{
"NDC": [
{
"NDCCode": "11994-091-01",
"PackageDescription": "1 VIAL in 1 CARTON (11994-091-01) / 12 mL in 1 VIAL",
"NDC11Code": "11994-0091-01",
"ProductNDC": "11994-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technelite",
"NonProprietaryName": "Technetium Tc99m Generator",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19751101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017771",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
"StrengthNumber": "250",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100928",
"SamplePackage": "N",
"IndicationAndUsage": "The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.",
"Description": "DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution."
},
{
"NDCCode": "11994-006-02",
"PackageDescription": "2 KIT in 1 PACKAGE, COMBINATION (11994-006-02) > 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (11994-002-01) * 1 mL in 1 VIAL (11994-004-01) ",
"NDC11Code": "11994-0006-02",
"ProductNDC": "11994-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neurolite",
"NonProprietaryName": "Bicisate Dihydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "19941123",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020256",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"Status": "Active",
"LastUpdate": "2022-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19941123",
"SamplePackage": "N",
"IndicationAndUsage": "Neurolite single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed. Neurolite is not indicated for assessment of functional viability of brain tissue. Also, Neurolite is not indicated for distinguishing between stroke and other brain lesions.",
"Description": "This kit formulation consists of two nonradioactive vials: Vial A contains bicisate dihydrochloride (N, N'-1,2-ethylenediylbis-L-cysteine diethyl ester dihydrochloride) and a reducing agent as a lyophilized solid and vial B contains a buffer solution. Both vials are sterile and non-pyrogenic. The contents of vial A are lyophilized and stored under nitrogen. The pH of the solution before lyophilization is 2.7 ± 0.25. This vial is stored at 15-25°C. Protect from light. The contents of vial B are stored under air. The pH of the solution is 7.6 ± 0.4. This vial is stored at 15-25°C. This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection. The precise structure of the Technetium complex is [N, N'-ethylenedi-L-cysteinato(3-)]oxo[99mTc] technetium (V), diethyl ester."
},
{
"NDCCode": "11994-006-05",
"PackageDescription": "5 KIT in 1 PACKAGE, COMBINATION (11994-006-05) > 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (11994-002-01) * 1 mL in 1 VIAL (11994-004-01) ",
"NDC11Code": "11994-0006-05",
"ProductNDC": "11994-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neurolite",
"NonProprietaryName": "Bicisate Dihydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "19941123",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020256",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"Status": "Active",
"LastUpdate": "2022-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19941123",
"SamplePackage": "N",
"IndicationAndUsage": "Neurolite single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed. Neurolite is not indicated for assessment of functional viability of brain tissue. Also, Neurolite is not indicated for distinguishing between stroke and other brain lesions.",
"Description": "This kit formulation consists of two nonradioactive vials: Vial A contains bicisate dihydrochloride (N, N'-1,2-ethylenediylbis-L-cysteine diethyl ester dihydrochloride) and a reducing agent as a lyophilized solid and vial B contains a buffer solution. Both vials are sterile and non-pyrogenic. The contents of vial A are lyophilized and stored under nitrogen. The pH of the solution before lyophilization is 2.7 ± 0.25. This vial is stored at 15-25°C. Protect from light. The contents of vial B are stored under air. The pH of the solution is 7.6 ± 0.4. This vial is stored at 15-25°C. This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection. The precise structure of the Technetium complex is [N, N'-ethylenedi-L-cysteinato(3-)]oxo[99mTc] technetium (V), diethyl ester."
},
{
"NDCCode": "11994-011-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (11994-011-01) / 1.5 mL in 1 VIAL, GLASS",
"NDC11Code": "11994-0011-01",
"ProductNDC": "11994-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Definity",
"NonProprietaryName": "Perflutren",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20010731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021064",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "PERFLUTREN",
"StrengthNumber": "6.52",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2024-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010731",
"SamplePackage": "N",
"IndicationAndUsage": "DEFINITY is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.",
"Description": "DEFINITY (perflutren lipid microsphere) injectable suspension is, after activation an ultrasound contrast agent for intravenous use. The perflutren lipid microspheres are composed of perflutren encapsulated in an outer lipid shell consisting of (R) – hexadecanoic acid, 1-[(phosphonoxy)methyl]-1,2-ethanediyl ester, monosodium salt (abbreviated DPPA); (R) - 4-hydroxy-N,N,N-trimethyl-10-oxo-7-[(1-oxohexadecyl)oxy]-3,4,9-trioxa-4-phosphapentacosan-1-aminium, 4-oxide, inner salt (abbreviated DPPC); and (R)-∝-[6-hydroxy-6-oxido-9-[(1-oxohexadecyl)oxy]-5,7,11-trioxa-2-aza-6-phosphahexacos-1-yl]- ω-methoxypoly(ox-1,2-ethanediyl), monosodium salt; commonly called N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3- phosphatidylethanolamine, monosodium salt (abbreviated MPEG5000 DPPE). Perflutren is chemically characterized as 1,1,1,2,2,3,3,3-octafluoropropane. It has a molecular weight of 188, empirical formula of C3F8 and has the following structural formula. DPPA has a molecular weight of 670, empirical formula of C35H68O8PNa, and following structural formula. DPPC has a molecular weight of 734, empirical formula of C40H80NO8P, and following structural formula. MPEG5000 DPPE has an approximate molecular weight of 5750 represented by empirical formula C265H527NO123PNa, contains <100ppm Ca2+ and Mg2+ and the following structural formula. Prior to activation, perflutren is in the headspace of the vial with a concentration of 6.52 mg/mL which is confirmed by positive IR spectroscopic testing in every vial. The lipid blend is in the clear, colorless, hypertonic, sterile liquid. Each mL of the liquid contains 0.75 mg lipid blend (consisting of 0.045 mg DPPA, 0.401 mg DPPC, and 0.304 mg MPEG5000 DPPE) and the following inactive ingredients: 103.5 mg propylene glycol, 126.2 mg glycerin, 2.34 mg sodium phosphate monobasic monohydrate, 2.16 mg sodium phosphate dibasic heptahydrate, and 4.87 mg sodium chloride in water for injection. The pH is 6.2 to 6.8. DEFINITY does not contain bacterial preservative. After activation with the aid of the VIALMIX or VIALMIX RFID, each mL of the activated DEFINITY as homogenous milky white suspension contains a maximum of 1.2 × 1010 perflutren lipid microspheres, and about 150 microL/mL (1.1 mg/mL) perflutren. The microsphere particle size parameters are listed in Table 2 below."
