{
"NDC": [
{
"NDCCode": "71858-0145-1",
"PackageDescription": "2 POUCH in 1 CARTON (71858-0145-1) / 5 AMPULE in 1 POUCH (71858-0145-4) / 1 mL in 1 AMPULE (71858-0145-6) ",
"NDC11Code": "71858-0145-01",
"ProductNDC": "71858-0145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirosint",
"ProprietaryNameSuffix": "Sol",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206977",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "137",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190301",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "Y",
"IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
},
{
"NDCCode": "71858-0145-2",
"PackageDescription": "6 POUCH in 1 CARTON (71858-0145-2) / 5 AMPULE in 1 POUCH (71858-0145-4) / 1 mL in 1 AMPULE (71858-0145-6) ",
"NDC11Code": "71858-0145-02",
"ProductNDC": "71858-0145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirosint",
"ProprietaryNameSuffix": "Sol",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206977",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "137",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250725",
"SamplePackage": "Y",
"IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
},
{
"NDCCode": "71858-0145-5",
"PackageDescription": "6 POUCH in 1 CARTON (71858-0145-5) / 5 AMPULE in 1 POUCH (71858-0145-4) / 1 mL in 1 AMPULE (71858-0145-6) ",
"NDC11Code": "71858-0145-05",
"ProductNDC": "71858-0145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirosint",
"ProprietaryNameSuffix": "Sol",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206977",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "137",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N",
"IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
},
{
"NDCCode": "0145-0002-61",
"PackageDescription": "10 TUBE in 1 CARTON (0145-0002-61) > 5 g in 1 TUBE (0145-0002-03)",
"NDC11Code": "00145-0002-61",
"ProductNDC": "0145-0002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vusion",
"NonProprietaryName": "Miconazole Nitrate, Zinc Oxide, White Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070514",
"EndMarketingDate": "20140930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021026",
"LabelerName": "Stiefel Laboratories Inc",
"SubstanceName": "MICONAZOLE NITRATE; PETROLATUM; ZINC OXIDE",
"StrengthNumber": "2.5; 813.5; 150",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Pharm_Classes": "Azole Antifungal [EPC],Azoles [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-10-03"
},
{
"NDCCode": "0145-0628-62",
"PackageDescription": "20 TUBE in 1 CARTON (0145-0628-62) > 5 mL in 1 TUBE (0145-0628-61) ",
"NDC11Code": "00145-0628-62",
"ProductNDC": "0145-0628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sarna",
"NonProprietaryName": "Camphor And Menthol",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110222",
"EndMarketingDate": "20201031",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Stiefel Laboratories, Inc",
"SubstanceName": "CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": ".6; .6",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110222",
"EndMarketingDatePackage": "20200130",
"SamplePackage": "N"
},
{
"NDCCode": "0145-0630-62",
"PackageDescription": "20 TUBE in 1 CARTON (0145-0630-62) > 5 mL in 1 TUBE (0145-0630-61) ",
"NDC11Code": "00145-0630-62",
"ProductNDC": "0145-0630",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sarna",
"NonProprietaryName": "Pramoxine Hydrochloride",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110222",
"EndMarketingDate": "20200930",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Stiefel Laboratories, Inc",
"SubstanceName": "PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110222",
"EndMarketingDatePackage": "20191231",
"SamplePackage": "N"
},
{
"NDCCode": "0145-2651-63",
"PackageDescription": "20 TUBE in 1 CARTON (0145-2651-63) > 5 g in 1 TUBE (0145-2651-61)",
"NDC11Code": "00145-2651-63",
"ProductNDC": "0145-2651",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Panoxyl",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140408",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Stiefel Laboratories Inc",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "0145-2660-62",
"PackageDescription": "20 TUBE in 1 CARTON (0145-2660-62) > 5 g in 1 TUBE (0145-2660-61) ",
"NDC11Code": "00145-2660-62",
"ProductNDC": "0145-2660",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Panoxyl",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110325",
