{
"NDC": [
{
"NDCCode": "43353-352-18",
"PackageDescription": "3000 TABLET in 1 BOTTLE (43353-352-18)",
"NDC11Code": "43353-0352-18",
"ProductNDC": "43353-352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079170",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration.The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5 yl](3R,5S)- 3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to offwhite powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.Rosuvastatin calcium tablets for oral administration contain 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin and the following inactive ingredients: crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin."
},
{
"NDCCode": "49349-352-18",
"PackageDescription": "18 TABLET in 1 BLISTER PACK (49349-352-18)",
"NDC11Code": "49349-0352-18",
"ProductNDC": "49349-352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076112",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "84556-352-01",
"PackageDescription": "18 g in 1 BOTTLE (84556-352-01) ",
"NDC11Code": "84556-0352-01",
"ProductNDC": "84556-352",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vgo Sunscreen Broad Spectrum",
"NonProprietaryName": "Octocrylene",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240718",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Hainan Shengtaizhuo International Information Development Co., LTD",
"SubstanceName": "OCTOCRYLENE",
"StrengthNumber": "1",
"StrengthUnit": "g/18g",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240718",
"SamplePackage": "N",
"IndicationAndUsage": " apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months of age: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses."
},
{
"NDCCode": "43353-352-15",
"PackageDescription": "15 TABLET in 1 BOTTLE (43353-352-15)",
"NDC11Code": "43353-0352-15",
"ProductNDC": "43353-352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079170",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration.The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5 yl](3R,5S)- 3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to offwhite powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.Rosuvastatin calcium tablets for oral administration contain 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin and the following inactive ingredients: crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin."
},
{
"NDCCode": "43353-352-19",
"PackageDescription": "3060 TABLET in 1 BOTTLE (43353-352-19)",
"NDC11Code": "43353-0352-19",
"ProductNDC": "43353-352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079170",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration.The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5 yl](3R,5S)- 3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to offwhite powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.Rosuvastatin calcium tablets for oral administration contain 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin and the following inactive ingredients: crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin."
},
{
"NDCCode": "43353-352-45",
"PackageDescription": "45 TABLET in 1 BOTTLE (43353-352-45)",
"NDC11Code": "43353-0352-45",
"ProductNDC": "43353-352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079170",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration.The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5 yl](3R,5S)- 3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to offwhite powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.Rosuvastatin calcium tablets for oral administration contain 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin and the following inactive ingredients: crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin."
},
{
"NDCCode": "43353-352-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (43353-352-60)",
"NDC11Code": "43353-0352-60",
"ProductNDC": "43353-352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079170",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration.The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5 yl](3R,5S)- 3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to offwhite powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.Rosuvastatin calcium tablets for oral administration contain 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin and the following inactive ingredients: crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin."
},
{
"NDCCode": "43353-004-18",
"PackageDescription": "3000 TABLET in 1 BOTTLE (43353-004-18)",
"NDC11Code": "43353-0004-18",
"ProductNDC": "43353-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090120",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-23",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"IndicationAndUsage": "Quetiapine Fumarate Tablets are an atypical antipsychotic indicated for the treatment of: : 1 Schizophrenia (1.1) , 2 Bipolar I disorder manic episodes (1.2) , 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine fumarate is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine Fumarate Tablets are supplied for oral administration as 25 mg (round, white), 50 mg (oval, white), 100 mg (round white), 200 mg (round, white), 300 mg (oval, white), and 400 mg (oval, white) tablets. Inactive ingredients in the 25 mg tablet are lactose, magnesium stearate, microcrystalline cellulose, povidone, purified water and sodium starch glycolate. Inactive ingredients in the 50 mg, 100 mg, 200 mg, 300 mg and 400 mg tablets are colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, purified water and sodium starch glycolate."
},
{
"NDCCode": "43353-008-18",
"PackageDescription": "3000 TABLET in 1 BOTTLE (43353-008-18)",
"NDC11Code": "43353-0008-18",
"ProductNDC": "43353-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090120",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-23",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"IndicationAndUsage": "Quetiapine Fumarate Tablets are an atypical antipsychotic indicated for the treatment of: : 1 Schizophrenia (1.1) , 2 Bipolar I disorder manic episodes (1.2) , 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine fumarate is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine Fumarate Tablets are supplied for oral administration as 25 mg (round, white), 50 mg (oval, white), 100 mg (round white), 200 mg (round, white), 300 mg (oval, white), and 400 mg (oval, white) tablets. Inactive ingredients in the 25 mg tablet are lactose, magnesium stearate, microcrystalline cellulose, povidone, purified water and sodium starch glycolate. Inactive ingredients in the 50 mg, 100 mg, 200 mg, 300 mg and 400 mg tablets are colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, purified water and sodium starch glycolate."
