{
"NDC": [
{
"NDCCode": "76420-636-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-636-30) ",
"NDC11Code": "76420-0636-30",
"ProductNDC": "76420-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208706",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231017",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C 18H 19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, 40 mg or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4 mg, 33.7 mg, 44.9 mg or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending."
},
{
"NDCCode": "76420-636-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-636-01) ",
"NDC11Code": "76420-0636-01",
"ProductNDC": "76420-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208706",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231017",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C 18H 19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, 40 mg or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4 mg, 33.7 mg, 44.9 mg or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending."
},
{
"NDCCode": "76420-636-20",
"PackageDescription": "20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-636-20) ",
"NDC11Code": "76420-0636-20",
"ProductNDC": "76420-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208706",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250403",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C 18H 19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, 40 mg or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4 mg, 33.7 mg, 44.9 mg or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending."
},
{
"NDCCode": "76420-636-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-636-60) ",
"NDC11Code": "76420-0636-60",
"ProductNDC": "76420-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208706",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20231017",
"SamplePackage": "N"
},
{
"NDCCode": "76420-636-90",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-636-90) ",
"NDC11Code": "76420-0636-90",
"ProductNDC": "76420-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208706",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231017",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C 18H 19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, 40 mg or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4 mg, 33.7 mg, 44.9 mg or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending."
},
{
"NDCCode": "13533-636-03",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (13533-636-03) / .5 mL in 1 SYRINGE, GLASS (13533-636-30) ",
"NDC11Code": "13533-0636-03",
"ProductNDC": "13533-636",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Hyperhep B",
"NonProprietaryName": "Hepatitis B Immune Globulin (human)",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19961009",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101146",
"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN",
"StrengthNumber": "220",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]",
"Status": "Active",
"LastUpdate": "2024-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19961009",
"SamplePackage": "N",
"IndicationAndUsage": "Recommendations on post-exposure prophylaxis are based on available efficacy data and on the likelihood of future HBV exposure for the person requiring treatment. In all exposures, a regimen combining Hepatitis B Immune Globulin (Human) with hepatitis B vaccine will provide both short- and long-term protection, will be less costly than the two-dose Hepatitis B Immune Globulin (Human) treatment alone, and is the treatment of choice.(9). HyperHEP B is indicated for post-exposure prophylaxis in the following situations.",
"Description": "Hepatitis B Immune Globulin (Human) — HyperHEP B® is a clear or slightly opalescent, and colorless or pale yellow sterile solution of human hepatitis B immune globulin for intramuscular administration. HyperHEP B contains no preservative. HyperHEP B is prepared from pools of human plasma collected from healthy donors by a combination of cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion exchange chromatography, nanofiltration and low pH incubation. HyperHEP B consists of a 15% to 18% protein solution at a pH of 4.1 to 4.8 in 0.16 M to 0.26 M glycine. The product contains anti-HBs antibody equivalent to or exceeding the potency of anti-HBs in a U.S. reference hepatitis B immune globulin (Center for Biologics Evaluation and Research, FDA). The U.S. reference has been tested against the World Health Organization standard Hepatitis B Immune Globulin and found to be equal to 220 international units (IU) per mL. When medicinal biological products are administered, the risk of infectious diseases due to transmission of pathogens cannot be totally excluded. However, in the case of products prepared from human plasma, the risk of transmission of pathogens is reduced by epidemiological surveillance of the donor population and selection of individual donors by medical interview; testing of individual donations and plasma pools; and the presence in the manufacturing processes of steps with demonstrated capacity to inactivate/remove pathogen. In the manufacturing process of HyperHEP B, there are several steps with the capacity for viral inactivation or removal.(1) The main steps of the manufacturing process that contribute to the virus clearance capacity are as follows: 1 Caprylate precipitation/depth filtration, 2 Caprylate incubation, 3 Depth filtration, 4 Column chromatography, 5 Nanofiltration, 6 Low pH final container incubation."
