{
"NDC": [
{
"NDCCode": "71858-0405-5",
"PackageDescription": "6 POUCH in 1 CARTON (71858-0405-5) / 5 SYSTEM in 1 POUCH (71858-0405-4) ",
"NDC11Code": "71858-0405-05",
"ProductNDC": "71858-0405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flector",
"NonProprietaryName": "Diclofenac Epolamine",
"DosageFormName": "SYSTEM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021234",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "DICLOFENAC EPOLAMINE",
"StrengthNumber": ".013",
"StrengthUnit": "g/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201101",
"SamplePackage": "N",
"IndicationAndUsage": "FLECTOR ® is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.",
"Description": "FLECTOR (diclofenac epolamine) topical system 1.3% is a nonsteroidal anti-inflammatory drug for topical application. FLECTOR is a 10 cm × 14 cm topical system comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin. The chemical name of diclofenac epolamine is 2-[(2,6-dichlorophenyl) amino]benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a molecular formula of C 20H 24Cl 2N 2O 3, and molecular weight 411.3, an n-octanol/water partition coefficient of 8 at pH 8.5, and the following chemical structure:. Each adhesive FLECTOR topical system contains 180 mg of diclofenac epolamine (13 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: butylene glycol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, fragrance (Dalin PH), gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium polyacrylate, sorbitol solution, tartaric acid, titanium dioxide, and purified water."
},
{
"NDCCode": "71858-0405-6",
"PackageDescription": "3 POUCH in 1 CARTON (71858-0405-6) / 5 SYSTEM in 1 POUCH (71858-0405-4) ",
"NDC11Code": "71858-0405-06",
"ProductNDC": "71858-0405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flector",
"NonProprietaryName": "Diclofenac Epolamine",
"DosageFormName": "SYSTEM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021234",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "DICLOFENAC EPOLAMINE",
"StrengthNumber": ".013",
"StrengthUnit": "g/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260201",
"SamplePackage": "N",
"IndicationAndUsage": "FLECTOR ® is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.",
"Description": "FLECTOR (diclofenac epolamine) topical system 1.3% is a nonsteroidal anti-inflammatory drug for topical application. FLECTOR is a 10 cm × 14 cm topical system comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin. The chemical name of diclofenac epolamine is 2-[(2,6-dichlorophenyl) amino]benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a molecular formula of C 20H 24Cl 2N 2O 3, and molecular weight 411.3, an n-octanol/water partition coefficient of 8 at pH 8.5, and the following chemical structure:. Each adhesive FLECTOR topical system contains 180 mg of diclofenac epolamine (13 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: butylene glycol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, fragrance (Dalin PH), gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium polyacrylate, sorbitol solution, tartaric acid, titanium dioxide, and purified water."
},
{
"NDCCode": "71858-0405-2",
"PackageDescription": "1 POUCH in 1 CARTON (71858-0405-2) / 2 SYSTEM in 1 POUCH (71858-0405-1) ",
"NDC11Code": "71858-0405-02",
"ProductNDC": "71858-0405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flector",
"NonProprietaryName": "Diclofenac Epolamine",
"DosageFormName": "SYSTEM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021234",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "DICLOFENAC EPOLAMINE",
"StrengthNumber": ".013",
"StrengthUnit": "g/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201101",
"SamplePackage": "Y",
"IndicationAndUsage": "FLECTOR ® is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.",
"Description": "FLECTOR (diclofenac epolamine) topical system 1.3% is a nonsteroidal anti-inflammatory drug for topical application. FLECTOR is a 10 cm × 14 cm topical system comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin. The chemical name of diclofenac epolamine is 2-[(2,6-dichlorophenyl) amino]benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a molecular formula of C 20H 24Cl 2N 2O 3, and molecular weight 411.3, an n-octanol/water partition coefficient of 8 at pH 8.5, and the following chemical structure:. Each adhesive FLECTOR topical system contains 180 mg of diclofenac epolamine (13 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: butylene glycol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, fragrance (Dalin PH), gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium polyacrylate, sorbitol solution, tartaric acid, titanium dioxide, and purified water."
