{
"NDC": [
{
"NDCCode": "0002-8315-91",
"PackageDescription": "1 VIAL in 1 CARTON (0002-8315-91) > 10 mL in 1 VIAL",
"NDC11Code": "00002-8315-91",
"ProductNDC": "0002-8315",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Humulin",
"ProprietaryNameSuffix": "N",
"NonProprietaryName": "Insulin Human",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20100610",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018781",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Status": "Deprecated",
"LastUpdate": "2015-02-13"
},
{
"NDCCode": "0002-8315-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0002-8315-01) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00002-8315-01",
"ProductNDC": "0002-8315",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Humulin",
"ProprietaryNameSuffix": "N",
"NonProprietaryName": "Insulin Human",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19830627",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA018781",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [CS], Insulin [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830627",
"SamplePackage": "N",
"IndicationAndUsage": "HUMULIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin isophane human is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin isophane human is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation. The amino acid sequence of insulin isophane human is identical to human insulin and has the empirical formula C257H383N65O77S6 with a molecular weight of 5.808 kDa. HUMULIN N (insulin isophane human) injectable suspension is an intermediate acting human insulin. It is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) for subcutaneous use. Each milliliter of HUMULIN N contains 100 units of insulin human, dibasic sodium phosphate (3.78 mg), glycerin (16 mg), metacresol (1.6 mg), phenol (0.65 mg), protamine sulfate (0.35 mg), zinc oxide content adjusted to provide 0.035 mg zinc ion, and Water for Injection. The pH is 7.0 to 7.5. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH."
},
{
"NDCCode": "0002-8315-17",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0002-8315-17) / 3 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00002-8315-17",
"ProductNDC": "0002-8315",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Humulin",
"ProprietaryNameSuffix": "N",
"NonProprietaryName": "Insulin Human",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19830627",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA018781",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [CS], Insulin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20100624",
"EndMarketingDatePackage": "20241210",
"SamplePackage": "N",
"IndicationAndUsage": "HUMULIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin isophane human is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin isophane human is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation. The amino acid sequence of insulin isophane human is identical to human insulin and has the empirical formula C257H383N65O77S6 with a molecular weight of 5.808 kDa. HUMULIN N (insulin isophane human) injectable suspension is an intermediate acting human insulin. It is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) for subcutaneous use. Each milliliter of HUMULIN N contains 100 units of insulin human, dibasic sodium phosphate (3.78 mg), glycerin (16 mg), metacresol (1.6 mg), phenol (0.65 mg), protamine sulfate (0.35 mg), zinc oxide content adjusted to provide zinc ion (approximately 0.025 mg for the vials or approximately 0.035 mg for the KwikPen), and Water for Injection. The pH is 7.0 to 7.5. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH."
},
{
"NDCCode": "0002-8315-99",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0002-8315-99) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00002-8315-99",
"ProductNDC": "0002-8315",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Humulin",
"ProprietaryNameSuffix": "N",
"NonProprietaryName": "Insulin Human",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19830627",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA018781",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [CS], Insulin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19830627",
"SamplePackage": "Y",
"IndicationAndUsage": "HUMULIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin isophane human is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin isophane human is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation. The amino acid sequence of insulin isophane human is identical to human insulin and has the empirical formula C257H383N65O77S6 with a molecular weight of 5.808 kDa. HUMULIN N (insulin isophane human) injectable suspension is an intermediate acting human insulin. It is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) for subcutaneous use. Each milliliter of HUMULIN N contains 100 units of insulin human, dibasic sodium phosphate (3.78 mg), glycerin (16 mg), metacresol (1.6 mg), phenol (0.65 mg), protamine sulfate (0.35 mg), zinc oxide content adjusted to provide zinc ion (approximately 0.025 mg for the vials or approximately 0.035 mg for the KwikPen), and Water for Injection. The pH is 7.0 to 7.5. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH."
