{
"NDC": [
{
"NDCCode": "0781-2265-22",
"PackageDescription": "2000 CAPSULE in 1 BOTTLE (0781-2265-22)",
"NDC11Code": "00781-2265-22",
"ProductNDC": "0781-2265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine Hydrochloride",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079018",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The 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. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac."
},
{
"NDCCode": "0781-2265-31",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0781-2265-31)",
"NDC11Code": "00781-2265-31",
"ProductNDC": "0781-2265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine Hydrochloride",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079018",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The 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. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac."
},
{
"NDCCode": "0781-2260-22",
"PackageDescription": "2000 CAPSULE in 1 BOTTLE (0781-2260-22)",
"NDC11Code": "00781-2260-22",
"ProductNDC": "0781-2260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine Hydrochloride",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079018",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The 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. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac."
},
{
"NDCCode": "0781-2261-22",
"PackageDescription": "2000 CAPSULE in 1 BOTTLE (0781-2261-22)",
"NDC11Code": "00781-2261-22",
"ProductNDC": "0781-2261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine Hydrochloride",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079018",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The 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. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac."
},
{
"NDCCode": "0781-2262-22",
"PackageDescription": "2000 CAPSULE in 1 BOTTLE (0781-2262-22)",
"NDC11Code": "00781-2262-22",
"ProductNDC": "0781-2262",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine Hydrochloride",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079018",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The 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. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac."
},
{
"NDCCode": "0781-2263-22",
"PackageDescription": "2000 CAPSULE in 1 BOTTLE (0781-2263-22)",
"NDC11Code": "00781-2263-22",
"ProductNDC": "0781-2263",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine Hydrochloride",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079018",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The 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. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac."
},
{
"NDCCode": "0781-2264-22",
"PackageDescription": "2000 CAPSULE in 1 BOTTLE (0781-2264-22)",
"NDC11Code": "00781-2264-22",
"ProductNDC": "0781-2264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine Hydrochloride",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079018",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The 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. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac."
},
{
"NDCCode": "0781-2266-22",
"PackageDescription": "2000 CAPSULE in 1 BOTTLE (0781-2266-22)",
"NDC11Code": "00781-2266-22",
"ProductNDC": "0781-2266",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine Hydrochloride",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079018",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The 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. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac."
},
{
"NDCCode": "0781-4028-22",
"PackageDescription": "240 mL in 1 BOTTLE, PLASTIC (0781-4028-22) ",
"NDC11Code": "00781-4028-22",
"ProductNDC": "0781-4028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorpromazine Hydrochloride",
"NonProprietaryName": "Chlorpromazine Hydrochloride",
"DosageFormName": "CONCENTRATE",
"RouteName": "ORAL",
"StartMarketingDate": "20230331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214542",
"LabelerName": "Sandoz, Inc.",
"SubstanceName": "CHLORPROMAZINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2025-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230331",
"SamplePackage": "N",
"IndicationAndUsage": "For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.",
"Description": "Chlorpromazine is 10-(3-dimethylaminopropyl)-2-chlorphenothiazine, a dimethylamine derivative of phenothiazine. It is present in an oral concentrate as the hydrochloride salt. Concentrate - Each mL of clear, colorless to pale yellow solution contains chlorpromazine hydrochloride, 30 or 100 mg. Inactive ingredients consist of citric acid anhydrous, edetate disodium, sodium benzoate, sodium citrate dihydrate, sucralose, and purified water."
},
{
"NDCCode": "0781-5384-22",
"PackageDescription": "2000 TABLET, FILM COATED in 1 BOTTLE (0781-5384-22)",
"NDC11Code": "00781-5384-22",
"ProductNDC": "0781-5384",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077575",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0781-6172-86",
"PackageDescription": "6 BOTTLE, GLASS in 1 CARTON (0781-6172-86) > 240 mL in 1 BOTTLE, GLASS (0781-6172-22) ",
"NDC11Code": "00781-6172-86",
"ProductNDC": "0781-6172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desflurane",
"NonProprietaryName": "Desflurane",
"DosageFormName": "LIQUID",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20180226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208234",
"LabelerName": "Sandoz Inc.",
"SubstanceName": "DESFLURANE",
"StrengthNumber": "240",
"StrengthUnit": "mL/240mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180226",
"SamplePackage": "N",
"IndicationAndUsage": "Desflurane, USP, Liquid for Inhalation, a general anesthetic, is an inhalation agent indicated: 1 for induction and/or maintenance of anesthesia in adults ( 1.1) , 2 for maintenance of anesthesia in pediatric patients following induction with agents other than Desflurane, USP, Liquid for Inhalation and intubation.",
"Description": "Desflurane, USP, Liquid for Inhalation, a nonflammable liquid administered via vaporizer, is a general inhalation anesthetic. It is (±)1,2,2,2-tetrafluoroethyl difluoromethyl ether. Some physical constants are. Partition coefficients at 37°C. Mean Component/Gas Partition Coefficients. Desflurane, USP is nonflammable as defined by the requirements of International Electrotechnical Commission 601-2-13. Desflurane, USP is a colorless, volatile liquid below 22.8°C. Data indicate that desflurane, USP is stable when stored under normal room lighting conditions according to instructions. Desflurane, USP is chemically stable. The only known degradation reaction is through prolonged direct contact with soda lime producing low levels of fluoroform (CHF 3). The amount of CHF 3 obtained is similar to that produced with MAC-equivalent doses of isoflurane. No discernible degradation occurs in the presence of strong acids. Desflurane, USP does not corrode stainless steel, brass, aluminum, anodized aluminum, nickel plated brass, copper, or beryllium."
