{
"NDC": [
{
"NDCCode": "83209-721-06",
"PackageDescription": "6 CAPSULE in 1 BLISTER PACK (83209-721-06) ",
"NDC11Code": "83209-0721-06",
"ProductNDC": "83209-721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240520",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "83209-150-06",
"PackageDescription": "6 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-06) ",
"NDC11Code": "83209-0150-06",
"ProductNDC": "83209-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212977",
"LabelerName": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240612",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults ( 1.1) , 2 Eradication of Helicobacter pylorito reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Treatment of active benign gastric ulcer in adults ( 1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6) , 7 Pathologic hypersecretory conditions in adults ( 1.7) .",
"Description": "The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1 H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg or 20 mg of omeprazole in the form of enteric-coated granules. The 10 mg and 20 mg capsule contains the following inactive ingredients: crospovidone, dibasic sodium phosphate, hypromellose, magnesium hydroxide granules (with corn starch), methacrylicacid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, purified water, silicon dioxide, sodium lauryl sulfate, sugar spheres (sucrose, corn starch, and purified water), talc, and titanium dioxide. The capsule shells for the 10 and 20 mg have the following inactive ingredients: gelatin and titanium dioxide. The ink used for printing contains: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Omeprazole delayed-release capsules meet USP Dissolution Test 2."
},
{
"NDCCode": "83209-220-06",
"PackageDescription": "6 CAPSULE in 1 BLISTER PACK (83209-220-06) ",
"NDC11Code": "83209-0220-06",
"ProductNDC": "83209-220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lithium Carbonate",
"NonProprietaryName": "Lithium Carbonate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240821",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079139",
"LabelerName": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale",
"SubstanceName": "LITHIUM CARBONATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240821",
"SamplePackage": "N",
"IndicationAndUsage": "Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: 1 Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies ( 14)] , 2 Maintenance treatment in patients 7 years and older [see Clinical Studies (14)].",
"Description": "Each capsule for oral administration contains lithium carbonate, USP 150 mg, 300 mg or 600 mg and the following inactive ingredients: colloidal silicon dioxide, gelatin, sodium lauryl sulfate, talc, titanium dioxide, FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and the imprinting ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. Lithium Carbonate, USP is a white, crystalline powder with molecular formula Li 2CO 3and molecular weight 73.89."
},
{
"NDCCode": "83209-721-10",
"PackageDescription": "10 CAPSULE in 1 BLISTER PACK (83209-721-10) ",
"NDC11Code": "83209-0721-10",
"ProductNDC": "83209-721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240520",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "83209-721-15",
"PackageDescription": "15 CAPSULE in 1 BLISTER PACK (83209-721-15) ",
"NDC11Code": "83209-0721-15",
"ProductNDC": "83209-721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240520",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "83209-721-20",
"PackageDescription": "20 CAPSULE in 1 BLISTER PACK (83209-721-20) ",
"NDC11Code": "83209-0721-20",
"ProductNDC": "83209-721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240520",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "83209-721-30",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (83209-721-30) ",
"NDC11Code": "83209-0721-30",
"ProductNDC": "83209-721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240520",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "83209-721-60",
"PackageDescription": "60 CAPSULE in 1 BLISTER PACK (83209-721-60) ",
"NDC11Code": "83209-0721-60",
"ProductNDC": "83209-721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240520",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "16571-721-06",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (16571-721-06) ",
"NDC11Code": "16571-0721-06",
"ProductNDC": "16571-721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091388",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120327",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine 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 is an atypical antipsychotic 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 USP is a white to off-white powder which is moderately soluble in water.Quetiapine is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 150 mg (round, light yellow), 200 mg (round, white), 300 mg (capsule shaped, white), and 400 mg (capsule shaped, yellow) tablets.Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose 6cp, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, sodium starch glycolate, talc, and titanium dioxide. In addition, the 25 mg contains iron oxide red and iron oxide yellow; the 100 mg, 150 mg, and 400 mg contains iron oxide yellow. The 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, and 400 mg tablets are printed with Opacode S-1-17823 black contains iron oxide black and shellac. Each 25 mg tablet contains 28.780 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.561 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.122 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.683 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.244 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.366 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.488 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "17271-721-06",
"PackageDescription": "20 BAG in 1 CASE (17271-721-06) / 500 mL in 1 BAG",
"NDC11Code": "17271-0721-06",
"ProductNDC": "17271-721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209448",
"LabelerName": "Becton Dickinson and Company",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200205",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose Injection is indicated as source of water and calories.",
"Description": "10% Dextrose Injection, USP is a sterile, non-pyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5). Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:. Water for Injection, USP is chemically designated H2O. Dextrose is derived from corn. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration. The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication ([see Instructions for Use (2.3)]). The primary function of the overwrap is to protect the container from the physical environment."
