
<Description>Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Pyrophosphate Injection for diagnostic use by intravenous injection. Each 10 mL vial contains 12.0 mg of sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate; pH is adjusted to 5.3-5.7 with hydrochloric acid prior to lyophilization. No bacteriostatic preservative is present. Sealed under nitrogen. The chemical names are: (1) Diphosphoric acid, Ditin (2 +) salt; (2) Ditin (2 +) pyrophosphate (4 -). The structural formula is:. When a solution of sterile, non-pyrogenic, oxidant-free isotonic Sodium Pertechnetate Tc 99m Injection U.S.P. is added to the vial, Technetium Tc 99m Pyrophosphate Injection is formed for intravenous injection. When a solution of sterile, non-pyrogenic, isotonic saline is added to the vial, it forms a blood pool imaging agent when Sodium Pertechnetate Tc 99m Injection is injected intravenously 30 minutes after the intravenous administration of the non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection. The precise structure of Technetium Tc 99m Pyrophosphate Injection is not known at this time.</Description>
</NDC>
<NDC>
<NDCCode>45567-0555-1</NDCCode>
<PackageDescription>5 VIAL in 1 CARTON (45567-0555-1) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>45567-0555-01</NDC11Code>
<ProductNDC>45567-0555</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kit For The Preparation Of Technetium Tc99m Sestamibi</ProprietaryName>
<NonProprietaryName>Technetium Tc-99m Sestamibi</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079157</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SESTAMIBI</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Myocardial Imaging: Technetium Tc 99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc 99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent’s labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Technetium Tc 99m Sestamibi is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Technetium Tc 99m Sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.</IndicationAndUsage>
<Description>Each 10mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: 1 Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate - 1 mg, 2 Sodium Citrate Dihydrate - 2.6 mg, 3 L-Cysteine Hydrochloride Monohydrate - 1 mg, 4 Mannitol - 20 mg, 5 Stannous Chloride, Dihydrate, minimum (SnCl 22H 2O) - 0.025 mg , 6 Stannous Chloride, Dihydrate (SnCl 22H 2O) - 0.075 mg , 7 Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl 22H 2O) - 0.086 mg .</Description>
</NDC>
<NDC>
<NDCCode>45567-0655-1</NDCCode>
<PackageDescription>5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (45567-0655-1) </PackageDescription>
<NDC11Code>45567-0655-01</NDC11Code>
<ProductNDC>45567-0655</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kit For The Preparation Of Technetium Tc99m Mertiatide</ProprietaryName>
<NonProprietaryName>Betiatide</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190902</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208994</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>BETIATIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190902</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Technetium Tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (See Pediatric Use.) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.</IndicationAndUsage>
<Description>Kit for the Preparation of Technetium Tc99m Mertiatide is used for the preparation of technetium Tc 99m mertiatide, a diagnostic radiopharmaceutical. It is supplied as a sterile, nonpyrogenic, lyophilized powder. Each vial contains betiatide (N-[N-[N-[(benzoylthio) acetyl]glycyl]glycyl]-glycine). After reconstitution with sterile sodium pertechnetate Tc 99m injection, the technetium Tc 99m mertiatide (disodium[N-[N-[N-(mercaptoacetyl) glycyl]glycyl] glycinato (2-) - N,N′,N″,S′]oxotechnetate (2-)) which is formed is suitable for intravenous administration. Each 10 milliliter vial contains 1 milligram betiatide, 0.05 milligram (minimum) stannous chloride dihydrate (SnCl 2∙2H 2O) and 0.2 milligram (maximum) total tin expressed as stannous chloride dihydrate (SnCl 2∙2H 2O), 40 milligrams sodium tartrate dihydrate (Na 2C 4H 2O 6∙2H 2O), and 20 milligrams lactose monohydrate. Prior to lyophilization, sodium hydroxide or hydrochloric acid may be added for pH adjustment. The pH of the reconstituted drug is between 5.0 and 6.0. No bacteriostatic preservative is present. The contents are sealed under argon. Betiatide is light sensitive and must be protected from light. Betiatide and technetium Tc 99m mertiatide have the following structural formulas:.</Description>
</NDC>
<NDC>
<NDCCode>45567-0755-3</NDCCode>
<PackageDescription>1 KIT in 1 KIT (45567-0755-3) * 1 mL in 1 VIAL (45567-0752-1) * 1 mL in 1 VIAL (45567-0753-1) </PackageDescription>
<NDC11Code>45567-0755-03</NDC11Code>
<ProductNDC>45567-0755</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kit For The Preparation Of Indium In 111 Pentetreotide</ProprietaryName>