},
{
"NDCCode": "0002-8215-91",
"PackageDescription": "1 VIAL in 1 CARTON (0002-8215-91) > 10 mL in 1 VIAL",
"NDC11Code": "00002-8215-91",
"ProductNDC": "0002-8215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Humulin",
"ProprietaryNameSuffix": "R",
"NonProprietaryName": "Insulin Human",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PARENTERAL",
"StartMarketingDate": "20100610",
"EndMarketingDate": "20150228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018780",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Status": "Deprecated",
"LastUpdate": "2015-03-06"
},
{
"NDCCode": "0002-8715-91",
"PackageDescription": "1 VIAL in 1 CARTON (0002-8715-91) > 10 mL in 1 VIAL",
"NDC11Code": "00002-8715-91",
"ProductNDC": "0002-8715",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Humulin",
"ProprietaryNameSuffix": "70/30",
"NonProprietaryName": "Insulin Human",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20100610",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019717",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Status": "Deprecated",
"LastUpdate": "2015-02-13"
},
{
"NDCCode": "62332-002-91",
"PackageDescription": "1000 TABLET in 1 BOTTLE (62332-002-91) ",
"NDC11Code": "62332-0002-91",
"ProductNDC": "62332-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078916",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160129",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: : 1 active duodenal ulcer (DU). , 2 active gastric ulcer (GU). , 3 symptomatic nonerosive gastroesophageal reflux disease (GERD). , 4 erosive esophagitis due to GERD, diagnosed by biopsy. .",
"Description": "The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: colloidal silicon dioxide, yellow iron oxide and red iron oxide, Lecithin, macrogel/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol."
},
{
"NDCCode": "74635-002-91",
"PackageDescription": "100 mL in 1 BOTTLE, PLASTIC (74635-002-91) ",
"NDC11Code": "74635-0002-91",
"ProductNDC": "74635-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer - Ipa",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200403",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Phillips 66 Company",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200408",
"SamplePackage": "N"
},
{
"NDCCode": "0002-3227-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3227-30) ",
"NDC11Code": "00002-3227-30",
"ProductNDC": "0002-3227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20021126",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030110",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. 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 ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3228-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3228-30) ",
"NDC11Code": "00002-3228-30",
"ProductNDC": "0002-3228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20021126",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030110",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. 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 ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3229-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3229-30) ",
"NDC11Code": "00002-3229-30",
"ProductNDC": "0002-3229",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20021126",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030110",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. 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 ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3238-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3238-30) ",
"NDC11Code": "00002-3238-30",
"ProductNDC": "0002-3238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20021126",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030110",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. 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 ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3239-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3239-30) ",
"NDC11Code": "00002-3239-30",
"ProductNDC": "0002-3239",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20021126",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030110",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. 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 ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3250-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3250-30) ",
"NDC11Code": "00002-3250-30",
"ProductNDC": "0002-3250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20050214",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050824",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. 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 ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3251-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3251-30) ",
"NDC11Code": "00002-3251-30",
"ProductNDC": "0002-3251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20050214",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050824",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. 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 ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "43898-0002-0",
"PackageDescription": "25 kg in 1 DRUM (43898-0002-0) ",
"NDC11Code": "43898-0002-00",
"ProductNDC": "43898-0002",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Glyburide Micronized",
"DosageFormName": "POWDER",
"StartMarketingDate": "19910102",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Lusochimica SPA",
"SubstanceName": "GLYBURIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "02-JAN-91"
},
{
"NDCCode": "51991-002-98",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (51991-002-98) / 20 mL in 1 VIAL, GLASS",
"NDC11Code": "51991-0002-98",
"ProductNDC": "51991-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20241230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218252",
"LabelerName": "Breckenridge Pharmaceutical Inc",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241230",
"SamplePackage": "N",
"IndicationAndUsage": "Methadone Hydrochloride Injection is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.Limitations of UseBecause of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration (see WARNINGS), and persist over the course of therapy, reserve opioid analgesics, including Methadone Hydrochloride Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Methadone Hydrochloride Injection is not indicated as an as-needed (prn) analgesic. For use in temporary treatment of opioid dependence in patients unable to take oral medication.Limitations of UseInjectable methadone products are not approved for the outpatient treatment of opioid dependence. In this patient population, parenteral methadone is to be used only for patients unable to take oral medication, such as hospitalized patients.",
"Description": "Methadone Hydrochloride Injection USP, 10 mg/mL is an opioid analgesic for parenteral use (intravenous, intramuscular or subcutaneous use). Methadone Hydrochloride Injection USP, 10 mg/mL contains methadone hydrochloride as the active pharmaceutical ingredient. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4- diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NO∙HCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. Methadone hydrochloride has the following structural formula. Methadone Hydrochloride Injection is a sterile injectable solution available in 20 mL multiple-dose vials. Each mL of the Methadone Hydrochloride Injection contains: 10 mg of methadone hydrochloride (equivalent to 8.95 mg of methadone free base), 5 mg of chlorobutanol, as a preservative, 9 mg of sodium chloride, as tonicity agent, and hydrochloric acid and sodium hydroxide as pH adjusters, in water for injection. The pH of the sterile injectable solution is between 3.0 to 6.5."