},
{
"NDCCode": "49967-721-06",
"PackageDescription": "236 g in 1 JAR (49967-721-06) ",
"NDC11Code": "49967-0721-06",
"ProductNDC": "49967-721",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cerave Developed With Dermatologists Healing",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "L�Oreal USA Products Inc",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "495",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260514",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily protects minor. cuts scrapes burns. temporarily protects and helps relieve chafed, chapped or cracked skin and lips. helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "64380-721-06",
"PackageDescription": "100 CAPSULE in 1 CONTAINER (64380-721-06) ",
"NDC11Code": "64380-0721-06",
"ProductNDC": "64380-721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140813",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090687",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140813",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus capsule is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, heart transplants, and pediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants. (1.1).",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in Tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S-[3R* [E(1S*,3S*,4S*)], 4S*,5R*,8S*, 9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]5,6,8,11,12,13,14,15,16, 17,18, 19,24, 25,26, 26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C44H69NO12●H2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform. Tacrolimus is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include croscarmellose sodium NF, hypromellose USP, lactose monohydrate NF, and magnesium stearate NF. The 0.5 mg capsule shell contains, FD & C Blue 1, FD & C Red 40, gelatin NF and titanium dioxide USP, the 1 mg capsule shell contains FD & C Blue 1, gelatin NF, iron oxide yellow and titanium dioxide USP, and the 5 mg capsule shell contains D & C Red 28, D & C Yellow 10, FD & C Blue 1, gelatin NF, and titanium dioxide USP."
},
{
"NDCCode": "65841-721-06",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-721-06) ",
"NDC11Code": "65841-0721-06",
"ProductNDC": "65841-721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20110511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090175",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110511",
"SamplePackage": "N"
},
{
"NDCCode": "68382-721-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68382-721-06) ",
"NDC11Code": "68382-0721-06",
"ProductNDC": "68382-721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nateglinide",
"NonProprietaryName": "Nateglinide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205248",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "NATEGLINIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glinide [EPC], Potassium Channel Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161027",
"SamplePackage": "N",
"IndicationAndUsage": "Nateglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Nateglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.",
"Description": "Nateglinide is an oral blood glucose-lowering drug of the glinide class. Nateglinide, (-)-N-[(trans-4- isopropylcyclohexane)carbonyl]-D-phenylalanine, is structurally unrelated to the oral sulfonylurea insulin secretagogues. The structural formula is as shown. Nateglinide, USP is a white powder with a molecular weight of 317.43 g/mol. It is freely soluble in methanol and alcohol, soluble in ether, sparingly soluble in acetonitrile and octanol, practically insoluble in water. Each nateglinide tablet, USP intended for oral administration contains nateglinide, USP 60 mg and 120 mg. In addition, each tablet contains the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, corn starch, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polysorbate 80, polyethylene glycol, povidone, talc and titanium dioxide. Additionally, each 120 mg tablet contains iron oxide red and iron oxide yellow."
},
{
"NDCCode": "43269-721-01",
"PackageDescription": "29 mL in 1 TUBE (43269-721-01)",
"NDC11Code": "43269-0721-01",
"ProductNDC": "43269-721",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Green Tea Antibacterial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111027",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SJ Creations, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "65",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-06-05",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "45802-721-53",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (45802-721-53) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "45802-0721-53",
"ProductNDC": "45802-721",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride",
"NonProprietaryName": "Cetirizine Hcl, Pseudoephedrine Hcl",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077170",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "5; 120",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140516",
"SamplePackage": "N"
},
{
"NDCCode": "45802-721-62",
"PackageDescription": "24 BLISTER PACK in 1 CARTON (45802-721-62) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "45802-0721-62",
"ProductNDC": "45802-721",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride",
"NonProprietaryName": "Cetirizine Hcl, Pseudoephedrine Hcl",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077170",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "5; 120",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20080410",
"SamplePackage": "N"
},
{
"NDCCode": "63029-721-01",
"PackageDescription": "1 JAR in 1 BOX (63029-721-01) > 10 mL in 1 JAR",
"NDC11Code": "63029-0721-01",
"ProductNDC": "63029-721",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "New Skin Bandage",
"NonProprietaryName": "Benzethonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Medtech Products Inc.",
"SubstanceName": "BENZETHONIUM CHLORIDE",
"StrengthNumber": ".06",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "69489-721-05",
"PackageDescription": "5 mL in 1 BOTTLE (69489-721-05) ",
"NDC11Code": "69489-0721-05",
"ProductNDC": "69489-721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exelderm",
"NonProprietaryName": "Sulconazole Nitrate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190607",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018738",
"LabelerName": "Journey Medical Corporation",
"SubstanceName": "SULCONAZOLE NITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210315",
"SamplePackage": "Y",
"IndicationAndUsage": "EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete's foot). Symptomatic relief usually occurs within a few days after starting EXELDERM SOLUTION and clinical improvement usually occurs within one week.",
"Description": "EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, USP, the active ingredient in EXELDERM SOLUTION, is an imidazole derivative with antifungal and antiyeast activity. Its chemical name is (±)-1-[2,4-dichloro-β-[(p-chlorobenzyl)-thio]-phenethyl] imidazole mononitrate and it has the following chemical structure. Sulconazole nitrate, USP is a white to off-white crystalline powder with a molecular weight of 460.77. It is freely soluble in pyridine; slightly soluble in ethanol, acetone, and chloroform; and very slightly soluble in water. It has a melting point of about 130°C. EXELDERM SOLUTION contains sulconazole nitrate, USP 10 mg/mL in a solution of propylene glycol, poloxamer 407, polysorbate 20, butylated hydroxyanisole, and purified water, with sodium hydroxide and, if necessary, nitric acid added to adjust the pH."