},
{
"NDCCode": "0517-0405-25",
"PackageDescription": "25 VIAL in 1 CARTON (0517-0405-25) > 5 mL in 1 VIAL",
"NDC11Code": "00517-0405-25",
"ProductNDC": "0517-0405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-06-21"
},
{
"NDCCode": "0703-0405-02",
"PackageDescription": "5 VIAL, SINGLE-DOSE in 1 TRAY (0703-0405-02) > 12.5 mL in 1 VIAL, SINGLE-DOSE (0703-0405-01)",
"NDC11Code": "00703-0405-02",
"ProductNDC": "0703-0405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levocarnitine",
"NonProprietaryName": "Levocarnitine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20010601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075881",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "LEVOCARNITINE",
"StrengthNumber": "2.5",
"StrengthUnit": "g/12.5mL",
"Pharm_Classes": "Carnitine [Chemical/Ingredient],Carnitine Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-03-03"
},
{
"NDCCode": "15631-0405-5",
"PackageDescription": "12500 PELLET in 1 PACKAGE (15631-0405-5) ",
"NDC11Code": "15631-0405-05",
"ProductNDC": "15631-0405",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinapis Nigra",
"NonProprietaryName": "Sinapis Nigra",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151002",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "BLACK MUSTARD SEED",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "38779-0405-3",
"PackageDescription": "5 g in 1 BOTTLE (38779-0405-3) ",
"NDC11Code": "38779-0405-03",
"ProductNDC": "38779-0405",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140818",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-21",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "03-OCT-17"
},
{
"NDCCode": "38779-0405-5",
"PackageDescription": "100 g in 1 JAR (38779-0405-5) ",
"NDC11Code": "38779-0405-05",
"ProductNDC": "38779-0405",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140818",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-21",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "03-OCT-17"
},
{
"NDCCode": "49288-0405-2",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0405-2)",
"NDC11Code": "49288-0405-02",
"ProductNDC": "49288-0405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pineapple",
"NonProprietaryName": "Pineapple",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "PINEAPPLE",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fruit Proteins [EXT],Increased Histamine Release [PE],Non-Standardized Food Allergenic Extract [EPC]",
"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": "49288-0405-5",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0405-5)",
"NDC11Code": "49288-0405-05",
"ProductNDC": "49288-0405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pineapple",
"NonProprietaryName": "Pineapple",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "PINEAPPLE",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fruit Proteins [EXT],Increased Histamine Release [PE],Non-Standardized Food Allergenic Extract [EPC]",
"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": "55545-0405-2",
"PackageDescription": "1 BAG in 1 DRUM (55545-0405-2) / 5 kg in 1 BAG",
"NDC11Code": "55545-0405-02",
"ProductNDC": "55545-0405",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Flurbiprofen",
"DosageFormName": "POWDER",
"StartMarketingDate": "19910101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "FDC Limited",
"SubstanceName": "FLURBIPROFEN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2023-12-21",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "01-JAN-91"
},
{
"NDCCode": "59762-0405-5",
"PackageDescription": "12 TABLET, FILM COATED in 1 DOSE PACK (59762-0405-5) ",
"NDC11Code": "59762-0405-05",
"ProductNDC": "59762-0405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risedronate Sodium",
"NonProprietaryName": "Risedronate Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20020517",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020835",
"LabelerName": "Greenstone LLC",
"SubstanceName": "RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE",
"StrengthNumber": "30.1; 4.9",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Bisphosphonate [EPC], Diphosphonates [CS], Diphosphonates [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20020517",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "Risedronate Sodium is a bisphosphonate indicated for: 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2), 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3), 4 Treatment of Paget’s disease (1.4).",
"Description": "Risedronate Sodium tablets is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Risedronate Sodium tablet for oral administration contains the equivalent of 5, 30, 35, 75, or 150 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The empirical formula for risedronate sodium hemi-pentahydrate is C7H10NO7P2Na 2.5 H2O. The chemical name of risedronate sodium is [1-hydroxy-2-(3-pyridinyl) ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following. Molecular Weight. Anhydrous: 305.10. Hemi-pentahydrate: 350.13. Risedronate sodium is a fine, white to off-white, odorless, crystalline powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive IngredientsAll dose strengths contain: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide. Dose strength-specific ingredients include: 5 mg—ferric oxide yellow, lactose monohydrate; 30 mg—lactose monohydrate; 35 mg—ferric oxide red, ferric oxide yellow, lactose monohydrate; 75 mg—ferric oxide red; 150 mg—FD&C blue #2 aluminum lake."