},
{
"NDCCode": "13537-636-24",
"PackageDescription": "1 BOTTLE in 1 BOX (13537-636-24) > 30 mL in 1 BOTTLE (13537-636-23) ",
"NDC11Code": "13537-0636-24",
"ProductNDC": "13537-636",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Pro Hydro-nutritive Foundation Spf 15",
"ProprietaryNameSuffix": "(rosa 6) - Pink",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150306",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".05; .02",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"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": "31722-636-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (31722-636-30) ",
"NDC11Code": "31722-0636-30",
"ProductNDC": "31722-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Silodosin",
"NonProprietaryName": "Silodosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204793",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "SILODOSIN",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200214",
"SamplePackage": "N",
"IndicationAndUsage": "Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.",
"Description": "Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "31722-636-31",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (31722-636-31) ",
"NDC11Code": "31722-0636-31",
"ProductNDC": "31722-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Silodosin",
"NonProprietaryName": "Silodosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204793",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "SILODOSIN",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200214",
"SamplePackage": "N",
"IndicationAndUsage": "Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.",
"Description": "Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "34908-636-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-636-30) ",
"NDC11Code": "34908-0636-30",
"ProductNDC": "34908-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208947",
"LabelerName": "Novast Laboratories, Ltd.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170831",
"SamplePackage": "N"
},
{
"NDCCode": "41250-636-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (41250-636-30) / 89 mL in 1 BOTTLE",
"NDC11Code": "41250-0636-30",
"ProductNDC": "41250-636",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meijer Saline",
"NonProprietaryName": "Nasal",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20210217",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "MEIJER",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "6.5",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210217",
"SamplePackage": "N",
"IndicationAndUsage": "provides instant, soothing relief to dry irritated nasal passages due to colds, allergies, dry air, pollution, smoke, air travel and use of decongestants/steroidal sprays."
},
{
"NDCCode": "41616-636-83",
"PackageDescription": "30 TABLET in 1 BOTTLE (41616-636-83)",
"NDC11Code": "41616-0636-83",
"ProductNDC": "41616-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090022",
"LabelerName": "Sun Pharma Global Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-09-07"
},
{
"NDCCode": "43744-636-30",
"PackageDescription": "50 g in 1 DRUM (43744-636-30)",
"NDC11Code": "43744-0636-30",
"ProductNDC": "43744-636",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110707",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "47335-636-83",
"PackageDescription": "30 TABLET in 1 BOTTLE (47335-636-83)",
"NDC11Code": "47335-0636-83",
"ProductNDC": "47335-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090022",
"LabelerName": "Sun Pharma Global FZE",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-02-13"
},
{
"NDCCode": "49349-636-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-636-02)",
"NDC11Code": "49349-0636-02",
"ProductNDC": "49349-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040123",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "2.5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2016-12-14"
},
{
"NDCCode": "49967-636-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (49967-636-01) > 30 mL in 1 BOTTLE",
"NDC11Code": "49967-0636-01",
"ProductNDC": "49967-636",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lancome Paris Nude Miracle Broad Spectrum Spf 15 Sunscreen",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "L'Oreal USA Products Inc",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N"
},
{
"NDCCode": "49999-636-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (49999-636-30)",
"NDC11Code": "49999-0636-30",
"ProductNDC": "49999-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100713",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of STRATTERA Capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) [see Clinical Studies (14)]. A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure to follow through on tasks, poor organization, avoids tasks requiring sustained mental effort, loses things, easily distracted, forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming, leaving seat, inappropriate running/climbing, difficulty with quiet activities, “on the go,” excessive talking, blurting answers, can't wait turn, intrusive. For a Combined Type diagnosis, both inattentive and hyperactive-impulsive criteria must be met. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.",
"Description": "Atomoxetine HCl is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA capsules are intended for oral administration only. Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and other inactive ingredients. The capsule shells also contain one or more of the following:."
},
{
"NDCCode": "50742-636-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-636-30) ",
"NDC11Code": "50742-0636-30",
"ProductNDC": "50742-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208947",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170831",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine extended-release tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).",
"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 is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (light yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients: The following are common in all 5 tablet strengths: microcrystalline cellulose, hypromellose, magnesium stearate, povidone, polyethylene glycol, and titanium dioxide. Additional inactive ingredients include: 50 mg - polyvinyl alcohol, talc, iron oxide yellow, iron oxide red, iron oxide black, lecithin (soya);150 mg - polydextrose and triacetin; 200 mg - polyvinyl alcohol, talc, lecithin (soya), D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake; 300 mg - polyvinyl alcohol, talc, lecithin (soya), iron oxide yellow and iron oxide black; 400 mg - polydextrose, and triacetin. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. Meets USP dissolution test 6."
