{
"NDC": [
{
"NDCCode": "48792-7869-4",
"PackageDescription": "44692 TABLET, FILM COATED in 1 BAG (48792-7869-4)",
"NDC11Code": "48792-7869-04",
"ProductNDC": "48792-7869",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"NonProprietaryName": "Azithromycin Monohydrate",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20200306",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "48792-7869-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (48792-7869-1) ",
"NDC11Code": "48792-7869-01",
"ProductNDC": "48792-7869",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin Monohydrate",
"NonProprietaryName": "Azithromycin Monohydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209045",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181220",
"SamplePackage": "N"
},
{
"NDCCode": "48792-7870-4",
"PackageDescription": "26536 TABLET, FILM COATED in 1 BAG (48792-7870-4)",
"NDC11Code": "48792-7870-04",
"ProductNDC": "48792-7870",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"NonProprietaryName": "Azithromycin Monohydrate",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20200307",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "0093-7869-65",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (0093-7869-65) / 1 LOZENGE in 1 BLISTER PACK (0093-7869-19) ",
"NDC11Code": "00093-7869-65",
"ProductNDC": "0093-7869",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Citrate",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "20151208",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020747",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "1200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151208",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Oral Transmucosal Fentanyl Citrate (OTFC) is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking OTFC. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)]., 3 As a part of the TIRF REMS, OTFC may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of OTFC, patient and prescriber enrollment are not required. .",
"Description": "Oral Transmucosal Fentanyl Citrate (OTFC) (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. OTFC is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed. OTFC is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the OTFC unit to be removed from the mouth if signs of excessive opioid effects appear during administration. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. Inactive Ingredients: Hydrated dextrates, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, and edible glue (modified food starch and confectioner’s sugar)."
},
{
"NDCCode": "48792-7839-1",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (48792-7839-1) ",
"NDC11Code": "48792-7839-01",
"ProductNDC": "48792-7839",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180507",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206524",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180507",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension ( 1.1) Amlodipine besylate tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease ( 1.2) Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "48792-7840-1",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (48792-7840-1) ",
"NDC11Code": "48792-7840-01",
"ProductNDC": "48792-7840",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180507",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206524",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180507",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension ( 1.1) Amlodipine besylate tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease ( 1.2) Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "48792-7841-1",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (48792-7841-1) ",
"NDC11Code": "48792-7841-01",
"ProductNDC": "48792-7841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180507",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206524",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180507",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension ( 1.1) Amlodipine besylate tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease ( 1.2) Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "48792-7865-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (48792-7865-1) ",
"NDC11Code": "48792-7865-01",
"ProductNDC": "48792-7865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linagliptin",
"NonProprietaryName": "Linagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208335",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "LINAGLIPTIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260101",
"SamplePackage": "N",
"IndicationAndUsage": "Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1). Limitations of Use: 1 Should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis ( 1) , 2 Has not been studied in patients with a history of pancreatitis ( 1) .",
"Description": "Linagliptin tablets contain, as the active ingredient, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Linagliptin is described chemically as 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The empirical formula is C 25H 28N 8O 2 and the molecular weight is 472.54 g/mol. The structural formula is:. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Each film-coated tablet of linagliptin contains 5 mg of linagliptin free base and the following inactive ingredients: mannitol, pregelatinized starch, copovidone, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide and polyethylene glycol."