},
{
"NDCCode": "53943-002-09",
"PackageDescription": "9 PATCH in 1 PACKAGE (53943-002-09) ",
"NDC11Code": "53943-0002-09",
"ProductNDC": "53943-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salicylic Acid",
"NonProprietaryName": "Medicated Corn Removers",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171219",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M030",
"LabelerName": "Discount Drug Mart",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "40",
"StrengthUnit": "mg/91",
"Status": "Deprecated",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "for the removal of corns. relieves pain by removing corns."
},
{
"NDCCode": "70874-0002-1",
"PackageDescription": "22 g in 1 APPLICATOR (70874-0002-1)",
"NDC11Code": "70874-0002-01",
"ProductNDC": "70874-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clbio Cleansing Pack",
"NonProprietaryName": "Coconut, Grape Seed, Apricot Kernel, Avocado, Schisandra Chinensis Fruit, Castor",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160825",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "CLBiO Co., LTD.",
"SubstanceName": "COCONUT OIL; GRAPE SEED OIL; APRICOT KERNEL OIL; AVOCADO OIL; SCHISANDRA CHINENSIS FRUIT; CASTOR OIL",
"StrengthNumber": "91.9; .3; .3; .3; .3; .3",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Apply soap to wet skin and rub, then rinse away with lukewarm water."
},
{
"NDCCode": "75391-002-30",
"PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (75391-002-30) ",
"NDC11Code": "75391-0002-30",
"ProductNDC": "75391-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sea Starwort Soothing Sunscreen Spf 35",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200515",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CU LIFESTYLE LLC",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "2.91",
"StrengthUnit": "mg/30mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200515",
"SamplePackage": "N"
},
{
"NDCCode": "78706-002-16",
"PackageDescription": "473 mL in 1 BOTTLE (78706-002-16) ",
"NDC11Code": "78706-0002-16",
"ProductNDC": "78706-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopropyl Alcohol 91%",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Virgin Scent Inc.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": ".91",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent the risk of infection in minor cuts, scrapes, and burns."
},
{
"NDCCode": "0406-8315-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-8315-01) ",
"NDC11Code": "00406-8315-01",
"ProductNDC": "0406-8315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20030731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076412",
"LabelerName": "SpecGx LLC",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030731",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including morphine sulfate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Morphine sulfate extended-release tablets are for oral use and contain morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, silicone dioxide, titanium dioxide, and triacetine. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate USP). The 15 mg tablets also contain: polyethylene glycol, polydextrose, and FD&C Blue No. 2. The 30 mg tablets also contain: polyethylene glycol, polydextrose, FD&C Blue No. 2, and D&C Red No. 7. The 60 mg tablets also contain: polyethylene glycol, polydextrose, FD&C Yellow No. 6, and iron oxide red. The 100 mg tablets also contain: iron oxide black. The 200 mg tablets also contain: polyethylene glycol, FD&C Blue No. 1, and D&C Yellow No. 10 Lake. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is."
