{
"NDC": [
{
"NDCCode": "0093-5171-44",
"PackageDescription": "4 BLISTER PACK in 1 BOX (0093-5171-44) > 1 TABLET in 1 BLISTER PACK (0093-5171-19)",
"NDC11Code": "00093-5171-44",
"ProductNDC": "0093-5171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080206",
"EndMarketingDate": "20180531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075710",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-06-01",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "0093-5171-20",
"PackageDescription": "20 BLISTER PACK in 1 PACKAGE (0093-5171-20) > 1 TABLET in 1 BLISTER PACK (0093-5171-19)",
"NDC11Code": "00093-5171-20",
"ProductNDC": "0093-5171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075710",
"LabelerName": "Teva Pharmaceuticals USA Inc",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-09-05"
},
{
"NDCCode": "0093-5171-29",
"PackageDescription": "12 BLISTER PACK in 1 PACKAGE (0093-5171-29) > 1 TABLET in 1 BLISTER PACK (0093-5171-19)",
"NDC11Code": "00093-5171-29",
"ProductNDC": "0093-5171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080206",
"EndMarketingDate": "20180531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075710",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-06-01",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "0093-3098-44",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (0093-3098-44) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19) ",
"NDC11Code": "00093-3098-44",
"ProductNDC": "0093-3098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risedronate Sodium",
"NonProprietaryName": "Risedronate Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077132",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "RISEDRONATE SODIUM MONOHYDRATE",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150601",
"SamplePackage": "N",
"IndicationAndUsage": "Risedronate sodium tablets are a bisphosphonate indicated for: : 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2) , 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3) , 4 Treatment of Paget’s disease (1.4).",
"Description": "Risedronate sodium tablets, USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 5, 30, or 35 mg of anhydrous risedronate sodium, USP in the form of the monohydrate. The chemical name of risedronate sodium, USP is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium monohydrate, USP is the following. C7H10NO7P2NaH2O M.W. Monohydrate: 323.10 Anhydrous: 305.10. Risedronate sodium monohydrate, USP is a white to off-white powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients. Colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized corn starch, sodium stearyl fumarate, and titanium dioxide. Additionally, the 5 mg tablets contain D&C yellow #10 lake, iron oxide yellow, and polysorbate 80; the 30 mg tablets contain polysorbate 80; and the 35 mg tablets contain FD&C yellow #6 aluminum lake, iron oxide yellow, iron oxide red, and polysorbate 80."
},
{
"NDCCode": "0093-5172-44",
"PackageDescription": "4 BLISTER PACK in 1 BOX (0093-5172-44) > 1 TABLET in 1 BLISTER PACK (0093-5172-19)",
"NDC11Code": "00093-5172-44",
"ProductNDC": "0093-5172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080206",
"EndMarketingDate": "20171231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075710",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0093-5509-44",
"PackageDescription": "4 BLISTER PACK in 1 BOX, UNIT-DOSE (0093-5509-44) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0093-5509-19)",
"NDC11Code": "00093-5509-44",
"ProductNDC": "0093-5509",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risedronate Sodium",
"NonProprietaryName": "Risedronate Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203217",
"LabelerName": "Teva Pharmaceuticals USA Inc",
"SubstanceName": "RISEDRONATE SODIUM MONOHYDRATE",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0093-8210-62",
"PackageDescription": "3 POUCH in 1 CARTON (0093-8210-62) / 1 BLISTER PACK in 1 POUCH (0093-8210-28) / 1 KIT in 1 BLISTER PACK * 24 TABLET, CHEWABLE in 1 BLISTER PACK (0093-3476-38) * 4 TABLET in 1 BLISTER PACK (0093-3525-44) ",
"NDC11Code": "00093-8210-62",
"ProductNDC": "0093-8210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finzala",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20220804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210087",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220804",
"SamplePackage": "N",
"IndicationAndUsage": "Finzala is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. .",
"Description": "Finzala® (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/20 mcg and ferrous fumarate tablets) provide an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: 1 24 white, round, flat-faced, beveled-edge, unscored tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. , 2 4 brown, round, flat-faced, beveled-edge, unscored tablets each containing 75 mg ferrous fumarate, USP."