},
{
"NDCCode": "0781-7054-49",
"PackageDescription": "1 KIT in 1 CARTON (0781-7054-49) * .8 g in 1 VIAL, PLASTIC (0781-8054-01) * 20 g in 1 JAR (0781-9054-22) ",
"NDC11Code": "00781-7054-49",
"ProductNDC": "0781-7054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin And Benzoyl Peroxide",
"NonProprietaryName": "Erythromycin And Benzoyl Peroxide",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065112",
"LabelerName": "Sandoz Inc.",
"Status": "Deprecated",
"LastUpdate": "2024-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20040329",
"SamplePackage": "N",
"IndicationAndUsage": "Erythromycin and benzoyl peroxide topical gel USP, 3%;5% is indicated for the topical treatment of acne vulgaris.",
"Description": "Erythromycin and benzoyl peroxide topical gel USP, 3%;5% contains erythromycin [(3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione]. Erythromycin is a macrolide antibiotic produced from a strain of Saccharopolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids. Chemically, erythromycin is (C37H67NO13). It has the following structural formula. Erythromycin has the molecular weight of 733.94. It is a white crystalline powder and has a solubility of approximately 1 mg/mL in water and is soluble in alcohol at 25°C. Erythromycin and benzoyl peroxide topical gel USP, 3%;5% also contains benzoyl peroxide for topical use. Benzoyl peroxide is an antibacterial and keratolytic agent. Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has the molecular weight of 242.23. It is a white granular powder and is sparingly soluble in water and alcohol and soluble in acetone, chloroform and ether. Each gram of erythromycin and benzoyl peroxide topical gel USP, 3%;5% contains, as dispensed, 30 mg (3%) of erythromycin, USP and 50 mg (5%) of benzoyl peroxide, USP in a gel of purified water, USP, alcohol 20%, carbomer homopolymer type C, NF, sodium hydroxide, NF, docusate sodium and fragrance."
},
{
"NDCCode": "0781-7263-68",
"PackageDescription": "1 KIT in 1 CARTON (0781-7263-68) * 5 g in 1 BOTTLE (0781-6514-39) * 20 g in 1 JAR (0781-7262-22) ",
"NDC11Code": "00781-7263-68",
"ProductNDC": "0781-7263",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin And Benzoyl Peroxide",
"NonProprietaryName": "Clindamycin And Benzoyl Peroxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20170815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204087",
"LabelerName": "Sandoz Inc.",
"Status": "Deprecated",
"LastUpdate": "2024-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170815",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.",
"Description": "For Dermatological Use Only - Not for Ophthalmic Use. *Reconstitute Before Dispensing*. Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. clindamycin phosphate. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl Peroxide. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide."