},
{
"NDCCode": "51150-636-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (51150-636-01) > 30 mL in 1 BOTTLE",
"NDC11Code": "51150-0636-01",
"ProductNDC": "51150-636",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lancome Paris Nude Miracle Broad Spectrum Spf 15 Sunscreen",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SICOS ET CIE",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2015-02-06"
},
{
"NDCCode": "51655-636-52",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-636-52) ",
"NDC11Code": "51655-0636-52",
"ProductNDC": "51655-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205936",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230614",
"SamplePackage": "N",
"IndicationAndUsage": "Spironolactone is an aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1). , 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.2). , 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response ( 1.3). , 4 Treatment of primary hyperaldosternism for: ( 1.4) Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia.",
"Description": "Spironolactone tablets, USP contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone, USP is practically insoluble in water, soluble in ethyl acetate and alcohol, freely soluble in benzene and in chloroform, slightly soluble in menthanol and very slightly soluble in fixed oils. Inactive ingredients include calcium sulfate dihydrate, colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, peppermint flavor, povidone and sodium lauryl sulfate. Additionally each tablet contains opadry II white 33F28398 which contains hydroxylpropyl methyl cellulose, lactose monohydrate, polyethylene glycol, talc and titanium dioxide."
},
{
"NDCCode": "60760-636-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-636-30) ",
"NDC11Code": "60760-0636-30",
"ProductNDC": "60760-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078539",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191015",
"SamplePackage": "N"
},
{
"NDCCode": "61786-636-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (61786-636-02)",
"NDC11Code": "61786-0636-02",
"ProductNDC": "61786-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077662",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2017-03-07"
},
{
"NDCCode": "63187-636-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (63187-636-30) ",
"NDC11Code": "63187-0636-30",
"ProductNDC": "63187-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078539",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160502",
"SamplePackage": "N",
"IndicationAndUsage": "1.Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. . 2.Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. . 3.Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. . 4.Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets, USP are recommended even where the incidence of postoperative nausea and/or vomiting is low.",
"Description": "The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline.Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red.Meets USP dissolution test 6."
},
{
"NDCCode": "64980-636-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (64980-636-03) ",
"NDC11Code": "64980-0636-03",
"ProductNDC": "64980-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211289",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251206",
"SamplePackage": "N",
"IndicationAndUsage": "Ranitidine Tablets are indicated in: 1 Short- term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of Ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo- controlled comparative studies have been carried out for periods of longer than 1 year., 3 The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 Short-term treatment of active, benign gastric ulcers. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year., 6 Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with Ranitidine Tablets USP, 150 mg twice daily., 7 Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Tablets USP, 150 mg 4 times daily., 8 Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.",
"Description": "Ranitidine Tablets USP are available for oral administration containing 150 mg or 300 mg of ranitidine. The active ingredient in Ranitidine Tablets USP, 150 mg and 300 mg is Ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl] methyl]thio]ethyl]-N´-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The emperical formula is C13H22N4O3SHCl, representing a molecular weight of 350.87. Ranitidine HCl is white to pale yellow, crystalline, practically odorless powder, sensitive to light and moisture. Melts at about 140°C with decomposition. Ranitidine is available as 150 mg and 300 mg tablets for oral administration. Each Ranitidine Tablet USP, 150 mg contains 150 mg ranitidine (equivalent to 168 mg of ranitidine HCl) and the following inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry® 200 Orange 203A530006 (Polyvinyl alcohol, talc, titanium dioxide, glycerol monostearate, sodium lauryl sulphate, FD&C yellow 6 and iron oxide yellow), purified water. Each Ranitidine Tablet USP, 300 mg contains 300 mg ranitidine (equivalent to 336 mg of ranitidine HCl) and the following inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry® 200 Yellow 203A520014 (Polyvinyl alcohol, talc, titanium dioxide, glycerol monostearate, sodium lauryl sulphate, FD&C yellow 5 and FD&C Blue 1), purified water. Contains color additives including FD&C Yellow No.5 (tartrazine). Meets FDA approved specifications for nitrosamine impurities."