},
{
"NDCCode": "0406-8315-23",
"PackageDescription": "1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0406-8315-23) ",
"NDC11Code": "00406-8315-23",
"ProductNDC": "0406-8315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20030731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076412",
"LabelerName": "SpecGx LLC",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030731",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including morphine sulfate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Morphine sulfate extended-release tablets are for oral use and contain morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, silicone dioxide, titanium dioxide, and triacetine. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate USP). The 15 mg tablets also contain: polyethylene glycol, polydextrose, and FD&C Blue No. 2. The 30 mg tablets also contain: polyethylene glycol, polydextrose, FD&C Blue No. 2, and D&C Red No. 7. The 60 mg tablets also contain: polyethylene glycol, polydextrose, FD&C Yellow No. 6, and iron oxide red. The 100 mg tablets also contain: iron oxide black. The 200 mg tablets also contain: polyethylene glycol, FD&C Blue No. 1, and D&C Yellow No. 10 Lake. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is."
},
{
"NDCCode": "0406-8315-62",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0406-8315-62) ",
"NDC11Code": "00406-8315-62",
"ProductNDC": "0406-8315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20030731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076412",
"LabelerName": "SpecGx LLC",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030731",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including morphine sulfate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Morphine sulfate extended-release tablets are for oral use and contain morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, silicone dioxide, titanium dioxide, and triacetine. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate USP). The 15 mg tablets also contain: polyethylene glycol, polydextrose, and FD&C Blue No. 2. The 30 mg tablets also contain: polyethylene glycol, polydextrose, FD&C Blue No. 2, and D&C Red No. 7. The 60 mg tablets also contain: polyethylene glycol, polydextrose, FD&C Yellow No. 6, and iron oxide red. The 100 mg tablets also contain: iron oxide black. The 200 mg tablets also contain: polyethylene glycol, FD&C Blue No. 1, and D&C Yellow No. 10 Lake. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is."
},
{
"NDCCode": "48951-8315-2",
"PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-8315-2) ",
"NDC11Code": "48951-8315-02",
"ProductNDC": "48951-8315",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pyrite Salvia",
"NonProprietaryName": "Pyrite Salvia",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc",
"SubstanceName": "ANGELICA ARCHANGELICA ROOT; HYOSCYAMUS NIGER; SAGE; SILVER NITRATE",
"StrengthNumber": "3; 7; 3; 15",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: FOR ORAL USE ONLY."
},
{
"NDCCode": "57955-8315-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-8315-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-8315-01",
"ProductNDC": "57955-8315",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Midwest Regional Allergies",
"NonProprietaryName": "Adenosinum Cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium Cepa, Ambrosia Artemisiaefolia, Cichorium Intybus, Conium Maculatum, Cortisone Aceticum, Euphrasia Officinalis, Fagopyrum Esculentum, Galphimia Glauca, Hedera Helix, Histaminum Hydrochloricum, Kali Muriaticum, Mucosa Nasalis Suis, Natrum Muriaticum, Rna, Rumex Crispus, Sabadilla, Secale Cornutum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131104",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; AMBROSIA ARTEMISIIFOLIA; CHICORY ROOT; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; CLAVICEPS PURPUREA SCLEROTIUM",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of allergy symptoms commonly experienced in IA, IL, IN, KS, MI, MN, MO, ND, NE, OH, SD, WI: 1 itchy, watery eyes, 2 runny nose, 3 sneezing, 4 sore throat, 5 sinus congestion, 6 cough, 7 stuffy nose, 8 fatigue, 9 itchy, irritated skin, 10 hoarseness, 11 headache."
},
{
"NDCCode": "58597-8315-1",
"PackageDescription": "1 g in 1 BOTTLE (58597-8315-1)",
"NDC11Code": "58597-8315-01",
"ProductNDC": "58597-8315",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Idoxuridine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140425",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "AMERICAN PHARMACEUTICAL INGREDIENTS LLC",
"SubstanceName": "IDOXURIDINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "58597-8315-2",
"PackageDescription": "5 g in 1 BOTTLE (58597-8315-2)",
"NDC11Code": "58597-8315-02",
"ProductNDC": "58597-8315",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Idoxuridine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140425",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "AMERICAN PHARMACEUTICAL INGREDIENTS LLC",
"SubstanceName": "IDOXURIDINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63629-8315-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (63629-8315-1) ",
"NDC11Code": "63629-8315-01",
"ProductNDC": "63629-8315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090515",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200513",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4."
