{
"NDC": [
{
"NDCCode": "48792-7855-1",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (48792-7855-1) ",
"NDC11Code": "48792-7855-01",
"ProductNDC": "48792-7855",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20180710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208146",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180710",
"SamplePackage": "N"
},
{
"NDCCode": "0169-7815-01",
"PackageDescription": "1 KIT in 1 KIT (0169-7815-01) * 4 mL in 1 VIAL, GLASS (0169-7855-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) ",
"NDC11Code": "00169-7815-01",
"ProductNDC": "0169-7815",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Novoeight",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20150401",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125466",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150401",
"SamplePackage": "N",
"IndicationAndUsage": "Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation. factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "Novoeight is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (0.9% sodium chloride). Novoeight is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000 or 3000 international units (IU) per vial. When reconstituted with the appropriate volume of diluent, the product contains the following components per mL: 18 mg sodium chloride, 1.5 mg L-histidine, 3 mg sucrose, 0.1 mg polysorbate 80, 0.055 mg L-methionine and 0.25 mg calcium chloride dihydrate. The product contains no preservative. Each vial of Novoeight is labeled with the actual rFVIII activity expressed in IU determined by the one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for FVIII Concentrates. One IU, as defined by the WHO standard for human FVIII, is approximately equal to the level of FVIII activity in 1 mL of fresh pooled human plasma. The specific activity of Novoeight is approximately 8340 IU per milligram of protein. The active ingredient in Novoeight is a recombinant (r) analogue of human coagulation factor VIII (FVIII) with a molecular mass of 166 kDa, calculated excluding post-translational modifications. The rFVIII molecule in Novoeight is a glycoprotein containing a heavy chain and a light chain, with 21 of the 908 amino acids of the B-domain of endogenous FVIII connected to the C-terminus of the heavy chain. Once activated, the resulting rFVIIIa has a comparable structure to the endogenous FVIIIa. Novoeight is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line which secretes rFVIII into the cell culture medium. The rFVIII protein is purified using a series of chromatography steps, one of which is the use of an immunoaffinity column in which a monoclonal antibody, produced in CHO cells and directed against FVIII, is employed to selectively isolate the rFVIII from the medium. The production process includes two dedicated viral clearance steps - a detergent treatment step for inactivation and a 20-nm filtration step for removal of viruses. No additives of human or animal origin are used in the cell culture, purification and formulation of Novoeight."
},
{
"NDCCode": "50090-7855-0",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-0) ",
"NDC11Code": "50090-7855-00",
"ProductNDC": "50090-7855",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075281",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260114",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.",
"Description": "Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "50090-7855-1",
"PackageDescription": "20 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-1) ",
"NDC11Code": "50090-7855-01",
"ProductNDC": "50090-7855",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075281",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260114",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.",
"Description": "Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "50090-7855-2",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-2) ",
"NDC11Code": "50090-7855-02",
"ProductNDC": "50090-7855",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075281",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260114",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.",
"Description": "Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "50090-7855-3",
"PackageDescription": "14 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-3) ",
"NDC11Code": "50090-7855-03",
"ProductNDC": "50090-7855",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075281",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260114",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.",
"Description": "Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "50090-7855-4",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-4) ",
"NDC11Code": "50090-7855-04",
"ProductNDC": "50090-7855",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075281",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260114",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.",
"Description": "Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "50090-7855-8",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-8) ",
"NDC11Code": "50090-7855-08",
"ProductNDC": "50090-7855",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075281",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260114",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.",
"Description": "Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "50090-7855-9",
"PackageDescription": "180 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-9) ",
"NDC11Code": "50090-7855-09",
"ProductNDC": "50090-7855",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075281",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260114",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.",
"Description": "Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "54127-7855-2",
"PackageDescription": "20 kg in 1 DRUM (54127-7855-2)",
"NDC11Code": "54127-7855-02",
"ProductNDC": "54127-7855",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Fesoterodine Fumarate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20081031",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CHEMI SPA",
"SubstanceName": "FESOTERODINE FUMARATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "68788-7855-2",
"PackageDescription": "20 TABLET in 1 BOTTLE (68788-7855-2) ",
"NDC11Code": "68788-7855-02",