},
{
"NDCCode": "0591-2265-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (0591-2265-30)",
"NDC11Code": "00591-2265-30",
"ProductNDC": "0591-2265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acitretin",
"NonProprietaryName": "Acitretin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202552",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "ACITRETIN",
"StrengthNumber": "22.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC],Retinoids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-02-01",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "58878-0001-4",
"PackageDescription": "2265.6 L in 1 CYLINDER (58878-0001-4) ",
"NDC11Code": "58878-0001-04",
"ProductNDC": "58878-0001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Shasta Welding Supply, Inc.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20091214",
"SamplePackage": "N"
},
{
"NDCCode": "0781-1762-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (0781-1762-10) ",
"NDC11Code": "00781-1762-10",
"ProductNDC": "0781-1762",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipramine Hydrochloride",
"NonProprietaryName": "Imipramine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19760420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084936",
"LabelerName": "Sandoz Inc",
"SubstanceName": "IMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19760420",
"SamplePackage": "N"
},
{
"NDCCode": "0781-1762-31",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0781-1762-31) ",
"NDC11Code": "00781-1762-31",
"ProductNDC": "0781-1762",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipramine Hydrochloride",
"NonProprietaryName": "Imipramine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19760420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084936",
"LabelerName": "Sandoz Inc",
"SubstanceName": "IMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19760420",
"SamplePackage": "N"
},
{
"NDCCode": "0781-1764-13",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0781-1764-13) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00781-1764-13",
"ProductNDC": "0781-1764",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipramine Hydrochloride",
"NonProprietaryName": "Imipramine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19760420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083745",
"LabelerName": "Sandoz Inc",
"SubstanceName": "IMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19760420",
"SamplePackage": "N"
},
{
"NDCCode": "0781-1764-31",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0781-1764-31) ",
"NDC11Code": "00781-1764-31",
"ProductNDC": "0781-1764",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipramine Hydrochloride",
"NonProprietaryName": "Imipramine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19760420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083745",
"LabelerName": "Sandoz Inc",
"SubstanceName": "IMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19760420",
"SamplePackage": "N"
},
{
"NDCCode": "0781-1766-13",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0781-1766-13) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00781-1766-13",
"ProductNDC": "0781-1766",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipramine Hydrochloride",
"NonProprietaryName": "Imipramine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19760420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084937",
"LabelerName": "Sandoz Inc",
"SubstanceName": "IMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19760420",
"SamplePackage": "N"
},
{
"NDCCode": "0781-1766-31",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0781-1766-31) ",
"NDC11Code": "00781-1766-31",
"ProductNDC": "0781-1766",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipramine Hydrochloride",
"NonProprietaryName": "Imipramine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19760420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084937",
"LabelerName": "Sandoz Inc",
"SubstanceName": "IMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19760420",
"SamplePackage": "N"
},
{
"NDCCode": "0781-3001-07",
"PackageDescription": "1 CARTRIDGE in 1 CARTON (0781-3001-07) / 1.5 mL in 1 CARTRIDGE",
"NDC11Code": "00781-3001-07",
"ProductNDC": "0781-3001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnitrope",
"NonProprietaryName": "Somatropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20060530",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021426",
"LabelerName": "Sandoz Inc",
"SubstanceName": "SOMATROPIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1.5mL",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060530",
"SamplePackage": "N",
"IndicationAndUsage": "OMNITROPE is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).",
"Description": "Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and a molecular weight of approximately 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. OMNITROPE (somatropin) injection is a clear, colorless, sterile solution for subcutaneous injection supplied in a cartridge for use with OMNITROPE Pen delivery system. Sodium hydroxide and/or phosphoric acid may be added during manufacture to adjust pH. OMNITROPE (somatropin) for injection is a white to off-white lyophilized powder supplied in a vial for subcutaneous injection after reconstitution. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust pH. Vials are co-packaged with accompanying 1.14 mL vials of a diluent containing Bacteriostatic Water for Injection with 1.5% benzyl alcohol as a preservative. After reconstitution, the concentration is 5 mg/mL. Each OMNITROPE cartridge or vial contains the following (see Table 4)."
},
{
"NDCCode": "0781-3001-26",
"PackageDescription": "5 CARTRIDGE in 1 CARTON (0781-3001-26) / 1.5 mL in 1 CARTRIDGE",
"NDC11Code": "00781-3001-26",
"ProductNDC": "0781-3001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnitrope",
"NonProprietaryName": "Somatropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20060530",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021426",
"LabelerName": "Sandoz Inc",
"SubstanceName": "SOMATROPIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1.5mL",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060530",
"SamplePackage": "N",
"IndicationAndUsage": "OMNITROPE is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).",
"Description": "Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and a molecular weight of approximately 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. OMNITROPE (somatropin) injection is a clear, colorless, sterile solution for subcutaneous injection supplied in a cartridge for use with OMNITROPE Pen delivery system. Sodium hydroxide and/or phosphoric acid may be added during manufacture to adjust pH. OMNITROPE (somatropin) for injection is a white to off-white lyophilized powder supplied in a vial for subcutaneous injection after reconstitution. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust pH. Vials are co-packaged with accompanying 1.14 mL vials of a diluent containing Bacteriostatic Water for Injection with 1.5% benzyl alcohol as a preservative. After reconstitution, the concentration is 5 mg/mL. Each OMNITROPE cartridge or vial contains the following (see Table 4)."