},
{
"NDCCode": "11994-012-01",
"PackageDescription": "10 VIAL in 1 BOX (11994-012-01) > 10 mL in 1 VIAL",
"NDC11Code": "11994-0012-01",
"ProductNDC": "11994-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ablavar",
"NonProprietaryName": "Gadofosveset Trisodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20081212",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021711",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "GADOFOSVESET TRISODIUM",
"StrengthNumber": "244",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-13"
},
{
"NDCCode": "11994-015-01",
"PackageDescription": "25 mL in 1 VIAL, MULTI-DOSE (11994-015-01) ",
"NDC11Code": "11994-0015-01",
"ProductNDC": "11994-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fludeoxyglucose F-18",
"NonProprietaryName": "Fludeoxyglucose F-18",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203664",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "FLUDEOXYGLUCOSE F-18",
"StrengthNumber": "200",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140204",
"SamplePackage": "N"
},
{
"NDCCode": "11994-016-01",
"PackageDescription": "3 mL in 1 VIAL, SINGLE-DOSE (11994-016-01) ",
"NDC11Code": "11994-0016-01",
"ProductNDC": "11994-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quadramet",
"NonProprietaryName": "Samarium Sm 153 Lexidronam",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970519",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020570",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "SAMARIUM SM-153 LEXIDRONAM PENTASODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mCi/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19970519",
"SamplePackage": "N"
},
{
"NDCCode": "11994-017-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (11994-017-01) / .35 mL in 1 VIAL, GLASS",
"NDC11Code": "11994-0017-01",
"ProductNDC": "11994-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Definity Rt",
"NonProprietaryName": "Perflutren",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021064",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "PERFLUTREN",
"StrengthNumber": "6.52",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2024-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "DEFINITY RT is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.",
"Description": "DEFINITY RT (perflutren lipid microsphere) injectable suspension is, after activation, an ultrasound contrast agent for intravenous use. The perflutren lipid microspheres are composed of perflutren encapsulated in an outer lipid shell consisting of (R) – hexadecanoic acid, 1-[(phosphonoxy)methyl]-1,2-ethanediyl ester, monosodium salt (abbreviated DPPA); (R) - 4-hydroxy-N,N,N-trimethyl-10-oxo-7-[(1-oxohexadecyl)oxy]-3,4,9-trioxa-4-phosphapentacosan-1-aminium, 4-oxide, inner salt (abbreviated DPPC); and (R)- ∝-[6-hydroxy-6-oxido-9-[(1-oxohexadecyl)oxy]-5,7,11-trioxa-2-aza-6-phosphahexacos-1-yl]- ω-methoxypoly(ox-1,2-ethanediyl), monosodium salt; commonly called N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3- phosphatidylethanolamine, monosodium salt (abbreviated MPEG5000 DPPE). Perflutren is chemically characterized as 1,1,1,2,2,3,3,3-octafluoropropane. It has a molecular weight of 188, empirical formula of C3F8 and has the following structural formula. DPPA has a molecular weight of 670, empirical formula of C35H68O8PNa, and following structural formula. DPPC has a molecular weight of 734, empirical formula of C40H80NO8P, and following structural formula. MPEG5000 DPPE has an approximate molecular weight of 5750 represented by empirical formula C265H527NO123PNa, contains <100ppm Ca2+ and Mg2+ and the following structural formula. Prior to activation, perflutren is in the headspace of the vial with a concentration of 6.52 mg/mL which is confirmed by positive IR spectroscopic testing in every vial. The lipid blend is in the clear, colorless to translucent (hazy), viscous sterile solution. Each mL of the solution contains 3.75 mg lipid blend (consisting of 0.225 mg DPPA, 2.005 mg DPPC, and 1.520 mg MPEG5000 DPPE) and the following inactive ingredients: 517.5 mg propylene glycol, 631 mg glycerin, 0.370 mg anhydrous sodium acetate, and 0.030 mg glacial acetic acid. The pH is 5.2 to 6.4. DEFINITY RT does not contain bacterial preservative. After activation with the aid of VIALMIX RFID and dilution with 1.4 mL of preservative-free 0.9% Sodium Chloride, Injection, USP, each mL of the activated DEFINITY RT as homogeneous milky white suspension contains 0.045 mg DPPA, 0.401 mg DPPC, 0.304 mg MPEG5000 DPPE, 0.074 mg anhydrous sodium acetate, 0.006 mg glacial acetic acid, a maximum of 1.2 × 1010 perflutren lipid microspheres, and about 80 microL/mL (0.65 mg/mL) perflutren. The microsphere particle size parameters are listed in Table 2 below."