},
{
"NDCCode": "65162-636-03",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-636-03) ",
"NDC11Code": "65162-0636-03",
"ProductNDC": "65162-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205119",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160620",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium, USP sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium, USP is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each pantoprazole sodium delayed-release tablet, USP contains 45.1 mg or 22.56 mg of pantoprazole sodium, USP sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively). Pantoprazole sodium delayed-release tablets, USP contains the following inactive ingredients: ammonium hydroxide, crospovidone, hydroxyl propyl cellulose, hypromellose, iron oxide black, iron oxide yellow, mannitol, methacrylic acid copolymer dispersion, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, shellac, sodium carbonate, sodium hydroxide, sodium stearyl fumarate, talc, titanium dioxide and triethyl citrate. Pantoprazole sodium delayed-release tablets, USP (40 mg and 20 mg) complies with USP dissolution test 2."
},
{
"NDCCode": "67046-636-30",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-636-30)",
"NDC11Code": "67046-0636-30",
"ProductNDC": "67046-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201109",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Quetiapine tablet USP is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia ( 1.1) , 2 Bipolar I disorder manic episodes ( 1.2) , 3 Bipolar disorder, depressive episodes ( 1.2) .",
"Description": "Quetiapine fumarate is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b, f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2.C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP are supplied for oral administration as 25 mg (quetiapine) round, pink tablets, 50 mg (quetiapine) round, white tablets, 100 mg (quetiapine) round, yellow tablets, 200 mg (quetiapine) round, white tablets, 300 mg (quetiapine) capsule-shaped, white tablets and 400 mg (quetiapine) capsule-shaped, yellow tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide black; and the 100 mg and 400 mg tablets contain iron oxide yellow."
},
{
"NDCCode": "68084-636-25",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-636-25) > 1 TABLET in 1 BLISTER PACK (68084-636-95) ",
"NDC11Code": "68084-0636-25",
"ProductNDC": "68084-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130117",
"EndMarketingDate": "20220131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090856",
"LabelerName": "American Health Packaging",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "145",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130117",
"EndMarketingDatePackage": "20220131",
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{
"NDCCode": "68180-636-06",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204991",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-16",
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{
"NDCCode": "70934-636-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-636-30) ",
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"ProductNDC": "70934-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200330",
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"LabelerName": "Denton Pharma, Inc. dba Northwind Pharmaceuticals",
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"StrengthNumber": "600",
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"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
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{
"NDCCode": "71205-636-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (71205-636-30) ",
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"ProductNDC": "71205-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Active",
"LastUpdate": "2022-07-28",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3‑-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide."
}
]
}
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<ProductNDC>76420-636</ProductNDC>
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<StartMarketingDatePackage>20250403</StartMarketingDatePackage>
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<Description>Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C 18H 19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, 40 mg or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4 mg, 33.7 mg, 44.9 mg or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending.</Description>
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<NDCCode>76420-636-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-636-60) </PackageDescription>
<NDC11Code>76420-0636-60</NDC11Code>
<ProductNDC>76420-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190325</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208706</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
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<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>76420-636-90</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-636-90) </PackageDescription>
<NDC11Code>76420-0636-90</NDC11Code>
<ProductNDC>76420-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208706</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
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<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<Description>Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C 18H 19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, 40 mg or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4 mg, 33.7 mg, 44.9 mg or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending.</Description>
</NDC>
<NDC>
<NDCCode>13533-636-03</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (13533-636-03) / .5 mL in 1 SYRINGE, GLASS (13533-636-30) </PackageDescription>
<NDC11Code>13533-0636-03</NDC11Code>
<ProductNDC>13533-636</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Hyperhep B</ProprietaryName>
<NonProprietaryName>Hepatitis B Immune Globulin (human)</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19961009</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101146</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN</SubstanceName>