},
{
"NDCCode": "69489-721-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (69489-721-30) / 30 mL in 1 BOTTLE",
"NDC11Code": "69489-0721-30",
"ProductNDC": "69489-721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exelderm",
"NonProprietaryName": "Sulconazole Nitrate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190607",
"EndMarketingDate": "20271031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018738",
"LabelerName": "Journey Medical Corporation",
"SubstanceName": "SULCONAZOLE NITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190607",
"EndMarketingDatePackage": "20271031",
"SamplePackage": "N",
"IndicationAndUsage": "EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum,and Microsporum canis;and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete's foot). Symptomatic relief usually occurs within a few days after starting EXELDERM SOLUTION and clinical improvement usually occurs within one week.",
"Description": "EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, USP, the active ingredient in EXELDERM SOLUTION, is an imidazole derivative with antifungal and antiyeast activity. Its chemical name is (±)-1-[2,4-dichloro-β-[(p-chlorobenzyl)-thio]-phenethyl] imidazole mononitrate and it has the following chemical structure. Sulconazole nitrate, USP is a white to off-white crystalline powder with a molecular weight of 460.77. It is freely soluble in pyridine; slightly soluble in ethanol, acetone, and chloroform; and very slightly soluble in water. It has a melting point of about 130°C. EXELDERM SOLUTION contains sulconazole nitrate, USP 10 mg/mL in a solution of propylene glycol, poloxamer 407, polysorbate 20, butylated hydroxyanisole, and purified water, with sodium hydroxide and, if necessary, nitric acid added to adjust the pH."
},
{
"NDCCode": "71288-721-11",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-721-11) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "71288-0721-11",
"ProductNDC": "71288-721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupivacaine Hydrochloride",
"NonProprietaryName": "Bupivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20231227",
"EndMarketingDate": "20260721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216040",
"LabelerName": "Meitheal Pharmaceuticals Inc",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20231227",
"EndMarketingDatePackage": "20260607",
"SamplePackage": "N",
"IndicationAndUsage": "Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Limitations of Use. Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.4, 5.5, 5.7, 5.9)].",
"Description": "Bupivacaine Hydrochloride Injection, USP contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection, USP is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4.0 and 6.5, in water for injection."
},
{
"NDCCode": "82046-721-01",
"PackageDescription": "15 TUBE in 1 CARTON (82046-721-01) / 5 mL in 1 TUBE",
"NDC11Code": "82046-0721-01",
"ProductNDC": "82046-721",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "La Roche Posay Laboratoire Dermatologique Anthelios Uv Air Mineral Serum Sunscreen Broad Spectrum Spf 50",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260529",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "L�Oreal USA Products Inc",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "26.6; 153.5",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260529",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "82046-721-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (82046-721-02) / 50 mL in 1 BOTTLE",
"NDC11Code": "82046-0721-02",
"ProductNDC": "82046-721",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "La Roche Posay Laboratoire Dermatologique Anthelios Uv Air Mineral Serum Sunscreen Broad Spectrum Spf 50",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260529",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "L�Oreal USA Products Inc",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "26.6; 153.5",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260529",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "83209-143-30",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (83209-143-30) ",
"NDC11Code": "83209-0143-30",
"ProductNDC": "83209-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
"NonProprietaryName": "Lovastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075991",
"LabelerName": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250225",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.",
"Description": "Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus.After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1 S -[1α( R*), 3α, 7β, 8β(2 S *,4 S *),8aβ]]-1,2,3, 7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C 24H 36O 5and its molecular weight is 404.55. Its structural formula is:. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, pregelatinized starch, sodium starch glycolate, butylated hydroxyanisole and talc. Butylated hydroxyanisole (BHA) is added as a preservative."
},
{
"NDCCode": "83209-150-05",
"PackageDescription": "5 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-05) ",
"NDC11Code": "83209-0150-05",
"ProductNDC": "83209-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212977",
"LabelerName": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240612",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults ( 1.1) , 2 Eradication of Helicobacter pylorito reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Treatment of active benign gastric ulcer in adults ( 1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6) , 7 Pathologic hypersecretory conditions in adults ( 1.7) .",
"Description": "The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1 H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg or 20 mg of omeprazole in the form of enteric-coated granules. The 10 mg and 20 mg capsule contains the following inactive ingredients: crospovidone, dibasic sodium phosphate, hypromellose, magnesium hydroxide granules (with corn starch), methacrylicacid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, purified water, silicon dioxide, sodium lauryl sulfate, sugar spheres (sucrose, corn starch, and purified water), talc, and titanium dioxide. The capsule shells for the 10 and 20 mg have the following inactive ingredients: gelatin and titanium dioxide. The ink used for printing contains: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Omeprazole delayed-release capsules meet USP Dissolution Test 2."