},
{
"NDCCode": "48792-7872-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (48792-7872-1) ",
"NDC11Code": "48792-7872-01",
"ProductNDC": "48792-7872",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213348",
"LabelerName": "Sunshine Lake Pharma Co.,Ltd.",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250514",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablets are factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1) , 2 for treatment of deep vein thrombosis (DVT) ( 1.2) , 3 for treatment of pulmonary embolism (PE) ( 1.3) , 4 for reduction in the risk of recurrence of DVT or PE ( 1.4) , 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5) , 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6) , 7 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9) , 8 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10) .",
"Description": "Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban Tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C 19H 18ClN 3O 5S and the molecular weight is 435.89. The structural formula is:. Rivaroxaban is a pure ( S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each Rivaroxaban Tablet, USP contains 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of Rivaroxaban Tablet, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for Rivaroxaban Tablets, USP 10 mg is Opadry II85F640050, containing ferric oxide red, ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 15 mg is Opadry II85F620048, containing ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 20 mg is Opadry II85F48105, containing polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "48792-7872-2",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (48792-7872-2) ",
"NDC11Code": "48792-7872-02",
"ProductNDC": "48792-7872",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213348",
"LabelerName": "Sunshine Lake Pharma Co.,Ltd.",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250514",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablets are factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1) , 2 for treatment of deep vein thrombosis (DVT) ( 1.2) , 3 for treatment of pulmonary embolism (PE) ( 1.3) , 4 for reduction in the risk of recurrence of DVT or PE ( 1.4) , 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5) , 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6) , 7 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9) , 8 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10) .",
"Description": "Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban Tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C 19H 18ClN 3O 5S and the molecular weight is 435.89. The structural formula is:. Rivaroxaban is a pure ( S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each Rivaroxaban Tablet, USP contains 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of Rivaroxaban Tablet, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for Rivaroxaban Tablets, USP 10 mg is Opadry II85F640050, containing ferric oxide red, ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 15 mg is Opadry II85F620048, containing ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 20 mg is Opadry II85F48105, containing polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "48792-7873-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (48792-7873-1) ",
"NDC11Code": "48792-7873-01",
"ProductNDC": "48792-7873",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213348",
"LabelerName": "Sunshine Lake Pharma Co.,Ltd.",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250514",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablets are factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1) , 2 for treatment of deep vein thrombosis (DVT) ( 1.2) , 3 for treatment of pulmonary embolism (PE) ( 1.3) , 4 for reduction in the risk of recurrence of DVT or PE ( 1.4) , 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5) , 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6) , 7 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9) , 8 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10) .",
"Description": "Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban Tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C 19H 18ClN 3O 5S and the molecular weight is 435.89. The structural formula is:. Rivaroxaban is a pure ( S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each Rivaroxaban Tablet, USP contains 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of Rivaroxaban Tablet, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for Rivaroxaban Tablets, USP 10 mg is Opadry II85F640050, containing ferric oxide red, ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 15 mg is Opadry II85F620048, containing ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 20 mg is Opadry II85F48105, containing polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "48792-7873-2",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (48792-7873-2) ",
"NDC11Code": "48792-7873-02",
"ProductNDC": "48792-7873",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213348",
"LabelerName": "Sunshine Lake Pharma Co.,Ltd.",
"SubstanceName": "RIVAROXABAN",
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"IndicationAndUsage": "Rivaroxaban tablets are factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1) , 2 for treatment of deep vein thrombosis (DVT) ( 1.2) , 3 for treatment of pulmonary embolism (PE) ( 1.3) , 4 for reduction in the risk of recurrence of DVT or PE ( 1.4) , 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5) , 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6) , 7 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9) , 8 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10) .",
"Description": "Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban Tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C 19H 18ClN 3O 5S and the molecular weight is 435.89. The structural formula is:. Rivaroxaban is a pure ( S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each Rivaroxaban Tablet, USP contains 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of Rivaroxaban Tablet, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for Rivaroxaban Tablets, USP 10 mg is Opadry II85F640050, containing ferric oxide red, ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 15 mg is Opadry II85F620048, containing ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 20 mg is Opadry II85F48105, containing polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
},
{
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"IndicationAndUsage": "Rivaroxaban tablets are factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1) , 2 for treatment of deep vein thrombosis (DVT) ( 1.2) , 3 for treatment of pulmonary embolism (PE) ( 1.3) , 4 for reduction in the risk of recurrence of DVT or PE ( 1.4) , 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5) , 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6) , 7 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9) , 8 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10) .",