},
{
"NDCCode": "11994-090-01",
"PackageDescription": "1 VIAL in 1 CARTON (11994-090-01) / 12 mL in 1 VIAL",
"NDC11Code": "11994-0090-01",
"ProductNDC": "11994-090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technelite",
"NonProprietaryName": "Technetium Tc99m Generator",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19751101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017771",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
"StrengthNumber": "250",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19751101",
"SamplePackage": "N",
"IndicationAndUsage": "The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.",
"Description": "DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution."
},
{
"NDCCode": "11994-091-03",
"PackageDescription": "1 VIAL in 1 CARTON (11994-091-03) / 16 mL in 1 VIAL",
"NDC11Code": "11994-0091-03",
"ProductNDC": "11994-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technelite",
"NonProprietaryName": "Technetium Tc99m Generator",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19751101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017771",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
"StrengthNumber": "250",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100928",
"SamplePackage": "N",
"IndicationAndUsage": "The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.",
"Description": "DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution."
},
{
"NDCCode": "11994-091-04",
"PackageDescription": "1 VIAL in 1 CARTON (11994-091-04) / 18 mL in 1 VIAL",
"NDC11Code": "11994-0091-04",
"ProductNDC": "11994-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technelite",
"NonProprietaryName": "Technetium Tc99m Generator",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19751101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017771",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
"StrengthNumber": "250",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100928",
"SamplePackage": "N",
"IndicationAndUsage": "The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.",
"Description": "DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution."
},
{
"NDCCode": "11994-091-05",
"PackageDescription": "1 VIAL in 1 CARTON (11994-091-05) / 20 mL in 1 VIAL",
"NDC11Code": "11994-0091-05",
"ProductNDC": "11994-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technelite",
"NonProprietaryName": "Technetium Tc99m Generator",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19751101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017771",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
"StrengthNumber": "250",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100928",
"SamplePackage": "N",
"IndicationAndUsage": "The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.",
"Description": "DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution."
},
{
"NDCCode": "11994-091-06",
"PackageDescription": "1 VIAL in 1 CARTON (11994-091-06) / 24 mL in 1 VIAL",
"NDC11Code": "11994-0091-06",
"ProductNDC": "11994-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technelite",
"NonProprietaryName": "Technetium Tc99m Generator",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19751101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017771",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
"StrengthNumber": "250",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100928",
"SamplePackage": "N",
"IndicationAndUsage": "The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.",
"Description": "DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution."
},
{
"NDCCode": "11994-091-07",
"PackageDescription": "1 VIAL in 1 CARTON (11994-091-07) / 30 mL in 1 VIAL",
"NDC11Code": "11994-0091-07",
"ProductNDC": "11994-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technelite",
"NonProprietaryName": "Technetium Tc99m Generator",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19751101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017771",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
"StrengthNumber": "250",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100928",
"SamplePackage": "N",
"IndicationAndUsage": "The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.",
"Description": "DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution."
},
{
"NDCCode": "11994-091-09",
"PackageDescription": "1 VIAL in 1 CARTON (11994-091-09) / 40 mL in 1 VIAL",
"NDC11Code": "11994-0091-09",
"ProductNDC": "11994-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technelite",
"NonProprietaryName": "Technetium Tc99m Generator",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19751101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017771",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
"StrengthNumber": "250",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100928",
"SamplePackage": "N",
"IndicationAndUsage": "The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.",
"Description": "DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution."
},
{
"NDCCode": "11994-091-10",
"PackageDescription": "1 VIAL in 1 CARTON (11994-091-10) / 50 mL in 1 VIAL",
"NDC11Code": "11994-0091-10",
"ProductNDC": "11994-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technelite",
"NonProprietaryName": "Technetium Tc99m Generator",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19751101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017771",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
"StrengthNumber": "250",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100928",
"SamplePackage": "N",
"IndicationAndUsage": "The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.",
"Description": "DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution."
},
{
"NDCCode": "11994-091-11",
"PackageDescription": "1 VIAL in 1 CARTON (11994-091-11) / 60 mL in 1 VIAL",
"NDC11Code": "11994-0091-11",
"ProductNDC": "11994-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technelite",
"NonProprietaryName": "Technetium Tc99m Generator",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19751101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017771",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
"StrengthNumber": "250",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100928",
"SamplePackage": "N",
"IndicationAndUsage": "The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.",
"Description": "DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution."
},
{
"NDCCode": "11994-091-12",
"PackageDescription": "1 VIAL in 1 CARTON (11994-091-12) / 72 mL in 1 VIAL",
"NDC11Code": "11994-0091-12",
"ProductNDC": "11994-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technelite",
"NonProprietaryName": "Technetium Tc99m Generator",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19751101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017771",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
"StrengthNumber": "250",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100928",
"SamplePackage": "N",
"IndicationAndUsage": "The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.",
"Description": "DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution."
},
{
"NDCCode": "11994-091-13",
"PackageDescription": "1 VIAL in 1 CARTON (11994-091-13) / 80 mL in 1 VIAL",
"NDC11Code": "11994-0091-13",
"ProductNDC": "11994-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technelite",
"NonProprietaryName": "Technetium Tc99m Generator",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19751101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017771",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
"StrengthNumber": "250",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100928",
"SamplePackage": "N",
"IndicationAndUsage": "The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.",
"Description": "DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution."
