{
"NDC": [
{
"NDCCode": "70748-258-07",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (70748-258-07) ",
"NDC11Code": "70748-0258-07",
"ProductNDC": "70748-258",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Posaconazole",
"NonProprietaryName": "Posaconazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213454",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "POSACONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210217",
"SamplePackage": "N",
"IndicationAndUsage": "Posaconazole is an azole antifungal indicated as follows: 1 Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD)or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2).",
"Description": "Posaconazole delayed-release tablets contain posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5 - (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2 - hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Posaconazole delayed-release tablet, for oral use, is yellow, coated, capsule-shaped tablets containing 100 mg of posaconazole. Each delayed-release tablet contains the inactive ingredients: partially neutralized methacrylic acid and ethyl acrylate copolymer, triethyl citrate, xylitol, hydroxypropyl cellulose, propyl gallate, cellulose, microcrystalline, silica, colloidal anhydrous, croscarmellose sodium, sodium stearyl fumarate and Opadry® II Yellow (consists of the following ingredients: polyvinyl alcohol partially hydrolyzed, macrogol, polyethylene glycol, titanium dioxide, talc, and iron oxide yellow)."
},
{
"NDCCode": "71919-258-07",
"PackageDescription": "15 mL in 1 VIAL, GLASS (71919-258-07) ",
"NDC11Code": "71919-0258-07",
"ProductNDC": "71919-258",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dolichos Pruriens",
"NonProprietaryName": "Mucuna Pruriens Fruit Trichome",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110624",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "MUCUNA PRURIENS FRUIT TRICHOME",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110624",
"SamplePackage": "N"
},
{
"NDCCode": "70748-102-07",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (70748-102-07) ",
"NDC11Code": "70748-0102-07",
"ProductNDC": "70748-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211579",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260417",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin hydrochloride extended-release tablets are combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin when used as a component of dapagliflozin and metformin hydrochloride extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end-stage kidney disease, (CV) death and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 CV death, hospitalization for heart failure and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors.",
"Description": "Dapagliflozin and metformin hydrochloride extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as, (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is. Metformin hydrochloride. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white crystalline powder with a molecular formula of C4H11N5HCl and a molecular weight of 165.6. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. Dapagliflozin and metformin hydrochloride extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride, 5 mg dapagliflozin and 1000 mg metformin hydrochloride, 10 mg dapagliflozin and 500 mg metformin hydrochloride, or 10 mg dapagliflozin and 1000 mg metformin hydrochloride. Each film-coated tablet of dapagliflozin and metformin hydrochloride extended-release tablet contains the following inactive ingredients: crospovidone, colloidal silicon dioxide, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone, sodium carboxymethyl cellulose, sodium stearyl fumarate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide. Additionally, the film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/500 mg tablets contains iron oxide red and iron oxide yellow. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/1000 mg contains iron oxide red and iron oxide black. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/500 mg contains iron oxide red and iron oxide yellow. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/1000 mg tablets contains D & C Yellow #10 Aluminum lake, FD & C Yellow #6/ sunset yellow FCF aluminum lake, FD & C Blue #2/ indigo carmine aluminum lake."
},
{
"NDCCode": "70748-195-07",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (70748-195-07) ",
"NDC11Code": "70748-0195-07",
"ProductNDC": "70748-195",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213808",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "24; 26",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250729",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. (1.1).",
"Description": "Sacubitril and valsartan tablets (sacubitril and valsartan) are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains sacubitril, sodium and valsartan, disodium. Following oral administration, sacubitril metabolizes to LBQ657. Sacubitril sodium is described chemically as 4-[[(2S,4R)-5-ethoxy-4-methyl-5-oxo-1-(4-phenylphenyl)pentan-2-yl]amino]-4-oxobutanoate; sodium salt with an empirical formula of C24H28NNaO5 and a molecular weight of 432.47 g/mol. The structural formula is. Valsartan is described chemically as N-[p-(o-1H-Tetrazol-5-ylphenyl)benzyl]-N-valeryl-L-valine, disodium salt with an empirical formula of C24H27N5Na2O3 and a molecular weight of 480.52 g/mol. The structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, mannitol, magnesium stearate (vegetable origin), talc, and silicon dioxide. The film-coat inactive ingredients are hypromellose, Macrogol and titanium dioxide. The 97 mg of sacubitril and 103 mg of valsartan tablet also contains talc."
},
{
"NDCCode": "70748-196-07",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (70748-196-07) ",
"NDC11Code": "70748-0196-07",
"ProductNDC": "70748-196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213808",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "49; 51",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250729",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. (1.1).",
"Description": "Sacubitril and valsartan tablets (sacubitril and valsartan) are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains sacubitril, sodium and valsartan, disodium. Following oral administration, sacubitril metabolizes to LBQ657. Sacubitril sodium is described chemically as 4-[[(2S,4R)-5-ethoxy-4-methyl-5-oxo-1-(4-phenylphenyl)pentan-2-yl]amino]-4-oxobutanoate; sodium salt with an empirical formula of C24H28NNaO5 and a molecular weight of 432.47 g/mol. The structural formula is. Valsartan is described chemically as N-[p-(o-1H-Tetrazol-5-ylphenyl)benzyl]-N-valeryl-L-valine, disodium salt with an empirical formula of C24H27N5Na2O3 and a molecular weight of 480.52 g/mol. The structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, mannitol, magnesium stearate (vegetable origin), talc, and silicon dioxide. The film-coat inactive ingredients are hypromellose, Macrogol and titanium dioxide. The 97 mg of sacubitril and 103 mg of valsartan tablet also contains talc."