},
{
"NDCCode": "63629-8315-2",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (63629-8315-2) ",
"NDC11Code": "63629-8315-02",
"ProductNDC": "63629-8315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090515",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200513",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0002-8315-91</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0002-8315-91) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>00002-8315-91</NDC11Code>
<ProductNDC>0002-8315</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Humulin</ProprietaryName>
<ProprietaryNameSuffix>N</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Human</NonProprietaryName>
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<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100610</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018781</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-02-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>0002-8315-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0002-8315-01) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
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<ProductNDC>0002-8315</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Humulin</ProprietaryName>
<ProprietaryNameSuffix>N</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Human</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19830627</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA018781</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
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<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [CS], Insulin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HUMULIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin isophane human is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin isophane human is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation. The amino acid sequence of insulin isophane human is identical to human insulin and has the empirical formula C257H383N65O77S6 with a molecular weight of 5.808 kDa. HUMULIN N (insulin isophane human) injectable suspension is an intermediate acting human insulin. It is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) for subcutaneous use. Each milliliter of HUMULIN N contains 100 units of insulin human, dibasic sodium phosphate (3.78 mg), glycerin (16 mg), metacresol (1.6 mg), phenol (0.65 mg), protamine sulfate (0.35 mg), zinc oxide content adjusted to provide 0.035 mg zinc ion, and Water for Injection. The pH is 7.0 to 7.5. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH.</Description>
</NDC>
<NDC>
<NDCCode>0002-8315-17</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0002-8315-17) / 3 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00002-8315-17</NDC11Code>
<ProductNDC>0002-8315</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Humulin</ProprietaryName>
<ProprietaryNameSuffix>N</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Human</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19830627</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA018781</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [CS], Insulin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100624</StartMarketingDatePackage>
<EndMarketingDatePackage>20241210</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HUMULIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin isophane human is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin isophane human is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation. The amino acid sequence of insulin isophane human is identical to human insulin and has the empirical formula C257H383N65O77S6 with a molecular weight of 5.808 kDa. HUMULIN N (insulin isophane human) injectable suspension is an intermediate acting human insulin. It is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) for subcutaneous use. Each milliliter of HUMULIN N contains 100 units of insulin human, dibasic sodium phosphate (3.78 mg), glycerin (16 mg), metacresol (1.6 mg), phenol (0.65 mg), protamine sulfate (0.35 mg), zinc oxide content adjusted to provide zinc ion (approximately 0.025 mg for the vials or approximately 0.035 mg for the KwikPen), and Water for Injection. The pH is 7.0 to 7.5. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH.</Description>
</NDC>
<NDC>
<NDCCode>0002-8315-99</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0002-8315-99) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00002-8315-99</NDC11Code>
<ProductNDC>0002-8315</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Humulin</ProprietaryName>
<ProprietaryNameSuffix>N</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Human</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19830627</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA018781</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [CS], Insulin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830627</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>HUMULIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin isophane human is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin isophane human is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation. The amino acid sequence of insulin isophane human is identical to human insulin and has the empirical formula C257H383N65O77S6 with a molecular weight of 5.808 kDa. HUMULIN N (insulin isophane human) injectable suspension is an intermediate acting human insulin. It is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) for subcutaneous use. Each milliliter of HUMULIN N contains 100 units of insulin human, dibasic sodium phosphate (3.78 mg), glycerin (16 mg), metacresol (1.6 mg), phenol (0.65 mg), protamine sulfate (0.35 mg), zinc oxide content adjusted to provide zinc ion (approximately 0.025 mg for the vials or approximately 0.035 mg for the KwikPen), and Water for Injection. The pH is 7.0 to 7.5. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH.</Description>
</NDC>
<NDC>
<NDCCode>0002-8215-91</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0002-8215-91) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>00002-8215-91</NDC11Code>