},
{
"NDCCode": "11994-091-36",
"PackageDescription": "1 VIAL in 1 CARTON (11994-091-36) / 4 mL in 1 VIAL",
"NDC11Code": "11994-0091-36",
"ProductNDC": "11994-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technelite",
"NonProprietaryName": "Technetium Tc99m Generator",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19751101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017771",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
"StrengthNumber": "250",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100928",
"SamplePackage": "N",
"IndicationAndUsage": "The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.",
"Description": "DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution."
},
{
"NDCCode": "11994-091-73",
"PackageDescription": "1 VIAL in 1 CARTON (11994-091-73) / 8 mL in 1 VIAL",
"NDC11Code": "11994-0091-73",
"ProductNDC": "11994-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technelite",
"NonProprietaryName": "Technetium Tc99m Generator",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19751101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017771",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
"StrengthNumber": "250",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100928",
"SamplePackage": "N",
"IndicationAndUsage": "The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.",
"Description": "DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution."
},
{
"NDCCode": "11994-091-92",
"PackageDescription": "1 VIAL in 1 CARTON (11994-091-92) / 10 mL in 1 VIAL",
"NDC11Code": "11994-0091-92",
"ProductNDC": "11994-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Technelite",
"NonProprietaryName": "Technetium Tc99m Generator",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19751101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017771",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
"StrengthNumber": "250",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100928",
"SamplePackage": "N",
"IndicationAndUsage": "The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.",
"Description": "DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution."
},
{
"NDCCode": "11994-012-02",
"PackageDescription": "10 VIAL in 1 BOX (11994-012-02) > 15 mL in 1 VIAL",
"NDC11Code": "11994-0012-02",
"ProductNDC": "11994-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ablavar",
"NonProprietaryName": "Gadofosveset Trisodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20081212",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021711",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "GADOFOSVESET TRISODIUM",
"StrengthNumber": "244",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-13"
},
{
"NDCCode": "10812-091-01",
"PackageDescription": "9.9 g in 1 CONTAINER (10812-091-01)",
"NDC11Code": "10812-0091-01",
"ProductNDC": "10812-091",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Healthy Skin Compact Makeup",
"ProprietaryNameSuffix": "Spf 55 Classic Ivory 10",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101206",
"EndMarketingDate": "20180901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "28; 80; 40; 90; 40",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2018-09-05",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "11489-091-01",
"PackageDescription": "1 JAR in 1 CARTON (11489-091-01) > 50 g in 1 JAR",
"NDC11Code": "11489-0091-01",
"ProductNDC": "11489-091",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No7 Lift And Luminate Day Cream Spf 15",
"NonProprietaryName": "Avobenzone,octisalate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151010",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "BCM Ltd",
"SubstanceName": "AVOBENZONE; OCTOCRYLENE; OCTISALATE",
"StrengthNumber": "1.5; 2; 1",
"StrengthUnit": "g/50g; g/50g; g/50g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Directions. Apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. Limit time in the sun, especially from 10 a.m - 2 p.m. wear long-sleeved shirts,pants,hats and sunglasses.",
"Description": "Reduces the appearance of wrinkles, visibly lifts and evens skin tone in just 2 weeks. The improved formulation from No7 contains brightening technology from our clinically proven Lift and Luminate Day and Night serum. It effectively targets the 3 key signs of visible aging in older skin. 1.Lines and wrinkles 2. Lack of firmness 3. Uneven skin tone. In 2 weeks wrinkles are visbly reduced, skin appears lifted and skn tone is more even. Formulated by No7, leaders in antiaging skin care science. For Best Results: After cleansing massage in small upward circles over your face and neck."
},
{
"NDCCode": "11673-091-01",
"PackageDescription": "30 mL in 1 BOTTLE, WITH APPLICATOR (11673-091-01) ",
"NDC11Code": "11673-0091-01",
"ProductNDC": "11673-091",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tolnaftate",
"NonProprietaryName": "Antifungal Liquid Maximum Strength",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210215",
"EndMarketingDate": "20250530",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Target Corporation",
"SubstanceName": "TOLNAFTATE",
"StrengthNumber": ".3",
"StrengthUnit": "g/30mL",
"Status": "Deprecated",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210215",
"EndMarketingDatePackage": "20250530",
"SamplePackage": "N",
"IndicationAndUsage": "proven clinically effective in the treatment of athlete's foot (tinea pedis) and ringworm (tinea corporis). prevents the recurrences of athlete's foot with daily use. for effective relief of itching, burning, cracking, redness and scaling."
},
{
"NDCCode": "13537-091-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-091-02) > 4 g in 1 TUBE (13537-091-01)",
"NDC11Code": "13537-0091-02",
"ProductNDC": "13537-091",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20",
"ProprietaryNameSuffix": "(rouge Intense) - Red",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161104",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".071; .16",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14141-091-01",
"PackageDescription": "30 g in 1 TUBE (14141-091-01) ",
"NDC11Code": "14141-0091-01",
"ProductNDC": "14141-091",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 15 Claire 2",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201112",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bel Star S.A. (Colombia)",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "6.5; 2.44; 1.57",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201112",
"SamplePackage": "N"
},
{
"NDCCode": "20151-091-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (20151-091-02) > 50 mL in 1 BOTTLE (20151-091-01)",
"NDC11Code": "20151-0091-02",
"ProductNDC": "20151-091",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydra Lifting Firming Moisturizing Cream",
"NonProprietaryName": "Glycerin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170225",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Casmara Cosmetics, SA",
"SubstanceName": "GLYCERIN",
"StrengthNumber": "11",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "apply every day gently onto clean face and neck. . can be used in the morning and/or night."