"Description": "Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban Tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C 19H 18ClN 3O 5S and the molecular weight is 435.89. The structural formula is:. Rivaroxaban is a pure ( S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each Rivaroxaban Tablet, USP contains 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of Rivaroxaban Tablet, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for Rivaroxaban Tablets, USP 10 mg is Opadry II85F640050, containing ferric oxide red, ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 15 mg is Opadry II85F620048, containing ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 20 mg is Opadry II85F48105, containing polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
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{
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"ProductNDC": "48792-7874",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ApplicationNumber": "ANDA213348",
"LabelerName": "Sunshine Lake Pharma Co.,Ltd.",
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"IndicationAndUsage": "Rivaroxaban tablets are factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1) , 2 for treatment of deep vein thrombosis (DVT) ( 1.2) , 3 for treatment of pulmonary embolism (PE) ( 1.3) , 4 for reduction in the risk of recurrence of DVT or PE ( 1.4) , 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5) , 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6) , 7 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9) , 8 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10) .",
"Description": "Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban Tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C 19H 18ClN 3O 5S and the molecular weight is 435.89. The structural formula is:. Rivaroxaban is a pure ( S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each Rivaroxaban Tablet, USP contains 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of Rivaroxaban Tablet, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for Rivaroxaban Tablets, USP 10 mg is Opadry II85F640050, containing ferric oxide red, ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 15 mg is Opadry II85F620048, containing ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 20 mg is Opadry II85F48105, containing polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "0615-7869-39",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076397",
"LabelerName": "NCS HealthCare of KY, Inc dba Vangard Labs",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "40",
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"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "68788-7869-1",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (68788-7869-1) ",
"NDC11Code": "68788-7869-01",
"ProductNDC": "68788-7869",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090007",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210215",
"SamplePackage": "N"
},
{
"NDCCode": "68788-7869-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (68788-7869-3) ",
"NDC11Code": "68788-7869-03",
"ProductNDC": "68788-7869",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090007",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "GABAPENTIN",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-06-23",
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"StartMarketingDatePackage": "20210215",
"SamplePackage": "N"
},
{
"NDCCode": "68788-7869-6",
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"NDC11Code": "68788-7869-06",
"ProductNDC": "68788-7869",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090007",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210215",
"SamplePackage": "N"
},
{
"NDCCode": "68788-7869-8",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (68788-7869-8) ",
"NDC11Code": "68788-7869-08",
"ProductNDC": "68788-7869",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090007",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "GABAPENTIN",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210215",
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},
{
"NDCCode": "68788-7869-9",
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"NDC11Code": "68788-7869-09",
"ProductNDC": "68788-7869",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090007",
"LabelerName": "Preferred Pharmaceuticals Inc.",
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"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210215",
"SamplePackage": "N"
},
{
"NDCCode": "48792-7809-6",
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"NDC11Code": "48792-7809-06",
"ProductNDC": "48792-7809",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zidovudine",
"NonProprietaryName": "Zidovudine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202058",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "ZIDOVUDINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-03-18"
},
{
"NDCCode": "48792-7810-1",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7810-1)",
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"ProductNDC": "48792-7810",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203584",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "CLARITHROMYCIN",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-10-25",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "48792-7811-1",
"PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (48792-7811-1) ",
"NDC11Code": "48792-7811-01",
"ProductNDC": "48792-7811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204062",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180910",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.",
"Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) -2 - ( p- isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77 °C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate, lactose monohydrate, polysorbate, polyethylene glycol, titanium dioxide, polyvinyl alcohol, talc."
},
{
"NDCCode": "48792-7812-1",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204062",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
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"StrengthUnit": "mg/1",
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"LastUpdate": "2025-10-17",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180910",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.",
"Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) -2 - ( p- isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77 °C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate, lactose monohydrate, polysorbate, polyethylene glycol, titanium dioxide, polyvinyl alcohol, talc."
},
{
"NDCCode": "48792-7813-1",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
"StartMarketingDate": "20180910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204062",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "IBUPROFEN",
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"StrengthUnit": "mg/1",
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"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180910",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.",
"Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) -2 - ( p- isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77 °C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate, lactose monohydrate, polysorbate, polyethylene glycol, titanium dioxide, polyvinyl alcohol, talc."