},
{
"NDCCode": "43353-015-18",
"PackageDescription": "3000 TABLET in 1 BOTTLE (43353-015-18)",
"NDC11Code": "43353-0015-18",
"ProductNDC": "43353-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azilect",
"NonProprietaryName": "Rasagiline Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060710",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021641",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "RASAGILINE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "AZILECT (rasagiline tablets) is indicated for the treatment of Parkinson’s disease (PD).",
"Description": "AZILECT® tablets contain rasagiline (as the mesylate), a propargylamine-based drug indicated for the treatment of idiopathic Parkinson’s disease. It is designated chemically as: 1H-Inden-1-amine, 2, 3-dihydro-N-2-propynyl-, (1R)-, methanesulfonate. The empirical formula of rasagiline mesylate is (C12H13N)CH4SO3 and its molecular weight is 267.34. Its structural formula is. Rasagiline mesylate is a white to off-white powder, freely soluble in water or ethanol and sparingly soluble in isopropanol. Each AZILECT tablet for oral administration contains rasagiline mesylate equivalent to 0.5 mg or 1 mg of rasagiline base. Each AZILECT tablet also contains the following inactive ingredients: mannitol, starch, pregelatinized starch, colloidal silicon dioxide, stearic acid and talc."
},
{
"NDCCode": "43353-044-18",
"PackageDescription": "16 TABLET, FILM COATED in 1 BOTTLE (43353-044-18) ",
"NDC11Code": "43353-0044-18",
"ProductNDC": "43353-044",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cialis",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20031126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021368",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150519",
"SamplePackage": "N",
"IndicationAndUsage": "CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1 erectile dysfunction (ED) (1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3) .",
"Description": "CIALIS (tadalafil) is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. CIALIS is available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "43353-165-18",
"PackageDescription": "3000 TABLET, COATED in 1 BOTTLE (43353-165-18)",
"NDC11Code": "43353-0165-18",
"ProductNDC": "43353-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200891",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"IndicationAndUsage": "Memantine hydrochloride is indiacted for the treatment of moderate to severe dementia of the Alzheimer's type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in methanol and sparingly soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, macrogol/polyethylene glycol 400, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "43353-170-18",
"PackageDescription": "3000 TABLET, FILM COATED in 1 BOTTLE (43353-170-18) ",
"NDC11Code": "43353-0170-18",
"ProductNDC": "43353-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090043",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160415",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine Hydrochloride Tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21N∙HCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine Hydrochloride Tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate and microcrystalline cellulose. In addition the following inactive ingredients are also present as components of the film coat: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, iron oxide yellow (5 mg), iron oxide red (5 mg) and iron oxide black (10 mg)."
},
{
"NDCCode": "43353-259-18",
"PackageDescription": "3000 TABLET in 1 BOTTLE (43353-259-18) ",
"NDC11Code": "43353-0259-18",
"ProductNDC": "43353-259",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"ProprietaryNameSuffix": "Antihistamine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076301",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221017",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "43353-741-52",
"PackageDescription": "18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-741-52)",
"NDC11Code": "43353-0741-52",
"ProductNDC": "43353-741",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levitra",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110422",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021400",
"LabelerName": "APHENA PHARMA SOLUTIONS - TENNESSEE, INC.",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "LEVITRA is indicated for the treatment of erectile dysfunction.",
"Description": "LEVITRA® is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “2.5”, “5”, “10”, and “20” on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide."
},
{
"NDCCode": "43353-748-52",
"PackageDescription": "18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-748-52)",
"NDC11Code": "43353-0748-52",
"ProductNDC": "43353-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levitra",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110422",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021400",
"LabelerName": "APHENA PHARMA SOLUTIONS - TENNESSEE, INC.",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "LEVITRA is indicated for the treatment of erectile dysfunction.",
"Description": "LEVITRA® is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “2.5”, “5”, “10”, and “20” on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide."
},
{
"NDCCode": "43353-782-18",
"PackageDescription": "3000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-782-18)",
"NDC11Code": "43353-0782-18",
"ProductNDC": "43353-782",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Afeditab",
"ProprietaryNameSuffix": "Cr",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20021101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075659",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Afeditab® CR is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Afeditab® CR is an extended release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2- nitrophenyl)-dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Afeditab® CR tablets contain either 30 mg or 60 mg of nifedipine for once-a-day oral administration. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate (60 mg), magnesium stearate, and microcrystalline cellulose (30 mg). The inert ingredients in the film coating are: hypromellose, iron oxide, polyethylene glycol, and titanium dioxide. The ingredients of the printing ink are: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac. Does not meet USP Drug Release Test."
},
{
"NDCCode": "43353-847-18",
"PackageDescription": "3000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-847-18)",
"NDC11Code": "43353-0847-18",
"ProductNDC": "43353-847",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090960",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Quetiapine Fumarate Tablets is an atypical antipsychotic indicated for the. Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in three 6 week clinical trials in patients with schizophrenia (14.1).",
"Description": "Quetiapine fumarate is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine fumarate tablets are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, fumaric acid, ethylcellulose, magnesium stearate, hypromellose, hydroxylpropyl cellulose, polyethylene glycol, and titanium dioxide. The 25 mg tablets also contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide."