},
{
"NDCCode": "27808-091-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (27808-091-01) ",
"NDC11Code": "27808-0091-01",
"ProductNDC": "27808-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20011130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207901",
"LabelerName": "Cranbury Pharmaceuticals, LLC",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20011130",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmethylphenidate hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].",
"Description": "Dexmethylphenidate hydrochloride tablets contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Dexmethylphenidate hydrochloride tablet is a central nervous system (CNS) stimulant, available in 3 tablet strengths. Dexmethylphenidate hydrochloride tablet is available as 2.5 mg, 5 mg, and 10 mg strength tablets for oral administration. Chemically, dexmethylphenidate hydrochloride tablet is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note: * = asymmetric carbon centers. Dexmethylphenidate hydrochloride tablet is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and FD&C Blue No.1 aluminum lake (2.5 mg tablets), D&C Yellow Lake No. 10 (5 mg tablets); the 10 mg tablets contain no dye."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
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<ProductNDC>11994-091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<ApplicationNumber>NDA017771</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
<Description>DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution.</Description>
</NDC>
<NDC>
<NDCCode>11994-006-02</NDCCode>
<PackageDescription>2 KIT in 1 PACKAGE, COMBINATION (11994-006-02) > 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (11994-002-01) * 1 mL in 1 VIAL (11994-004-01) </PackageDescription>
<NDC11Code>11994-0006-02</NDC11Code>
<ProductNDC>11994-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neurolite</ProprietaryName>
<NonProprietaryName>Bicisate Dihydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19941123</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020256</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19941123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Neurolite single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed. Neurolite is not indicated for assessment of functional viability of brain tissue. Also, Neurolite is not indicated for distinguishing between stroke and other brain lesions.</IndicationAndUsage>
<Description>This kit formulation consists of two nonradioactive vials: Vial A contains bicisate dihydrochloride (N, N'-1,2-ethylenediylbis-L-cysteine diethyl ester dihydrochloride) and a reducing agent as a lyophilized solid and vial B contains a buffer solution. Both vials are sterile and non-pyrogenic. The contents of vial A are lyophilized and stored under nitrogen. The pH of the solution before lyophilization is 2.7 ± 0.25. This vial is stored at 15-25°C. Protect from light. The contents of vial B are stored under air. The pH of the solution is 7.6 ± 0.4. This vial is stored at 15-25°C. This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection. The precise structure of the Technetium complex is [N, N'-ethylenedi-L-cysteinato(3-)]oxo[99mTc] technetium (V), diethyl ester.</Description>
</NDC>
<NDC>
<NDCCode>11994-006-05</NDCCode>
<PackageDescription>5 KIT in 1 PACKAGE, COMBINATION (11994-006-05) > 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (11994-002-01) * 1 mL in 1 VIAL (11994-004-01) </PackageDescription>
<NDC11Code>11994-0006-05</NDC11Code>
<ProductNDC>11994-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neurolite</ProprietaryName>
<NonProprietaryName>Bicisate Dihydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19941123</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020256</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19941123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Neurolite single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed. Neurolite is not indicated for assessment of functional viability of brain tissue. Also, Neurolite is not indicated for distinguishing between stroke and other brain lesions.</IndicationAndUsage>
<Description>This kit formulation consists of two nonradioactive vials: Vial A contains bicisate dihydrochloride (N, N'-1,2-ethylenediylbis-L-cysteine diethyl ester dihydrochloride) and a reducing agent as a lyophilized solid and vial B contains a buffer solution. Both vials are sterile and non-pyrogenic. The contents of vial A are lyophilized and stored under nitrogen. The pH of the solution before lyophilization is 2.7 ± 0.25. This vial is stored at 15-25°C. Protect from light. The contents of vial B are stored under air. The pH of the solution is 7.6 ± 0.4. This vial is stored at 15-25°C. This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection. The precise structure of the Technetium complex is [N, N'-ethylenedi-L-cysteinato(3-)]oxo[99mTc] technetium (V), diethyl ester.</Description>
</NDC>
<NDC>
<NDCCode>11994-011-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (11994-011-01) / 1.5 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>11994-0011-01</NDC11Code>
<ProductNDC>11994-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Definity</ProprietaryName>
<NonProprietaryName>Perflutren</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20010731</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021064</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>PERFLUTREN</SubstanceName>
<StrengthNumber>6.52</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DEFINITY is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.</IndicationAndUsage>
<Description>DEFINITY (perflutren lipid microsphere) injectable suspension is, after activation an ultrasound contrast agent for intravenous use. The perflutren lipid microspheres are composed of perflutren encapsulated in an outer lipid shell consisting of (R) – hexadecanoic acid, 1-[(phosphonoxy)methyl]-1,2-ethanediyl ester, monosodium salt (abbreviated DPPA); (R) - 4-hydroxy-N,N,N-trimethyl-10-oxo-7-[(1-oxohexadecyl)oxy]-3,4,9-trioxa-4-phosphapentacosan-1-aminium, 4-oxide, inner salt (abbreviated DPPC); and (R)-∝-[6-hydroxy-6-oxido-9-[(1-oxohexadecyl)oxy]-5,7,11-trioxa-2-aza-6-phosphahexacos-1-yl]- ω-methoxypoly(ox-1,2-ethanediyl), monosodium salt; commonly called N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3- phosphatidylethanolamine, monosodium salt (abbreviated MPEG5000 DPPE). Perflutren is chemically characterized as 1,1,1,2,2,3,3,3-octafluoropropane. It has a molecular weight of 188, empirical formula of C3F8 and has the following structural formula. DPPA has a molecular weight of 670, empirical formula of C35H68O8PNa, and following structural formula. DPPC has a molecular weight of 734, empirical formula of C40H80NO8P, and following structural formula. MPEG5000 DPPE has an approximate molecular weight of 5750 represented by empirical formula