},
{
"NDCCode": "48792-7814-1",
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"ProductNDC": "48792-7814",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
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"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204968",
"LabelerName": "Sunshine Lake Pharma CO., LTD.",
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"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190219",
"SamplePackage": "N"
},
{
"NDCCode": "48792-7815-1",
"PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (48792-7815-1) ",
"NDC11Code": "48792-7815-01",
"ProductNDC": "48792-7815",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
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"RouteName": "ORAL",
"StartMarketingDate": "20190219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204968",
"LabelerName": "Sunshine Lake Pharma CO., LTD.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "750",
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"LastUpdate": "2021-11-10",
"PackageNdcExcludeFlag": "N",
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{
"NDCCode": "48792-7817-1",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7817-1)",
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"ProductNDC": "48792-7817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
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"RouteName": "ORAL",
"StartMarketingDate": "20150929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203584",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
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"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "48792-7821-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (48792-7821-1) ",
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"ProductNDC": "48792-7821",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prasugrel",
"NonProprietaryName": "Prasugrel Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206021",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "PRASUGREL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N"
}
]
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<NDCList>
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<PackageDescription>44692 TABLET, FILM COATED in 1 BAG (48792-7869-4)</PackageDescription>
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<ProductNDC>48792-7869</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<NonProprietaryName>Azithromycin Monohydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20200306</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<NDCCode>48792-7869-1</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (48792-7869-1) </PackageDescription>
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<ProductNDC>48792-7869</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin Monohydrate</ProprietaryName>
<NonProprietaryName>Azithromycin Monohydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209045</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>48792-7870-4</NDCCode>
<PackageDescription>26536 TABLET, FILM COATED in 1 BAG (48792-7870-4)</PackageDescription>
<NDC11Code>48792-7870-04</NDC11Code>
<ProductNDC>48792-7870</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<NonProprietaryName>Azithromycin Monohydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20200307</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0093-7869-65</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (0093-7869-65) / 1 LOZENGE in 1 BLISTER PACK (0093-7869-19) </PackageDescription>
<NDC11Code>00093-7869-65</NDC11Code>
<ProductNDC>0093-7869</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Citrate</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>20151208</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020747</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151208</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oral Transmucosal Fentanyl Citrate (OTFC) is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking OTFC. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)]., 3 As a part of the TIRF REMS, OTFC may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of OTFC, patient and prescriber enrollment are not required. .</IndicationAndUsage>
<Description>Oral Transmucosal Fentanyl Citrate (OTFC) (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. OTFC is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed. OTFC is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the OTFC unit to be removed from the mouth if signs of excessive opioid effects appear during administration. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. Inactive Ingredients: Hydrated dextrates, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, and edible glue (modified food starch and confectioner’s sugar).</Description>
</NDC>
<NDC>
<NDCCode>48792-7839-1</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (48792-7839-1) </PackageDescription>
<NDC11Code>48792-7839-01</NDC11Code>
<ProductNDC>48792-7839</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180507</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206524</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension ( 1.1) Amlodipine besylate tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease ( 1.2) Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>48792-7840-1</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (48792-7840-1) </PackageDescription>
<NDC11Code>48792-7840-01</NDC11Code>
<ProductNDC>48792-7840</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180507</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206524</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension ( 1.1) Amlodipine besylate tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease ( 1.2) Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>48792-7841-1</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (48792-7841-1) </PackageDescription>
<NDC11Code>48792-7841-01</NDC11Code>
<ProductNDC>48792-7841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180507</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206524</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension ( 1.1) Amlodipine besylate tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions., 2 Coronary Artery Disease ( 1.2) Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>48792-7865-1</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (48792-7865-1) </PackageDescription>
<NDC11Code>48792-7865-01</NDC11Code>
<ProductNDC>48792-7865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linagliptin</ProprietaryName>
<NonProprietaryName>Linagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208335</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>LINAGLIPTIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1). Limitations of Use: 1 Should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis ( 1) , 2 Has not been studied in patients with a history of pancreatitis ( 1) .</IndicationAndUsage>