},
{
"NDCCode": "70748-197-07",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (70748-197-07) ",
"NDC11Code": "70748-0197-07",
"ProductNDC": "70748-197",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213808",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "97; 103",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250729",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. (1.1).",
"Description": "Sacubitril and valsartan tablets (sacubitril and valsartan) are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains sacubitril, sodium and valsartan, disodium. Following oral administration, sacubitril metabolizes to LBQ657. Sacubitril sodium is described chemically as 4-[[(2S,4R)-5-ethoxy-4-methyl-5-oxo-1-(4-phenylphenyl)pentan-2-yl]amino]-4-oxobutanoate; sodium salt with an empirical formula of C24H28NNaO5 and a molecular weight of 432.47 g/mol. The structural formula is. Valsartan is described chemically as N-[p-(o-1H-Tetrazol-5-ylphenyl)benzyl]-N-valeryl-L-valine, disodium salt with an empirical formula of C24H27N5Na2O3 and a molecular weight of 480.52 g/mol. The structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, mannitol, magnesium stearate (vegetable origin), talc, and silicon dioxide. The film-coat inactive ingredients are hypromellose, Macrogol and titanium dioxide. The 97 mg of sacubitril and 103 mg of valsartan tablet also contains talc."
},
{
"NDCCode": "70748-208-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (70748-208-07) / 60 TABLET in 1 BOTTLE",
"NDC11Code": "70748-0208-07",
"ProductNDC": "70748-208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214350",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260130",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide. The molecular formula is C22H26ClN7O2S, which corresponds to a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, magnesium stearate, talc. The tablet coating consists of hypromellose, medium chain triglycerides, titanium dioxide."
},
{
"NDCCode": "70748-209-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (70748-209-07) / 60 TABLET in 1 BOTTLE",
"NDC11Code": "70748-0209-07",
"ProductNDC": "70748-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214350",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260130",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide. The molecular formula is C22H26ClN7O2S, which corresponds to a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, magnesium stearate, talc. The tablet coating consists of hypromellose, medium chain triglycerides, titanium dioxide."
},
{
"NDCCode": "70748-210-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (70748-210-07) / 60 TABLET in 1 BOTTLE",
"NDC11Code": "70748-0210-07",
"ProductNDC": "70748-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214350",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260130",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide. The molecular formula is C22H26ClN7O2S, which corresponds to a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, magnesium stearate, talc. The tablet coating consists of hypromellose, medium chain triglycerides, titanium dioxide."
},
{
"NDCCode": "70748-215-07",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (70748-215-07) ",
"NDC11Code": "70748-0215-07",
"ProductNDC": "70748-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen And Esomeprazole Magnesium",
"NonProprietaryName": "Naproxen And Esomeprazole Magnesium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200304",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022511",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM; NAPROXEN",
"StrengthNumber": "20; 375",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200304",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, are indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablets is indicated for relief of signs and symptoms of: 1 osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults., 2 juvenile idiopathic arthritis (JIA) in adolescent patients.",
"Description": "The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablet is combination of a nonsteroidal anti- inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) for oral administration. The inactive ingredients are carnauba wax, colloidal silicon dioxide, croscarmellose sodium, iron oxide yellow, glyceryl monostearate, hypromellose, iron oxide black, magnesium stearate, methacrylic acid copolymer dispersion, methylparaben, polysorbate 80, polydextrose, polyethylene glycol, povidone, propylene glycol, propylparaben, titanium dioxide, and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure:. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3.Naproxen is an odorless, white to off-white crystalline substance. It is lipid soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2- pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C17H18N3O3S)2 Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C."
},
{
"NDCCode": "70748-216-07",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (70748-216-07) ",
"NDC11Code": "70748-0216-07",
"ProductNDC": "70748-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen And Esomeprazole Magnesium",
"NonProprietaryName": "Naproxen And Esomeprazole Magnesium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200304",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022511",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM; NAPROXEN",
"StrengthNumber": "20; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200304",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, are indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablets is indicated for relief of signs and symptoms of: 1 osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults., 2 juvenile idiopathic arthritis (JIA) in adolescent patients.",
"Description": "The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablet is combination of a nonsteroidal anti- inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) for oral administration. The inactive ingredients are carnauba wax, colloidal silicon dioxide, croscarmellose sodium, iron oxide yellow, glyceryl monostearate, hypromellose, iron oxide black, magnesium stearate, methacrylic acid copolymer dispersion, methylparaben, polysorbate 80, polydextrose, polyethylene glycol, povidone, propylene glycol, propylparaben, titanium dioxide, and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure:. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3.Naproxen is an odorless, white to off-white crystalline substance. It is lipid soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2- pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C17H18N3O3S)2 Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C."