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<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Recommendations on post-exposure prophylaxis are based on available efficacy data and on the likelihood of future HBV exposure for the person requiring treatment. In all exposures, a regimen combining Hepatitis B Immune Globulin (Human) with hepatitis B vaccine will provide both short- and long-term protection, will be less costly than the two-dose Hepatitis B Immune Globulin (Human) treatment alone, and is the treatment of choice.(9). HyperHEP B is indicated for post-exposure prophylaxis in the following situations.</IndicationAndUsage>
<Description>Hepatitis B Immune Globulin (Human) — HyperHEP B® is a clear or slightly opalescent, and colorless or pale yellow sterile solution of human hepatitis B immune globulin for intramuscular administration. HyperHEP B contains no preservative. HyperHEP B is prepared from pools of human plasma collected from healthy donors by a combination of cold ethanol fractionation, caprylate precipitation and filtration, caprylate incubation, anion exchange chromatography, nanofiltration and low pH incubation. HyperHEP B consists of a 15% to 18% protein solution at a pH of 4.1 to 4.8 in 0.16 M to 0.26 M glycine. The product contains anti-HBs antibody equivalent to or exceeding the potency of anti-HBs in a U.S. reference hepatitis B immune globulin (Center for Biologics Evaluation and Research, FDA). The U.S. reference has been tested against the World Health Organization standard Hepatitis B Immune Globulin and found to be equal to 220 international units (IU) per mL. When medicinal biological products are administered, the risk of infectious diseases due to transmission of pathogens cannot be totally excluded. However, in the case of products prepared from human plasma, the risk of transmission of pathogens is reduced by epidemiological surveillance of the donor population and selection of individual donors by medical interview; testing of individual donations and plasma pools; and the presence in the manufacturing processes of steps with demonstrated capacity to inactivate/remove pathogen. In the manufacturing process of HyperHEP B, there are several steps with the capacity for viral inactivation or removal.(1) The main steps of the manufacturing process that contribute to the virus clearance capacity are as follows: 1 Caprylate precipitation/depth filtration, 2 Caprylate incubation, 3 Depth filtration, 4 Column chromatography, 5 Nanofiltration, 6 Low pH final container incubation.</Description>
</NDC>
<NDC>
<NDCCode>13537-636-24</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (13537-636-24) > 30 mL in 1 BOTTLE (13537-636-23) </PackageDescription>
<NDC11Code>13537-0636-24</NDC11Code>
<ProductNDC>13537-636</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Pro Hydro-nutritive Foundation Spf 15</ProprietaryName>
<ProprietaryNameSuffix>(rosa 6) - Pink</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150306</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.05; .02</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<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>31722-636-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (31722-636-30) </PackageDescription>
<NDC11Code>31722-0636-30</NDC11Code>
<ProductNDC>31722-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Silodosin</ProprietaryName>
<NonProprietaryName>Silodosin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204793</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SILODOSIN</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>31722-636-31</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (31722-636-31) </PackageDescription>
<NDC11Code>31722-0636-31</NDC11Code>
<ProductNDC>31722-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Silodosin</ProprietaryName>
<NonProprietaryName>Silodosin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204793</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SILODOSIN</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of Silodosin is 2,3-Dihydro-1-(3-hydroxy-propyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy) phenoxy] ethyl]amino]-propyl]-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.55. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide. The imprinting ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>34908-636-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-636-30) </PackageDescription>
<NDC11Code>34908-0636-30</NDC11Code>
<ProductNDC>34908-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208947</ApplicationNumber>
<LabelerName>Novast Laboratories, Ltd.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41250-636-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41250-636-30) / 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>41250-0636-30</NDC11Code>
<ProductNDC>41250-636</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Meijer Saline</ProprietaryName>
<NonProprietaryName>Nasal</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20210217</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>MEIJER</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>6.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>provides instant, soothing relief to dry irritated nasal passages due to colds, allergies, dry air, pollution, smoke, air travel and use of decongestants/steroidal sprays.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41616-636-83</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (41616-636-83)</PackageDescription>
<NDC11Code>41616-0636-83</NDC11Code>
<ProductNDC>41616-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090022</ApplicationNumber>
<LabelerName>Sun Pharma Global Inc.</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>43744-636-30</NDCCode>
<PackageDescription>50 g in 1 DRUM (43744-636-30)</PackageDescription>
<NDC11Code>43744-0636-30</NDC11Code>
<ProductNDC>43744-636</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110707</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47335-636-83</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (47335-636-83)</PackageDescription>
<NDC11Code>47335-0636-83</NDC11Code>
<ProductNDC>47335-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090022</ApplicationNumber>
<LabelerName>Sun Pharma Global FZE</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>49349-636-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (49349-636-02)</PackageDescription>
<NDC11Code>49349-0636-02</NDC11Code>