<ProductNDC>0002-8215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Humulin</ProprietaryName>
<ProprietaryNameSuffix>R</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Human</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PARENTERAL</RouteName>
<StartMarketingDate>20100610</StartMarketingDate>
<EndMarketingDate>20150228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018780</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-03-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>0002-8715-91</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0002-8715-91) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>00002-8715-91</NDC11Code>
<ProductNDC>0002-8715</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Humulin</ProprietaryName>
<ProprietaryNameSuffix>70/30</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Human</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100610</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019717</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-02-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>62332-002-91</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (62332-002-91) </PackageDescription>
<NDC11Code>62332-0002-91</NDC11Code>
<ProductNDC>62332-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078916</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: : 1 active duodenal ulcer (DU). , 2 active gastric ulcer (GU). , 3 symptomatic nonerosive gastroesophageal reflux disease (GERD). , 4 erosive esophagitis due to GERD, diagnosed by biopsy. .</IndicationAndUsage>
<Description>The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: colloidal silicon dioxide, yellow iron oxide and red iron oxide, Lecithin, macrogel/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>74635-002-91</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, PLASTIC (74635-002-91) </PackageDescription>
<NDC11Code>74635-0002-91</NDC11Code>
<ProductNDC>74635-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer - Ipa</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200403</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Phillips 66 Company</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0002-3227-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3227-30) </PackageDescription>
<NDC11Code>00002-3227-30</NDC11Code>
<ProductNDC>0002-3227</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strattera</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021126</StartMarketingDate>
<EndMarketingDate>20270731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030110</StartMarketingDatePackage>
<EndMarketingDatePackage>20270731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. 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 ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.</Description>
</NDC>
<NDC>
<NDCCode>0002-3228-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3228-30) </PackageDescription>
<NDC11Code>00002-3228-30</NDC11Code>
<ProductNDC>0002-3228</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strattera</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021126</StartMarketingDate>
<EndMarketingDate>20270731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Eli Lilly and Company</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>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030110</StartMarketingDatePackage>
<EndMarketingDatePackage>20270731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. 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 ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.</Description>
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<IndicationAndUsage>STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. 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 ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.</Description>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030110</StartMarketingDatePackage>
<EndMarketingDatePackage>20270731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. 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 ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.</Description>
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<NDC>
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<ProductNDC>0002-3239</ProductNDC>
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<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2026-07-22</LastUpdate>
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<StartMarketingDatePackage>20030110</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. 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 ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.</Description>
</NDC>
<NDC>
<NDCCode>0002-3250-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3250-30) </PackageDescription>
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<ProductNDC>0002-3250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strattera</ProprietaryName>
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<StartMarketingDate>20050214</StartMarketingDate>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
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<StartMarketingDatePackage>20050824</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. 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 ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.</Description>
</NDC>
<NDC>
<NDCCode>0002-3251-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3251-30) </PackageDescription>
<NDC11Code>00002-3251-30</NDC11Code>
<ProductNDC>0002-3251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strattera</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050824</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. 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 ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.</Description>
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<NDC>
<NDCCode>43898-0002-0</NDCCode>
<PackageDescription>25 kg in 1 DRUM (43898-0002-0) </PackageDescription>
<NDC11Code>43898-0002-00</NDC11Code>