},
{
"NDCCode": "70748-173-26",
"PackageDescription": "180 TABLET in 1 BOTTLE (70748-173-26) ",
"NDC11Code": "70748-0173-26",
"ProductNDC": "70748-173",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sevelamer Hydrochloride",
"NonProprietaryName": "Sevelamer Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213145",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "SEVELAMER HYDROCHLORIDE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220225",
"SamplePackage": "N",
"IndicationAndUsage": "Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied.",
"Description": "The active ingredient in sevelamer hydrochloride tablets is sevelamer hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer hydrochloride is poly (allylamine hydrochloride) crosslinked with epichlorohydrin in which 40 % of the amines are protonated. It is known chemically as poly (allylamine-co-N, N'-diallyl-1,3-diamino-2-hydroxypropane) hydrochloride. Sevelamer hydrochloride is hydrophilic, but insoluble in water. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Hydrochloride. The primary amine groups shown in the structure are derived directly from poly (allylamine hydrochloride). The crosslinking groups consist of two secondary amine groups derived from poly (allylamine hydrochloride) and one molecule of epichlorohydrin. Sevelamer Hydrochloride Tablets: Each film-coated tablet of sevelamer hydrochloride contains either 400 mg or 800 mg of sevelamer hydrochloride on an anhydrous basis. The inactive ingredients are colloidal silicon dioxide, stearic acid and Opadry Clear 84F590009 containing polyethylene glycol, polyvinyl alcohol, and talc. The tablet imprint contains Opacode S-1-17823 Black containing ferrosoferric oxide, propylene glycol and shellac."
},
{
"NDCCode": "70748-273-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (70748-273-01) / .6 mL in 1 SYRINGE",
"NDC11Code": "70748-0273-01",
"ProductNDC": "70748-273",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armlupeg",
"NonProprietaryName": "Pegfilgrastim-unne",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761212",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "PEGFILGRASTIM",
"StrengthNumber": "6",
"StrengthUnit": "mg/.6mL",
"Pharm_Classes": "Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "Armlupeg is a leukocyte growth factor indicated to : 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1) , 2 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2).",
"Description": "Pegfilgrastim-unne is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim-unne, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-unne is approximately 39 kD. Armlupeg (pegfilgrastim-unne) injection is a sterile, clear, colorless, preservative-free solution intended for subcutaneous use only and is supplied in a single-dose prefilled syringe with a 27‑gauge ½\" needle and rigid needle shield, with UltraSafe Plus PassiveTM Needle Guard. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL). Each prefilled syringe contains 0.6 mL solution of 6 mg pegfilgrastim-unne (based on protein weight), glacial acetic acid (0.77 mg), polysorbate 20 (0.02 mg), sodium acetate (0.066 mg) and sorbitol (30 mg) in Water for Injection, USP. The pH is 4."
},
{
"NDCCode": "70748-370-02",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (70748-370-02) / 2 mL in 1 VIAL, SINGLE-DOSE (70748-370-01) ",
"NDC11Code": "70748-0370-02",
"ProductNDC": "70748-370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sugammadex",
"NonProprietaryName": "Sugammadex",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214338",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "SUGAMMADEX SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "gamma-Cyclodextrins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260728",
"SamplePackage": "N",
"IndicationAndUsage": "Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl) - 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin Octa sodium salt with a molecular weight of 2178.01. The structural formula is:. Sugammadex injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear and colorless to slightly brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.785 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is."
},
{
"NDCCode": "70748-371-02",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (70748-371-02) / 5 mL in 1 VIAL, SINGLE-DOSE (70748-371-01) ",
"NDC11Code": "70748-0371-02",
"ProductNDC": "70748-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sugammadex",
"NonProprietaryName": "Sugammadex",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214338",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "SUGAMMADEX SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "gamma-Cyclodextrins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260728",
"SamplePackage": "N",
"IndicationAndUsage": "Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl) - 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin Octa sodium salt with a molecular weight of 2178.01. The structural formula is:. Sugammadex injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear and colorless to slightly brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.785 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is."
},
{
"NDCCode": "0409-7122-07",
"PackageDescription": "6 POUCH in 1 CASE (0409-7122-07) > 1 BAG in 1 POUCH > 2000 mL in 1 BAG",
"NDC11Code": "00409-7122-07",
"ProductNDC": "0409-7122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn Ii",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19911219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020041",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; N-ACETYL-TYROSINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE",
"StrengthNumber": "1490; 1527; 1050; 1107; 750; 450; 990; 1500; 1575; 258; 405; 447; 1083; 795; 600; 300; 750",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-03-18"
},
{
"NDCCode": "10237-258-20",
"PackageDescription": "20 mL in 1 BOTTLE, PLASTIC (10237-258-20) ",
"NDC11Code": "10237-0258-20",
"ProductNDC": "10237-258",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Therabreath Healthy Gums",
"NonProprietaryName": "Cetylpyridinium Chloride",
"DosageFormName": "RINSE",
"RouteName": "ORAL",
"StartMarketingDate": "20230213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
"StrengthNumber": ".01",
"StrengthUnit": "mg/20mL",
"Status": "Deprecated",
"LastUpdate": "2024-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240408",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent gingivitis, an early form of gum disease and bleeding gums. Helps control plaque that leads to gingivitis and bleeding gums."
},
{
"NDCCode": "30142-258-01",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (30142-258-01) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY (30142-258-04) ",
"NDC11Code": "30142-0258-01",
"ProductNDC": "30142-258",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fluticasone Propionate",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208150",
"LabelerName": "The Kroger Co.",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion , 2 runny nose , 3 sneezing , 4 itchy nose , 5 itchy, watery eyes."
},
{
"NDCCode": "30142-258-02",
"PackageDescription": "2 BOTTLE, SPRAY in 1 CARTON (30142-258-02) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "30142-0258-02",
"ProductNDC": "30142-258",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fluticasone Propionate",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208150",
"LabelerName": "The Kroger Co.",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion , 2 runny nose , 3 sneezing , 4 itchy nose , 5 itchy, watery eyes."