"EndMarketingDate": "20201031",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Stiefel Laboratories Inc",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "58.7",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110325",
"EndMarketingDatePackage": "20201031",
"SamplePackage": "N"
},
{
"NDCCode": "0145-5371-61",
"PackageDescription": "20 TUBE in 1 CARTON (0145-5371-61) > 5 g in 1 TUBE (0145-5371-01)",
"NDC11Code": "00145-5371-61",
"ProductNDC": "0145-5371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duac",
"NonProprietaryName": "Clindamycin Phosphate And Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050741",
"LabelerName": "Stiefel Laboratories Inc",
"SubstanceName": "BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "50; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-08-17"
},
{
"NDCCode": "0430-0145-14",
"PackageDescription": "5 POUCH in 1 CARTON (0430-0145-14) > 1 BLISTER PACK in 1 POUCH > 28 TABLET in 1 BLISTER PACK",
"NDC11Code": "00430-0145-14",
"ProductNDC": "0430-0145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Femhrt",
"NonProprietaryName": "Norethindrone Acetate/ethinyl Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091001",
"EndMarketingDate": "20220430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021065",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "ETHINYL ESTRADIOL; NORETHINDRONE ACETATE",
"StrengthNumber": "2.5; .5",
"StrengthUnit": "ug/1; mg/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20091001",
"EndMarketingDatePackage": "20220430",
"SamplePackage": "N"
},
{
"NDCCode": "15631-0145-5",
"PackageDescription": "12500 PELLET in 1 PACKAGE (15631-0145-5) ",
"NDC11Code": "15631-0145-05",
"ProductNDC": "15631-0145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cocculus Indicus",
"NonProprietaryName": "Cocculus Indicus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151002",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "ANAMIRTA COCCULUS SEED",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "49288-0145-2",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0145-2)",
"NDC11Code": "49288-0145-02",
"ProductNDC": "49288-0145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reed Canary Grass",
"NonProprietaryName": "Reed Canary Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "PHALARIS ARUNDINACEA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "49288-0145-5",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0145-5)",
"NDC11Code": "49288-0145-05",
"ProductNDC": "49288-0145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reed Canary Grass",
"NonProprietaryName": "Reed Canary Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "PHALARIS ARUNDINACEA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "51552-0145-3",
"PackageDescription": "5 g in 1 CONTAINER (51552-0145-3) ",
"NDC11Code": "51552-0145-03",
"ProductNDC": "51552-0145",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "POWDER",
"StartMarketingDate": "19980401",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "01-APR-98",
"EndMarketingDatePackage": "31-AUG-22"
},
{
"NDCCode": "51552-0145-5",
"PackageDescription": "100 g in 1 CONTAINER (51552-0145-5) ",
"NDC11Code": "51552-0145-05",
"ProductNDC": "51552-0145",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "POWDER",
"StartMarketingDate": "19980401",
"EndMarketingDate": "20270331",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2023-10-31",
"StartMarketingDatePackage": "01-APR-98",
"EndMarketingDatePackage": "31-MAR-27"
},
{
"NDCCode": "66478-0145-5",
"PackageDescription": "1 BAG in 1 DRUM (66478-0145-5) / 25000 g in 1 BAG (66478-0145-6) ",
"NDC11Code": "66478-0145-05",
"ProductNDC": "66478-0145",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20131108",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Nanjing White Whale Pharmaceutical Co., Ltd",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-10-03",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "08-NOV-13"
},
{
"NDCCode": "71335-0145-5",
"PackageDescription": "56 TABLET in 1 BOTTLE (71335-0145-5) ",
"NDC11Code": "71335-0145-05",
"ProductNDC": "71335-0145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202556",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211227",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
"Description": "Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula:. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, FD & C yellow, lactose monohydrate, magnesium stearate, pregelatinized starch (starch 1500) and sodium starch glycolate."