},
{
"NDCCode": "43353-850-18",
"PackageDescription": "3000 TABLET in 1 BOTTLE, PLASTIC (43353-850-18)",
"NDC11Code": "43353-0850-18",
"ProductNDC": "43353-850",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"Description": "Aripiprazole is a psychotropic drug that is available as ABILIFY® (aripiprazole) Tablets, ABILIFY DISCMELT® (aripiprazole) Orally Disintegrating Tablets, ABILIFY® (aripiprazole) Oral Solution, and ABILIFY® (aripiprazole) Injection, a solution for intramuscular injection. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. ABILIFY DISCMELT Orally Disintegrating Tablets are available in 10 mg and 15 mg strengths. Inactive ingredients include acesulfame potassium, aspartame, calcium silicate, croscarmellose sodium, crospovidone, crème de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. ABILIFY Oral Solution is a clear, colorless to light-yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include disodium edetate, fructose, glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose, and purified water. The oral solution is flavored with natural orange cream and other natural flavors. ABILIFY Injection is available in single-dose vials as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) clear, colorless, sterile, aqueous solution for intramuscular use only. Inactive ingredients for this solution include 150 mg/mL of sulfobutylether β-cyclodextrin (SBECD), tartaric acid, sodium hydroxide, and water for injection."
},
{
"NDCCode": "43353-852-18",
"PackageDescription": "3000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-852-18)",
"NDC11Code": "43353-0852-18",
"ProductNDC": "43353-852",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090960",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Quetiapine Fumarate Tablets is an atypical antipsychotic indicated for the. Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in three 6 week clinical trials in patients with schizophrenia (14.1).",
"Description": "Quetiapine fumarate is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine fumarate tablets are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, fumaric acid, ethylcellulose, magnesium stearate, hypromellose, hydroxylpropyl cellulose, polyethylene glycol, and titanium dioxide. The 25 mg tablets also contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide."
},
{
"NDCCode": "43353-895-18",
"PackageDescription": "3000 TABLET in 1 BOTTLE, PLASTIC (43353-895-18)",
"NDC11Code": "43353-0895-18",
"ProductNDC": "43353-895",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide",
"NonProprietaryName": "Glyburide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19840501",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA017532",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "GLYBURIDE",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "43353-933-18",
"PackageDescription": "3000 TABLET in 1 BOTTLE, PLASTIC (43353-933-18)",
"NDC11Code": "43353-0933-18",
"ProductNDC": "43353-933",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077309",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Acyclovir tablet is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir tablet is a formulation for oral administration. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Each 400 mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225.2. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula."
},
{
"NDCCode": "43353-955-18",
"PackageDescription": "3000 TABLET, FILM COATED in 1 BOTTLE (43353-955-18)",
"NDC11Code": "43353-0955-18",
"ProductNDC": "43353-955",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077745",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"IndicationAndUsage": "Quetiapine Fumarate Tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine Fumarate Tablets are a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. The structural formula is. C42H50N6O4S2C4H4O4 M.W. 883.11 (fumarate salt). Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine Fumarate Tablets are supplied for oral administration as 25 mg (round, light orange), 50 mg (round, white to off-white), 100 mg (round, light orange), 200 mg (round, white to off-white), 300 mg (capsule-shaped, pale yellow), and 400 mg (capsule-shaped, white to off-white) tablets. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide and triacetin. Additionally, the 25 mg, 100 mg, and 300 mg tablets contain iron oxide yellow; the 25 mg and 100 mg tablets contain FD&C yellow #6/sunset yellow FCF/aluminum lake; and the 50 mg, 200 mg, and 400 mg tablets contain polydextrose and polyethylene glycol."
},
{
"NDCCode": "43353-957-18",
"PackageDescription": "3000 TABLET, FILM COATED in 1 BOTTLE (43353-957-18)",
"NDC11Code": "43353-0957-18",
"ProductNDC": "43353-957",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077745",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"IndicationAndUsage": "Quetiapine Fumarate Tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine Fumarate Tablets are a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. The structural formula is. C42H50N6O4S2C4H4O4 M.W. 883.11 (fumarate salt). Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine Fumarate Tablets are supplied for oral administration as 25 mg (round, light orange), 50 mg (round, white to off-white), 100 mg (round, light orange), 200 mg (round, white to off-white), 300 mg (capsule-shaped, pale yellow), and 400 mg (capsule-shaped, white to off-white) tablets. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide and triacetin. Additionally, the 25 mg, 100 mg, and 300 mg tablets contain iron oxide yellow; the 25 mg and 100 mg tablets contain FD&C yellow #6/sunset yellow FCF/aluminum lake; and the 50 mg, 200 mg, and 400 mg tablets contain polydextrose and polyethylene glycol."