<ProductNDC>43898-0002</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Glyburide Micronized</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19910102</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Lusochimica SPA</LabelerName>
<SubstanceName>GLYBURIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-JAN-91</StartMarketingDatePackage>
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<NDC>
<NDCCode>51991-002-98</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (51991-002-98) / 20 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>51991-0002-98</NDC11Code>
<ProductNDC>51991-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20241230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218252</ApplicationNumber>
<LabelerName>Breckenridge Pharmaceutical Inc</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methadone Hydrochloride Injection is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.Limitations of UseBecause of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration (see WARNINGS), and persist over the course of therapy, reserve opioid analgesics, including Methadone Hydrochloride Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Methadone Hydrochloride Injection is not indicated as an as-needed (prn) analgesic. For use in temporary treatment of opioid dependence in patients unable to take oral medication.Limitations of UseInjectable methadone products are not approved for the outpatient treatment of opioid dependence. In this patient population, parenteral methadone is to be used only for patients unable to take oral medication, such as hospitalized patients.</IndicationAndUsage>
<Description>Methadone Hydrochloride Injection USP, 10 mg/mL is an opioid analgesic for parenteral use (intravenous, intramuscular or subcutaneous use). Methadone Hydrochloride Injection USP, 10 mg/mL contains methadone hydrochloride as the active pharmaceutical ingredient. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4- diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NO∙HCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. Methadone hydrochloride has the following structural formula. Methadone Hydrochloride Injection is a sterile injectable solution available in 20 mL multiple-dose vials. Each mL of the Methadone Hydrochloride Injection contains: 10 mg of methadone hydrochloride (equivalent to 8.95 mg of methadone free base), 5 mg of chlorobutanol, as a preservative, 9 mg of sodium chloride, as tonicity agent, and hydrochloric acid and sodium hydroxide as pH adjusters, in water for injection. The pH of the sterile injectable solution is between 3.0 to 6.5.</Description>
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<PackageDescription>9 PATCH in 1 PACKAGE (53943-002-09) </PackageDescription>
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<NonProprietaryName>Medicated Corn Removers</NonProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M030</ApplicationNumber>
<LabelerName>Discount Drug Mart</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/91</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the removal of corns. relieves pain by removing corns.</IndicationAndUsage>
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<PackageDescription>22 g in 1 APPLICATOR (70874-0002-1)</PackageDescription>
<NDC11Code>70874-0002-01</NDC11Code>
<ProductNDC>70874-0002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clbio Cleansing Pack</ProprietaryName>
<NonProprietaryName>Coconut, Grape Seed, Apricot Kernel, Avocado, Schisandra Chinensis Fruit, Castor</NonProprietaryName>
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<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>CLBiO Co., LTD.</LabelerName>
<SubstanceName>COCONUT OIL; GRAPE SEED OIL; APRICOT KERNEL OIL; AVOCADO OIL; SCHISANDRA CHINENSIS FRUIT; CASTOR OIL</SubstanceName>
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<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Apply soap to wet skin and rub, then rinse away with lukewarm water.</IndicationAndUsage>
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<PackageDescription>30 mL in 1 BOTTLE, PLASTIC (75391-002-30) </PackageDescription>
<NDC11Code>75391-0002-30</NDC11Code>
<ProductNDC>75391-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sea Starwort Soothing Sunscreen Spf 35</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CU LIFESTYLE LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>2.91</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
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<PackageDescription>473 mL in 1 BOTTLE (78706-002-16) </PackageDescription>
<NDC11Code>78706-0002-16</NDC11Code>
<ProductNDC>78706-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isopropyl Alcohol 91%</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Virgin Scent Inc.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
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<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help prevent the risk of infection in minor cuts, scrapes, and burns.</IndicationAndUsage>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<SubstanceName>MORPHINE SULFATE</SubstanceName>
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<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
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<Status>Active</Status>
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<StartMarketingDatePackage>20030731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including morphine sulfate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Morphine sulfate extended-release tablets are for oral use and contain morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, silicone dioxide, titanium dioxide, and triacetine. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate USP). The 15 mg tablets also contain: polyethylene glycol, polydextrose, and FD&C Blue No. 2. The 30 mg tablets also contain: polyethylene glycol, polydextrose, FD&C Blue No. 2, and D&C Red No. 7. The 60 mg tablets also contain: polyethylene glycol, polydextrose, FD&C Yellow No. 6, and iron oxide red. The 100 mg tablets also contain: iron oxide black. The 200 mg tablets also contain: polyethylene glycol, FD&C Blue No. 1, and D&C Yellow No. 10 Lake. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