},
{
"NDCCode": "71858-0105-1",
"PackageDescription": "2 POUCH in 1 CARTON (71858-0105-1) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) ",
"NDC11Code": "71858-0105-01",
"ProductNDC": "71858-0105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirosint",
"ProprietaryNameSuffix": "Sol",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206977",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "13",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190301",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "Y",
"IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
},
{
"NDCCode": "71858-0105-2",
"PackageDescription": "6 POUCH in 1 CARTON (71858-0105-2) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) ",
"NDC11Code": "71858-0105-02",
"ProductNDC": "71858-0105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirosint",
"ProprietaryNameSuffix": "Sol",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206977",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "13",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250725",
"SamplePackage": "Y",
"IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
},
{
"NDCCode": "71858-0105-5",
"PackageDescription": "6 POUCH in 1 CARTON (71858-0105-5) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) ",
"NDC11Code": "71858-0105-05",
"ProductNDC": "71858-0105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirosint",
"ProprietaryNameSuffix": "Sol",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206977",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "13",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N",
"IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
},
{
"NDCCode": "71858-0110-1",
"PackageDescription": "2 POUCH in 1 CARTON (71858-0110-1) / 5 AMPULE in 1 POUCH (71858-0110-4) / 1 mL in 1 AMPULE (71858-0110-6) ",
"NDC11Code": "71858-0110-01",
"ProductNDC": "71858-0110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirosint",
"ProprietaryNameSuffix": "Sol",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206977",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "25",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190301",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "Y",
"IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
},
{
"NDCCode": "71858-0110-2",
"PackageDescription": "6 POUCH in 1 CARTON (71858-0110-2) / 5 AMPULE in 1 POUCH (71858-0110-4) / 1 mL in 1 AMPULE (71858-0110-6) ",
"NDC11Code": "71858-0110-02",
"ProductNDC": "71858-0110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirosint",
"ProprietaryNameSuffix": "Sol",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206977",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "25",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250725",
"SamplePackage": "Y",
"IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
},
{
"NDCCode": "71858-0110-5",
"PackageDescription": "6 POUCH in 1 CARTON (71858-0110-5) / 5 AMPULE in 1 POUCH (71858-0110-4) / 1 mL in 1 AMPULE (71858-0110-6) ",
"NDC11Code": "71858-0110-05",
"ProductNDC": "71858-0110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirosint",
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"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206977",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "25",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N",
"IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
},
{
"NDCCode": "71858-0112-1",
"PackageDescription": "2 POUCH in 1 CARTON (71858-0112-1) / 5 AMPULE in 1 POUCH (71858-0112-4) / 1 mL in 1 AMPULE (71858-0112-6) ",
"NDC11Code": "71858-0112-01",
"ProductNDC": "71858-0112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirosint",
"ProprietaryNameSuffix": "Sol",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206977",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "37.5",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210701",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "Y",
"IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
},
{
"NDCCode": "71858-0112-2",
"PackageDescription": "6 POUCH in 1 CARTON (71858-0112-2) / 5 AMPULE in 1 POUCH (71858-0112-4) / 1 mL in 1 AMPULE (71858-0112-6) ",
"NDC11Code": "71858-0112-02",
"ProductNDC": "71858-0112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirosint",
"ProprietaryNameSuffix": "Sol",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206977",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "37.5",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250725",
"SamplePackage": "Y",
"IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
},
{
"NDCCode": "71858-0112-5",
"PackageDescription": "6 POUCH in 1 CARTON (71858-0112-5) / 5 AMPULE in 1 POUCH (71858-0112-4) / 1 mL in 1 AMPULE (71858-0112-6) ",
"NDC11Code": "71858-0112-05",
"ProductNDC": "71858-0112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirosint",
"ProprietaryNameSuffix": "Sol",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206977",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "37.5",
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"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210701",
"SamplePackage": "N",
"IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
},
{
"NDCCode": "71858-0113-1",