},
{
"NDCCode": "0472-0013-04",
"PackageDescription": "120 mL in 1 BOTTLE (0472-0013-04) ",
"NDC11Code": "00472-0013-04",
"ProductNDC": "0472-0013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Griseofulvin",
"NonProprietaryName": "Griseofulvin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20070726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065394",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "GRISEOFULVIN",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070726",
"SamplePackage": "N",
"IndicationAndUsage": "Griseofulvin oral suspension, USP is indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely: Tinea corporis. Tinea pedis Tinea cruris Tinea barbae Tinea capitis. Tinea unguium when caused by one or more of the following species of fungi. Epidermophyton floccosum Microsporum audouinii Microsporum canis Microsporum gypseum Trichophyton crateriform Trichophyton gallinae Trichophyton interdigitalis Trichophyton megnini Trichophyton mentagrophytes Trichophyton rubrum Trichophyton schoenleini Trichophyton sulphureum Trichophyton tonsurans Trichophyton verrucosum. Note: Prior to therapy, a dermatophyte should be identified as responsible for the infection. Prior to initiating treatment, appropriate specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis. Griseofulvin is not effective in the following. Bacterial infections Candidiasis (Moniliasis) Histoplasmosis Actinomycosis Sporotrichosis Chromoblastomycosis Coccidioidomycosis North American Blastomycosis Cryptococcosis (Torulosis) Tinea versicolor Nocardiosis. The use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone.",
"Description": "Griseofulvin microsize contains griseofulvin microsize for oral administration. The active ingredient, griseofulvin, USP is a fungistatic antibiotic, derived from a species of Penicillium. The chemical name of griseofulvin, USP is 7-chloro-2’,4,6-trimethoxy-6’β-methylspiro[benzofuran - 2(3H),1’-[2]cyclohexane]-3-4’-dione. Its structural formula is:. C17H17ClO6 M.W. 352.77. Griseofulvin, USP occurs as a white to creamy white, bitter tasting powder which is very slightly soluble in water and sparingly soluble in alcohol. Griseofulvin microsize contains particles of approximately 2 to 4 μm in diameter. Griseofulvin oral suspension, USP is an orange colored suspension. Each 5 mL of griseofulvin oral suspension, USP contains 125 mg of griseofulvin microsize and also contains alcohol 0.2%, artificial orange vanilla flavor, docusate sodium, FD&C Red No. 40, FD&C Yellow No. 6, magnesium aluminum silicate, menthol, methylparaben, propylene glycol, propylparaben, saccharin sodium, simethicone emulsion, sodium alginate, sucrose, and purified water."
},
{
"NDCCode": "13537-352-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-352-02) > 4 g in 1 TUBE (13537-352-01)",
"NDC11Code": "13537-0352-02",
"ProductNDC": "13537-352",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika",
"ProprietaryNameSuffix": "Maximum Color Spf 18",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110517",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation (San Juan, P.R)",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".073; .0165",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "49967-352-01",
"PackageDescription": "1 JAR in 1 CARTON (49967-352-01) > 50 mL in 1 JAR",
"NDC11Code": "49967-0352-01",
"ProductNDC": "49967-352",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Yves Saint Laurent",
"ProprietaryNameSuffix": "Forever Youth Liberator",
"NonProprietaryName": "Avobenzone Octisalate Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "L'Oreal USA Products Inc",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "1.05; 1.75; 2.45",
"StrengthUnit": "mL/50mL; mL/50mL; mL/50mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "51407-352-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-352-05) ",
"NDC11Code": "51407-0352-05",
"ProductNDC": "51407-352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076122",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20200221",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .",
"Description": "Mirtazapine tablets, USP contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture:. Mirtazapine, USP is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin."
},
{
"NDCCode": "51407-352-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-352-30) ",
"NDC11Code": "51407-0352-30",
"ProductNDC": "51407-352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076122",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200221",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .",
"Description": "Mirtazapine tablets, USP contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture:. Mirtazapine, USP is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin."
},
{
"NDCCode": "52959-352-07",
"PackageDescription": "7 CAPSULE, DELAYED RELEASE in 1 VIAL (52959-352-07) ",
"NDC11Code": "52959-0352-07",
"ProductNDC": "52959-352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091269",
"LabelerName": "H.J. Harkins Co., Inc",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180109",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Short-Term Treatment of Active Duodenal Ulcer. Lansoprazole delayed-release capsules are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer. [See CLINICAL STUDIES (14)]. 1.2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence. Triple Therapy: Lansoprazole delayed-release capsules /amoxicillin /clarithromycin. Lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. [See CLINICAL STUDIES (14)]. Please refer to the full prescribing information for amoxicillin and clarithromycin. Dual Therapy: Lansoprazole delayed-release capsules /amoxicillin. Dual Therapy: Lansoprazole delayed-release capsules /amoxicillinLansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin package insert, MICROBIOLOGY section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. [See CLINICAL STUDIES (14)]. Please refer to the full prescribing information for amoxicillin. 1.3 Maintenance of Healed Duodenal Ulcers. Lansoprazole delayed-release capsules are indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months. [See CLINICAL STUDIES (14)]. 1.4 Short-Term Treatment of Active Benign Gastric Ulcer. Lansoprazole delayed-release capsules are indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer. [See CLINICAL STUDIES (14)]. 1.5 Healing of NSAID-Associated Gastric Ulcer. Lansoprazole delayed-release capsules are indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks. [See CLINICAL STUDIES (14)]. 1.6 Risk Reduction of NSAID-Associated Gastric Ulcer. Lansoprazole delayed-release capsules are indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks. [See CLINICAL STUDIES (14)]. 1.7 Gastroesophageal Reflux Disease (GERD). Short-Term Treatment of Symptomatic GERD. Lansoprazole delayed-release capsules is indicated for the treatment of heartburn and other symptoms associated with GERD for upto 8 weeks. [See CLINICAL STUDIES (14)]. Short-Term Treatment of Erosive Esophagitis. Lansoprazole delayed-release capsules is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of lansoprazole delayed-release capsules may be considered. [See CLINICAL STUDIES (14)]. 1.8 Maintenance of Healing of Erosive Esophagitis (EE). Lansoprazole delayed-release capsules are indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months. [See CLINICAL STUDIES (14)]. 1.9 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES). Lansoprazole delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. [See CLINICAL STUDIES (14)].",
"Description": "The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamideand practically insoluble in water. Lansoprazole USP is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole USP is supplied as delayed-release capsules. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules."