<ProductNDC>49349-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040123</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>2.5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2016-12-14</LastUpdate>
</NDC>
<NDC>
<NDCCode>49967-636-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49967-636-01) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>49967-0636-01</NDC11Code>
<ProductNDC>49967-636</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lancome Paris Nude Miracle Broad Spectrum Spf 15 Sunscreen</ProprietaryName>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49999-636-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (49999-636-30)</PackageDescription>
<NDC11Code>49999-0636-30</NDC11Code>
<ProductNDC>49999-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strattera</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100713</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>STRATTERA is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of STRATTERA Capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) [see Clinical Studies (14)]. A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure to follow through on tasks, poor organization, avoids tasks requiring sustained mental effort, loses things, easily distracted, forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming, leaving seat, inappropriate running/climbing, difficulty with quiet activities, “on the go,” excessive talking, blurting answers, can't wait turn, intrusive. For a Combined Type diagnosis, both inattentive and hyperactive-impulsive criteria must be met. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.</IndicationAndUsage>
<Description>Atomoxetine HCl is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA capsules are intended for oral administration only. Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and other inactive ingredients. The capsule shells also contain one or more of the following:.</Description>
</NDC>
<NDC>
<NDCCode>50742-636-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-636-30) </PackageDescription>
<NDC11Code>50742-0636-30</NDC11Code>
<ProductNDC>50742-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208947</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine extended-release tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).</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 is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (light yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients: The following are common in all 5 tablet strengths: microcrystalline cellulose, hypromellose, magnesium stearate, povidone, polyethylene glycol, and titanium dioxide. Additional inactive ingredients include: 50 mg - polyvinyl alcohol, talc, iron oxide yellow, iron oxide red, iron oxide black, lecithin (soya);150 mg - polydextrose and triacetin; 200 mg - polyvinyl alcohol, talc, lecithin (soya), D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake; 300 mg - polyvinyl alcohol, talc, lecithin (soya), iron oxide yellow and iron oxide black; 400 mg - polydextrose, and triacetin. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. Meets USP dissolution test 6.</Description>
</NDC>
<NDC>
<NDCCode>51150-636-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (51150-636-01) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>51150-0636-01</NDC11Code>
<ProductNDC>51150-636</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lancome Paris Nude Miracle Broad Spectrum Spf 15 Sunscreen</ProprietaryName>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SICOS ET CIE</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-02-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>51655-636-52</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-636-52) </PackageDescription>
<NDC11Code>51655-0636-52</NDC11Code>
<ProductNDC>51655-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone</ProprietaryName>
<NonProprietaryName>Spironolactone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205936</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>SPIRONOLACTONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Spironolactone is an aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1). , 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.2). , 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response ( 1.3). , 4 Treatment of primary hyperaldosternism for: ( 1.4) Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia.</IndicationAndUsage>
<Description>Spironolactone tablets, USP contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone, USP is practically insoluble in water, soluble in ethyl acetate and alcohol, freely soluble in benzene and in chloroform, slightly soluble in menthanol and very slightly soluble in fixed oils. Inactive ingredients include calcium sulfate dihydrate, colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, peppermint flavor, povidone and sodium lauryl sulfate. Additionally each tablet contains opadry II white 33F28398 which contains hydroxylpropyl methyl cellulose, lactose monohydrate, polyethylene glycol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>60760-636-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-636-30) </PackageDescription>
<NDC11Code>60760-0636-30</NDC11Code>
<ProductNDC>60760-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078539</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61786-636-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (61786-636-02)</PackageDescription>
<NDC11Code>61786-0636-02</NDC11Code>
<ProductNDC>61786-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160325</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077662</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-03-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>63187-636-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (63187-636-30) </PackageDescription>
<NDC11Code>63187-0636-30</NDC11Code>
<ProductNDC>63187-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078539</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. . 2.Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. . 3.Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. . 4.Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets, USP are recommended even where the incidence of postoperative nausea and/or vomiting is low.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline.Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red.Meets USP dissolution test 6.</Description>