},
{
"NDCCode": "0406-0093-44",
"PackageDescription": "50 kg in 1 DRUM (0406-0093-44) ",
"NDC11Code": "00406-0093-44",
"ProductNDC": "0406-0093",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen Anhydrous Basis",
"DosageFormName": "POWDER",
"StartMarketingDate": "19821220",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "SpecGx LLC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": ".9",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-07-27",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20-DEC-82"
},
{
"NDCCode": "62756-093-44",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (62756-093-44) > 1 mL in 1 VIAL, SINGLE-DOSE (62756-093-40)",
"NDC11Code": "62756-0093-44",
"ProductNDC": "62756-093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Octreotide Acetate",
"NonProprietaryName": "Octreotide Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20120831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077372",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "OCTREOTIDE ACETATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-02-17"
},
{
"NDCCode": "0093-3219-15",
"PackageDescription": "1 TUBE in 1 CARTON (0093-3219-15) > 15 g in 1 TUBE",
"NDC11Code": "00093-3219-15",
"ProductNDC": "0093-3219",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketoconazole",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075581",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190208",
"SamplePackage": "N",
"IndicationAndUsage": "Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); and in the treatment of cutaneous candidiasis caused by Candida spp.",
"Description": "Ketoconazole Cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%. Each gram, for topical administration, contains ketoconazole 20 mg and is formulated in an aqueous cream vehicle consisting of propylene glycol, purified water, cetyl alcohol, stearyl alcohol, isopropyl myristate, sorbitan monostearate, polysorbate 60, polysorbate 80, and sodium sulfite, anhydrous. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula. C26H28Cl2N4O4 M.W. 531.44."
},
{
"NDCCode": "0093-3219-30",
"PackageDescription": "1 TUBE in 1 CARTON (0093-3219-30) > 30 g in 1 TUBE",
"NDC11Code": "00093-3219-30",
"ProductNDC": "0093-3219",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketoconazole",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075581",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190208",
"SamplePackage": "N",
"IndicationAndUsage": "Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); and in the treatment of cutaneous candidiasis caused by Candida spp.",
"Description": "Ketoconazole Cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%. Each gram, for topical administration, contains ketoconazole 20 mg and is formulated in an aqueous cream vehicle consisting of propylene glycol, purified water, cetyl alcohol, stearyl alcohol, isopropyl myristate, sorbitan monostearate, polysorbate 60, polysorbate 80, and sodium sulfite, anhydrous. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula. C26H28Cl2N4O4 M.W. 531.44."
},
{
"NDCCode": "0093-3219-92",
"PackageDescription": "1 TUBE in 1 CARTON (0093-3219-92) > 60 g in 1 TUBE",
"NDC11Code": "00093-3219-92",
"ProductNDC": "0093-3219",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketoconazole",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075581",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190208",
"SamplePackage": "N",
"IndicationAndUsage": "Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); and in the treatment of cutaneous candidiasis caused by Candida spp.",
"Description": "Ketoconazole Cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%. Each gram, for topical administration, contains ketoconazole 20 mg and is formulated in an aqueous cream vehicle consisting of propylene glycol, purified water, cetyl alcohol, stearyl alcohol, isopropyl myristate, sorbitan monostearate, polysorbate 60, polysorbate 80, and sodium sulfite, anhydrous. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula. C26H28Cl2N4O4 M.W. 531.44."