}
]
}
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<StartMarketingDate>20170202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079170</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration.The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5 yl](3R,5S)- 3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to offwhite powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.Rosuvastatin calcium tablets for oral administration contain 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin and the following inactive ingredients: crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>49349-352-18</NDCCode>
<PackageDescription>18 TABLET in 1 BLISTER PACK (49349-352-18)</PackageDescription>
<NDC11Code>49349-0352-18</NDC11Code>
<ProductNDC>49349-352</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076112</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
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<PackageDescription>18 g in 1 BOTTLE (84556-352-01) </PackageDescription>
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<ProductNDC>84556-352</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vgo Sunscreen Broad Spectrum</ProprietaryName>
<NonProprietaryName>Octocrylene</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240718</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Hainan Shengtaizhuo International Information Development Co., LTD</LabelerName>
<SubstanceName>OCTOCRYLENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/18g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months of age: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses.</IndicationAndUsage>
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<NDC>
<NDCCode>43353-352-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (43353-352-15)</PackageDescription>
<NDC11Code>43353-0352-15</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration.The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5 yl](3R,5S)- 3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to offwhite powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.Rosuvastatin calcium tablets for oral administration contain 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin and the following inactive ingredients: crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>43353-352-19</NDCCode>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration.The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5 yl](3R,5S)- 3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to offwhite powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.Rosuvastatin calcium tablets for oral administration contain 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin and the following inactive ingredients: crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.</Description>
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<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079170</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration.The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5 yl](3R,5S)- 3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to offwhite powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.Rosuvastatin calcium tablets for oral administration contain 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin and the following inactive ingredients: crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>43353-352-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (43353-352-60)</PackageDescription>
<NDC11Code>43353-0352-60</NDC11Code>
<ProductNDC>43353-352</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079170</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration.The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5 yl](3R,5S)- 3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to offwhite powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.Rosuvastatin calcium tablets for oral administration contain 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin and the following inactive ingredients: crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>43353-004-18</NDCCode>
<PackageDescription>3000 TABLET in 1 BOTTLE (43353-004-18)</PackageDescription>
<NDC11Code>43353-0004-18</NDC11Code>
<ProductNDC>43353-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090120</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-23</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Quetiapine Fumarate Tablets are an atypical antipsychotic indicated for the treatment of: : 1 Schizophrenia (1.1) , 2 Bipolar I disorder manic episodes (1.2) , 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine fumarate is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine Fumarate Tablets are supplied for oral administration as 25 mg (round, white), 50 mg (oval, white), 100 mg (round white), 200 mg (round, white), 300 mg (oval, white), and 400 mg (oval, white) tablets. Inactive ingredients in the 25 mg tablet are lactose, magnesium stearate, microcrystalline cellulose, povidone, purified water and sodium starch glycolate. Inactive ingredients in the 50 mg, 100 mg, 200 mg, 300 mg and 400 mg tablets are colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, purified water and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>43353-008-18</NDCCode>
<PackageDescription>3000 TABLET in 1 BOTTLE (43353-008-18)</PackageDescription>
<NDC11Code>43353-0008-18</NDC11Code>
<ProductNDC>43353-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090120</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-23</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Quetiapine Fumarate Tablets are an atypical antipsychotic indicated for the treatment of: : 1 Schizophrenia (1.1) , 2 Bipolar I disorder manic episodes (1.2) , 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine fumarate is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine Fumarate Tablets are supplied for oral administration as 25 mg (round, white), 50 mg (oval, white), 100 mg (round white), 200 mg (round, white), 300 mg (oval, white), and 400 mg (oval, white) tablets. Inactive ingredients in the 25 mg tablet are lactose, magnesium stearate, microcrystalline cellulose, povidone, purified water and sodium starch glycolate. Inactive ingredients in the 50 mg, 100 mg, 200 mg, 300 mg and 400 mg tablets are colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, purified water and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>43353-015-18</NDCCode>
<PackageDescription>3000 TABLET in 1 BOTTLE (43353-015-18)</PackageDescription>
<NDC11Code>43353-0015-18</NDC11Code>
<ProductNDC>43353-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azilect</ProprietaryName>
<NonProprietaryName>Rasagiline Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060710</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021641</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>RASAGILINE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>AZILECT (rasagiline tablets) is indicated for the treatment of Parkinson’s disease (PD).</IndicationAndUsage>