},
{
"NDCCode": "30142-258-03",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (30142-258-03) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY (30142-258-05) ",
"NDC11Code": "30142-0258-03",
"ProductNDC": "30142-258",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fluticasone Propionate",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208150",
"LabelerName": "The Kroger Co.",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion , 2 runny nose , 3 sneezing , 4 itchy nose , 5 itchy, watery eyes."
},
{
"NDCCode": "33342-258-66",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (33342-258-66) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "33342-0258-66",
"ProductNDC": "33342-258",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseltamivir Phosphate",
"NonProprietaryName": "Oseltamivir Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207211",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "OSELTAMIVIR PHOSPHATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170921",
"SamplePackage": "N",
"IndicationAndUsage": "Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2) Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).",
"Description": "Oseltamivir phosphate capsules, USP an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate USP. In addition to the active ingredient, each capsule contains croscarmellose sodium, isopropyl alcohol, povidone, pregelatinised starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow, titanium dioxide. The 45 mg capsule shell contains gelatin, iron oxide black, titanium dioxide. The 75 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow, titanium dioxide, iron oxide black. Each capsule is printed with blue ink, which includes shellac, propylene glycol and FD&C Blue No. 2 as the colorant. Oseltamivir phosphate, USP is a white crystalline solid with the chemical name (3R,4R,5S)-4-acetylamino-5-amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C16H28N2O4 (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows."
},
{
"NDCCode": "51316-036-48",
"PackageDescription": "258 g in 1 CAN (51316-036-48) ",
"NDC11Code": "51316-0036-48",
"ProductNDC": "51316-036",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Health Spf 50 Clear",
"NonProprietaryName": "Avobenzone Homosalate Octisalate Octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191015",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "CVS PHARMACY",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 50; 40",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2024-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231006",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "58892-258-50",
"PackageDescription": "53 g in 1 BOTTLE, PUMP (58892-258-50) ",
"NDC11Code": "58892-0258-50",
"ProductNDC": "58892-258",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proceuticals Private Label By Tizo Daily Defense Tinted Mineral Sunscreen",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240708",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Fallien Cosmeceuticals, LTD",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": "30; 100",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2024-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240708",
"SamplePackage": "N",
"IndicationAndUsage": "DIRECTIONS: Apply liberally 15 minutes before sun exposure. Reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Children under 6 months: Ask a doctor Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 am-2 pm Wear long-sleeved shirts, pants, hats, and sunglasses."
},
{
"NDCCode": "59450-941-15",
"PackageDescription": "258 g in 1 CAN (59450-941-15) ",
"NDC11Code": "59450-0941-15",
"ProductNDC": "59450-941",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sport Sunscreen Spf 30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "The Kroger Co.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE",
"StrengthNumber": "30; 100; 50",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231107",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "59651-258-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (59651-258-01) ",
"NDC11Code": "59651-0258-01",
"ProductNDC": "59651-258",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191025",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202445",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2023-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191025",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone hydrochloride tablets are indicated to: 1 prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease., 2 prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease., 3 treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital.",
"Description": "Propafenone hydrochloride is an antiarrhythmic drug supplied in film-coated tablets of 150 mg, 225 mg and 300 mg for oral administration. Propafenone has some structural similarities to beta-blocking agents. Chemically, propafenone hydrochloride is 2’-[2-hydroxy-3-(propylamino)-propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. The structural formula of propafenone hydrochloride is given below:. Propafenone hydrochloride occurs as white crystalline powder. It is soluble in methanol and in hot water; slightly soluble in alcohol and in chloroform; very slightly soluble in acetone; insoluble in diethyl ether and in toluene. The following inactive ingredients are contained in the tablet: corn starch, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "62106-1165-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1165-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1165-08",
"ProductNDC": "62106-1165",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 258",
"NonProprietaryName": "Berberis Vulgaris, Bryonia Dioica, Lycopodium Clavatum, Mercurialis Annua, Hydrastis Canadensis, Boldo, Solidago Virgaurea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150602",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "LYCOPODIUM CLAVATUM SPORE; MERCURIALIS ANNUA FLOWERING TOP; GOLDENSEAL; PEUMUS BOLDUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT",
"StrengthNumber": "4; 4; 4; 4; 4; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Status": "Active",
"LastUpdate": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150602",
"SamplePackage": "N"
},
{
"NDCCode": "63940-058-48",
"PackageDescription": "258 g in 1 CAN (63940-058-48) ",
"NDC11Code": "63940-0058-48",
"ProductNDC": "63940-058",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Face Values Ultra Sport Active Spf 30 Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080313",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "HARMON STORES, INC.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 100; 50; 20; 40",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20080313",
"SamplePackage": "N"
},
{
"NDCCode": "63940-070-48",
"PackageDescription": "258 g in 1 CAN (63940-070-48) ",
"NDC11Code": "63940-0070-48",
"ProductNDC": "63940-070",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Face Values Ultra Sport Active Spf 15 Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080227",
"EndMarketingDate": "20250106",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "HARMON STORES, INC.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE",
"StrengthNumber": "20; 100; 50",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080227",
"EndMarketingDatePackage": "20250106",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "63940-084-48",
"PackageDescription": "258 g in 1 CAN (63940-084-48) ",
"NDC11Code": "63940-0084-48",