<NonProprietaryName>Indium In-111 Pentetreotide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250325</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212785</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indium In 111 pentetreotide injection, after radiolabeling is an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.</IndicationAndUsage>
<Description>Indium In 111 pentetreotide is the kit for the preparation of indium In 111 pentetreotide injection, a radioactive diagnostic agent. It is a kit consisting of two components. 1). A 10-mL Pentetreotide Reaction Vial which contains a lyophilized mixture of. (i) 10 mcg pentetreotide [N-(diethylenetriamine-N,N,N',N”-tetraacetic acid-N”-acetyl)-D-phenylalanyl-L- hemicystyl-L-phenylalanyl-D- tryptophyl-L-lysyl-L-threonyl-L-hemicystyl-L-threoninol cyclic (2→7) disulfide], (also known as octreotide DTPA). (ii) 2 mg gentisic acid [2, 5-dihydroxybenzoic acid]. (iii) 4.9 mg trisodium citrate, anhydrous. (iv) 0.37 mg citric acid, anhydrous, and. (v) 10 mg inositol. Pentetreotide has the following structural formula. Prior to lyophilization, sodium hydroxide or hydrochloric acid may have been added for pH adjustment. The vial contents are sterile and nonpyrogenic. No bacteriostatic preservative is present. 2). A 10-mL vial of Indium In 111 Chloride Solution, which contains: 1.1 mL of 111 MBq/mL (3 mCi/mL) indium In 111 chloride in 0.02N HCl at time of calibration. The vial also contains ferric chloride at a concentration of 3.5 mcg/mL (ferric ion, 1.2 mcg/mL). The vial contents are sterile and nonpyrogenic. No bacteriostatic preservative is present. Indium In 111 pentetreotide injection is prepared by combining the two kit components ( see INSTRUCTIONS FOR THE PREPARATION OF INDIUM In 111 PENTETREOTIDE INJECTION). Indium In 111 reacts with the diethylenetriaminetetraacetic acid portion of the pentetreotide molecule to form indium In 111 pentetreotide. The pH of the resultant indium In 111 pentetreotide injection is between 3.8 and 4.3. No bacteriostatic preservative is present. The indium In 111 pentetreotide injection is suitable for intravenous administration as is, or it may be diluted to a maximum volume of 3 mL with 0.9% Sodium Chloride Injection, USP, immediately before intravenous administration. In either case, the radiolabeling yield of indium In 111 pentetreotide injection should be determined before administration to the patient. A method recommended for determining the labeling yield is presented at the end of this package insert (see RECOMMENDED METHOD FOR DETERMINATION OF RADIOLABELING YIELD OF INDIUM In 111 PENTETREOTIDE INJECTION).</Description>
</NDC>
<NDC>
<NDCCode>0168-0455-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0455-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0455-30</NDC11Code>
<ProductNDC>0168-0455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tazarotene Cream</ProprietaryName>
<NonProprietaryName>Tazarotene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211175</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TAZAROTENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tazarotene cream, 0.1% is indicated as an adjunctive agent for use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs.</IndicationAndUsage>
<Description>Tazarotene cream, 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene cream, 0.1% contains 1 mg of tazarotene in a white cream base. Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[2-(4,4-dimethylthiochroman-6-yl)ethynyl] nicotinate. The compound has an empirical formula of C21H21NO2S and molecular weight of 351.46. The structural formula is shown below. Tazarotene cream contains the following inactive ingredients: benzyl alcohol 1%, carbomer 974P; carbomer 1342, edetate disodium, medium chain triglycerides, mineral oil, purified water, sodium thiosulfate, sorbitan monooleate, and sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>10544-455-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (10544-455-30)</PackageDescription>
<NDC11Code>10544-0455-30</NDC11Code>
<ProductNDC>10544-455</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076471</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-455-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (16714-455-01) </PackageDescription>
<NDC11Code>16714-0455-01</NDC11Code>
<ProductNDC>16714-455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine</ProprietaryName>