},
{
"NDCCode": "0781-3004-07",
"PackageDescription": "1 CARTRIDGE in 1 CARTON (0781-3004-07) / 1.5 mL in 1 CARTRIDGE",
"NDC11Code": "00781-3004-07",
"ProductNDC": "0781-3004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnitrope",
"NonProprietaryName": "Somatropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20060530",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021426",
"LabelerName": "Sandoz Inc",
"SubstanceName": "SOMATROPIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1.5mL",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060530",
"SamplePackage": "N",
"IndicationAndUsage": "OMNITROPE is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).",
"Description": "Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and a molecular weight of approximately 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. OMNITROPE (somatropin) injection is a clear, colorless, sterile solution for subcutaneous injection supplied in a cartridge for use with OMNITROPE Pen delivery system. Sodium hydroxide and/or phosphoric acid may be added during manufacture to adjust pH. OMNITROPE (somatropin) for injection is a white to off-white lyophilized powder supplied in a vial for subcutaneous injection after reconstitution. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust pH. Vials are co-packaged with accompanying 1.14 mL vials of a diluent containing Bacteriostatic Water for Injection with 1.5% benzyl alcohol as a preservative. After reconstitution, the concentration is 5 mg/mL. Each OMNITROPE cartridge or vial contains the following (see Table 4)."
},
{
"NDCCode": "0781-3004-26",
"PackageDescription": "5 CARTRIDGE in 1 CARTON (0781-3004-26) / 1.5 mL in 1 CARTRIDGE",
"NDC11Code": "00781-3004-26",
"ProductNDC": "0781-3004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnitrope",
"NonProprietaryName": "Somatropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20060530",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021426",
"LabelerName": "Sandoz Inc",
"SubstanceName": "SOMATROPIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1.5mL",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060530",
"SamplePackage": "N",
"IndicationAndUsage": "OMNITROPE is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).",
"Description": "Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and a molecular weight of approximately 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. OMNITROPE (somatropin) injection is a clear, colorless, sterile solution for subcutaneous injection supplied in a cartridge for use with OMNITROPE Pen delivery system. Sodium hydroxide and/or phosphoric acid may be added during manufacture to adjust pH. OMNITROPE (somatropin) for injection is a white to off-white lyophilized powder supplied in a vial for subcutaneous injection after reconstitution. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust pH. Vials are co-packaged with accompanying 1.14 mL vials of a diluent containing Bacteriostatic Water for Injection with 1.5% benzyl alcohol as a preservative. After reconstitution, the concentration is 5 mg/mL. Each OMNITROPE cartridge or vial contains the following (see Table 4)."
},
{
"NDCCode": "0781-3059-95",
"PackageDescription": "10 AMPULE in 1 CARTON (0781-3059-95) / 2 mL in 1 AMPULE (0781-3059-72) ",
"NDC11Code": "00781-3059-95",
"ProductNDC": "0781-3059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL",
"StartMarketingDate": "20030821",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040481",
"LabelerName": "Sandoz Inc",
"SubstanceName": "DIGOXIN",
"StrengthNumber": "250",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030821",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin injection is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in adults with chronic atrial fibrillation. (1.3).",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin exists as clear to white odorless crystals or white, odorless crystalline powder that melts with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin injection, USP is a sterile solution of digoxin for intravenous or intramuscular injection. Each mL contains: digoxin 0.25 mg, propylene glycol 40% (v/v), anhydrous ethanol 10% (v/v), dibasic sodium phosphate 0.3% (w/v) and anhydrous citric acid 0.08% (w/v) to adjust pH between 6.8 and 7.2, and water for injection. Dilution is not required."
},
{
"NDCCode": "0781-3220-70",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0781-3220-70) > 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00781-3220-70",
"ProductNDC": "0781-3220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rocuronium Bromide",
"NonProprietaryName": "Rocuronium Bromide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20081205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079195",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ROCURONIUM BROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20081205",
"SamplePackage": "N"
},
{
"NDCCode": "0781-3220-75",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0781-3220-75) > 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00781-3220-75",
"ProductNDC": "0781-3220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rocuronium Bromide",
"NonProprietaryName": "Rocuronium Bromide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20081205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079195",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ROCURONIUM BROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20081205",
"SamplePackage": "N"
},
{
"NDCCode": "0781-3312-75",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3312-75) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00781-3312-75",
"ProductNDC": "0781-3312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Palonosetron Hydrochloride",
"NonProprietaryName": "Palonosetron Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202521",
"LabelerName": "Sandoz Inc",
"SubstanceName": "PALONOSETRON HYDROCHLORIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180323",
"SamplePackage": "N",
"IndicationAndUsage": "Palonosetron injection is indicated in adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)., 2 acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC)., 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.",
"Description": "Palonosetron hydrochloride is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenz[de]isoquinoline hydrochloride. The molecular formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron HCl injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron HCl injection is available as a 5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron equivalent to 0.28 mg palonosetron hydrochloride, 207.5 mg mannitol, disodium edetate and citrate buffer in water for intravenous administration. Hydrochloric acid or sodium hydroxide may have been added to adjust pH. The pH of the solution in the 5 mL vial is 4.5 to 5.5."