"PackageDescription": "2 POUCH in 1 CARTON (71858-0113-1) / 5 AMPULE in 1 POUCH (71858-0113-4) / 1 mL in 1 AMPULE (71858-0113-6) ",
"NDC11Code": "71858-0113-01",
"ProductNDC": "71858-0113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirosint",
"ProprietaryNameSuffix": "Sol",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206977",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "44",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210701",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "Y",
"IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
},
{
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"PackageDescription": "6 POUCH in 1 CARTON (71858-0113-2) / 5 AMPULE in 1 POUCH (71858-0113-4) / 1 mL in 1 AMPULE (71858-0113-6) ",
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"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
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<StartMarketingDate>20151002</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>ANAMIRTA COCCULUS SEED</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49288-0145-2</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0145-2)</PackageDescription>
<NDC11Code>49288-0145-02</NDC11Code>
<ProductNDC>49288-0145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Reed Canary Grass</ProprietaryName>
<NonProprietaryName>Reed Canary Grass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>PHALARIS ARUNDINACEA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0145-5</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0145-5)</PackageDescription>
<NDC11Code>49288-0145-05</NDC11Code>
<ProductNDC>49288-0145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Reed Canary Grass</ProprietaryName>
<NonProprietaryName>Reed Canary Grass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>PHALARIS ARUNDINACEA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>51552-0145-3</NDCCode>
<PackageDescription>5 g in 1 CONTAINER (51552-0145-3) </PackageDescription>
<NDC11Code>51552-0145-03</NDC11Code>
<ProductNDC>51552-0145</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19980401</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-APR-98</StartMarketingDatePackage>
<EndMarketingDatePackage>31-AUG-22</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51552-0145-5</NDCCode>
<PackageDescription>100 g in 1 CONTAINER (51552-0145-5) </PackageDescription>
<NDC11Code>51552-0145-05</NDC11Code>
<ProductNDC>51552-0145</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19980401</StartMarketingDate>
<EndMarketingDate>20270331</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-10-31</LastUpdate>
<StartMarketingDatePackage>01-APR-98</StartMarketingDatePackage>
<EndMarketingDatePackage>31-MAR-27</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>66478-0145-5</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (66478-0145-5) / 25000 g in 1 BAG (66478-0145-6) </PackageDescription>
<NDC11Code>66478-0145-05</NDC11Code>
<ProductNDC>66478-0145</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20131108</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Nanjing White Whale Pharmaceutical Co., Ltd</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-10-03</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>08-NOV-13</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>71335-0145-5</NDCCode>
<PackageDescription>56 TABLET in 1 BOTTLE (71335-0145-5) </PackageDescription>
<NDC11Code>71335-0145-05</NDC11Code>
<ProductNDC>71335-0145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202556</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
<Description>Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula:. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, FD & C yellow, lactose monohydrate, magnesium stearate, pregelatinized starch (starch 1500) and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>71858-0105-1</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (71858-0105-1) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) </PackageDescription>
<NDC11Code>71858-0105-01</NDC11Code>
<ProductNDC>71858-0105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>13</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .</IndicationAndUsage>
<Description>TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water.</Description>
</NDC>
<NDC>
<NDCCode>71858-0105-2</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (71858-0105-2) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) </PackageDescription>
<NDC11Code>71858-0105-02</NDC11Code>
<ProductNDC>71858-0105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>13</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250725</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .</IndicationAndUsage>
<Description>TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water.</Description>
</NDC>
<NDC>
<NDCCode>71858-0105-5</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (71858-0105-5) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) </PackageDescription>
<NDC11Code>71858-0105-05</NDC11Code>
<ProductNDC>71858-0105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>13</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .</IndicationAndUsage>
<Description>TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water.</Description>
</NDC>
<NDC>