},
{
"NDCCode": "83209-150-10",
"PackageDescription": "10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-10) ",
"NDC11Code": "83209-0150-10",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
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"RouteName": "ORAL",
"StartMarketingDate": "20240612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212977",
"LabelerName": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults ( 1.1) , 2 Eradication of Helicobacter pylorito reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Treatment of active benign gastric ulcer in adults ( 1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6) , 7 Pathologic hypersecretory conditions in adults ( 1.7) .",
"Description": "The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1 H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg or 20 mg of omeprazole in the form of enteric-coated granules. The 10 mg and 20 mg capsule contains the following inactive ingredients: crospovidone, dibasic sodium phosphate, hypromellose, magnesium hydroxide granules (with corn starch), methacrylicacid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, purified water, silicon dioxide, sodium lauryl sulfate, sugar spheres (sucrose, corn starch, and purified water), talc, and titanium dioxide. The capsule shells for the 10 and 20 mg have the following inactive ingredients: gelatin and titanium dioxide. The ink used for printing contains: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Omeprazole delayed-release capsules meet USP Dissolution Test 2."
},
{
"NDCCode": "83209-150-15",
"PackageDescription": "15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-15) ",
"NDC11Code": "83209-0150-15",
"ProductNDC": "83209-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212977",
"LabelerName": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults ( 1.1) , 2 Eradication of Helicobacter pylorito reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Treatment of active benign gastric ulcer in adults ( 1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6) , 7 Pathologic hypersecretory conditions in adults ( 1.7) .",
"Description": "The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1 H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg or 20 mg of omeprazole in the form of enteric-coated granules. The 10 mg and 20 mg capsule contains the following inactive ingredients: crospovidone, dibasic sodium phosphate, hypromellose, magnesium hydroxide granules (with corn starch), methacrylicacid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, purified water, silicon dioxide, sodium lauryl sulfate, sugar spheres (sucrose, corn starch, and purified water), talc, and titanium dioxide. The capsule shells for the 10 and 20 mg have the following inactive ingredients: gelatin and titanium dioxide. The ink used for printing contains: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Omeprazole delayed-release capsules meet USP Dissolution Test 2."
},
{
"NDCCode": "83209-150-20",
"PackageDescription": "20 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-20) ",
"NDC11Code": "83209-0150-20",
"ProductNDC": "83209-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212977",
"LabelerName": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240612",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults ( 1.1) , 2 Eradication of Helicobacter pylorito reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Treatment of active benign gastric ulcer in adults ( 1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6) , 7 Pathologic hypersecretory conditions in adults ( 1.7) .",
"Description": "The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1 H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg or 20 mg of omeprazole in the form of enteric-coated granules. The 10 mg and 20 mg capsule contains the following inactive ingredients: crospovidone, dibasic sodium phosphate, hypromellose, magnesium hydroxide granules (with corn starch), methacrylicacid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, purified water, silicon dioxide, sodium lauryl sulfate, sugar spheres (sucrose, corn starch, and purified water), talc, and titanium dioxide. The capsule shells for the 10 and 20 mg have the following inactive ingredients: gelatin and titanium dioxide. The ink used for printing contains: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Omeprazole delayed-release capsules meet USP Dissolution Test 2."
},
{
"NDCCode": "83209-150-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-30) ",
"NDC11Code": "83209-0150-30",
"ProductNDC": "83209-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212977",
"LabelerName": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20240612",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults ( 1.1) , 2 Eradication of Helicobacter pylorito reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Treatment of active benign gastric ulcer in adults ( 1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6) , 7 Pathologic hypersecretory conditions in adults ( 1.7) .",
"Description": "The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1 H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg or 20 mg of omeprazole in the form of enteric-coated granules. The 10 mg and 20 mg capsule contains the following inactive ingredients: crospovidone, dibasic sodium phosphate, hypromellose, magnesium hydroxide granules (with corn starch), methacrylicacid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, purified water, silicon dioxide, sodium lauryl sulfate, sugar spheres (sucrose, corn starch, and purified water), talc, and titanium dioxide. The capsule shells for the 10 and 20 mg have the following inactive ingredients: gelatin and titanium dioxide. The ink used for printing contains: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Omeprazole delayed-release capsules meet USP Dissolution Test 2."
},
{
"NDCCode": "83209-190-14",
"PackageDescription": "14 TABLET in 1 BLISTER PACK (83209-190-14) ",
"NDC11Code": "83209-0190-14",
"ProductNDC": "83209-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078250",
"LabelerName": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240823",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen tablets and naproxen sodium tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.",
"Description": "Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows. Naproxen Tablets, USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C 14H 14O 3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C 14H 13NaO 3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively:. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol."