},
{
"NDCCode": "0093-4136-64",
"PackageDescription": "60 mL in 1 BOTTLE (0093-4136-64) ",
"NDC11Code": "00093-4136-64",
"ProductNDC": "0093-4136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefdinir",
"NonProprietaryName": "Cefdinir",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20070508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065332",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CEFDINIR MONOHYDRATE",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2024-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070508",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension, USP and other antibacterial drugs, cefdinir for oral suspension, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir for oral suspension, USP is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
"Description": "Cefdinir for oral suspension, USP contains the active ingredient cefdinir monohydrate, USP, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir monohydrate, USP is (6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. Cefdinir monohydrate, USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7 phosphate buffer. Cefdinir monohydrate, USP has the structural formula shown below. C14H13N5O5S2H2O M.W. 413.44. Cefdinir for oral suspension, USP, after reconstitution, contains 125 mg or 250 mg cefdinir per 5 mL and the following inactive ingredients: artificial cherry-mixed fruit flavor, anhydrous citric acid, colloidal silicon dioxide, guar gum, magnesium stearate, sodium benzoate, sodium citrate (anhydrous), sucrose, and xanthan gum."
},
{
"NDCCode": "0093-4136-73",
"PackageDescription": "100 mL in 1 BOTTLE (0093-4136-73) ",
"NDC11Code": "00093-4136-73",
"ProductNDC": "0093-4136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefdinir",
"NonProprietaryName": "Cefdinir",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20070508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065332",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CEFDINIR MONOHYDRATE",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2024-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070508",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension, USP and other antibacterial drugs, cefdinir for oral suspension, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir for oral suspension, USP is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
"Description": "Cefdinir for oral suspension, USP contains the active ingredient cefdinir monohydrate, USP, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir monohydrate, USP is (6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. Cefdinir monohydrate, USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7 phosphate buffer. Cefdinir monohydrate, USP has the structural formula shown below. C14H13N5O5S2H2O M.W. 413.44. Cefdinir for oral suspension, USP, after reconstitution, contains 125 mg or 250 mg cefdinir per 5 mL and the following inactive ingredients: artificial cherry-mixed fruit flavor, anhydrous citric acid, colloidal silicon dioxide, guar gum, magnesium stearate, sodium benzoate, sodium citrate (anhydrous), sucrose, and xanthan gum."
},
{
"NDCCode": "0093-4137-64",
"PackageDescription": "60 mL in 1 BOTTLE (0093-4137-64) ",
"NDC11Code": "00093-4137-64",
"ProductNDC": "0093-4137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefdinir",
"NonProprietaryName": "Cefdinir",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20070508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065332",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CEFDINIR MONOHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2024-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070508",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension, USP and other antibacterial drugs, cefdinir for oral suspension, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir for oral suspension, USP is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
"Description": "Cefdinir for oral suspension, USP contains the active ingredient cefdinir monohydrate, USP, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir monohydrate, USP is (6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. Cefdinir monohydrate, USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7 phosphate buffer. Cefdinir monohydrate, USP has the structural formula shown below. C14H13N5O5S2H2O M.W. 413.44. Cefdinir for oral suspension, USP, after reconstitution, contains 125 mg or 250 mg cefdinir per 5 mL and the following inactive ingredients: artificial cherry-mixed fruit flavor, anhydrous citric acid, colloidal silicon dioxide, guar gum, magnesium stearate, sodium benzoate, sodium citrate (anhydrous), sucrose, and xanthan gum."
},
{
"NDCCode": "0093-4137-73",
"PackageDescription": "100 mL in 1 BOTTLE (0093-4137-73) ",
"NDC11Code": "00093-4137-73",
"ProductNDC": "0093-4137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefdinir",
"NonProprietaryName": "Cefdinir",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20070508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065332",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CEFDINIR MONOHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2024-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070508",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension, USP and other antibacterial drugs, cefdinir for oral suspension, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir for oral suspension, USP is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
"Description": "Cefdinir for oral suspension, USP contains the active ingredient cefdinir monohydrate, USP, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir monohydrate, USP is (6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. Cefdinir monohydrate, USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7 phosphate buffer. Cefdinir monohydrate, USP has the structural formula shown below. C14H13N5O5S2H2O M.W. 413.44. Cefdinir for oral suspension, USP, after reconstitution, contains 125 mg or 250 mg cefdinir per 5 mL and the following inactive ingredients: artificial cherry-mixed fruit flavor, anhydrous citric acid, colloidal silicon dioxide, guar gum, magnesium stearate, sodium benzoate, sodium citrate (anhydrous), sucrose, and xanthan gum."