"ProductNDC": "63940-084",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Harmon Face Values Ultra Sport Active Sunscreen Spf 30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080313",
"EndMarketingDate": "20250728",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "HARMON STORES, INC.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 50; 20",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080313",
"EndMarketingDatePackage": "20250728",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "63940-088-48",
"PackageDescription": "258 g in 1 CAN (63940-088-48) ",
"NDC11Code": "63940-0088-48",
"ProductNDC": "63940-088",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Harmon Face Values Ultra Sport Active Sunscreen Spf 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090522",
"EndMarketingDate": "20250728",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "HARMON STORES, INC.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 50; 40",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090522",
"EndMarketingDatePackage": "20250728",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>70748-258-07</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (70748-258-07) </PackageDescription>
<NDC11Code>70748-0258-07</NDC11Code>
<ProductNDC>70748-258</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Posaconazole</ProprietaryName>
<NonProprietaryName>Posaconazole</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213454</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POSACONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Posaconazole is an azole antifungal indicated as follows: 1 Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD)or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2).</IndicationAndUsage>
<Description>Posaconazole delayed-release tablets contain posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5 - (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2 - hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Posaconazole delayed-release tablet, for oral use, is yellow, coated, capsule-shaped tablets containing 100 mg of posaconazole. Each delayed-release tablet contains the inactive ingredients: partially neutralized methacrylic acid and ethyl acrylate copolymer, triethyl citrate, xylitol, hydroxypropyl cellulose, propyl gallate, cellulose, microcrystalline, silica, colloidal anhydrous, croscarmellose sodium, sodium stearyl fumarate and Opadry® II Yellow (consists of the following ingredients: polyvinyl alcohol partially hydrolyzed, macrogol, polyethylene glycol, titanium dioxide, talc, and iron oxide yellow).</Description>
</NDC>
<NDC>
<NDCCode>71919-258-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-258-07) </PackageDescription>
<NDC11Code>71919-0258-07</NDC11Code>
<ProductNDC>71919-258</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dolichos Pruriens</ProprietaryName>
<NonProprietaryName>Mucuna Pruriens Fruit Trichome</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110624</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>MUCUNA PRURIENS FRUIT TRICHOME</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70748-102-07</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (70748-102-07) </PackageDescription>
<NDC11Code>70748-0102-07</NDC11Code>
<ProductNDC>70748-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211579</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 1000</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin and metformin hydrochloride extended-release tablets are combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin when used as a component of dapagliflozin and metformin hydrochloride extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end-stage kidney disease, (CV) death and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 CV death, hospitalization for heart failure and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin hydrochloride extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as, (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is. Metformin hydrochloride. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white crystalline powder with a molecular formula of C4H11N5HCl and a molecular weight of 165.6. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. Dapagliflozin and metformin hydrochloride extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride, 5 mg dapagliflozin and 1000 mg metformin hydrochloride, 10 mg dapagliflozin and 500 mg metformin hydrochloride, or 10 mg dapagliflozin and 1000 mg metformin hydrochloride. Each film-coated tablet of dapagliflozin and metformin hydrochloride extended-release tablet contains the following inactive ingredients: crospovidone, colloidal silicon dioxide, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone, sodium carboxymethyl cellulose, sodium stearyl fumarate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide. Additionally, the film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/500 mg tablets contains iron oxide red and iron oxide yellow. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/1000 mg contains iron oxide red and iron oxide black. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/500 mg contains iron oxide red and iron oxide yellow. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/1000 mg tablets contains D & C Yellow #10 Aluminum lake, FD & C Yellow #6/ sunset yellow FCF aluminum lake, FD & C Blue #2/ indigo carmine aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>70748-195-07</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70748-195-07) </PackageDescription>
<NDC11Code>70748-0195-07</NDC11Code>
<ProductNDC>70748-195</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213808</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>24; 26</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. (1.1).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets (sacubitril and valsartan) are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains sacubitril, sodium and valsartan, disodium. Following oral administration, sacubitril metabolizes to LBQ657. Sacubitril sodium is described chemically as 4-[[(2S,4R)-5-ethoxy-4-methyl-5-oxo-1-(4-phenylphenyl)pentan-2-yl]amino]-4-oxobutanoate; sodium salt with an empirical formula of C24H28NNaO5 and a molecular weight of 432.47 g/mol. The structural formula is. Valsartan is described chemically as N-[p-(o-1H-Tetrazol-5-ylphenyl)benzyl]-N-valeryl-L-valine, disodium salt with an empirical formula of C24H27N5Na2O3 and a molecular weight of 480.52 g/mol. The structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, mannitol, magnesium stearate (vegetable origin), talc, and silicon dioxide. The film-coat inactive ingredients are hypromellose, Macrogol and titanium dioxide. The 97 mg of sacubitril and 103 mg of valsartan tablet also contains talc.</Description>
</NDC>
<NDC>
<NDCCode>70748-196-07</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70748-196-07) </PackageDescription>
<NDC11Code>70748-0196-07</NDC11Code>