<NonProprietaryName>Quetiapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151201</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202152</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151201</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f ] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablet, USP is supplied for oral administration as 25 mg (round, pink), 50 mg (round, white to off white), 100 mg (round, yellow), 200 mg (round, white to off white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow. Each 25 mg tablet contains quetiapine fumarate, USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains quetiapine fumarate, USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains quetiapine fumarate, USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains quetiapine fumarate, USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains quetiapine fumarate, USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains quetiapine fumarate, USP equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>16729-455-15</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (16729-455-15) </PackageDescription>
<NDC11Code>16729-0455-15</NDC11Code>
<ProductNDC>16729-455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212399</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>16729-455-17</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (16729-455-17) </PackageDescription>
<NDC11Code>16729-0455-17</NDC11Code>
<ProductNDC>16729-455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212399</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>17856-0455-1</NDCCode>
<PackageDescription>72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0455-1) > 5 mL in 1 CUP, UNIT-DOSE</PackageDescription>
<NDC11Code>17856-0455-01</NDC11Code>
<ProductNDC>17856-0455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088008</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>1.5; 5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is a combination of hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist, indicated for the symptomatic relief of cough in patients 18 years of age and older. Important Limitations of Use. : 1 Not indicated for pediatric patients under 18 years of age., 2 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL contains hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist. Each spoonful (5 mL) of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP, for oral administration. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL also contains the following inactive ingredients: Alcohol (less than 0.1%), Caramel, NF; Cherry Flavor; D&C Red No. 33; Glycerin, USP; Liquid Sugar; Methylparaben, NF; Propylene Glycol, USP; Propylparaben, NF and Sorbitol Solution, USP. Citric Acid, USP or Sodium Citrate, USP may be added for pH adjustment. Hydrocodone Bitartrate. The chemical name for hydrocodone is bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]- 2,3 dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α -Epoxy-3- methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.50 and has the following chemical structure. Homatropine Methylbromide. The chemical name for homatropine methylbromide is 8-Azoniabicyclo [3.2.1] octane, 3[(hydroxyphenylacetyl)-oxy]-8,8-dimethyl-, bromide,endo-. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure.</Description>
</NDC>
<NDC>
<NDCCode>21695-455-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-455-30)</PackageDescription>
<NDC11Code>21695-0455-30</NDC11Code>
<ProductNDC>21695-455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Invega</ProprietaryName>
<NonProprietaryName>Paliperidone</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021999</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INVEGA® is an atypical antipsychotic agent indicated for the : 1 acute and maintenance treatment of schizophrenia (1.1), 2 acute treatment of schizoaffective disorder as monotherapy (1.2), 3 acute treatment of schizoaffective disorder as an adjunct to mood stabilizers and/or antidepressants (1.2) .</IndicationAndUsage>
<Description>Paliperidone, the active ingredient in INVEGA® Extended-Release Tablets, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. INVEGA® contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.49. The structural formula is. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. INVEGA® (paliperidone) Extended-Release Tablets are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. INVEGA® utilizes OROS® osmotic drug-release technology [see Description (11.1)]. Inactive ingredients are carnauba wax, cellulose acetate, hydroxyethyl cellulose, propylene glycol, polyethylene glycol, polyethylene oxides, povidone, sodium chloride, stearic acid, butylated hydroxytoluene, hypromellose, titanium dioxide, and iron oxides. The 3 mg tablets also contain lactose monohydrate and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>30142-455-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (30142-455-26) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>30142-0455-26</NDC11Code>
<ProductNDC>30142-455</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Pain And Fever</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131214</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache, 6 sore throat, 7 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30698-455-01</NDCCode>
<PackageDescription>300 mL in 1 BOTTLE (30698-455-01) </PackageDescription>
<NDC11Code>30698-0455-01</NDC11Code>