"ProductNDC": "68788-7855",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090485",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "37.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210129",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including tramadol hydrochloride and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Tramadol hydrochloride and acetaminophen tablets, USP combines two analgesics, tramadol hydrochloride, USP and opioid agonist, and acetaminophen, USP. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablet are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized corn starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "68788-7855-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68788-7855-3) ",
"NDC11Code": "68788-7855-03",
"ProductNDC": "68788-7855",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090485",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "37.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210129",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including tramadol hydrochloride and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Tramadol hydrochloride and acetaminophen tablets, USP combines two analgesics, tramadol hydrochloride, USP and opioid agonist, and acetaminophen, USP. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablet are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized corn starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "68788-7855-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (68788-7855-9) ",
"NDC11Code": "68788-7855-09",
"ProductNDC": "68788-7855",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090485",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "37.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210129",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including tramadol hydrochloride and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Tramadol hydrochloride and acetaminophen tablets, USP combines two analgesics, tramadol hydrochloride, USP and opioid agonist, and acetaminophen, USP. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablet are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized corn starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "48792-7809-6",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7809-6)",
"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)",
"NDC11Code": "48792-7810-01",
"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",
"StrengthNumber": "500",
"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",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (48792-7812-1) ",
"NDC11Code": "48792-7812-01",
"ProductNDC": "48792-7812",
"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": "600",
"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": "48792-7813-1",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (48792-7813-1) ",
"NDC11Code": "48792-7813-01",
"ProductNDC": "48792-7813",
"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": "400",
"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": "48792-7814-1",
"PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (48792-7814-1) ",
"NDC11Code": "48792-7814-01",
"ProductNDC": "48792-7814",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204968",
"LabelerName": "Sunshine Lake Pharma CO., LTD.",
"SubstanceName": "LEVOFLOXACIN",
"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",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204968",
"LabelerName": "Sunshine Lake Pharma CO., LTD.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190219",
"SamplePackage": "N"
},
{
"NDCCode": "48792-7816-1",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (48792-7816-1) ",
"NDC11Code": "48792-7816-01",
"ProductNDC": "48792-7816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204968",
"LabelerName": "Sunshine Lake Pharma CO., LTD.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190219",
"SamplePackage": "N"
},
{
"NDCCode": "48792-7817-1",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7817-1)",
"NDC11Code": "48792-7817-01",
"ProductNDC": "48792-7817",
"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",
"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",
"LastUpdate": "2018-10-25",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "48792-7821-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (48792-7821-1) ",
"NDC11Code": "48792-7821-01",
"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",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190130",
"SamplePackage": "N"
},
{
"NDCCode": "48792-7822-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (48792-7822-1) ",
"NDC11Code": "48792-7822-01",
"ProductNDC": "48792-7822",
"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": "5",
"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",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190130",
"SamplePackage": "N"
},
{
"NDCCode": "48792-7823-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7823-1) ",
"NDC11Code": "48792-7823-01",
"ProductNDC": "48792-7823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Moxifloxacin",
"NonProprietaryName": "Moxifloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181012",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206295",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181012",
"SamplePackage": "N"
},
{
"NDCCode": "48792-7824-1",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (48792-7824-1) ",
"NDC11Code": "48792-7824-01",
"ProductNDC": "48792-7824",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206238",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181130",
"SamplePackage": "N"
},
{
"NDCCode": "48792-7825-1",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (48792-7825-1) ",
"NDC11Code": "48792-7825-01",
"ProductNDC": "48792-7825",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206238",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181130",
"SamplePackage": "N"
},
{
"NDCCode": "48792-7826-1",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (48792-7826-1) ",
"NDC11Code": "48792-7826-01",
"ProductNDC": "48792-7826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206238",
"LabelerName": "Sunshine Lake Pharma Co., Ltd.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181130",
"SamplePackage": "N"
},
{
"NDCCode": "48792-7827-1",
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<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.</IndicationAndUsage>
<Description>Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze.</Description>
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<Description>Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze.</Description>