}
]
}
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<NDCList>
<NDC>
<NDCCode>83209-721-06</NDCCode>
<PackageDescription>6 CAPSULE in 1 BLISTER PACK (83209-721-06) </PackageDescription>
<NDC11Code>83209-0721-06</NDC11Code>
<ProductNDC>83209-721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078619</ApplicationNumber>
<LabelerName>Boswell Pharmacy Services LLC d/b/a BPS Wholesale</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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<NDC>
<NDCCode>83209-150-06</NDCCode>
<PackageDescription>6 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-06) </PackageDescription>
<NDC11Code>83209-0150-06</NDC11Code>
<ProductNDC>83209-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212977</ApplicationNumber>
<LabelerName>Boswell Pharmacy Services LLC d/b/a BPS Wholesale</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults ( 1.1) , 2 Eradication of Helicobacter pylorito reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Treatment of active benign gastric ulcer in adults ( 1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6) , 7 Pathologic hypersecretory conditions in adults ( 1.7) .</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1 H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg or 20 mg of omeprazole in the form of enteric-coated granules. The 10 mg and 20 mg capsule contains the following inactive ingredients: crospovidone, dibasic sodium phosphate, hypromellose, magnesium hydroxide granules (with corn starch), methacrylicacid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, purified water, silicon dioxide, sodium lauryl sulfate, sugar spheres (sucrose, corn starch, and purified water), talc, and titanium dioxide. The capsule shells for the 10 and 20 mg have the following inactive ingredients: gelatin and titanium dioxide. The ink used for printing contains: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Omeprazole delayed-release capsules meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>83209-220-06</NDCCode>
<PackageDescription>6 CAPSULE in 1 BLISTER PACK (83209-220-06) </PackageDescription>
<NDC11Code>83209-0220-06</NDC11Code>
<ProductNDC>83209-220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lithium Carbonate</ProprietaryName>
<NonProprietaryName>Lithium Carbonate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240821</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079139</ApplicationNumber>
<LabelerName>Boswell Pharmacy Services LLC d/b/a BPS Wholesale</LabelerName>
<SubstanceName>LITHIUM CARBONATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: 1 Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies ( 14)] , 2 Maintenance treatment in patients 7 years and older [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Each capsule for oral administration contains lithium carbonate, USP 150 mg, 300 mg or 600 mg and the following inactive ingredients: colloidal silicon dioxide, gelatin, sodium lauryl sulfate, talc, titanium dioxide, FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and the imprinting ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. Lithium Carbonate, USP is a white, crystalline powder with molecular formula Li 2CO 3and molecular weight 73.89.</Description>
</NDC>
<NDC>
<NDCCode>83209-721-10</NDCCode>
<PackageDescription>10 CAPSULE in 1 BLISTER PACK (83209-721-10) </PackageDescription>
<NDC11Code>83209-0721-10</NDC11Code>
<ProductNDC>83209-721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078619</ApplicationNumber>
<LabelerName>Boswell Pharmacy Services LLC d/b/a BPS Wholesale</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>83209-721-15</NDCCode>
<PackageDescription>15 CAPSULE in 1 BLISTER PACK (83209-721-15) </PackageDescription>
<NDC11Code>83209-0721-15</NDC11Code>
<ProductNDC>83209-721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078619</ApplicationNumber>
<LabelerName>Boswell Pharmacy Services LLC d/b/a BPS Wholesale</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>83209-721-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BLISTER PACK (83209-721-20) </PackageDescription>
<NDC11Code>83209-0721-20</NDC11Code>
<ProductNDC>83209-721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078619</ApplicationNumber>
<LabelerName>Boswell Pharmacy Services LLC d/b/a BPS Wholesale</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>83209-721-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (83209-721-30) </PackageDescription>
<NDC11Code>83209-0721-30</NDC11Code>
<ProductNDC>83209-721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078619</ApplicationNumber>
<LabelerName>Boswell Pharmacy Services LLC d/b/a BPS Wholesale</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>83209-721-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BLISTER PACK (83209-721-60) </PackageDescription>
<NDC11Code>83209-0721-60</NDC11Code>
<ProductNDC>83209-721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078619</ApplicationNumber>
<LabelerName>Boswell Pharmacy Services LLC d/b/a BPS Wholesale</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>16571-721-06</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16571-721-06) </PackageDescription>
<NDC11Code>16571-0721-06</NDC11Code>
<ProductNDC>16571-721</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>ANDA091388</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine 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 is an atypical antipsychotic 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 USP is a white to off-white powder which is moderately soluble in water.Quetiapine is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 150 mg (round, light yellow), 200 mg (round, white), 300 mg (capsule shaped, white), and 400 mg (capsule shaped, yellow) tablets.Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose 6cp, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, sodium starch glycolate, talc, and titanium dioxide. In addition, the 25 mg contains iron oxide red and iron oxide yellow; the 100 mg, 150 mg, and 400 mg contains iron oxide yellow. The 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, and 400 mg tablets are printed with Opacode S-1-17823 black contains iron oxide black and shellac. Each 25 mg tablet contains 28.780 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.561 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.122 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.683 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.244 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.366 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.488 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>17271-721-06</NDCCode>
<PackageDescription>20 BAG in 1 CASE (17271-721-06) / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>17271-0721-06</NDC11Code>
<ProductNDC>17271-721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209448</ApplicationNumber>
<LabelerName>Becton Dickinson and Company</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose Injection is indicated as source of water and calories.</IndicationAndUsage>