<Description>Linagliptin tablets contain, as the active ingredient, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Linagliptin is described chemically as 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-. The empirical formula is C 25H 28N 8O 2 and the molecular weight is 472.54 g/mol. The structural formula is:. Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL). Each film-coated tablet of linagliptin contains 5 mg of linagliptin free base and the following inactive ingredients: mannitol, pregelatinized starch, copovidone, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>48792-7872-1</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (48792-7872-1) </PackageDescription>
<NDC11Code>48792-7872-01</NDC11Code>
<ProductNDC>48792-7872</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivaroxaban</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213348</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co.,Ltd.</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivaroxaban tablets are factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1) , 2 for treatment of deep vein thrombosis (DVT) ( 1.2) , 3 for treatment of pulmonary embolism (PE) ( 1.3) , 4 for reduction in the risk of recurrence of DVT or PE ( 1.4) , 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5) , 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6) , 7 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9) , 8 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10) .</IndicationAndUsage>
<Description>Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban Tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C 19H 18ClN 3O 5S and the molecular weight is 435.89. The structural formula is:. Rivaroxaban is a pure ( S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each Rivaroxaban Tablet, USP contains 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of Rivaroxaban Tablet, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for Rivaroxaban Tablets, USP 10 mg is Opadry II85F640050, containing ferric oxide red, ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 15 mg is Opadry II85F620048, containing ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 20 mg is Opadry II85F48105, containing polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>48792-7872-2</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (48792-7872-2) </PackageDescription>
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<IndicationAndUsage>Rivaroxaban tablets are factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1) , 2 for treatment of deep vein thrombosis (DVT) ( 1.2) , 3 for treatment of pulmonary embolism (PE) ( 1.3) , 4 for reduction in the risk of recurrence of DVT or PE ( 1.4) , 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5) , 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6) , 7 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9) , 8 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10) .</IndicationAndUsage>
<Description>Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban Tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C 19H 18ClN 3O 5S and the molecular weight is 435.89. The structural formula is:. Rivaroxaban is a pure ( S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each Rivaroxaban Tablet, USP contains 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of Rivaroxaban Tablet, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for Rivaroxaban Tablets, USP 10 mg is Opadry II85F640050, containing ferric oxide red, ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 15 mg is Opadry II85F620048, containing ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 20 mg is Opadry II85F48105, containing polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
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<IndicationAndUsage>Rivaroxaban tablets are factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1) , 2 for treatment of deep vein thrombosis (DVT) ( 1.2) , 3 for treatment of pulmonary embolism (PE) ( 1.3) , 4 for reduction in the risk of recurrence of DVT or PE ( 1.4) , 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5) , 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6) , 7 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9) , 8 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10) .</IndicationAndUsage>
<Description>Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban Tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C 19H 18ClN 3O 5S and the molecular weight is 435.89. The structural formula is:. Rivaroxaban is a pure ( S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each Rivaroxaban Tablet, USP contains 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of Rivaroxaban Tablet, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for Rivaroxaban Tablets, USP 10 mg is Opadry II85F640050, containing ferric oxide red, ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 15 mg is Opadry II85F620048, containing ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 20 mg is Opadry II85F48105, containing polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
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<IndicationAndUsage>Rivaroxaban tablets are factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1) , 2 for treatment of deep vein thrombosis (DVT) ( 1.2) , 3 for treatment of pulmonary embolism (PE) ( 1.3) , 4 for reduction in the risk of recurrence of DVT or PE ( 1.4) , 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5) , 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6) , 7 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9) , 8 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10) .</IndicationAndUsage>
<Description>Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban Tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C 19H 18ClN 3O 5S and the molecular weight is 435.89. The structural formula is:. Rivaroxaban is a pure ( S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each Rivaroxaban Tablet, USP contains 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of Rivaroxaban Tablet, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for Rivaroxaban Tablets, USP 10 mg is Opadry II85F640050, containing ferric oxide red, ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 15 mg is Opadry II85F620048, containing ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 20 mg is Opadry II85F48105, containing polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