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<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.</IndicationAndUsage>
<Description>Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze.</Description>
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<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.</IndicationAndUsage>
<Description>Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze.</Description>
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<Description>Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze.</Description>
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<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.</IndicationAndUsage>
<Description>Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze.</Description>
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<StartMarketingDatePackage>20260114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac sodium delayed-release tablets are indicated.</IndicationAndUsage>
<Description>Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>54127-7855-2</NDCCode>
<PackageDescription>20 kg in 1 DRUM (54127-7855-2)</PackageDescription>
<NDC11Code>54127-7855-02</NDC11Code>
<ProductNDC>54127-7855</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Fesoterodine Fumarate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20081031</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CHEMI SPA</LabelerName>
<SubstanceName>FESOTERODINE FUMARATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68788-7855-2</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (68788-7855-2) </PackageDescription>
<NDC11Code>68788-7855-02</NDC11Code>
<ProductNDC>68788-7855</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090485</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>37.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including tramadol hydrochloride and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Tramadol hydrochloride and acetaminophen tablets, USP combines two analgesics, tramadol hydrochloride, USP and opioid agonist, and acetaminophen, USP. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablet are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized corn starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68788-7855-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68788-7855-3) </PackageDescription>
<NDC11Code>68788-7855-03</NDC11Code>
<ProductNDC>68788-7855</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090485</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>37.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including tramadol hydrochloride and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Tramadol hydrochloride and acetaminophen tablets, USP combines two analgesics, tramadol hydrochloride, USP and opioid agonist, and acetaminophen, USP. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablet are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized corn starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68788-7855-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68788-7855-9) </PackageDescription>
<NDC11Code>68788-7855-09</NDC11Code>
<ProductNDC>68788-7855</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090485</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>37.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including tramadol hydrochloride and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Tramadol hydrochloride and acetaminophen tablets, USP combines two analgesics, tramadol hydrochloride, USP and opioid agonist, and acetaminophen, USP. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablet are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized corn starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>48792-7809-6</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7809-6)</PackageDescription>
<NDC11Code>48792-7809-06</NDC11Code>
<ProductNDC>48792-7809</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zidovudine</ProprietaryName>
<NonProprietaryName>Zidovudine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<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>
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<NDCCode>48792-7817-1</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7817-1)</PackageDescription>
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<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>
<NDC>
<NDCCode>48792-7822-1</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (48792-7822-1) </PackageDescription>
<NDC11Code>48792-7822-01</NDC11Code>
<ProductNDC>48792-7822</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>5</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>
<NDC>
<NDCCode>48792-7823-1</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7823-1) </PackageDescription>
<NDC11Code>48792-7823-01</NDC11Code>
<ProductNDC>48792-7823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Moxifloxacin</ProprietaryName>
<NonProprietaryName>Moxifloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181012</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206295</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48792-7824-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (48792-7824-1) </PackageDescription>
<NDC11Code>48792-7824-01</NDC11Code>
<ProductNDC>48792-7824</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206238</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48792-7825-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (48792-7825-1) </PackageDescription>
<NDC11Code>48792-7825-01</NDC11Code>
<ProductNDC>48792-7825</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206238</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48792-7826-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (48792-7826-1) </PackageDescription>
<NDC11Code>48792-7826-01</NDC11Code>
<ProductNDC>48792-7826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206238</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48792-7827-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (48792-7827-1) </PackageDescription>
<NDC11Code>48792-7827-01</NDC11Code>
<ProductNDC>48792-7827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206238</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48792-7828-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (48792-7828-1) </PackageDescription>
<NDC11Code>48792-7828-01</NDC11Code>
<ProductNDC>48792-7828</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206238</ApplicationNumber>
<LabelerName>Sunshine Lake Pharma Co., Ltd.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>