},
{
"NDCCode": "0781-3412-92",
"PackageDescription": "10 VIAL, GLASS in 1 PACKAGE (0781-3412-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (0781-3412-15) ",
"NDC11Code": "00781-3412-92",
"ProductNDC": "0781-3412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19870219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062738",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2025-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19870219",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by Streptococcus pneumoniae. Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.",
"Description": "Ampicillin for Injection, USP, the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a white to cream-tinged, crystalline powder. The reconstituted solution is clear, colorless and free from visible particulates. Each ADD-Vantage® vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 2.9 milliequivalents of sodium per gram of ampicillin. It has the following molecular structure. The molecular formula is C16H18N3NaO4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0781-2265-22</NDCCode>
<PackageDescription>2000 CAPSULE in 1 BOTTLE (0781-2265-22)</PackageDescription>
<NDC11Code>00781-2265-22</NDC11Code>
<ProductNDC>0781-2265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079018</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The 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. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0781-2265-31</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0781-2265-31)</PackageDescription>
<NDC11Code>00781-2265-31</NDC11Code>
<ProductNDC>0781-2265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079018</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The 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. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0781-2260-22</NDCCode>
<PackageDescription>2000 CAPSULE in 1 BOTTLE (0781-2260-22)</PackageDescription>
<NDC11Code>00781-2260-22</NDC11Code>
<ProductNDC>0781-2260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079018</ApplicationNumber>
<LabelerName>Sandoz Inc</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>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The 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. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0781-2261-22</NDCCode>
<PackageDescription>2000 CAPSULE in 1 BOTTLE (0781-2261-22)</PackageDescription>
<NDC11Code>00781-2261-22</NDC11Code>
<ProductNDC>0781-2261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079018</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The 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. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0781-2262-22</NDCCode>
<PackageDescription>2000 CAPSULE in 1 BOTTLE (0781-2262-22)</PackageDescription>
<NDC11Code>00781-2262-22</NDC11Code>
<ProductNDC>0781-2262</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079018</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The 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. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0781-2263-22</NDCCode>
<PackageDescription>2000 CAPSULE in 1 BOTTLE (0781-2263-22)</PackageDescription>
<NDC11Code>00781-2263-22</NDC11Code>
<ProductNDC>0781-2263</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079018</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The 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. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0781-2264-22</NDCCode>
<PackageDescription>2000 CAPSULE in 1 BOTTLE (0781-2264-22)</PackageDescription>
<NDC11Code>00781-2264-22</NDC11Code>
<ProductNDC>0781-2264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079018</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The 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. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0781-2266-22</NDCCode>
<PackageDescription>2000 CAPSULE in 1 BOTTLE (0781-2266-22)</PackageDescription>
<NDC11Code>00781-2266-22</NDC11Code>
<ProductNDC>0781-2266</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079018</ApplicationNumber>
<LabelerName>Sandoz Inc</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>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The 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. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0781-4028-22</NDCCode>
<PackageDescription>240 mL in 1 BOTTLE, PLASTIC (0781-4028-22) </PackageDescription>
<NDC11Code>00781-4028-22</NDC11Code>
<ProductNDC>0781-4028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214542</ApplicationNumber>
<LabelerName>Sandoz, Inc.</LabelerName>
<SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.</IndicationAndUsage>
<Description>Chlorpromazine is 10-(3-dimethylaminopropyl)-2-chlorphenothiazine, a dimethylamine derivative of phenothiazine. It is present in an oral concentrate as the hydrochloride salt. Concentrate - Each mL of clear, colorless to pale yellow solution contains chlorpromazine hydrochloride, 30 or 100 mg. Inactive ingredients consist of citric acid anhydrous, edetate disodium, sodium benzoate, sodium citrate dihydrate, sucralose, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>0781-5384-22</NDCCode>
<PackageDescription>2000 TABLET, FILM COATED in 1 BOTTLE (0781-5384-22)</PackageDescription>
<NDC11Code>00781-5384-22</NDC11Code>
<ProductNDC>0781-5384</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077575</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0781-6172-86</NDCCode>
<PackageDescription>6 BOTTLE, GLASS in 1 CARTON (0781-6172-86) > 240 mL in 1 BOTTLE, GLASS (0781-6172-22) </PackageDescription>
<NDC11Code>00781-6172-86</NDC11Code>
<ProductNDC>0781-6172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desflurane</ProprietaryName>
<NonProprietaryName>Desflurane</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20180226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208234</ApplicationNumber>
<LabelerName>Sandoz Inc.</LabelerName>
<SubstanceName>DESFLURANE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mL/240mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desflurane, USP, Liquid for Inhalation, a general anesthetic, is an inhalation agent indicated: 1 for induction and/or maintenance of anesthesia in adults ( 1.1) , 2 for maintenance of anesthesia in pediatric patients following induction with agents other than Desflurane, USP, Liquid for Inhalation and intubation.</IndicationAndUsage>