},
{
"NDCCode": "0093-4145-56",
"PackageDescription": "6 POUCH in 1 CARTON (0093-4145-56) > 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4145-45) > 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00093-4145-56",
"ProductNDC": "0093-4145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol",
"NonProprietaryName": "Levalbuterol",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090297",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
"StrengthNumber": ".31",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-10-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190107",
"SamplePackage": "N",
"IndicationAndUsage": "Levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
"Description": "Levalbuterol Inhalation Solution USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 188°C and is soluble in water and slightly soluble in ethanol. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg (0.0103%) of levalbuterol (as 0.36 mg of levalbuterol HCl) or 0.63 mg (0.021%) of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg (0.042%) of levalbuterol (as 1.44 mg of levalbuterol HCl), sodium chloride to adjust tonicity, 0.33 mg of edetate disodium dihydrate, 6 mg of trisodium citrate dihydrate and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5)."
},
{
"NDCCode": "0093-4146-56",
"PackageDescription": "6 POUCH in 1 CARTON (0093-4146-56) > 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4146-45) > 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00093-4146-56",
"ProductNDC": "0093-4146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol",
"NonProprietaryName": "Levalbuterol",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090297",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
"StrengthNumber": ".63",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-10-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190107",
"SamplePackage": "N",
"IndicationAndUsage": "Levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
"Description": "Levalbuterol Inhalation Solution USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 188°C and is soluble in water and slightly soluble in ethanol. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg (0.0103%) of levalbuterol (as 0.36 mg of levalbuterol HCl) or 0.63 mg (0.021%) of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg (0.042%) of levalbuterol (as 1.44 mg of levalbuterol HCl), sodium chloride to adjust tonicity, 0.33 mg of edetate disodium dihydrate, 6 mg of trisodium citrate dihydrate and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5)."
},
{
"NDCCode": "0093-4147-56",
"PackageDescription": "30 POUCH in 1 CARTON (0093-4147-56) > 1 VIAL, SINGLE-DOSE in 1 POUCH (0093-4147-19) > .5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00093-4147-56",
"ProductNDC": "0093-4147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol",
"NonProprietaryName": "Levalbuterol",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20141216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200875",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20141216",
"SamplePackage": "N",
"IndicationAndUsage": "Levalbuterol inhalation solution (concentrate) is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
"Description": "Levalbuterol Inhalation Solution USP (Concentrate) is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol hydrochloride, USP is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol hydrochloride, USP is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol hydrochloride, USP is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 188°C and is soluble in water and slightly soluble in ethanol. Levalbuterol hydrochloride, USP is the USAN modified name for (R)-albuterol hydrochloride in the United States. Levalbuterol Inhalation Solution USP (Concentrate) is supplied in 0.5 mL unit-dose vials that must be diluted with normal saline before administration by nebulization. Each 0.5 mL unit-dose vial contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol hydrochloride, USP), 4 mg sodium chloride to adjust tonicity, and 0.055 mg edetate sodium dihydrate, 1 mg of trisodium citrate dihydrate, and sulfuric acid to adjust pH to 4.0 (3.3 to 4.5)."
},
{
"NDCCode": "0093-4148-56",
"PackageDescription": "6 POUCH in 1 CARTON (0093-4148-56) > 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4148-45) > 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00093-4148-56",
"ProductNDC": "0093-4148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol",
"NonProprietaryName": "Levalbuterol",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090297",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-10-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190107",
"SamplePackage": "N",
"IndicationAndUsage": "Levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
"Description": "Levalbuterol Inhalation Solution USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 188°C and is soluble in water and slightly soluble in ethanol. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg (0.0103%) of levalbuterol (as 0.36 mg of levalbuterol HCl) or 0.63 mg (0.021%) of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg (0.042%) of levalbuterol (as 1.44 mg of levalbuterol HCl), sodium chloride to adjust tonicity, 0.33 mg of edetate disodium dihydrate, 6 mg of trisodium citrate dihydrate and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5)."