C265H527NO123PNa, contains <100ppm Ca2+ and Mg2+ and the following structural formula. Prior to activation, perflutren is in the headspace of the vial with a concentration of 6.52 mg/mL which is confirmed by positive IR spectroscopic testing in every vial. The lipid blend is in the clear, colorless, hypertonic, sterile liquid. Each mL of the liquid contains 0.75 mg lipid blend (consisting of 0.045 mg DPPA, 0.401 mg DPPC, and 0.304 mg MPEG5000 DPPE) and the following inactive ingredients: 103.5 mg propylene glycol, 126.2 mg glycerin, 2.34 mg sodium phosphate monobasic monohydrate, 2.16 mg sodium phosphate dibasic heptahydrate, and 4.87 mg sodium chloride in water for injection. The pH is 6.2 to 6.8. DEFINITY does not contain bacterial preservative. After activation with the aid of the VIALMIX or VIALMIX RFID, each mL of the activated DEFINITY as homogenous milky white suspension contains a maximum of 1.2 × 1010 perflutren lipid microspheres, and about 150 microL/mL (1.1 mg/mL) perflutren. The microsphere particle size parameters are listed in Table 2 below.</Description>
</NDC>
<NDC>
<NDCCode>11994-012-01</NDCCode>
<PackageDescription>10 VIAL in 1 BOX (11994-012-01) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>11994-0012-01</NDC11Code>
<ProductNDC>11994-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ablavar</ProprietaryName>
<NonProprietaryName>Gadofosveset Trisodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20081212</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021711</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>GADOFOSVESET TRISODIUM</SubstanceName>
<StrengthNumber>244</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>11994-015-01</NDCCode>
<PackageDescription>25 mL in 1 VIAL, MULTI-DOSE (11994-015-01) </PackageDescription>
<NDC11Code>11994-0015-01</NDC11Code>
<ProductNDC>11994-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fludeoxyglucose F-18</ProprietaryName>
<NonProprietaryName>Fludeoxyglucose F-18</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203664</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>FLUDEOXYGLUCOSE F-18</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11994-016-01</NDCCode>
<PackageDescription>3 mL in 1 VIAL, SINGLE-DOSE (11994-016-01) </PackageDescription>
<NDC11Code>11994-0016-01</NDC11Code>
<ProductNDC>11994-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quadramet</ProprietaryName>
<NonProprietaryName>Samarium Sm 153 Lexidronam</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970519</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020570</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>SAMARIUM SM-153 LEXIDRONAM PENTASODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11994-017-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (11994-017-01) / .35 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>11994-0017-01</NDC11Code>
<ProductNDC>11994-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Definity Rt</ProprietaryName>
<NonProprietaryName>Perflutren</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021064</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>PERFLUTREN</SubstanceName>
<StrengthNumber>6.52</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DEFINITY RT is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.</IndicationAndUsage>
<Description>DEFINITY RT (perflutren lipid microsphere) injectable suspension is, after activation, an ultrasound contrast agent for intravenous use. The perflutren lipid microspheres are composed of perflutren encapsulated in an outer lipid shell consisting of (R) – hexadecanoic acid, 1-[(phosphonoxy)methyl]-1,2-ethanediyl ester, monosodium salt (abbreviated DPPA); (R) - 4-hydroxy-N,N,N-trimethyl-10-oxo-7-[(1-oxohexadecyl)oxy]-3,4,9-trioxa-4-phosphapentacosan-1-aminium, 4-oxide, inner salt (abbreviated DPPC); and (R)- ∝-[6-hydroxy-6-oxido-9-[(1-oxohexadecyl)oxy]-5,7,11-trioxa-2-aza-6-phosphahexacos-1-yl]- ω-methoxypoly(ox-1,2-ethanediyl), monosodium salt; commonly called N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3- phosphatidylethanolamine, monosodium salt (abbreviated MPEG5000 DPPE). Perflutren is chemically characterized as 1,1,1,2,2,3,3,3-octafluoropropane. It has a molecular weight of 188, empirical formula of C3F8 and has the following structural formula. DPPA has a molecular weight of 670, empirical formula of C35H68O8PNa, and following structural formula. DPPC has a molecular weight of 734, empirical formula of C40H80NO8P, and following structural formula. MPEG5000 DPPE has an approximate molecular weight of 5750 represented by empirical formula C265H527NO123PNa, contains <100ppm Ca2+ and Mg2+ and the following structural formula. Prior to activation, perflutren is in the headspace of the vial with a concentration of 6.52 mg/mL which is confirmed by positive IR spectroscopic testing in every vial. The lipid blend is in the clear, colorless to translucent (hazy), viscous sterile solution. Each mL of the solution contains 3.75 mg lipid blend (consisting of 0.225 mg DPPA, 2.005 mg DPPC, and 1.520 mg MPEG5000 DPPE) and the following inactive ingredients: 517.5 mg propylene glycol, 631 mg glycerin, 0.370 mg anhydrous sodium acetate, and 0.030 mg glacial acetic acid. The pH is 5.2 to 6.4. DEFINITY RT does not contain bacterial preservative. After activation with the aid of VIALMIX RFID and dilution with 1.4 mL of preservative-free 0.9% Sodium Chloride, Injection, USP, each mL of the activated DEFINITY RT as homogeneous milky white suspension contains 0.045 mg DPPA, 0.401 mg DPPC, 0.304 mg MPEG5000 DPPE, 0.074 mg anhydrous sodium acetate, 0.006 mg glacial acetic acid, a maximum of 1.2 × 1010 perflutren lipid microspheres, and about 80 microL/mL (0.65 mg/mL) perflutren. The microsphere particle size parameters are listed in Table 2 below.</Description>
</NDC>
<NDC>
<NDCCode>11994-090-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (11994-090-01) / 12 mL in 1 VIAL</PackageDescription>
<NDC11Code>11994-0090-01</NDC11Code>
<ProductNDC>11994-090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Technelite</ProprietaryName>
<NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19751101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017771</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19751101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
<Description>DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution.</Description>
</NDC>
<NDC>
<NDCCode>11994-091-03</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (11994-091-03) / 16 mL in 1 VIAL</PackageDescription>
<NDC11Code>11994-0091-03</NDC11Code>
<ProductNDC>11994-091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Technelite</ProprietaryName>
<NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19751101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017771</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
<Description>DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution.</Description>