<Description>AZILECT® tablets contain rasagiline (as the mesylate), a propargylamine-based drug indicated for the treatment of idiopathic Parkinson’s disease. It is designated chemically as: 1H-Inden-1-amine, 2, 3-dihydro-N-2-propynyl-, (1R)-, methanesulfonate. The empirical formula of rasagiline mesylate is (C12H13N)CH4SO3 and its molecular weight is 267.34. Its structural formula is. Rasagiline mesylate is a white to off-white powder, freely soluble in water or ethanol and sparingly soluble in isopropanol. Each AZILECT tablet for oral administration contains rasagiline mesylate equivalent to 0.5 mg or 1 mg of rasagiline base. Each AZILECT tablet also contains the following inactive ingredients: mannitol, starch, pregelatinized starch, colloidal silicon dioxide, stearic acid and talc.</Description>
</NDC>
<NDC>
<NDCCode>43353-044-18</NDCCode>
<PackageDescription>16 TABLET, FILM COATED in 1 BOTTLE (43353-044-18) </PackageDescription>
<NDC11Code>43353-0044-18</NDC11Code>
<ProductNDC>43353-044</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cialis</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021368</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1 erectile dysfunction (ED) (1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3) .</IndicationAndUsage>
<Description>CIALIS (tadalafil) is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. CIALIS is available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>43353-165-18</NDCCode>
<PackageDescription>3000 TABLET, COATED in 1 BOTTLE (43353-165-18)</PackageDescription>
<NDC11Code>43353-0165-18</NDC11Code>
<ProductNDC>43353-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200891</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Memantine hydrochloride is indiacted for the treatment of moderate to severe dementia of the Alzheimer's type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in methanol and sparingly soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, macrogol/polyethylene glycol 400, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>43353-170-18</NDCCode>
<PackageDescription>3000 TABLET, FILM COATED in 1 BOTTLE (43353-170-18) </PackageDescription>
<NDC11Code>43353-0170-18</NDC11Code>
<ProductNDC>43353-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090043</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine Hydrochloride Tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21N∙HCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine Hydrochloride Tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate and microcrystalline cellulose. In addition the following inactive ingredients are also present as components of the film coat: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, iron oxide yellow (5 mg), iron oxide red (5 mg) and iron oxide black (10 mg).</Description>
</NDC>
<NDC>
<NDCCode>43353-259-18</NDCCode>
<PackageDescription>3000 TABLET in 1 BOTTLE (43353-259-18) </PackageDescription>
<NDC11Code>43353-0259-18</NDC11Code>
<ProductNDC>43353-259</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<ProprietaryNameSuffix>Antihistamine</ProprietaryNameSuffix>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076301</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43353-741-52</NDCCode>
<PackageDescription>18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-741-52)</PackageDescription>
<NDC11Code>43353-0741-52</NDC11Code>
<ProductNDC>43353-741</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levitra</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110422</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021400</ApplicationNumber>
<LabelerName>APHENA PHARMA SOLUTIONS - TENNESSEE, INC.</LabelerName>
<SubstanceName>VARDENAFIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>LEVITRA is indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>LEVITRA® is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “2.5”, “5”, “10”, and “20” on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-748-52</NDCCode>
<PackageDescription>18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-748-52)</PackageDescription>
<NDC11Code>43353-0748-52</NDC11Code>
<ProductNDC>43353-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levitra</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110422</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021400</ApplicationNumber>
<LabelerName>APHENA PHARMA SOLUTIONS - TENNESSEE, INC.</LabelerName>
<SubstanceName>VARDENAFIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>LEVITRA is indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>LEVITRA® is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “2.5”, “5”, “10”, and “20” on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-782-18</NDCCode>
<PackageDescription>3000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-782-18)</PackageDescription>
<NDC11Code>43353-0782-18</NDC11Code>
<ProductNDC>43353-782</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Afeditab</ProprietaryName>
<ProprietaryNameSuffix>Cr</ProprietaryNameSuffix>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075659</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Afeditab® CR is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Afeditab® CR is an extended release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2- nitrophenyl)-dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Afeditab® CR tablets contain either 30 mg or 60 mg of nifedipine for once-a-day oral administration. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate (60 mg), magnesium stearate, and microcrystalline cellulose (30 mg). The inert ingredients in the film coating are: hypromellose, iron oxide, polyethylene glycol, and titanium dioxide. The ingredients of the printing ink are: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac. Does not meet USP Drug Release Test.</Description>
</NDC>
<NDC>
<NDCCode>43353-847-18</NDCCode>
<PackageDescription>3000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-847-18)</PackageDescription>
<NDC11Code>43353-0847-18</NDC11Code>
<ProductNDC>43353-847</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090960</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Quetiapine Fumarate Tablets is an atypical antipsychotic indicated for the. Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in three 6 week clinical trials in patients with schizophrenia (14.1).</IndicationAndUsage>
<Description>Quetiapine fumarate is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine fumarate tablets are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, fumaric acid, ethylcellulose, magnesium stearate, hypromellose, hydroxylpropyl cellulose, polyethylene glycol, and titanium dioxide. The 25 mg tablets also contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-850-18</NDCCode>