<Description>10% Dextrose Injection, USP is a sterile, non-pyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (3.2 to 6.5). Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula:. Water for Injection, USP is chemically designated H2O. Dextrose is derived from corn. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration. The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication ([see Instructions for Use (2.3)]). The primary function of the overwrap is to protect the container from the physical environment.</Description>
</NDC>
<NDC>
<NDCCode>49967-721-06</NDCCode>
<PackageDescription>236 g in 1 JAR (49967-721-06) </PackageDescription>
<NDC11Code>49967-0721-06</NDC11Code>
<ProductNDC>49967-721</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cerave Developed With Dermatologists Healing</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>L�Oreal USA Products Inc</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>495</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily protects minor. cuts scrapes burns. temporarily protects and helps relieve chafed, chapped or cracked skin and lips. helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64380-721-06</NDCCode>
<PackageDescription>100 CAPSULE in 1 CONTAINER (64380-721-06) </PackageDescription>
<NDC11Code>64380-0721-06</NDC11Code>
<ProductNDC>64380-721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140813</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090687</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus capsule is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, heart transplants, and pediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants. (1.1).</IndicationAndUsage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in Tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S-[3R* [E(1S*,3S*,4S*)], 4S*,5R*,8S*, 9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]5,6,8,11,12,13,14,15,16, 17,18, 19,24, 25,26, 26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C44H69NO12●H2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform. Tacrolimus is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include croscarmellose sodium NF, hypromellose USP, lactose monohydrate NF, and magnesium stearate NF. The 0.5 mg capsule shell contains, FD & C Blue 1, FD & C Red 40, gelatin NF and titanium dioxide USP, the 1 mg capsule shell contains FD & C Blue 1, gelatin NF, iron oxide yellow and titanium dioxide USP, and the 5 mg capsule shell contains D & C Red 28, D & C Yellow 10, FD & C Blue 1, gelatin NF, and titanium dioxide USP.</Description>
</NDC>
<NDC>
<NDCCode>65841-721-06</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-721-06) </PackageDescription>
<NDC11Code>65841-0721-06</NDC11Code>
<ProductNDC>65841-721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090175</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-721-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68382-721-06) </PackageDescription>
<NDC11Code>68382-0721-06</NDC11Code>
<ProductNDC>68382-721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nateglinide</ProprietaryName>
<NonProprietaryName>Nateglinide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205248</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>NATEGLINIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glinide [EPC], Potassium Channel Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nateglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Nateglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.</IndicationAndUsage>
<Description>Nateglinide is an oral blood glucose-lowering drug of the glinide class. Nateglinide, (-)-N-[(trans-4- isopropylcyclohexane)carbonyl]-D-phenylalanine, is structurally unrelated to the oral sulfonylurea insulin secretagogues. The structural formula is as shown. Nateglinide, USP is a white powder with a molecular weight of 317.43 g/mol. It is freely soluble in methanol and alcohol, soluble in ether, sparingly soluble in acetonitrile and octanol, practically insoluble in water. Each nateglinide tablet, USP intended for oral administration contains nateglinide, USP 60 mg and 120 mg. In addition, each tablet contains the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, corn starch, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polysorbate 80, polyethylene glycol, povidone, talc and titanium dioxide. Additionally, each 120 mg tablet contains iron oxide red and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>43269-721-01</NDCCode>
<PackageDescription>29 mL in 1 TUBE (43269-721-01)</PackageDescription>
<NDC11Code>43269-0721-01</NDC11Code>
<ProductNDC>43269-721</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Green Tea Antibacterial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111027</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SJ Creations, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>65</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-06-05</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>45802-721-53</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (45802-721-53) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>45802-0721-53</NDC11Code>
<ProductNDC>45802-721</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hcl, Pseudoephedrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077170</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 120</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45802-721-62</NDCCode>
<PackageDescription>24 BLISTER PACK in 1 CARTON (45802-721-62) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>45802-0721-62</NDC11Code>
<ProductNDC>45802-721</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hcl, Pseudoephedrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077170</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 120</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63029-721-01</NDCCode>
<PackageDescription>1 JAR in 1 BOX (63029-721-01) > 10 mL in 1 JAR</PackageDescription>
<NDC11Code>63029-0721-01</NDC11Code>
<ProductNDC>63029-721</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>New Skin Bandage</ProprietaryName>
<NonProprietaryName>Benzethonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Medtech Products Inc.</LabelerName>
<SubstanceName>BENZETHONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.06</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69489-721-05</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE (69489-721-05) </PackageDescription>
<NDC11Code>69489-0721-05</NDC11Code>
<ProductNDC>69489-721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exelderm</ProprietaryName>
<NonProprietaryName>Sulconazole Nitrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190607</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018738</ApplicationNumber>
<LabelerName>Journey Medical Corporation</LabelerName>
<SubstanceName>SULCONAZOLE NITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210315</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete's foot). Symptomatic relief usually occurs within a few days after starting EXELDERM SOLUTION and clinical improvement usually occurs within one week.</IndicationAndUsage>