<Description>Desflurane, USP, Liquid for Inhalation, a nonflammable liquid administered via vaporizer, is a general inhalation anesthetic. It is (±)1,2,2,2-tetrafluoroethyl difluoromethyl ether. Some physical constants are. Partition coefficients at 37°C. Mean Component/Gas Partition Coefficients. Desflurane, USP is nonflammable as defined by the requirements of International Electrotechnical Commission 601-2-13. Desflurane, USP is a colorless, volatile liquid below 22.8°C. Data indicate that desflurane, USP is stable when stored under normal room lighting conditions according to instructions. Desflurane, USP is chemically stable. The only known degradation reaction is through prolonged direct contact with soda lime producing low levels of fluoroform (CHF 3). The amount of CHF 3 obtained is similar to that produced with MAC-equivalent doses of isoflurane. No discernible degradation occurs in the presence of strong acids. Desflurane, USP does not corrode stainless steel, brass, aluminum, anodized aluminum, nickel plated brass, copper, or beryllium.</Description>
</NDC>
<NDC>
<NDCCode>0781-7054-49</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0781-7054-49) * .8 g in 1 VIAL, PLASTIC (0781-8054-01) * 20 g in 1 JAR (0781-9054-22) </PackageDescription>
<NDC11Code>00781-7054-49</NDC11Code>
<ProductNDC>0781-7054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin And Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Erythromycin And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20040329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065112</ApplicationNumber>
<LabelerName>Sandoz Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Erythromycin and benzoyl peroxide topical gel USP, 3%;5% is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Erythromycin and benzoyl peroxide topical gel USP, 3%;5% contains erythromycin [(3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione]. Erythromycin is a macrolide antibiotic produced from a strain of Saccharopolyspora erythraea (formerly Streptomyces erythreus). It is a base and readily forms salts with acids. Chemically, erythromycin is (C37H67NO13). It has the following structural formula. Erythromycin has the molecular weight of 733.94. It is a white crystalline powder and has a solubility of approximately 1 mg/mL in water and is soluble in alcohol at 25°C. Erythromycin and benzoyl peroxide topical gel USP, 3%;5% also contains benzoyl peroxide for topical use. Benzoyl peroxide is an antibacterial and keratolytic agent. Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has the molecular weight of 242.23. It is a white granular powder and is sparingly soluble in water and alcohol and soluble in acetone, chloroform and ether. Each gram of erythromycin and benzoyl peroxide topical gel USP, 3%;5% contains, as dispensed, 30 mg (3%) of erythromycin, USP and 50 mg (5%) of benzoyl peroxide, USP in a gel of purified water, USP, alcohol 20%, carbomer homopolymer type C, NF, sodium hydroxide, NF, docusate sodium and fragrance.</Description>
</NDC>
<NDC>
<NDCCode>0781-7263-68</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0781-7263-68) * 5 g in 1 BOTTLE (0781-6514-39) * 20 g in 1 JAR (0781-7262-22) </PackageDescription>
<NDC11Code>00781-7263-68</NDC11Code>
<ProductNDC>0781-7263</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204087</ApplicationNumber>
<LabelerName>Sandoz Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>For Dermatological Use Only - Not for Ophthalmic Use. *Reconstitute Before Dispensing*. Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. clindamycin phosphate. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl Peroxide. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0591-2265-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (0591-2265-30)</PackageDescription>
<NDC11Code>00591-2265-30</NDC11Code>
<ProductNDC>0591-2265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acitretin</ProprietaryName>
<NonProprietaryName>Acitretin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202552</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>ACITRETIN</SubstanceName>
<StrengthNumber>22.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-01</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>58878-0001-4</NDCCode>
<PackageDescription>2265.6 L in 1 CYLINDER (58878-0001-4) </PackageDescription>
<NDC11Code>58878-0001-04</NDC11Code>
<ProductNDC>58878-0001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Shasta Welding Supply, Inc.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1762-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (0781-1762-10) </PackageDescription>
<NDC11Code>00781-1762-10</NDC11Code>
<ProductNDC>0781-1762</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Imipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19760420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084936</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>IMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19760420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1762-31</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0781-1762-31) </PackageDescription>
<NDC11Code>00781-1762-31</NDC11Code>
<ProductNDC>0781-1762</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Imipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19760420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084936</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>IMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19760420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1764-13</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (0781-1764-13) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00781-1764-13</NDC11Code>
<ProductNDC>0781-1764</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Imipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19760420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083745</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>IMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19760420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1764-31</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0781-1764-31) </PackageDescription>
<NDC11Code>00781-1764-31</NDC11Code>