},
{
"NDCCode": "82347-0405-5",
"PackageDescription": "6 POUCH in 1 CARTON (82347-0405-5) / 5 SYSTEM in 1 POUCH (82347-0405-4) ",
"NDC11Code": "82347-0405-05",
"ProductNDC": "82347-0405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Epolamine",
"NonProprietaryName": "Diclofenac Epolamine",
"DosageFormName": "SYSTEM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221118",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021234",
"LabelerName": "YARAL Pharma Inc.",
"SubstanceName": "DICLOFENAC EPOLAMINE",
"StrengthNumber": ".013",
"StrengthUnit": "g/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221118",
"SamplePackage": "N",
"IndicationAndUsage": "DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.",
"Description": "DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drug for topical application. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a 10 cm × 14 cm topical system comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin. The chemical name of diclofenac epolamine is 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a molecular formula of C 20H 24Cl 2N 2O 3, and molecular weight 411.3, an n-octanol/water partition coefficient of 8 at pH 8.5, and the following chemical structure:. Each adhesive topical system contains 180 mg of diclofenac epolamine (13 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: butylene glycol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, fragrance (Dalin PH), gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium polyacrylate, sorbitol solution, tartaric acid, titanium dioxide, and purified water."
},
{
"NDCCode": "82347-0405-6",
"PackageDescription": "3 POUCH in 1 CARTON (82347-0405-6) / 5 SYSTEM in 1 POUCH (82347-0405-4) ",
"NDC11Code": "82347-0405-06",
"ProductNDC": "82347-0405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Epolamine",
"NonProprietaryName": "Diclofenac Epolamine",
"DosageFormName": "SYSTEM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221118",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021234",
"LabelerName": "YARAL Pharma Inc.",
"SubstanceName": "DICLOFENAC EPOLAMINE",
"StrengthNumber": ".013",
"StrengthUnit": "g/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250115",
"SamplePackage": "N",
"IndicationAndUsage": "DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.",
"Description": "DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drug for topical application. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a 10 cm × 14 cm topical system comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin. The chemical name of diclofenac epolamine is 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a molecular formula of C 20H 24Cl 2N 2O 3, and molecular weight 411.3, an n-octanol/water partition coefficient of 8 at pH 8.5, and the following chemical structure:. Each adhesive topical system contains 180 mg of diclofenac epolamine (13 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: butylene glycol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, fragrance (Dalin PH), gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium polyacrylate, sorbitol solution, tartaric acid, titanium dioxide, and purified water."
},
{
"NDCCode": "87234-0405-5",
"PackageDescription": "6 POUCH in 1 CARTON (87234-0405-5) / 5 SYSTEM in 1 POUCH (87234-0405-3) ",
"NDC11Code": "87234-0405-05",
"ProductNDC": "87234-0405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclox Patch 30ct",
"NonProprietaryName": "Diclofenac Epolamine 1.3% Patch",
"DosageFormName": "SYSTEM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260522",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021234",
"LabelerName": "Injecta Medcial LLC",
"SubstanceName": "DICLOFENAC EPOLAMINE",
"StrengthNumber": ".013",
"StrengthUnit": "g/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260522",
"SamplePackage": "N",
"IndicationAndUsage": "DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.",
"Description": "DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drug for topical application. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a 10 cm × 14 cm topical system comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin. The chemical name of diclofenac epolamine is 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a molecular formula of C 20H 24Cl 2N 2O 3, and molecular weight 411.3, an n-octanol/water partition coefficient of 8 at pH 8.5, and the following chemical structure. Each adhesive topical system contains 180 mg of diclofenac epolamine (13 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: butylene glycol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, fragrance (Dalin PH), gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium polyacrylate, sorbitol solution, tartaric acid, titanium dioxide, and purified water."