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<IndicationAndUsage>Rivaroxaban tablets are factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1) , 2 for treatment of deep vein thrombosis (DVT) ( 1.2) , 3 for treatment of pulmonary embolism (PE) ( 1.3) , 4 for reduction in the risk of recurrence of DVT or PE ( 1.4) , 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5) , 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6) , 7 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9) , 8 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10) .</IndicationAndUsage>
<Description>Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban Tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C 19H 18ClN 3O 5S and the molecular weight is 435.89. The structural formula is:. Rivaroxaban is a pure ( S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each Rivaroxaban Tablet, USP contains 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of Rivaroxaban Tablet, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for Rivaroxaban Tablets, USP 10 mg is Opadry II85F640050, containing ferric oxide red, ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 15 mg is Opadry II85F620048, containing ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 20 mg is Opadry II85F48105, containing polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
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<IndicationAndUsage>Rivaroxaban tablets are factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1) , 2 for treatment of deep vein thrombosis (DVT) ( 1.2) , 3 for treatment of pulmonary embolism (PE) ( 1.3) , 4 for reduction in the risk of recurrence of DVT or PE ( 1.4) , 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5) , 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6) , 7 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9) , 8 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10) .</IndicationAndUsage>
<Description>Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban Tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C 19H 18ClN 3O 5S and the molecular weight is 435.89. The structural formula is:. Rivaroxaban is a pure ( S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each Rivaroxaban Tablet, USP contains 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of Rivaroxaban Tablet, USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for Rivaroxaban Tablets, USP 10 mg is Opadry II85F640050, containing ferric oxide red, ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 15 mg is Opadry II85F620048, containing ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide, and for Rivaroxaban Tablets, USP 20 mg is Opadry II85F48105, containing polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202058</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>ZIDOVUDINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-03-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>48792-7810-1</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7810-1)</PackageDescription>
<NDC11Code>48792-7810-01</NDC11Code>
<ProductNDC>48792-7810</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clarithromycin</ProprietaryName>
<NonProprietaryName>Clarithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203584</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>CLARITHROMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-25</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>48792-7811-1</NDCCode>
<PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (48792-7811-1) </PackageDescription>
<NDC11Code>48792-7811-01</NDC11Code>
<ProductNDC>48792-7811</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204062</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) -2 - ( p- isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77 °C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate, lactose monohydrate, polysorbate, polyethylene glycol, titanium dioxide, polyvinyl alcohol, talc.</Description>
</NDC>
<NDC>
<NDCCode>48792-7812-1</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (48792-7812-1) </PackageDescription>
<NDC11Code>48792-7812-01</NDC11Code>
<ProductNDC>48792-7812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204062</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) -2 - ( p- isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77 °C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate, lactose monohydrate, polysorbate, polyethylene glycol, titanium dioxide, polyvinyl alcohol, talc.</Description>
</NDC>
<NDC>
<NDCCode>48792-7813-1</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (48792-7813-1) </PackageDescription>
<NDC11Code>48792-7813-01</NDC11Code>
<ProductNDC>48792-7813</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204062</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) -2 - ( p- isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77 °C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate, lactose monohydrate, polysorbate, polyethylene glycol, titanium dioxide, polyvinyl alcohol, talc.</Description>
</NDC>
<NDC>
<NDCCode>48792-7814-1</NDCCode>
<PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (48792-7814-1) </PackageDescription>
<NDC11Code>48792-7814-01</NDC11Code>
<ProductNDC>48792-7814</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204968</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma CO., LTD.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48792-7815-1</NDCCode>
<PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (48792-7815-1) </PackageDescription>
<NDC11Code>48792-7815-01</NDC11Code>
<ProductNDC>48792-7815</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204968</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma CO., LTD.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48792-7816-1</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (48792-7816-1) </PackageDescription>
<NDC11Code>48792-7816-01</NDC11Code>
<ProductNDC>48792-7816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204968</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma CO., LTD.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48792-7817-1</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7817-1)</PackageDescription>
<NDC11Code>48792-7817-01</NDC11Code>
<ProductNDC>48792-7817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clarithromycin</ProprietaryName>
<NonProprietaryName>Clarithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203584</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>CLARITHROMYCIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-25</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>48792-7821-1</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (48792-7821-1) </PackageDescription>
<NDC11Code>48792-7821-01</NDC11Code>
<ProductNDC>48792-7821</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prasugrel</ProprietaryName>
<NonProprietaryName>Prasugrel Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206021</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>PRASUGREL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>