<ProductNDC>70748-196</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213808</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>49; 51</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. (1.1).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets (sacubitril and valsartan) are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains sacubitril, sodium and valsartan, disodium. Following oral administration, sacubitril metabolizes to LBQ657. Sacubitril sodium is described chemically as 4-[[(2S,4R)-5-ethoxy-4-methyl-5-oxo-1-(4-phenylphenyl)pentan-2-yl]amino]-4-oxobutanoate; sodium salt with an empirical formula of C24H28NNaO5 and a molecular weight of 432.47 g/mol. The structural formula is. Valsartan is described chemically as N-[p-(o-1H-Tetrazol-5-ylphenyl)benzyl]-N-valeryl-L-valine, disodium salt with an empirical formula of C24H27N5Na2O3 and a molecular weight of 480.52 g/mol. The structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, mannitol, magnesium stearate (vegetable origin), talc, and silicon dioxide. The film-coat inactive ingredients are hypromellose, Macrogol and titanium dioxide. The 97 mg of sacubitril and 103 mg of valsartan tablet also contains talc.</Description>
</NDC>
<NDC>
<NDCCode>70748-197-07</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70748-197-07) </PackageDescription>
<NDC11Code>70748-0197-07</NDC11Code>
<ProductNDC>70748-197</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213808</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>97; 103</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. (1.1).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets (sacubitril and valsartan) are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains sacubitril, sodium and valsartan, disodium. Following oral administration, sacubitril metabolizes to LBQ657. Sacubitril sodium is described chemically as 4-[[(2S,4R)-5-ethoxy-4-methyl-5-oxo-1-(4-phenylphenyl)pentan-2-yl]amino]-4-oxobutanoate; sodium salt with an empirical formula of C24H28NNaO5 and a molecular weight of 432.47 g/mol. The structural formula is. Valsartan is described chemically as N-[p-(o-1H-Tetrazol-5-ylphenyl)benzyl]-N-valeryl-L-valine, disodium salt with an empirical formula of C24H27N5Na2O3 and a molecular weight of 480.52 g/mol. The structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, mannitol, magnesium stearate (vegetable origin), talc, and silicon dioxide. The film-coat inactive ingredients are hypromellose, Macrogol and titanium dioxide. The 97 mg of sacubitril and 103 mg of valsartan tablet also contains talc.</Description>
</NDC>
<NDC>
<NDCCode>70748-208-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70748-208-07) / 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>70748-0208-07</NDC11Code>
<ProductNDC>70748-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214350</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide. The molecular formula is C22H26ClN7O2S, which corresponds to a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, magnesium stearate, talc. The tablet coating consists of hypromellose, medium chain triglycerides, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70748-209-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70748-209-07) / 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>70748-0209-07</NDC11Code>
<ProductNDC>70748-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214350</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide. The molecular formula is C22H26ClN7O2S, which corresponds to a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, magnesium stearate, talc. The tablet coating consists of hypromellose, medium chain triglycerides, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70748-210-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70748-210-07) / 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>70748-0210-07</NDC11Code>
<ProductNDC>70748-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214350</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide. The molecular formula is C22H26ClN7O2S, which corresponds to a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, magnesium stearate, talc. The tablet coating consists of hypromellose, medium chain triglycerides, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70748-215-07</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (70748-215-07) </PackageDescription>
<NDC11Code>70748-0215-07</NDC11Code>
<ProductNDC>70748-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen And Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Naproxen And Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200304</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022511</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM; NAPROXEN</SubstanceName>
<StrengthNumber>20; 375</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200304</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, are indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablets is indicated for relief of signs and symptoms of: 1 osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults., 2 juvenile idiopathic arthritis (JIA) in adolescent patients.</IndicationAndUsage>
<Description>The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablet is combination of a nonsteroidal anti- inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) for oral administration. The inactive ingredients are carnauba wax, colloidal silicon dioxide, croscarmellose sodium, iron oxide yellow, glyceryl monostearate, hypromellose, iron oxide black, magnesium stearate, methacrylic acid copolymer dispersion, methylparaben, polysorbate 80, polydextrose, polyethylene glycol, povidone, propylene glycol, propylparaben, titanium dioxide, and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure:. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3.Naproxen is an odorless, white to off-white crystalline substance. It is lipid soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2- pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C17H18N3O3S)2 Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.</Description>
</NDC>
<NDC>
<NDCCode>70748-216-07</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (70748-216-07) </PackageDescription>
<NDC11Code>70748-0216-07</NDC11Code>
<ProductNDC>70748-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen And Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Naproxen And Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200304</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022511</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM; NAPROXEN</SubstanceName>
<StrengthNumber>20; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200304</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, are indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablets is indicated for relief of signs and symptoms of: 1 osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults., 2 juvenile idiopathic arthritis (JIA) in adolescent patients.</IndicationAndUsage>
<Description>The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablet is combination of a nonsteroidal anti- inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) for oral administration. The inactive ingredients are carnauba wax, colloidal silicon dioxide, croscarmellose sodium, iron oxide yellow, glyceryl monostearate, hypromellose, iron oxide black, magnesium stearate, methacrylic acid copolymer dispersion, methylparaben, polysorbate 80, polydextrose, polyethylene glycol, povidone, propylene glycol, propylparaben, titanium dioxide, and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure:. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3.Naproxen is an odorless, white to off-white crystalline substance. It is lipid soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2- pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S- isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C17H18N3O3S)2 Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.</Description>
</NDC>
<NDC>
<NDCCode>70748-173-26</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (70748-173-26) </PackageDescription>
<NDC11Code>70748-0173-26</NDC11Code>