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<NDCCode>0406-8315-23</NDCCode>
<PackageDescription>1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0406-8315-23) </PackageDescription>
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<ProductNDC>0406-8315</ProductNDC>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20030731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076412</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
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<LastUpdate>2026-09-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including morphine sulfate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Morphine sulfate extended-release tablets are for oral use and contain morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, silicone dioxide, titanium dioxide, and triacetine. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate USP). The 15 mg tablets also contain: polyethylene glycol, polydextrose, and FD&C Blue No. 2. The 30 mg tablets also contain: polyethylene glycol, polydextrose, FD&C Blue No. 2, and D&C Red No. 7. The 60 mg tablets also contain: polyethylene glycol, polydextrose, FD&C Yellow No. 6, and iron oxide red. The 100 mg tablets also contain: iron oxide black. The 200 mg tablets also contain: polyethylene glycol, FD&C Blue No. 1, and D&C Yellow No. 10 Lake. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0406-8315-62</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0406-8315-62) </PackageDescription>
<NDC11Code>00406-8315-62</NDC11Code>
<ProductNDC>0406-8315</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076412</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including morphine sulfate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Morphine sulfate extended-release tablets are for oral use and contain morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, silicone dioxide, titanium dioxide, and triacetine. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate USP). The 15 mg tablets also contain: polyethylene glycol, polydextrose, and FD&C Blue No. 2. The 30 mg tablets also contain: polyethylene glycol, polydextrose, FD&C Blue No. 2, and D&C Red No. 7. The 60 mg tablets also contain: polyethylene glycol, polydextrose, FD&C Yellow No. 6, and iron oxide red. The 100 mg tablets also contain: iron oxide black. The 200 mg tablets also contain: polyethylene glycol, FD&C Blue No. 1, and D&C Yellow No. 10 Lake. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>48951-8315-2</NDCCode>
<PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-8315-2) </PackageDescription>
<NDC11Code>48951-8315-02</NDC11Code>
<ProductNDC>48951-8315</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pyrite Salvia</ProprietaryName>
<NonProprietaryName>Pyrite Salvia</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc</LabelerName>
<SubstanceName>ANGELICA ARCHANGELICA ROOT; HYOSCYAMUS NIGER; SAGE; SILVER NITRATE</SubstanceName>
<StrengthNumber>3; 7; 3; 15</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: FOR ORAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-8315-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-8315-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-8315-01</NDC11Code>
<ProductNDC>57955-8315</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Midwest Regional Allergies</ProprietaryName>
<NonProprietaryName>Adenosinum Cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium Cepa, Ambrosia Artemisiaefolia, Cichorium Intybus, Conium Maculatum, Cortisone Aceticum, Euphrasia Officinalis, Fagopyrum Esculentum, Galphimia Glauca, Hedera Helix, Histaminum Hydrochloricum, Kali Muriaticum, Mucosa Nasalis Suis, Natrum Muriaticum, Rna, Rumex Crispus, Sabadilla, Secale Cornutum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; AMBROSIA ARTEMISIIFOLIA; CHICORY ROOT; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; CLAVICEPS PURPUREA SCLEROTIUM</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of allergy symptoms commonly experienced in IA, IL, IN, KS, MI, MN, MO, ND, NE, OH, SD, WI: 1 itchy, watery eyes, 2 runny nose, 3 sneezing, 4 sore throat, 5 sinus congestion, 6 cough, 7 stuffy nose, 8 fatigue, 9 itchy, irritated skin, 10 hoarseness, 11 headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58597-8315-1</NDCCode>
<PackageDescription>1 g in 1 BOTTLE (58597-8315-1)</PackageDescription>
<NDC11Code>58597-8315-01</NDC11Code>
<ProductNDC>58597-8315</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Idoxuridine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140425</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>AMERICAN PHARMACEUTICAL INGREDIENTS LLC</LabelerName>
<SubstanceName>IDOXURIDINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>58597-8315-2</NDCCode>
<PackageDescription>5 g in 1 BOTTLE (58597-8315-2)</PackageDescription>
<NDC11Code>58597-8315-02</NDC11Code>
<ProductNDC>58597-8315</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Idoxuridine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140425</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>AMERICAN PHARMACEUTICAL INGREDIENTS LLC</LabelerName>
<SubstanceName>IDOXURIDINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63629-8315-1</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (63629-8315-1) </PackageDescription>
<NDC11Code>63629-8315-01</NDC11Code>
<ProductNDC>63629-8315</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090515</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4.</Description>
</NDC>
<NDC>
<NDCCode>63629-8315-2</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (63629-8315-2) </PackageDescription>
<NDC11Code>63629-8315-02</NDC11Code>
<ProductNDC>63629-8315</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090515</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4.</Description>
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