</NDC>
<NDC>
<NDCCode>11994-091-04</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (11994-091-04) / 18 mL in 1 VIAL</PackageDescription>
<NDC11Code>11994-0091-04</NDC11Code>
<ProductNDC>11994-091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Technelite</ProprietaryName>
<NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19751101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017771</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
<Description>DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution.</Description>
</NDC>
<NDC>
<NDCCode>11994-091-05</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (11994-091-05) / 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>11994-0091-05</NDC11Code>
<ProductNDC>11994-091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Technelite</ProprietaryName>
<NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19751101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017771</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
<Description>DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution.</Description>
</NDC>
<NDC>
<NDCCode>11994-091-06</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (11994-091-06) / 24 mL in 1 VIAL</PackageDescription>
<NDC11Code>11994-0091-06</NDC11Code>
<ProductNDC>11994-091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<StartMarketingDate>19751101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017771</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
<Description>DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution.</Description>
</NDC>
<NDC>
<NDCCode>11994-091-07</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (11994-091-07) / 30 mL in 1 VIAL</PackageDescription>
<NDC11Code>11994-0091-07</NDC11Code>
<ProductNDC>11994-091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Technelite</ProprietaryName>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19751101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017771</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
<Description>DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution.</Description>
</NDC>
<NDC>
<NDCCode>11994-091-09</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (11994-091-09) / 40 mL in 1 VIAL</PackageDescription>
<NDC11Code>11994-0091-09</NDC11Code>
<ProductNDC>11994-091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Technelite</ProprietaryName>
<NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19751101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017771</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
<Description>DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution.</Description>
</NDC>
<NDC>
<NDCCode>11994-091-10</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (11994-091-10) / 50 mL in 1 VIAL</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19751101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
<Description>DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution.</Description>
</NDC>
<NDC>
<NDCCode>11994-091-11</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (11994-091-11) / 60 mL in 1 VIAL</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
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<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
<Description>DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution.</Description>
</NDC>
<NDC>
<NDCCode>11994-091-12</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (11994-091-12) / 72 mL in 1 VIAL</PackageDescription>
<NDC11Code>11994-0091-12</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
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<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
<Description>DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution.</Description>
</NDC>
<NDC>
<NDCCode>11994-091-13</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (11994-091-13) / 80 mL in 1 VIAL</PackageDescription>
<NDC11Code>11994-0091-13</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<StartMarketingDate>19751101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017771</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
<Description>DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution.</Description>
</NDC>
<NDC>
<NDCCode>11994-091-36</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (11994-091-36) / 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>11994-0091-36</NDC11Code>
<ProductNDC>11994-091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Technelite</ProprietaryName>
<NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19751101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017771</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
<Description>DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution.</Description>
</NDC>
<NDC>
<NDCCode>11994-091-73</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (11994-091-73) / 8 mL in 1 VIAL</PackageDescription>
<NDC11Code>11994-0091-73</NDC11Code>
<ProductNDC>11994-091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Technelite</ProprietaryName>
<NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19751101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017771</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
<Description>DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution.</Description>
</NDC>
<NDC>
<NDCCode>11994-091-92</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (11994-091-92) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>11994-0091-92</NDC11Code>
<ProductNDC>11994-091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Technelite</ProprietaryName>
<NonProprietaryName>Technetium Tc99m Generator</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19751101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017771</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>TECHNETIUM TC-99M SODIUM PERTECHNETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: 1 Thyroid Imaging, 2 Salivary Gland Imaging, 3 Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux., 4 Nasolacrimal Drainage System Imaging.</IndicationAndUsage>
<Description>DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator, is in 0.9% Sodium Chloride Injection, USP as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the TECHNELITE®, Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micrograms of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which must be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after the elution (12 hours). Lantheus Medical Imaging, Inc. TECHNELITE®, Technetium Tc 99m Generator consists of a column containing uranium fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in a cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells marked SALINE CHARGE and COLLECT. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consists of 0.9% Sodium Chloride Injection, USP, prepacked into septum-sealed vials, to make the solution isotonic. The eluate collection vial is evacuated, sterile and non-pyrogenic. A sterile 0.22 micrometer bacteriological filter is incorporated between the column outlet and the collection vials. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a silicone needle seal over the charge needle and a vented needle cover over the collect needle. A sterile collect needle seal is supplied for the customer to aseptically reseal the collect needle after each elution.</Description>
