{
"NDC": [
{
"NDCCode": "65862-058-91",
"PackageDescription": "9000 TABLET in 1 BAG (65862-058-91) ",
"NDC11Code": "65862-0058-91",
"ProductNDC": "65862-058",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"StartMarketingDate": "20081007",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-01-23",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "07-OCT-08"
},
{
"NDCCode": "65862-058-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (65862-058-30) ",
"NDC11Code": "65862-0058-30",
"ProductNDC": "65862-058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077731",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20081007",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration.Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline.Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "72205-058-91",
"PackageDescription": "100 TABLET in 1 BOTTLE (72205-058-91) ",
"NDC11Code": "72205-0058-91",
"ProductNDC": "72205-058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215362",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260210",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide tablets, USP are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide, USP is a loop diuretic available as 0.5 mg (white to off white), 1 mg (white to off white) and 2 mg (white to off white) tablets for oral administration; each tablet also contains anhydrous lactose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white or almost white, crystalline powder having a calculated molecular weight of 364.42, and the following structural formula. Molecular formula: C17H20N2O5S. FDA approved dissolution test specifications differ from USP. FDA-approved impurity specifications differ from the USP."
},
{
"NDCCode": "73414-058-91",
"PackageDescription": "3780 mL in 1 BOTTLE (73414-058-91) ",
"NDC11Code": "73414-0058-91",
"ProductNDC": "73414-058",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Antiseptic",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Seaway Pharma Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "65862-062-91",
"PackageDescription": "9000 TABLET, FILM COATED in 1 BAG (65862-062-91) ",
"NDC11Code": "65862-0062-91",
"ProductNDC": "65862-062",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20070911",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-05-24",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "11-SEP-07"
},
{
"NDCCode": "65862-101-91",
"PackageDescription": "9000 TABLET in 1 BAG (65862-101-91) ",
"NDC11Code": "65862-0101-91",
"ProductNDC": "65862-101",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"StartMarketingDate": "20070717",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-03-25",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "17-JUL-07"
},
{
"NDCCode": "66621-0790-2",
"PackageDescription": "1 VIAL in 1 CARTON (66621-0790-2) / 10 mL in 1 VIAL (66621-0790-1) ",
"NDC11Code": "66621-0790-02",
"ProductNDC": "66621-0790",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Anavip",
"NonProprietaryName": "Crotalidae Immune F(ab)2(equine)",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150506",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125488",
"LabelerName": "Rare Disease Therapeutics, Inc",
"SubstanceName": "PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE)",
"StrengthNumber": "12",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150506",
"SamplePackage": "N",
"IndicationAndUsage": "ANAVIP [crotalidae immune F(ab')2 (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American Pit Viper envenomation. (1).",
"Description": "ANAVIP [crotalidae immune F(ab')2 (equine)] is a sterile, lyophilized, polyvalent preparation of equine immunoglobulin F(ab')2 fragments, manufactured from the plasma of horses immunized with venom of Bothrops asper and Crotalus simus (formerly Crotalus durissus). The product is obtained by pepsin digestion of horse plasma to remove the Fc portion of immunoglobulin, followed by fractionation and purification steps. The F(ab')2 content is not less than 85%, F(ab') content is not more than 7%, and the product contains less than 5% intact immunoglobulin. Each vial of ANAVIP contains 25.2-56.8 mg of sodium chloride, 47.30 - 91.35 mg of sucrose, and 95.03-183.15 mg of glycine as stabilizers. Trace amounts of pepsin (≤50 ng/vial), cresol (≤0.058 mg/vial), borates (≤1 mg/vial), and sulfates (≤1.7 mg/vial) may be present from the manufacturing process. Each vial contains no more than 120 mg of protein and will be neutralize not less than 780 times the LD50 of Bothrops asper (Terciopelo or fer-de-lance) venom, 790 times the LD50 of Crotalus simus (formerly Crotalus durissus) (Central American Rattlesnake) venom, 244 times the LD50 of Crotalus adamanteus (Eastern Diamondback Rattlesnake) venom, 147 times the LD50 of Crotalus atrox (Western Diamondback Rattlesnake) venom, 185 times the LD50 of Crotalus scutulatus (Mohave Rattlesnake) venom, 28 times the LD50 of Agkistrodon contortrix (Copperhead) venom and 61 times the LD50 of Agkistrodon piscivorus (Cottonmouth or Water Moccasin) venom in a mouse neutralization assay.The manufacturing procedures that contribute to the reduction of risk of viral transmission include pepsin digestion, ammonium sulfate precipitation/heat treatment and nanofiltration."