<Description>EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, USP, the active ingredient in EXELDERM SOLUTION, is an imidazole derivative with antifungal and antiyeast activity. Its chemical name is (±)-1-[2,4-dichloro-β-[(p-chlorobenzyl)-thio]-phenethyl] imidazole mononitrate and it has the following chemical structure. Sulconazole nitrate, USP is a white to off-white crystalline powder with a molecular weight of 460.77. It is freely soluble in pyridine; slightly soluble in ethanol, acetone, and chloroform; and very slightly soluble in water. It has a melting point of about 130°C. EXELDERM SOLUTION contains sulconazole nitrate, USP 10 mg/mL in a solution of propylene glycol, poloxamer 407, polysorbate 20, butylated hydroxyanisole, and purified water, with sodium hydroxide and, if necessary, nitric acid added to adjust the pH.</Description>
</NDC>
<NDC>
<NDCCode>69489-721-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69489-721-30) / 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>69489-0721-30</NDC11Code>
<ProductNDC>69489-721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exelderm</ProprietaryName>
<NonProprietaryName>Sulconazole Nitrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190607</StartMarketingDate>
<EndMarketingDate>20271031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018738</ApplicationNumber>
<LabelerName>Journey Medical Corporation</LabelerName>
<SubstanceName>SULCONAZOLE NITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190607</StartMarketingDatePackage>
<EndMarketingDatePackage>20271031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum,and Microsporum canis;and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete's foot). Symptomatic relief usually occurs within a few days after starting EXELDERM SOLUTION and clinical improvement usually occurs within one week.</IndicationAndUsage>
<Description>EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, USP, the active ingredient in EXELDERM SOLUTION, is an imidazole derivative with antifungal and antiyeast activity. Its chemical name is (±)-1-[2,4-dichloro-β-[(p-chlorobenzyl)-thio]-phenethyl] imidazole mononitrate and it has the following chemical structure. Sulconazole nitrate, USP is a white to off-white crystalline powder with a molecular weight of 460.77. It is freely soluble in pyridine; slightly soluble in ethanol, acetone, and chloroform; and very slightly soluble in water. It has a melting point of about 130°C. EXELDERM SOLUTION contains sulconazole nitrate, USP 10 mg/mL in a solution of propylene glycol, poloxamer 407, polysorbate 20, butylated hydroxyanisole, and purified water, with sodium hydroxide and, if necessary, nitric acid added to adjust the pH.</Description>
</NDC>
<NDC>
<NDCCode>71288-721-11</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (71288-721-11) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>71288-0721-11</NDC11Code>
<ProductNDC>71288-721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20231227</StartMarketingDate>
<EndMarketingDate>20260721</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216040</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20231227</StartMarketingDatePackage>
<EndMarketingDatePackage>20260607</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Limitations of Use. Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.4, 5.5, 5.7, 5.9)].</IndicationAndUsage>
<Description>Bupivacaine Hydrochloride Injection, USP contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection, USP is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4.0 and 6.5, in water for injection.</Description>
</NDC>
<NDC>
<NDCCode>82046-721-01</NDCCode>
<PackageDescription>15 TUBE in 1 CARTON (82046-721-01) / 5 mL in 1 TUBE</PackageDescription>
<NDC11Code>82046-0721-01</NDC11Code>
<ProductNDC>82046-721</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>La Roche Posay Laboratoire Dermatologique Anthelios Uv Air Mineral Serum Sunscreen Broad Spectrum Spf 50</ProprietaryName>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260529</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>L�Oreal USA Products Inc</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>26.6; 153.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82046-721-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (82046-721-02) / 50 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>82046-0721-02</NDC11Code>
<ProductNDC>82046-721</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>La Roche Posay Laboratoire Dermatologique Anthelios Uv Air Mineral Serum Sunscreen Broad Spectrum Spf 50</ProprietaryName>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260529</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>L�Oreal USA Products Inc</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>26.6; 153.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83209-143-30</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (83209-143-30) </PackageDescription>
<NDC11Code>83209-0143-30</NDC11Code>
<ProductNDC>83209-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075991</ApplicationNumber>
<LabelerName>Boswell Pharmacy Services LLC d/b/a BPS Wholesale</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.</IndicationAndUsage>
<Description>Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus.After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1 S -[1α( R*), 3α, 7β, 8β(2 S *,4 S *),8aβ]]-1,2,3, 7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C 24H 36O 5and its molecular weight is 404.55. Its structural formula is:. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, pregelatinized starch, sodium starch glycolate, butylated hydroxyanisole and talc. Butylated hydroxyanisole (BHA) is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>83209-150-05</NDCCode>
<PackageDescription>5 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-05) </PackageDescription>
<NDC11Code>83209-0150-05</NDC11Code>
<ProductNDC>83209-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212977</ApplicationNumber>
<LabelerName>Boswell Pharmacy Services LLC d/b/a BPS Wholesale</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults ( 1.1) , 2 Eradication of Helicobacter pylorito reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Treatment of active benign gastric ulcer in adults ( 1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6) , 7 Pathologic hypersecretory conditions in adults ( 1.7) .</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1 H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg or 20 mg of omeprazole in the form of enteric-coated granules. The 10 mg and 20 mg capsule contains the following inactive ingredients: crospovidone, dibasic sodium phosphate, hypromellose, magnesium hydroxide granules (with corn starch), methacrylicacid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, purified water, silicon dioxide, sodium lauryl sulfate, sugar spheres (sucrose, corn starch, and purified water), talc, and titanium dioxide. The capsule shells for the 10 and 20 mg have the following inactive ingredients: gelatin and titanium dioxide. The ink used for printing contains: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Omeprazole delayed-release capsules meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>83209-150-10</NDCCode>