<ProductNDC>0781-1764</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Imipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19760420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083745</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>IMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19760420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1766-13</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (0781-1766-13) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00781-1766-13</NDC11Code>
<ProductNDC>0781-1766</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Imipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19760420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084937</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>IMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19760420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-1766-31</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0781-1766-31) </PackageDescription>
<NDC11Code>00781-1766-31</NDC11Code>
<ProductNDC>0781-1766</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Imipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19760420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084937</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>IMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19760420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-3001-07</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 CARTON (0781-3001-07) / 1.5 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00781-3001-07</NDC11Code>
<ProductNDC>0781-3001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnitrope</ProprietaryName>
<NonProprietaryName>Somatropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060530</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021426</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>SOMATROPIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1.5mL</StrengthUnit>
<Pharm_Classes>Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNITROPE is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).</IndicationAndUsage>
<Description>Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and a molecular weight of approximately 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. OMNITROPE (somatropin) injection is a clear, colorless, sterile solution for subcutaneous injection supplied in a cartridge for use with OMNITROPE Pen delivery system. Sodium hydroxide and/or phosphoric acid may be added during manufacture to adjust pH. OMNITROPE (somatropin) for injection is a white to off-white lyophilized powder supplied in a vial for subcutaneous injection after reconstitution. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust pH. Vials are co-packaged with accompanying 1.14 mL vials of a diluent containing Bacteriostatic Water for Injection with 1.5% benzyl alcohol as a preservative. After reconstitution, the concentration is 5 mg/mL. Each OMNITROPE cartridge or vial contains the following (see Table 4).</Description>
</NDC>
<NDC>
<NDCCode>0781-3001-26</NDCCode>
<PackageDescription>5 CARTRIDGE in 1 CARTON (0781-3001-26) / 1.5 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00781-3001-26</NDC11Code>
<ProductNDC>0781-3001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnitrope</ProprietaryName>
<NonProprietaryName>Somatropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060530</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021426</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>SOMATROPIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1.5mL</StrengthUnit>
<Pharm_Classes>Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNITROPE is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).</IndicationAndUsage>
<Description>Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and a molecular weight of approximately 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. OMNITROPE (somatropin) injection is a clear, colorless, sterile solution for subcutaneous injection supplied in a cartridge for use with OMNITROPE Pen delivery system. Sodium hydroxide and/or phosphoric acid may be added during manufacture to adjust pH. OMNITROPE (somatropin) for injection is a white to off-white lyophilized powder supplied in a vial for subcutaneous injection after reconstitution. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust pH. Vials are co-packaged with accompanying 1.14 mL vials of a diluent containing Bacteriostatic Water for Injection with 1.5% benzyl alcohol as a preservative. After reconstitution, the concentration is 5 mg/mL. Each OMNITROPE cartridge or vial contains the following (see Table 4).</Description>
</NDC>
<NDC>
<NDCCode>0781-3004-07</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 CARTON (0781-3004-07) / 1.5 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00781-3004-07</NDC11Code>
<ProductNDC>0781-3004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnitrope</ProprietaryName>
<NonProprietaryName>Somatropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060530</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021426</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>SOMATROPIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1.5mL</StrengthUnit>
<Pharm_Classes>Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNITROPE is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).</IndicationAndUsage>
<Description>Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and a molecular weight of approximately 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. OMNITROPE (somatropin) injection is a clear, colorless, sterile solution for subcutaneous injection supplied in a cartridge for use with OMNITROPE Pen delivery system. Sodium hydroxide and/or phosphoric acid may be added during manufacture to adjust pH. OMNITROPE (somatropin) for injection is a white to off-white lyophilized powder supplied in a vial for subcutaneous injection after reconstitution. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust pH. Vials are co-packaged with accompanying 1.14 mL vials of a diluent containing Bacteriostatic Water for Injection with 1.5% benzyl alcohol as a preservative. After reconstitution, the concentration is 5 mg/mL. Each OMNITROPE cartridge or vial contains the following (see Table 4).</Description>
</NDC>
<NDC>
<NDCCode>0781-3004-26</NDCCode>