},
{
"NDCCode": "65862-238-22",
"PackageDescription": "2000 CAPSULE in 1 BOTTLE (65862-238-22) ",
"NDC11Code": "65862-0238-22",
"ProductNDC": "65862-238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170530",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "65862-238-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (65862-238-30) ",
"NDC11Code": "65862-0238-30",
"ProductNDC": "65862-238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170530",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "65862-239-22",
"PackageDescription": "2000 CAPSULE in 1 BOTTLE (65862-239-22) ",
"NDC11Code": "65862-0239-22",
"ProductNDC": "65862-239",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170530",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "65862-239-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (65862-239-30) ",
"NDC11Code": "65862-0239-30",
"ProductNDC": "65862-239",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170530",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "65862-240-22",
"PackageDescription": "2000 CAPSULE in 1 BOTTLE (65862-240-22) ",
"NDC11Code": "65862-0240-22",
"ProductNDC": "65862-240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170530",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "65862-240-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (65862-240-30) ",
"NDC11Code": "65862-0240-30",
"ProductNDC": "65862-240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170530",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "65862-241-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (65862-241-30) ",
"NDC11Code": "65862-0241-30",
"ProductNDC": "65862-241",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170530",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "65862-241-99",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (65862-241-99) ",
"NDC11Code": "65862-0241-99",
"ProductNDC": "65862-241",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170530",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "65862-242-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (65862-242-30) ",
"NDC11Code": "65862-0242-30",
"ProductNDC": "65862-242",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170530",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "65862-242-99",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (65862-242-99) ",
"NDC11Code": "65862-0242-99",
"ProductNDC": "65862-242",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170530",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "65862-243-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (65862-243-05) ",
"NDC11Code": "65862-0243-05",
"ProductNDC": "65862-243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170530",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "65862-243-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (65862-243-30) ",
"NDC11Code": "65862-0243-30",
"ProductNDC": "65862-243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170530",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "65862-244-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (65862-244-05) ",
"NDC11Code": "65862-0244-05",
"ProductNDC": "65862-244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170530",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "65862-244-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (65862-244-30) ",
"NDC11Code": "65862-0244-30",
"ProductNDC": "65862-244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079016",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170530",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "65862-327-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (65862-327-01) ",
"NDC11Code": "65862-0327-01",
"ProductNDC": "65862-327",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090124",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080804",
"SamplePackage": "N",
"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."
},
{
"NDCCode": "65862-327-10",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (65862-327-10) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "65862-0327-10",
"ProductNDC": "65862-327",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090124",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080804",
"SamplePackage": "N",
"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."
},
{
"NDCCode": "65862-327-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (65862-327-30) ",
"NDC11Code": "65862-0327-30",
"ProductNDC": "65862-327",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090124",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080804",
"SamplePackage": "N",
"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."
},
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"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."
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"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."
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{
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"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."
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{
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"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."
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{
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"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."
},
{
"NDCCode": "65862-329-01",
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"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."
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<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
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<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration.Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline.Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2.</Description>
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<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
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<StartMarketingDatePackage>20260210</StartMarketingDatePackage>
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<IndicationAndUsage>Bumetanide tablets, USP are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide, USP is a loop diuretic available as 0.5 mg (white to off white), 1 mg (white to off white) and 2 mg (white to off white) tablets for oral administration; each tablet also contains anhydrous lactose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white or almost white, crystalline powder having a calculated molecular weight of 364.42, and the following structural formula. Molecular formula: C17H20N2O5S. FDA approved dissolution test specifications differ from USP. FDA-approved impurity specifications differ from the USP.</Description>
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<LabelerName>Seaway Pharma Inc.</LabelerName>
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<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
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<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2024-05-24</LastUpdate>
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<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2026-03-25</LastUpdate>
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<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ANAVIP [crotalidae immune F(ab')2 (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American Pit Viper envenomation. (1).</IndicationAndUsage>