},
{
"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",
"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": "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",
"StrengthUnit": "ug/mL",
"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",
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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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"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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"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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"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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"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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"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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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>38779-0405-3</NDCCode>
<PackageDescription>5 g in 1 BOTTLE (38779-0405-3) </PackageDescription>
<NDC11Code>38779-0405-03</NDC11Code>
<ProductNDC>38779-0405</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dexamethasone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140818</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>DEXAMETHASONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-21</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-OCT-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0405-5</NDCCode>
<PackageDescription>100 g in 1 JAR (38779-0405-5) </PackageDescription>
<NDC11Code>38779-0405-05</NDC11Code>
<ProductNDC>38779-0405</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dexamethasone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140818</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>DEXAMETHASONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-21</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-OCT-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>49288-0405-2</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0405-2)</PackageDescription>
<NDC11Code>49288-0405-02</NDC11Code>
<ProductNDC>49288-0405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pineapple</ProprietaryName>
<NonProprietaryName>Pineapple</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>PINEAPPLE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fruit Proteins [EXT],Increased Histamine Release [PE],Non-Standardized Food Allergenic Extract [EPC]</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>49288-0405-5</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0405-5)</PackageDescription>
<NDC11Code>49288-0405-05</NDC11Code>
<ProductNDC>49288-0405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pineapple</ProprietaryName>
<NonProprietaryName>Pineapple</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>PINEAPPLE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fruit Proteins [EXT],Increased Histamine Release [PE],Non-Standardized Food Allergenic Extract [EPC]</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>55545-0405-2</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (55545-0405-2) / 5 kg in 1 BAG</PackageDescription>
<NDC11Code>55545-0405-02</NDC11Code>
<ProductNDC>55545-0405</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Flurbiprofen</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19910101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>FDC Limited</LabelerName>
<SubstanceName>FLURBIPROFEN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-21</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-91</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59762-0405-5</NDCCode>
<PackageDescription>12 TABLET, FILM COATED in 1 DOSE PACK (59762-0405-5) </PackageDescription>
<NDC11Code>59762-0405-05</NDC11Code>
<ProductNDC>59762-0405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risedronate Sodium</ProprietaryName>
<NonProprietaryName>Risedronate Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020517</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020835</ApplicationNumber>
<LabelerName>Greenstone LLC</LabelerName>
<SubstanceName>RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE</SubstanceName>
<StrengthNumber>30.1; 4.9</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Bisphosphonate [EPC], Diphosphonates [CS], Diphosphonates [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020517</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risedronate Sodium is a bisphosphonate indicated for: 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2), 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3), 4 Treatment of Paget’s disease (1.4).</IndicationAndUsage>
<Description>Risedronate Sodium tablets is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Risedronate Sodium tablet for oral administration contains the equivalent of 5, 30, 35, 75, or 150 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The empirical formula for risedronate sodium hemi-pentahydrate is C7H10NO7P2Na 2.5 H2O. The chemical name of risedronate sodium is [1-hydroxy-2-(3-pyridinyl) ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following. Molecular Weight. Anhydrous: 305.10. Hemi-pentahydrate: 350.13. Risedronate sodium is a fine, white to off-white, odorless, crystalline powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive IngredientsAll dose strengths contain: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide. Dose strength-specific ingredients include: 5 mg—ferric oxide yellow, lactose monohydrate; 30 mg—lactose monohydrate; 35 mg—ferric oxide red, ferric oxide yellow, lactose monohydrate; 75 mg—ferric oxide red; 150 mg—FD&C blue #2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>82347-0405-5</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (82347-0405-5) / 5 SYSTEM in 1 POUCH (82347-0405-4) </PackageDescription>
<NDC11Code>82347-0405-05</NDC11Code>
<ProductNDC>82347-0405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Epolamine</ProprietaryName>
<NonProprietaryName>Diclofenac Epolamine</NonProprietaryName>
<DosageFormName>SYSTEM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221118</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021234</ApplicationNumber>
<LabelerName>YARAL Pharma Inc.</LabelerName>
<SubstanceName>DICLOFENAC EPOLAMINE</SubstanceName>
<StrengthNumber>.013</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.</IndicationAndUsage>