<ProductNDC>70748-173</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sevelamer Hydrochloride</ProprietaryName>
<NonProprietaryName>Sevelamer Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213145</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SEVELAMER HYDROCHLORIDE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied.</IndicationAndUsage>
<Description>The active ingredient in sevelamer hydrochloride tablets is sevelamer hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer hydrochloride is poly (allylamine hydrochloride) crosslinked with epichlorohydrin in which 40 % of the amines are protonated. It is known chemically as poly (allylamine-co-N, N'-diallyl-1,3-diamino-2-hydroxypropane) hydrochloride. Sevelamer hydrochloride is hydrophilic, but insoluble in water. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Hydrochloride. The primary amine groups shown in the structure are derived directly from poly (allylamine hydrochloride). The crosslinking groups consist of two secondary amine groups derived from poly (allylamine hydrochloride) and one molecule of epichlorohydrin. Sevelamer Hydrochloride Tablets: Each film-coated tablet of sevelamer hydrochloride contains either 400 mg or 800 mg of sevelamer hydrochloride on an anhydrous basis. The inactive ingredients are colloidal silicon dioxide, stearic acid and Opadry Clear 84F590009 containing polyethylene glycol, polyvinyl alcohol, and talc. The tablet imprint contains Opacode S-1-17823 Black containing ferrosoferric oxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>70748-273-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (70748-273-01) / .6 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>70748-0273-01</NDC11Code>
<ProductNDC>70748-273</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armlupeg</ProprietaryName>
<NonProprietaryName>Pegfilgrastim-unne</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761212</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PEGFILGRASTIM</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/.6mL</StrengthUnit>
<Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armlupeg is a leukocyte growth factor indicated to : 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1) , 2 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2).</IndicationAndUsage>
<Description>Pegfilgrastim-unne is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim-unne, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-unne is approximately 39 kD. Armlupeg (pegfilgrastim-unne) injection is a sterile, clear, colorless, preservative-free solution intended for subcutaneous use only and is supplied in a single-dose prefilled syringe with a 27‑gauge ½" needle and rigid needle shield, with UltraSafe Plus PassiveTM Needle Guard. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL). Each prefilled syringe contains 0.6 mL solution of 6 mg pegfilgrastim-unne (based on protein weight), glacial acetic acid (0.77 mg), polysorbate 20 (0.02 mg), sodium acetate (0.066 mg) and sorbitol (30 mg) in Water for Injection, USP. The pH is 4.</Description>
</NDC>
<NDC>
<NDCCode>70748-370-02</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70748-370-02) / 2 mL in 1 VIAL, SINGLE-DOSE (70748-370-01) </PackageDescription>
<NDC11Code>70748-0370-02</NDC11Code>
<ProductNDC>70748-370</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sugammadex</ProprietaryName>
<NonProprietaryName>Sugammadex</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214338</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl) - 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin Octa sodium salt with a molecular weight of 2178.01. The structural formula is:. Sugammadex injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear and colorless to slightly brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.785 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>70748-371-02</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70748-371-02) / 5 mL in 1 VIAL, SINGLE-DOSE (70748-371-01) </PackageDescription>
<NDC11Code>70748-0371-02</NDC11Code>
<ProductNDC>70748-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sugammadex</ProprietaryName>
<NonProprietaryName>Sugammadex</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214338</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl) - 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin Octa sodium salt with a molecular weight of 2178.01. The structural formula is:. Sugammadex injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear and colorless to slightly brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.785 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0409-7122-07</NDCCode>
<PackageDescription>6 POUCH in 1 CASE (0409-7122-07) > 1 BAG in 1 POUCH > 2000 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-7122-07</NDC11Code>
<ProductNDC>0409-7122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn Ii</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19911219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020041</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; N-ACETYL-TYROSINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE</SubstanceName>
<StrengthNumber>1490; 1527; 1050; 1107; 750; 450; 990; 1500; 1575; 258; 405; 447; 1083; 795; 600; 300; 750</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-03-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>10237-258-20</NDCCode>
<PackageDescription>20 mL in 1 BOTTLE, PLASTIC (10237-258-20) </PackageDescription>
<NDC11Code>10237-0258-20</NDC11Code>
<ProductNDC>10237-258</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Therabreath Healthy Gums</ProprietaryName>
<NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
<StrengthNumber>.01</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent gingivitis, an early form of gum disease and bleeding gums. Helps control plaque that leads to gingivitis and bleeding gums.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-258-01</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (30142-258-01) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY (30142-258-04) </PackageDescription>
<NDC11Code>30142-0258-01</NDC11Code>
<ProductNDC>30142-258</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208150</ApplicationNumber>
<LabelerName>The Kroger Co.</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion , 2 runny nose , 3 sneezing , 4 itchy nose , 5 itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-258-02</NDCCode>
<PackageDescription>2 BOTTLE, SPRAY in 1 CARTON (30142-258-02) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>30142-0258-02</NDC11Code>
<ProductNDC>30142-258</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208150</ApplicationNumber>
<LabelerName>The Kroger Co.</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion , 2 runny nose , 3 sneezing , 4 itchy nose , 5 itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-258-03</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (30142-258-03) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY (30142-258-05) </PackageDescription>
<NDC11Code>30142-0258-03</NDC11Code>
<ProductNDC>30142-258</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208150</ApplicationNumber>
<LabelerName>The Kroger Co.</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion , 2 runny nose , 3 sneezing , 4 itchy nose , 5 itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33342-258-66</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (33342-258-66) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0258-66</NDC11Code>