<PackageDescription>3000 TABLET in 1 BOTTLE, PLASTIC (43353-850-18)</PackageDescription>
<NDC11Code>43353-0850-18</NDC11Code>
<ProductNDC>43353-850</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021436</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<Description>Aripiprazole is a psychotropic drug that is available as ABILIFY® (aripiprazole) Tablets, ABILIFY DISCMELT® (aripiprazole) Orally Disintegrating Tablets, ABILIFY® (aripiprazole) Oral Solution, and ABILIFY® (aripiprazole) Injection, a solution for intramuscular injection. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. ABILIFY DISCMELT Orally Disintegrating Tablets are available in 10 mg and 15 mg strengths. Inactive ingredients include acesulfame potassium, aspartame, calcium silicate, croscarmellose sodium, crospovidone, crème de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. ABILIFY Oral Solution is a clear, colorless to light-yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include disodium edetate, fructose, glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose, and purified water. The oral solution is flavored with natural orange cream and other natural flavors. ABILIFY Injection is available in single-dose vials as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) clear, colorless, sterile, aqueous solution for intramuscular use only. Inactive ingredients for this solution include 150 mg/mL of sulfobutylether β-cyclodextrin (SBECD), tartaric acid, sodium hydroxide, and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>43353-852-18</NDCCode>
<PackageDescription>3000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-852-18)</PackageDescription>
<NDC11Code>43353-0852-18</NDC11Code>
<ProductNDC>43353-852</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090960</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Quetiapine Fumarate Tablets is an atypical antipsychotic indicated for the. Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in three 6 week clinical trials in patients with schizophrenia (14.1).</IndicationAndUsage>
<Description>Quetiapine fumarate is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine fumarate tablets are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, fumaric acid, ethylcellulose, magnesium stearate, hypromellose, hydroxylpropyl cellulose, polyethylene glycol, and titanium dioxide. The 25 mg tablets also contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-895-18</NDCCode>
<PackageDescription>3000 TABLET in 1 BOTTLE, PLASTIC (43353-895-18)</PackageDescription>
<NDC11Code>43353-0895-18</NDC11Code>
<ProductNDC>43353-895</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide</ProprietaryName>
<NonProprietaryName>Glyburide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840501</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA017532</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>GLYBURIDE</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43353-933-18</NDCCode>
<PackageDescription>3000 TABLET in 1 BOTTLE, PLASTIC (43353-933-18)</PackageDescription>
<NDC11Code>43353-0933-18</NDC11Code>
<ProductNDC>43353-933</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077309</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acyclovir tablet is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir tablet is a formulation for oral administration. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Each 400 mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225.2. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>43353-955-18</NDCCode>
<PackageDescription>3000 TABLET, FILM COATED in 1 BOTTLE (43353-955-18)</PackageDescription>
<NDC11Code>43353-0955-18</NDC11Code>
<ProductNDC>43353-955</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077745</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Quetiapine Fumarate Tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine Fumarate Tablets are a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. The structural formula is. C42H50N6O4S2C4H4O4 M.W. 883.11 (fumarate salt). Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine Fumarate Tablets are supplied for oral administration as 25 mg (round, light orange), 50 mg (round, white to off-white), 100 mg (round, light orange), 200 mg (round, white to off-white), 300 mg (capsule-shaped, pale yellow), and 400 mg (capsule-shaped, white to off-white) tablets. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide and triacetin. Additionally, the 25 mg, 100 mg, and 300 mg tablets contain iron oxide yellow; the 25 mg and 100 mg tablets contain FD&C yellow #6/sunset yellow FCF/aluminum lake; and the 50 mg, 200 mg, and 400 mg tablets contain polydextrose and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>43353-957-18</NDCCode>
<PackageDescription>3000 TABLET, FILM COATED in 1 BOTTLE (43353-957-18)</PackageDescription>
<NDC11Code>43353-0957-18</NDC11Code>
<ProductNDC>43353-957</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077745</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Quetiapine Fumarate Tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine Fumarate Tablets are a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. The structural formula is. C42H50N6O4S2C4H4O4 M.W. 883.11 (fumarate salt). Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine Fumarate Tablets are supplied for oral administration as 25 mg (round, light orange), 50 mg (round, white to off-white), 100 mg (round, light orange), 200 mg (round, white to off-white), 300 mg (capsule-shaped, pale yellow), and 400 mg (capsule-shaped, white to off-white) tablets. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide and triacetin. Additionally, the 25 mg, 100 mg, and 300 mg tablets contain iron oxide yellow; the 25 mg and 100 mg tablets contain FD&C yellow #6/sunset yellow FCF/aluminum lake; and the 50 mg, 200 mg, and 400 mg tablets contain polydextrose and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0472-0013-04</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (0472-0013-04) </PackageDescription>
<NDC11Code>00472-0013-04</NDC11Code>
<ProductNDC>0472-0013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Griseofulvin</ProprietaryName>