<NDCCode>71858-0110-1</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (71858-0110-1) / 5 AMPULE in 1 POUCH (71858-0110-4) / 1 mL in 1 AMPULE (71858-0110-6) </PackageDescription>
<NDC11Code>71858-0110-01</NDC11Code>
<ProductNDC>71858-0110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .</IndicationAndUsage>
<Description>TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water.</Description>
</NDC>
<NDC>
<NDCCode>71858-0110-2</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (71858-0110-2) / 5 AMPULE in 1 POUCH (71858-0110-4) / 1 mL in 1 AMPULE (71858-0110-6) </PackageDescription>
<NDC11Code>71858-0110-02</NDC11Code>
<ProductNDC>71858-0110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250725</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .</IndicationAndUsage>
<Description>TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water.</Description>
</NDC>
<NDC>
<NDCCode>71858-0110-5</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (71858-0110-5) / 5 AMPULE in 1 POUCH (71858-0110-4) / 1 mL in 1 AMPULE (71858-0110-6) </PackageDescription>
<NDC11Code>71858-0110-05</NDC11Code>
<ProductNDC>71858-0110</ProductNDC>
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<ProprietaryName>Tirosint</ProprietaryName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
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<StrengthNumber>25</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .</IndicationAndUsage>
<Description>TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water.</Description>
</NDC>
<NDC>
<NDCCode>71858-0112-1</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (71858-0112-1) / 5 AMPULE in 1 POUCH (71858-0112-4) / 1 mL in 1 AMPULE (71858-0112-6) </PackageDescription>
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<ProductNDC>71858-0112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
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<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .</IndicationAndUsage>
<Description>TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water.</Description>
</NDC>
<NDC>
<NDCCode>71858-0112-2</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (71858-0112-2) / 5 AMPULE in 1 POUCH (71858-0112-4) / 1 mL in 1 AMPULE (71858-0112-6) </PackageDescription>
<NDC11Code>71858-0112-02</NDC11Code>
<ProductNDC>71858-0112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
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<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250725</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .</IndicationAndUsage>
<Description>TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water.</Description>
</NDC>
<NDC>
<NDCCode>71858-0112-5</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (71858-0112-5) / 5 AMPULE in 1 POUCH (71858-0112-4) / 1 mL in 1 AMPULE (71858-0112-6) </PackageDescription>
<NDC11Code>71858-0112-05</NDC11Code>
<ProductNDC>71858-0112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .</IndicationAndUsage>
<Description>TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water.</Description>
</NDC>
<NDC>
<NDCCode>71858-0113-1</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (71858-0113-1) / 5 AMPULE in 1 POUCH (71858-0113-4) / 1 mL in 1 AMPULE (71858-0113-6) </PackageDescription>
<NDC11Code>71858-0113-01</NDC11Code>
<ProductNDC>71858-0113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>44</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .</IndicationAndUsage>
<Description>TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water.</Description>
</NDC>
<NDC>
<NDCCode>71858-0113-2</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (71858-0113-2) / 5 AMPULE in 1 POUCH (71858-0113-4) / 1 mL in 1 AMPULE (71858-0113-6) </PackageDescription>
<NDC11Code>71858-0113-02</NDC11Code>
<ProductNDC>71858-0113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>44</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250725</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .</IndicationAndUsage>
<Description>TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water.</Description>
</NDC>
<NDC>
<NDCCode>71858-0113-5</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (71858-0113-5) / 5 AMPULE in 1 POUCH (71858-0113-4) / 1 mL in 1 AMPULE (71858-0113-6) </PackageDescription>
<NDC11Code>71858-0113-05</NDC11Code>
<ProductNDC>71858-0113</ProductNDC>
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<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
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<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
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<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .</IndicationAndUsage>
<Description>TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water.</Description>
</NDC>
<NDC>
<NDCCode>71858-0115-1</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (71858-0115-1) / 5 AMPULE in 1 POUCH (71858-0115-4) / 1 mL in 1 AMPULE (71858-0115-6) </PackageDescription>
<NDC11Code>71858-0115-01</NDC11Code>
<ProductNDC>71858-0115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .</IndicationAndUsage>
<Description>TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water.</Description>
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