</NDC>
<NDC>
<NDCCode>11994-012-02</NDCCode>
<PackageDescription>10 VIAL in 1 BOX (11994-012-02) > 15 mL in 1 VIAL</PackageDescription>
<NDC11Code>11994-0012-02</NDC11Code>
<ProductNDC>11994-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ablavar</ProprietaryName>
<NonProprietaryName>Gadofosveset Trisodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20081212</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021711</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>GADOFOSVESET TRISODIUM</SubstanceName>
<StrengthNumber>244</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>10812-091-01</NDCCode>
<PackageDescription>9.9 g in 1 CONTAINER (10812-091-01)</PackageDescription>
<NDC11Code>10812-0091-01</NDC11Code>
<ProductNDC>10812-091</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Healthy Skin Compact Makeup</ProprietaryName>
<ProprietaryNameSuffix>Spf 55 Classic Ivory 10</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101206</StartMarketingDate>
<EndMarketingDate>20180901</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>28; 80; 40; 90; 40</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-09-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>11489-091-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (11489-091-01) > 50 g in 1 JAR</PackageDescription>
<NDC11Code>11489-0091-01</NDC11Code>
<ProductNDC>11489-091</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No7 Lift And Luminate Day Cream Spf 15</ProprietaryName>
<NonProprietaryName>Avobenzone,octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151010</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>BCM Ltd</LabelerName>
<SubstanceName>AVOBENZONE; OCTOCRYLENE; OCTISALATE</SubstanceName>
<StrengthNumber>1.5; 2; 1</StrengthNumber>
<StrengthUnit>g/50g; g/50g; g/50g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions. Apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. Limit time in the sun, especially from 10 a.m - 2 p.m. wear long-sleeved shirts,pants,hats and sunglasses.</IndicationAndUsage>
<Description>Reduces the appearance of wrinkles, visibly lifts and evens skin tone in just 2 weeks. The improved formulation from No7 contains brightening technology from our clinically proven Lift and Luminate Day and Night serum. It effectively targets the 3 key signs of visible aging in older skin. 1.Lines and wrinkles 2. Lack of firmness 3. Uneven skin tone. In 2 weeks wrinkles are visbly reduced, skin appears lifted and skn tone is more even. Formulated by No7, leaders in antiaging skin care science. For Best Results: After cleansing massage in small upward circles over your face and neck.</Description>
</NDC>
<NDC>
<NDCCode>11673-091-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, WITH APPLICATOR (11673-091-01) </PackageDescription>
<NDC11Code>11673-0091-01</NDC11Code>
<ProductNDC>11673-091</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tolnaftate</ProprietaryName>
<NonProprietaryName>Antifungal Liquid Maximum Strength</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210215</StartMarketingDate>
<EndMarketingDate>20250530</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>TOLNAFTATE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>g/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210215</StartMarketingDatePackage>
<EndMarketingDatePackage>20250530</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>proven clinically effective in the treatment of athlete's foot (tinea pedis) and ringworm (tinea corporis). prevents the recurrences of athlete's foot with daily use. for effective relief of itching, burning, cracking, redness and scaling.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13537-091-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-091-02) > 4 g in 1 TUBE (13537-091-01)</PackageDescription>
<NDC11Code>13537-0091-02</NDC11Code>
<ProductNDC>13537-091</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20</ProprietaryName>
<ProprietaryNameSuffix>(rouge Intense) - Red</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.071; .16</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14141-091-01</NDCCode>
<PackageDescription>30 g in 1 TUBE (14141-091-01) </PackageDescription>
<NDC11Code>14141-0091-01</NDC11Code>
<ProductNDC>14141-091</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 15 Claire 2</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bel Star S.A. (Colombia)</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>6.5; 2.44; 1.57</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>20151-091-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (20151-091-02) > 50 mL in 1 BOTTLE (20151-091-01)</PackageDescription>
<NDC11Code>20151-0091-02</NDC11Code>
<ProductNDC>20151-091</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydra Lifting Firming Moisturizing Cream</ProprietaryName>
<NonProprietaryName>Glycerin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170225</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Casmara Cosmetics, SA</LabelerName>
<SubstanceName>GLYCERIN</SubstanceName>
<StrengthNumber>11</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>apply every day gently onto clean face and neck. . can be used in the morning and/or night.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>27808-091-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (27808-091-01) </PackageDescription>
<NDC11Code>27808-0091-01</NDC11Code>
<ProductNDC>27808-091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20011130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207901</ApplicationNumber>
<LabelerName>Cranbury Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20011130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmethylphenidate hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dexmethylphenidate hydrochloride tablets contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Dexmethylphenidate hydrochloride tablet is a central nervous system (CNS) stimulant, available in 3 tablet strengths. Dexmethylphenidate hydrochloride tablet is available as 2.5 mg, 5 mg, and 10 mg strength tablets for oral administration. Chemically, dexmethylphenidate hydrochloride tablet is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Note: * = asymmetric carbon centers. Dexmethylphenidate hydrochloride tablet is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and FD&C Blue No.1 aluminum lake (2.5 mg tablets), D&C Yellow Lake No. 10 (5 mg tablets); the 10 mg tablets contain no dye.</Description>
</NDC>
</NDCList>