<NonProprietaryName>Griseofulvin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065394</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>GRISEOFULVIN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Griseofulvin oral suspension, USP is indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely: Tinea corporis. Tinea pedis Tinea cruris Tinea barbae Tinea capitis. Tinea unguium when caused by one or more of the following species of fungi. Epidermophyton floccosum Microsporum audouinii Microsporum canis Microsporum gypseum Trichophyton crateriform Trichophyton gallinae Trichophyton interdigitalis Trichophyton megnini Trichophyton mentagrophytes Trichophyton rubrum Trichophyton schoenleini Trichophyton sulphureum Trichophyton tonsurans Trichophyton verrucosum. Note: Prior to therapy, a dermatophyte should be identified as responsible for the infection. Prior to initiating treatment, appropriate specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis. Griseofulvin is not effective in the following. Bacterial infections Candidiasis (Moniliasis) Histoplasmosis Actinomycosis Sporotrichosis Chromoblastomycosis Coccidioidomycosis North American Blastomycosis Cryptococcosis (Torulosis) Tinea versicolor Nocardiosis. The use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone.</IndicationAndUsage>
<Description>Griseofulvin microsize contains griseofulvin microsize for oral administration. The active ingredient, griseofulvin, USP is a fungistatic antibiotic, derived from a species of Penicillium. The chemical name of griseofulvin, USP is 7-chloro-2’,4,6-trimethoxy-6’β-methylspiro[benzofuran - 2(3H),1’-[2]cyclohexane]-3-4’-dione. Its structural formula is:. C17H17ClO6 M.W. 352.77. Griseofulvin, USP occurs as a white to creamy white, bitter tasting powder which is very slightly soluble in water and sparingly soluble in alcohol. Griseofulvin microsize contains particles of approximately 2 to 4 μm in diameter. Griseofulvin oral suspension, USP is an orange colored suspension. Each 5 mL of griseofulvin oral suspension, USP contains 125 mg of griseofulvin microsize and also contains alcohol 0.2%, artificial orange vanilla flavor, docusate sodium, FD&C Red No. 40, FD&C Yellow No. 6, magnesium aluminum silicate, menthol, methylparaben, propylene glycol, propylparaben, saccharin sodium, simethicone emulsion, sodium alginate, sucrose, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>13537-352-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-352-02) > 4 g in 1 TUBE (13537-352-01)</PackageDescription>
<NDC11Code>13537-0352-02</NDC11Code>
<ProductNDC>13537-352</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika</ProprietaryName>
<ProprietaryNameSuffix>Maximum Color Spf 18</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation (San Juan, P.R)</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.073; .0165</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49967-352-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (49967-352-01) > 50 mL in 1 JAR</PackageDescription>
<NDC11Code>49967-0352-01</NDC11Code>
<ProductNDC>49967-352</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Yves Saint Laurent</ProprietaryName>
<ProprietaryNameSuffix>Forever Youth Liberator</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone Octisalate Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1.05; 1.75; 2.45</StrengthNumber>
<StrengthUnit>mL/50mL; mL/50mL; mL/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51407-352-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-352-05) </PackageDescription>
<NDC11Code>51407-0352-05</NDC11Code>
<ProductNDC>51407-352</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076122</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Mirtazapine tablets, USP contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture:. Mirtazapine, USP is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>51407-352-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-352-30) </PackageDescription>
<NDC11Code>51407-0352-30</NDC11Code>
<ProductNDC>51407-352</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076122</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Mirtazapine tablets, USP contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture:. Mirtazapine, USP is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>52959-352-07</NDCCode>
<PackageDescription>7 CAPSULE, DELAYED RELEASE in 1 VIAL (52959-352-07) </PackageDescription>
<NDC11Code>52959-0352-07</NDC11Code>
<ProductNDC>52959-352</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091269</ApplicationNumber>
<LabelerName>H.J. Harkins Co., Inc</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Short-Term Treatment of Active Duodenal Ulcer. Lansoprazole delayed-release capsules are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer. [See CLINICAL STUDIES (14)]. 1.2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence. Triple Therapy: Lansoprazole delayed-release capsules /amoxicillin /clarithromycin. Lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. [See CLINICAL STUDIES (14)]. Please refer to the full prescribing information for amoxicillin and clarithromycin. Dual Therapy: Lansoprazole delayed-release capsules /amoxicillin. Dual Therapy: Lansoprazole delayed-release capsules /amoxicillinLansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin package insert, MICROBIOLOGY section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. [See CLINICAL STUDIES (14)]. Please refer to the full prescribing information for amoxicillin. 1.3 Maintenance of Healed Duodenal Ulcers. Lansoprazole delayed-release capsules are indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months. [See CLINICAL STUDIES (14)]. 1.4 Short-Term Treatment of Active Benign Gastric Ulcer. Lansoprazole delayed-release capsules are indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer. [See CLINICAL STUDIES (14)]. 1.5 Healing of NSAID-Associated Gastric Ulcer. Lansoprazole delayed-release capsules are indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks. [See CLINICAL STUDIES (14)]. 1.6 Risk Reduction of NSAID-Associated Gastric Ulcer. Lansoprazole delayed-release capsules are indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks. [See CLINICAL STUDIES (14)]. 1.7 Gastroesophageal Reflux Disease (GERD). Short-Term Treatment of Symptomatic GERD. Lansoprazole delayed-release capsules is indicated for the treatment of heartburn and other symptoms associated with GERD for upto 8 weeks. [See CLINICAL STUDIES (14)]. Short-Term Treatment of Erosive Esophagitis. Lansoprazole delayed-release capsules is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of lansoprazole delayed-release capsules may be considered. [See CLINICAL STUDIES (14)]. 1.8 Maintenance of Healing of Erosive Esophagitis (EE). Lansoprazole delayed-release capsules are indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months. [See CLINICAL STUDIES (14)]. 1.9 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES). Lansoprazole delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. [See CLINICAL STUDIES (14)].</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamideand practically insoluble in water. Lansoprazole USP is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole USP is supplied as delayed-release capsules. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules.</Description>
</NDC>
</NDCList>