},
{
"NDCCode": "0093-5245-65",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (0093-5245-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5245-19) ",
"NDC11Code": "00093-5245-65",
"ProductNDC": "0093-5245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20120217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077243",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120217",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1).",
"Description": "Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine and has the following chemical structure:. C17H20N4S M.W. 312.44. Olanzapine, USP is a yellow crystalline powder, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg (16 micromol), 10 mg (32 micromol), 15 mg (48 micromol) or 20 mg (64 micromol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, sodium stearyl fumarate, strawberry flavor and xylitol. Meets USP Disintegration Test 2."
},
{
"NDCCode": "0093-5246-65",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (0093-5246-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5246-19) ",
"NDC11Code": "00093-5246-65",
"ProductNDC": "0093-5246",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20120217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077243",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120217",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1).",
"Description": "Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine and has the following chemical structure:. C17H20N4S M.W. 312.44. Olanzapine, USP is a yellow crystalline powder, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg (16 micromol), 10 mg (32 micromol), 15 mg (48 micromol) or 20 mg (64 micromol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, sodium stearyl fumarate, strawberry flavor and xylitol. Meets USP Disintegration Test 2."
},
{
"NDCCode": "0093-5247-65",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (0093-5247-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5247-19) ",
"NDC11Code": "00093-5247-65",
"ProductNDC": "0093-5247",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20120124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077243",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120224",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1).",
"Description": "Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine and has the following chemical structure:. C17H20N4S M.W. 312.44. Olanzapine, USP is a yellow crystalline powder, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg (16 micromol), 10 mg (32 micromol), 15 mg (48 micromol) or 20 mg (64 micromol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, sodium stearyl fumarate, strawberry flavor and xylitol. Meets USP Disintegration Test 2."
},
{
"NDCCode": "0093-5248-65",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (0093-5248-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5248-19) ",
"NDC11Code": "00093-5248-65",
"ProductNDC": "0093-5248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20120124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077243",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120224",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1).",
"Description": "Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine and has the following chemical structure:. C17H20N4S M.W. 312.44. Olanzapine, USP is a yellow crystalline powder, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg (16 micromol), 10 mg (32 micromol), 15 mg (48 micromol) or 20 mg (64 micromol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, sodium stearyl fumarate, strawberry flavor and xylitol. Meets USP Disintegration Test 2."
},
{
"NDCCode": "0093-5503-56",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0093-5503-56) ",
"NDC11Code": "00093-5503-56",
"ProductNDC": "0093-5503",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine And Fluoxetine",
"NonProprietaryName": "Olanzapine And Fluoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202074",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "OLANZAPINE; FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "3; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130410",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]., 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].",
"Description": "Olanzapine and Fluoxetine Capsules, USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa®, and Zyprexa® Zydis®) and fluoxetine hydrochloride, USP (the active ingredient in Prozac® and Sarafem®). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The chemical structures are. C17H20N4S M.W. 312.44. C17H18F3NOHCl M.W. 345.79. Olanzapine, USP is a pale yellow to yellow crystalline powder, which is practically insoluble in water. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40."
},
{
"NDCCode": "0093-5504-56",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0093-5504-56) ",
"NDC11Code": "00093-5504-56",
"ProductNDC": "0093-5504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine And Fluoxetine",
"NonProprietaryName": "Olanzapine And Fluoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077528",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "OLANZAPINE; FLUOXETINE HYDROCHLORIDE",
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"Description": "Olanzapine and Fluoxetine Capsules, USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa®, and Zyprexa® Zydis®) and fluoxetine hydrochloride, USP (the active ingredient in Prozac® and Sarafem®). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The chemical structures are. C17H20N4S M.W. 312.44. C17H18F3NOHCl M.W. 345.79. Olanzapine, USP is a pale yellow to yellow crystalline powder, which is practically insoluble in water. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40."
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{
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"Description": "Olanzapine and Fluoxetine Capsules, USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa®, and Zyprexa® Zydis®) and fluoxetine hydrochloride, USP (the active ingredient in Prozac® and Sarafem®). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The chemical structures are. C17H20N4S M.W. 312.44. C17H18F3NOHCl M.W. 345.79. Olanzapine, USP is a pale yellow to yellow crystalline powder, which is practically insoluble in water. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40."