<Description>ANAVIP [crotalidae immune F(ab')2 (equine)] is a sterile, lyophilized, polyvalent preparation of equine immunoglobulin F(ab')2 fragments, manufactured from the plasma of horses immunized with venom of Bothrops asper and Crotalus simus (formerly Crotalus durissus). The product is obtained by pepsin digestion of horse plasma to remove the Fc portion of immunoglobulin, followed by fractionation and purification steps. The F(ab')2 content is not less than 85%, F(ab') content is not more than 7%, and the product contains less than 5% intact immunoglobulin. Each vial of ANAVIP contains 25.2-56.8 mg of sodium chloride, 47.30 - 91.35 mg of sucrose, and 95.03-183.15 mg of glycine as stabilizers. Trace amounts of pepsin (≤50 ng/vial), cresol (≤0.058 mg/vial), borates (≤1 mg/vial), and sulfates (≤1.7 mg/vial) may be present from the manufacturing process. Each vial contains no more than 120 mg of protein and will be neutralize not less than 780 times the LD50 of Bothrops asper (Terciopelo or fer-de-lance) venom, 790 times the LD50 of Crotalus simus (formerly Crotalus durissus) (Central American Rattlesnake) venom, 244 times the LD50 of Crotalus adamanteus (Eastern Diamondback Rattlesnake) venom, 147 times the LD50 of Crotalus atrox (Western Diamondback Rattlesnake) venom, 185 times the LD50 of Crotalus scutulatus (Mohave Rattlesnake) venom, 28 times the LD50 of Agkistrodon contortrix (Copperhead) venom and 61 times the LD50 of Agkistrodon piscivorus (Cottonmouth or Water Moccasin) venom in a mouse neutralization assay.The manufacturing procedures that contribute to the reduction of risk of viral transmission include pepsin digestion, ammonium sulfate precipitation/heat treatment and nanofiltration.</Description>
</NDC>
<NDC>
<NDCCode>65862-238-22</NDCCode>
<PackageDescription>2000 CAPSULE in 1 BOTTLE (65862-238-22) </PackageDescription>
<NDC11Code>65862-0238-22</NDC11Code>
<ProductNDC>65862-238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>65862-238-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (65862-238-30) </PackageDescription>
<NDC11Code>65862-0238-30</NDC11Code>
<ProductNDC>65862-238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>65862-239-22</NDCCode>
<PackageDescription>2000 CAPSULE in 1 BOTTLE (65862-239-22) </PackageDescription>
<NDC11Code>65862-0239-22</NDC11Code>
<ProductNDC>65862-239</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</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>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>65862-239-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (65862-239-30) </PackageDescription>
<NDC11Code>65862-0239-30</NDC11Code>
<ProductNDC>65862-239</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</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>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>65862-240-22</NDCCode>
<PackageDescription>2000 CAPSULE in 1 BOTTLE (65862-240-22) </PackageDescription>
<NDC11Code>65862-0240-22</NDC11Code>
<ProductNDC>65862-240</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>65862-240-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (65862-240-30) </PackageDescription>
<NDC11Code>65862-0240-30</NDC11Code>
<ProductNDC>65862-240</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>65862-241-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (65862-241-30) </PackageDescription>
<NDC11Code>65862-0241-30</NDC11Code>
<ProductNDC>65862-241</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</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>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>65862-241-99</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (65862-241-99) </PackageDescription>
<NDC11Code>65862-0241-99</NDC11Code>
<ProductNDC>65862-241</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</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>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>65862-242-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (65862-242-30) </PackageDescription>
<NDC11Code>65862-0242-30</NDC11Code>
<ProductNDC>65862-242</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</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>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
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<PackageDescription>1000 CAPSULE in 1 BOTTLE (65862-242-99) </PackageDescription>
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<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>65862-243-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (65862-243-30) </PackageDescription>
<NDC11Code>65862-0243-30</NDC11Code>
<ProductNDC>65862-243</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
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<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</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>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>65862-244-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (65862-244-05) </PackageDescription>
<NDC11Code>65862-0244-05</NDC11Code>
<ProductNDC>65862-244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>65862-244-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (65862-244-30) </PackageDescription>
<NDC11Code>65862-0244-30</NDC11Code>
<ProductNDC>65862-244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079016</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are for oral administration only. Each atomoxetine capsule USP contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.428 mg, 20.570 mg, 28.569 mg, 45.711 mg, 68.567 mg, 91.422 mg and 114.278 mg of atomoxetine hydrochloride, respectively). The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>65862-327-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (65862-327-01) </PackageDescription>
<NDC11Code>65862-0327-01</NDC11Code>
<ProductNDC>65862-327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090124</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).</IndicationAndUsage>
<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>65862-327-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (65862-327-10) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>65862-327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20080804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090124</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).</IndicationAndUsage>
<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
</NDC>
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<ProductNDC>65862-327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090124</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).</IndicationAndUsage>
<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
</NDC>
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<NDCCode>65862-327-99</NDCCode>
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<ProductNDC>65862-327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090124</ApplicationNumber>
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<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).</IndicationAndUsage>
<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
</NDC>
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<PackageDescription>1 BLISTER PACK in 1 CARTON (65862-328-04) / 4 TABLET in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>65862-328</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090124</ApplicationNumber>
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<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
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<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
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<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
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<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
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<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.The molecular formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.</Description>
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