<ProductNDC>33342-258</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseltamivir Phosphate</ProprietaryName>
<NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207211</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2) Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).</IndicationAndUsage>
<Description>Oseltamivir phosphate capsules, USP an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate USP. In addition to the active ingredient, each capsule contains croscarmellose sodium, isopropyl alcohol, povidone, pregelatinised starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow, titanium dioxide. The 45 mg capsule shell contains gelatin, iron oxide black, titanium dioxide. The 75 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow, titanium dioxide, iron oxide black. Each capsule is printed with blue ink, which includes shellac, propylene glycol and FD&C Blue No. 2 as the colorant. Oseltamivir phosphate, USP is a white crystalline solid with the chemical name (3R,4R,5S)-4-acetylamino-5-amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C16H28N2O4 (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows.</Description>
</NDC>
<NDC>
<NDCCode>51316-036-48</NDCCode>
<PackageDescription>258 g in 1 CAN (51316-036-48) </PackageDescription>
<NDC11Code>51316-0036-48</NDC11Code>
<ProductNDC>51316-036</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Health Spf 50 Clear</ProprietaryName>
<NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191015</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>CVS PHARMACY</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 50; 40</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58892-258-50</NDCCode>
<PackageDescription>53 g in 1 BOTTLE, PUMP (58892-258-50) </PackageDescription>
<NDC11Code>58892-0258-50</NDC11Code>
<ProductNDC>58892-258</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Proceuticals Private Label By Tizo Daily Defense Tinted Mineral Sunscreen</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240708</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Fallien Cosmeceuticals, LTD</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>30; 100</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DIRECTIONS: Apply liberally 15 minutes before sun exposure. Reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Children under 6 months: Ask a doctor Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 am-2 pm Wear long-sleeved shirts, pants, hats, and sunglasses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59450-941-15</NDCCode>
<PackageDescription>258 g in 1 CAN (59450-941-15) </PackageDescription>
<NDC11Code>59450-0941-15</NDC11Code>
<ProductNDC>59450-941</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sport Sunscreen Spf 30</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231107</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>The Kroger Co.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE</SubstanceName>
<StrengthNumber>30; 100; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59651-258-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (59651-258-01) </PackageDescription>
<NDC11Code>59651-0258-01</NDC11Code>
<ProductNDC>59651-258</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191025</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202445</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propafenone hydrochloride tablets are indicated to: 1 prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease., 2 prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease., 3 treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital.</IndicationAndUsage>
<Description>Propafenone hydrochloride is an antiarrhythmic drug supplied in film-coated tablets of 150 mg, 225 mg and 300 mg for oral administration. Propafenone has some structural similarities to beta-blocking agents. Chemically, propafenone hydrochloride is 2’-[2-hydroxy-3-(propylamino)-propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. The structural formula of propafenone hydrochloride is given below:. Propafenone hydrochloride occurs as white crystalline powder. It is soluble in methanol and in hot water; slightly soluble in alcohol and in chloroform; very slightly soluble in acetone; insoluble in diethyl ether and in toluene. The following inactive ingredients are contained in the tablet: corn starch, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>62106-1165-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1165-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1165-08</NDC11Code>
<ProductNDC>62106-1165</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 258</ProprietaryName>
<NonProprietaryName>Berberis Vulgaris, Bryonia Dioica, Lycopodium Clavatum, Mercurialis Annua, Hydrastis Canadensis, Boldo, Solidago Virgaurea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150602</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>LYCOPODIUM CLAVATUM SPORE; MERCURIALIS ANNUA FLOWERING TOP; GOLDENSEAL; PEUMUS BOLDUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63940-058-48</NDCCode>
<PackageDescription>258 g in 1 CAN (63940-058-48) </PackageDescription>
<NDC11Code>63940-0058-48</NDC11Code>
<ProductNDC>63940-058</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Face Values Ultra Sport Active Spf 30 Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080313</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>HARMON STORES, INC.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 100; 50; 20; 40</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63940-070-48</NDCCode>
<PackageDescription>258 g in 1 CAN (63940-070-48) </PackageDescription>
<NDC11Code>63940-0070-48</NDC11Code>
<ProductNDC>63940-070</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Face Values Ultra Sport Active Spf 15 Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080227</StartMarketingDate>
<EndMarketingDate>20250106</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>HARMON STORES, INC.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE</SubstanceName>
<StrengthNumber>20; 100; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20080227</StartMarketingDatePackage>
<EndMarketingDatePackage>20250106</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63940-084-48</NDCCode>
<PackageDescription>258 g in 1 CAN (63940-084-48) </PackageDescription>
<NDC11Code>63940-0084-48</NDC11Code>
<ProductNDC>63940-084</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Harmon Face Values Ultra Sport Active Sunscreen Spf 30</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080313</StartMarketingDate>
<EndMarketingDate>20250728</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>HARMON STORES, INC.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 50; 20</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20080313</StartMarketingDatePackage>
<EndMarketingDatePackage>20250728</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63940-088-48</NDCCode>
<PackageDescription>258 g in 1 CAN (63940-088-48) </PackageDescription>
<NDC11Code>63940-0088-48</NDC11Code>
<ProductNDC>63940-088</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Harmon Face Values Ultra Sport Active Sunscreen Spf 50</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090522</StartMarketingDate>
<EndMarketingDate>20250728</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>HARMON STORES, INC.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 50; 40</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090522</StartMarketingDatePackage>
<EndMarketingDatePackage>20250728</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
</NDCList>