<PackageDescription>10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-10) </PackageDescription>
<NDC11Code>83209-0150-10</NDC11Code>
<ProductNDC>83209-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212977</ApplicationNumber>
<LabelerName>Boswell Pharmacy Services LLC d/b/a BPS Wholesale</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults ( 1.1) , 2 Eradication of Helicobacter pylorito reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Treatment of active benign gastric ulcer in adults ( 1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6) , 7 Pathologic hypersecretory conditions in adults ( 1.7) .</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1 H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg or 20 mg of omeprazole in the form of enteric-coated granules. The 10 mg and 20 mg capsule contains the following inactive ingredients: crospovidone, dibasic sodium phosphate, hypromellose, magnesium hydroxide granules (with corn starch), methacrylicacid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, purified water, silicon dioxide, sodium lauryl sulfate, sugar spheres (sucrose, corn starch, and purified water), talc, and titanium dioxide. The capsule shells for the 10 and 20 mg have the following inactive ingredients: gelatin and titanium dioxide. The ink used for printing contains: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Omeprazole delayed-release capsules meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>83209-150-15</NDCCode>
<PackageDescription>15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-15) </PackageDescription>
<NDC11Code>83209-0150-15</NDC11Code>
<ProductNDC>83209-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212977</ApplicationNumber>
<LabelerName>Boswell Pharmacy Services LLC d/b/a BPS Wholesale</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults ( 1.1) , 2 Eradication of Helicobacter pylorito reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Treatment of active benign gastric ulcer in adults ( 1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6) , 7 Pathologic hypersecretory conditions in adults ( 1.7) .</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1 H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg or 20 mg of omeprazole in the form of enteric-coated granules. The 10 mg and 20 mg capsule contains the following inactive ingredients: crospovidone, dibasic sodium phosphate, hypromellose, magnesium hydroxide granules (with corn starch), methacrylicacid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, purified water, silicon dioxide, sodium lauryl sulfate, sugar spheres (sucrose, corn starch, and purified water), talc, and titanium dioxide. The capsule shells for the 10 and 20 mg have the following inactive ingredients: gelatin and titanium dioxide. The ink used for printing contains: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Omeprazole delayed-release capsules meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>83209-150-20</NDCCode>
<PackageDescription>20 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-20) </PackageDescription>
<NDC11Code>83209-0150-20</NDC11Code>
<ProductNDC>83209-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212977</ApplicationNumber>
<LabelerName>Boswell Pharmacy Services LLC d/b/a BPS Wholesale</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults ( 1.1) , 2 Eradication of Helicobacter pylorito reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Treatment of active benign gastric ulcer in adults ( 1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6) , 7 Pathologic hypersecretory conditions in adults ( 1.7) .</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1 H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg or 20 mg of omeprazole in the form of enteric-coated granules. The 10 mg and 20 mg capsule contains the following inactive ingredients: crospovidone, dibasic sodium phosphate, hypromellose, magnesium hydroxide granules (with corn starch), methacrylicacid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, purified water, silicon dioxide, sodium lauryl sulfate, sugar spheres (sucrose, corn starch, and purified water), talc, and titanium dioxide. The capsule shells for the 10 and 20 mg have the following inactive ingredients: gelatin and titanium dioxide. The ink used for printing contains: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Omeprazole delayed-release capsules meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>83209-150-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-30) </PackageDescription>
<NDC11Code>83209-0150-30</NDC11Code>
<ProductNDC>83209-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212977</ApplicationNumber>
<LabelerName>Boswell Pharmacy Services LLC d/b/a BPS Wholesale</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults ( 1.1) , 2 Eradication of Helicobacter pylorito reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Treatment of active benign gastric ulcer in adults ( 1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6) , 7 Pathologic hypersecretory conditions in adults ( 1.7) .</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1 H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg or 20 mg of omeprazole in the form of enteric-coated granules. The 10 mg and 20 mg capsule contains the following inactive ingredients: crospovidone, dibasic sodium phosphate, hypromellose, magnesium hydroxide granules (with corn starch), methacrylicacid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, purified water, silicon dioxide, sodium lauryl sulfate, sugar spheres (sucrose, corn starch, and purified water), talc, and titanium dioxide. The capsule shells for the 10 and 20 mg have the following inactive ingredients: gelatin and titanium dioxide. The ink used for printing contains: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Omeprazole delayed-release capsules meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>83209-190-14</NDCCode>
<PackageDescription>14 TABLET in 1 BLISTER PACK (83209-190-14) </PackageDescription>
<NDC11Code>83209-0190-14</NDC11Code>
<ProductNDC>83209-190</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078250</ApplicationNumber>
<LabelerName>Boswell Pharmacy Services LLC d/b/a BPS Wholesale</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen tablets and naproxen sodium tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.</IndicationAndUsage>
<Description>Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows. Naproxen Tablets, USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C 14H 14O 3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C 14H 13NaO 3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively:. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol.</Description>
</NDC>
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