<ProductNDC>30698-455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Raldesy</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Trazodone Hydrochloride Oral</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218637</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RALDESY TMis indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>RALDESY contains trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1- piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2 H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. Molecular Formula: C 19H 22CIN 5O HCL. Molecular Weight:408.33. RALDESY Oral Solution: Each mL contains 10 mg of Trazodone Hydrochloride, USP equivalent to 9.1 mg of trazodone base. The following inactive ingredients: disodium edetate, glycerin, ortho phosphoric acid, propyl gallate, propylene glycol, purified water, sodium benzoate,sorbitol, and sucralose. The pH of the oral solution is 3.8 to 4.8.</Description>
</NDC>
<NDC>
<NDCCode>30698-455-02</NDCCode>
<PackageDescription>150 mL in 1 BOTTLE (30698-455-02) </PackageDescription>
<NDC11Code>30698-0455-02</NDC11Code>
<ProductNDC>30698-455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Raldesy</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Trazodone Hydrochloride Oral</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218637</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RALDESY TMis indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>RALDESY contains trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1- piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2 H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. Molecular Formula: C 19H 22CIN 5O HCL. Molecular Weight:408.33. RALDESY Oral Solution: Each mL contains 10 mg of Trazodone Hydrochloride, USP equivalent to 9.1 mg of trazodone base. The following inactive ingredients: disodium edetate, glycerin, ortho phosphoric acid, propyl gallate, propylene glycol, purified water, sodium benzoate,sorbitol, and sucralose. The pH of the oral solution is 3.8 to 4.8.</Description>
</NDC>
<NDC>
<NDCCode>30698-455-05</NDCCode>
<PackageDescription>150 mL in 1 BOTTLE (30698-455-05) </PackageDescription>
<NDC11Code>30698-0455-05</NDC11Code>
<ProductNDC>30698-455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Raldesy</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Trazodone Hydrochloride Oral</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218637</ApplicationNumber>
<LabelerName>Validus Pharmaceuticals LLC</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250221</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>RALDESY TMis indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>RALDESY contains trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1- piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2 H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. Molecular Formula: C 19H 22CIN 5O HCL. Molecular Weight:408.33. RALDESY Oral Solution: Each mL contains 10 mg of Trazodone Hydrochloride, USP equivalent to 9.1 mg of trazodone base. The following inactive ingredients: disodium edetate, glycerin, ortho phosphoric acid, propyl gallate, propylene glycol, purified water, sodium benzoate,sorbitol, and sucralose. The pH of the oral solution is 3.8 to 4.8.</Description>
</NDC>
<NDC>
<NDCCode>31722-455-31</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (31722-455-31) / 5 mL in 1 VIAL (31722-455-32) </PackageDescription>
<NDC11Code>31722-0455-31</NDC11Code>
<ProductNDC>31722-455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zinc Sulfate</ProprietaryName>
<NonProprietaryName>Zinc Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219585</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ZINC SULFATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zinc sulfate injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>Zinc Sulfate Injection, USP is a sterile, non-pyrogenic, clear, colorless, and odorless solution intended for use as a trace element and an additive to intravenous solutions for parenteral nutrition. 10 mg/10 mL Pharmacy Bulk Package vial: Each mL contains 1 mg of zinc present as 2.46 mg of zinc sulfate and water for injection q.s. 30 mg/10 mL Pharmacy Bulk Package vial: Each mL contains 3 mg of zinc present as 7.41 mg of zinc sulfate and water for injection q.s. 25 mg/5 mL Pharmacy Bulk Package vial: Each mL contains 5 mg of zinc present as 12.32 mg of zinc sulfate and water for injection q.s. All presentations do not contain preservatives. The pH range is 2 to 4; pH may be adjusted with sulfuric acid. 1 mg/mL of zinc sulfate injection contains no more than 1,500 mcg/L of aluminum and has a calculated osmolarity of 33 mOsmol/L. 3 mg/mL of zinc sulfate injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 96.5 mOsmol/L. 5 mg/mL of zinc sulfate injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 157.2 mOsmol/L. Zinc sulfate heptahydrate USP has a molecular weight of 287.54 g/mol and a formula of ZnSO 4·7H 2O.</Description>
</NDC>
</NDCList>