<PackageDescription>5 CARTRIDGE in 1 CARTON (0781-3004-26) / 1.5 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00781-3004-26</NDC11Code>
<ProductNDC>0781-3004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnitrope</ProprietaryName>
<NonProprietaryName>Somatropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060530</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021426</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>SOMATROPIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1.5mL</StrengthUnit>
<Pharm_Classes>Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNITROPE is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).</IndicationAndUsage>
<Description>Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and a molecular weight of approximately 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. OMNITROPE (somatropin) injection is a clear, colorless, sterile solution for subcutaneous injection supplied in a cartridge for use with OMNITROPE Pen delivery system. Sodium hydroxide and/or phosphoric acid may be added during manufacture to adjust pH. OMNITROPE (somatropin) for injection is a white to off-white lyophilized powder supplied in a vial for subcutaneous injection after reconstitution. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust pH. Vials are co-packaged with accompanying 1.14 mL vials of a diluent containing Bacteriostatic Water for Injection with 1.5% benzyl alcohol as a preservative. After reconstitution, the concentration is 5 mg/mL. Each OMNITROPE cartridge or vial contains the following (see Table 4).</Description>
</NDC>
<NDC>
<NDCCode>0781-3059-95</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (0781-3059-95) / 2 mL in 1 AMPULE (0781-3059-72) </PackageDescription>
<NDC11Code>00781-3059-95</NDC11Code>
<ProductNDC>0781-3059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digoxin</ProprietaryName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL</RouteName>
<StartMarketingDate>20030821</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040481</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC], Cardiac Glycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Digoxin injection is a cardiac glycoside indicated for: 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in adults with chronic atrial fibrillation. (1.3).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin exists as clear to white odorless crystals or white, odorless crystalline powder that melts with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin injection, USP is a sterile solution of digoxin for intravenous or intramuscular injection. Each mL contains: digoxin 0.25 mg, propylene glycol 40% (v/v), anhydrous ethanol 10% (v/v), dibasic sodium phosphate 0.3% (w/v) and anhydrous citric acid 0.08% (w/v) to adjust pH between 6.8 and 7.2, and water for injection. Dilution is not required.</Description>
</NDC>
<NDC>
<NDCCode>0781-3220-70</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0781-3220-70) > 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00781-3220-70</NDC11Code>
<ProductNDC>0781-3220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rocuronium Bromide</ProprietaryName>
<NonProprietaryName>Rocuronium Bromide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20081205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079195</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ROCURONIUM BROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-3220-75</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0781-3220-75) > 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00781-3220-75</NDC11Code>
<ProductNDC>0781-3220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rocuronium Bromide</ProprietaryName>
<NonProprietaryName>Rocuronium Bromide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20081205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079195</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ROCURONIUM BROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-3312-75</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3312-75) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00781-3312-75</NDC11Code>
<ProductNDC>0781-3312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Palonosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Palonosetron Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202521</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>PALONOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Palonosetron injection is indicated in adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)., 2 acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC)., 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.</IndicationAndUsage>
<Description>Palonosetron hydrochloride is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenz[de]isoquinoline hydrochloride. The molecular formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron HCl injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron HCl injection is available as a 5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron equivalent to 0.28 mg palonosetron hydrochloride, 207.5 mg mannitol, disodium edetate and citrate buffer in water for intravenous administration. Hydrochloric acid or sodium hydroxide may have been added to adjust pH. The pH of the solution in the 5 mL vial is 4.5 to 5.5.</Description>
</NDC>
<NDC>
<NDCCode>0781-3412-92</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 PACKAGE (0781-3412-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (0781-3412-15) </PackageDescription>
<NDC11Code>00781-3412-92</NDC11Code>
<ProductNDC>0781-3412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19870219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062738</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by Streptococcus pneumoniae. Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Ampicillin for Injection, USP, the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a white to cream-tinged, crystalline powder. The reconstituted solution is clear, colorless and free from visible particulates. Each ADD-Vantage® vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 2.9 milliequivalents of sodium per gram of ampicillin. It has the following molecular structure. The molecular formula is C16H18N3NaO4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10.</Description>
</NDC>
</NDCList>