<Description>DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drug for topical application. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a 10 cm × 14 cm topical system comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin. The chemical name of diclofenac epolamine is 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a molecular formula of C 20H 24Cl 2N 2O 3, and molecular weight 411.3, an n-octanol/water partition coefficient of 8 at pH 8.5, and the following chemical structure:. Each adhesive topical system contains 180 mg of diclofenac epolamine (13 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: butylene glycol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, fragrance (Dalin PH), gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium polyacrylate, sorbitol solution, tartaric acid, titanium dioxide, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>82347-0405-6</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (82347-0405-6) / 5 SYSTEM in 1 POUCH (82347-0405-4) </PackageDescription>
<NDC11Code>82347-0405-06</NDC11Code>
<ProductNDC>82347-0405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Epolamine</ProprietaryName>
<NonProprietaryName>Diclofenac Epolamine</NonProprietaryName>
<DosageFormName>SYSTEM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221118</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021234</ApplicationNumber>
<LabelerName>YARAL Pharma Inc.</LabelerName>
<SubstanceName>DICLOFENAC EPOLAMINE</SubstanceName>
<StrengthNumber>.013</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.</IndicationAndUsage>
<Description>DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drug for topical application. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a 10 cm × 14 cm topical system comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin. The chemical name of diclofenac epolamine is 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a molecular formula of C 20H 24Cl 2N 2O 3, and molecular weight 411.3, an n-octanol/water partition coefficient of 8 at pH 8.5, and the following chemical structure:. Each adhesive topical system contains 180 mg of diclofenac epolamine (13 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: butylene glycol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, fragrance (Dalin PH), gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium polyacrylate, sorbitol solution, tartaric acid, titanium dioxide, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>87234-0405-5</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (87234-0405-5) / 5 SYSTEM in 1 POUCH (87234-0405-3) </PackageDescription>
<NDC11Code>87234-0405-05</NDC11Code>
<ProductNDC>87234-0405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclox Patch 30ct</ProprietaryName>
<NonProprietaryName>Diclofenac Epolamine 1.3% Patch</NonProprietaryName>
<DosageFormName>SYSTEM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260522</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021234</ApplicationNumber>
<LabelerName>Injecta Medcial LLC</LabelerName>
<SubstanceName>DICLOFENAC EPOLAMINE</SubstanceName>
<StrengthNumber>.013</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.</IndicationAndUsage>
<Description>DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drug for topical application. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a 10 cm × 14 cm topical system comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin. The chemical name of diclofenac epolamine is 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a molecular formula of C 20H 24Cl 2N 2O 3, and molecular weight 411.3, an n-octanol/water partition coefficient of 8 at pH 8.5, and the following chemical structure. Each adhesive topical system contains 180 mg of diclofenac epolamine (13 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: butylene glycol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, fragrance (Dalin PH), gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium polyacrylate, sorbitol solution, tartaric acid, titanium dioxide, and purified water.</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>
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<ProductNDC>71858-0105</ProductNDC>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
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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>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>
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<ProprietaryName>Tirosint</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
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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>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>
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<ProductNDC>71858-0110</ProductNDC>
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<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
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<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>
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<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>
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<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
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<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
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<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>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>
<NDC11Code>71858-0112-01</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>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>
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<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>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>
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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>
<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>
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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>20250725</StartMarketingDatePackage>
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<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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<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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<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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<PackageDescription>6 POUCH in 1 CARTON (71858-0115-2) / 5 AMPULE in 1 POUCH (71858-0115-4) / 1 mL in 1 AMPULE (71858-0115-6) </PackageDescription>
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<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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<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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