</NDC>
<NDC>
<NDCCode>64980-636-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (64980-636-03) </PackageDescription>
<NDC11Code>64980-0636-03</NDC11Code>
<ProductNDC>64980-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211289</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranitidine Tablets are indicated in: 1 Short- term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of Ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo- controlled comparative studies have been carried out for periods of longer than 1 year., 3 The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 Short-term treatment of active, benign gastric ulcers. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year., 6 Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with Ranitidine Tablets USP, 150 mg twice daily., 7 Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Tablets USP, 150 mg 4 times daily., 8 Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.</IndicationAndUsage>
<Description>Ranitidine Tablets USP are available for oral administration containing 150 mg or 300 mg of ranitidine. The active ingredient in Ranitidine Tablets USP, 150 mg and 300 mg is Ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl] methyl]thio]ethyl]-N´-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The emperical formula is C13H22N4O3SHCl, representing a molecular weight of 350.87. Ranitidine HCl is white to pale yellow, crystalline, practically odorless powder, sensitive to light and moisture. Melts at about 140°C with decomposition. Ranitidine is available as 150 mg and 300 mg tablets for oral administration. Each Ranitidine Tablet USP, 150 mg contains 150 mg ranitidine (equivalent to 168 mg of ranitidine HCl) and the following inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry® 200 Orange 203A530006 (Polyvinyl alcohol, talc, titanium dioxide, glycerol monostearate, sodium lauryl sulphate, FD&C yellow 6 and iron oxide yellow), purified water. Each Ranitidine Tablet USP, 300 mg contains 300 mg ranitidine (equivalent to 336 mg of ranitidine HCl) and the following inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry® 200 Yellow 203A520014 (Polyvinyl alcohol, talc, titanium dioxide, glycerol monostearate, sodium lauryl sulphate, FD&C yellow 5 and FD&C Blue 1), purified water. Contains color additives including FD&C Yellow No.5 (tartrazine). Meets FDA approved specifications for nitrosamine impurities.</Description>
</NDC>
<NDC>
<NDCCode>65162-636-03</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-636-03) </PackageDescription>
<NDC11Code>65162-0636-03</NDC11Code>
<ProductNDC>65162-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205119</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium, USP sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium, USP is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each pantoprazole sodium delayed-release tablet, USP contains 45.1 mg or 22.56 mg of pantoprazole sodium, USP sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively). Pantoprazole sodium delayed-release tablets, USP contains the following inactive ingredients: ammonium hydroxide, crospovidone, hydroxyl propyl cellulose, hypromellose, iron oxide black, iron oxide yellow, mannitol, methacrylic acid copolymer dispersion, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, shellac, sodium carbonate, sodium hydroxide, sodium stearyl fumarate, talc, titanium dioxide and triethyl citrate. Pantoprazole sodium delayed-release tablets, USP (40 mg and 20 mg) complies with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>67046-636-30</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-636-30)</PackageDescription>
<NDC11Code>67046-0636-30</NDC11Code>
<ProductNDC>67046-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201109</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Quetiapine tablet USP is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia ( 1.1) , 2 Bipolar I disorder manic episodes ( 1.2) , 3 Bipolar disorder, depressive episodes ( 1.2) .</IndicationAndUsage>
<Description>Quetiapine fumarate is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b, f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2.C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP are supplied for oral administration as 25 mg (quetiapine) round, pink tablets, 50 mg (quetiapine) round, white tablets, 100 mg (quetiapine) round, yellow tablets, 200 mg (quetiapine) round, white tablets, 300 mg (quetiapine) capsule-shaped, white tablets and 400 mg (quetiapine) capsule-shaped, yellow tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide black; and the 100 mg and 400 mg tablets contain iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>68084-636-25</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-636-25) > 1 TABLET in 1 BLISTER PACK (68084-636-95) </PackageDescription>
<NDC11Code>68084-0636-25</NDC11Code>
<ProductNDC>68084-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130117</StartMarketingDate>
<EndMarketingDate>20220131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090856</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>145</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130117</StartMarketingDatePackage>
<EndMarketingDatePackage>20220131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68180-636-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68180-636-06) </PackageDescription>
<NDC11Code>68180-0636-06</NDC11Code>
<ProductNDC>68180-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200924</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204991</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70934-636-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-636-30) </PackageDescription>
<NDC11Code>70934-0636-30</NDC11Code>
<ProductNDC>70934-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200651</ApplicationNumber>
<LabelerName>Denton Pharma, Inc. dba Northwind Pharmaceuticals</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71205-636-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (71205-636-30) </PackageDescription>
<NDC11Code>71205-0636-30</NDC11Code>
<ProductNDC>71205-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077859</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3‑-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
</NDCList>