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"Description": "Olanzapine and Fluoxetine Capsules, USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa®, and Zyprexa® Zydis®) and fluoxetine hydrochloride, USP (the active ingredient in Prozac® and Sarafem®). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The chemical structures are. C17H20N4S M.W. 312.44. C17H18F3NOHCl M.W. 345.79. Olanzapine, USP is a pale yellow to yellow crystalline powder, which is practically insoluble in water. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40."
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{
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"RouteName": "TOPICAL",
"StartMarketingDate": "20230217",
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"LabelerName": "Teva Pharmaceuticals USA, Inc.",
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"IndicationAndUsage": "Doxepin hydrochloride cream, 5% is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus (see DOSAGE AND ADMINISTRATION).",
"Description": "Doxepin hydrochloride cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride, USP (equivalent to 44.3 mg of doxepin). Doxepin hydrochloride, USP is one of a class of agents known as dibenzoxepin tricyclic antidepressant compounds. It is an isomeric mixture of N,N-dimethyldibenz[b,e]oxepin-∆11(6H),γ-propylaminehydrochloride. Doxepin hydrochloride, USP has a molecular formula of C19H21NOHCl and a molecular weight of 315.84. Doxepin hydrochloride cream, 5% is a white cream and contains the following inactive ingredients: sorbitol solution, cetyl alcohol, isopropyl myristate, glyceryl stearate, PEG-100 stearate, white petrolatum, benzyl alcohol, titanium dioxide, and purified water."
}
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<StartMarketingDatePackage>20220804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Finzala is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. .</IndicationAndUsage>
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<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>.9</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-07-27</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-DEC-82</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>62756-093-44</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 PACKAGE (62756-093-44) > 1 mL in 1 VIAL, SINGLE-DOSE (62756-093-40)</PackageDescription>
<NDC11Code>62756-0093-44</NDC11Code>
<ProductNDC>62756-093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Octreotide Acetate</ProprietaryName>
<NonProprietaryName>Octreotide Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20120831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077372</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>OCTREOTIDE ACETATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>0093-3219-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0093-3219-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00093-3219-15</NDC11Code>
<ProductNDC>0093-3219</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketoconazole</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075581</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); and in the treatment of cutaneous candidiasis caused by Candida spp.</IndicationAndUsage>
<Description>Ketoconazole Cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%. Each gram, for topical administration, contains ketoconazole 20 mg and is formulated in an aqueous cream vehicle consisting of propylene glycol, purified water, cetyl alcohol, stearyl alcohol, isopropyl myristate, sorbitan monostearate, polysorbate 60, polysorbate 80, and sodium sulfite, anhydrous. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula. C26H28Cl2N4O4 M.W. 531.44.</Description>
</NDC>
<NDC>
<NDCCode>0093-3219-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0093-3219-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>00093-3219-30</NDC11Code>
<ProductNDC>0093-3219</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketoconazole</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075581</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); and in the treatment of cutaneous candidiasis caused by Candida spp.</IndicationAndUsage>
<Description>Ketoconazole Cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%. Each gram, for topical administration, contains ketoconazole 20 mg and is formulated in an aqueous cream vehicle consisting of propylene glycol, purified water, cetyl alcohol, stearyl alcohol, isopropyl myristate, sorbitan monostearate, polysorbate 60, polysorbate 80, and sodium sulfite, anhydrous. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula. C26H28Cl2N4O4 M.W. 531.44.</Description>
</NDC>
<NDC>
<NDCCode>0093-3219-92</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0093-3219-92) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>00093-3219-92</NDC11Code>
<ProductNDC>0093-3219</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketoconazole</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075581</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); and in the treatment of cutaneous candidiasis caused by Candida spp.</IndicationAndUsage>
<Description>Ketoconazole Cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%. Each gram, for topical administration, contains ketoconazole 20 mg and is formulated in an aqueous cream vehicle consisting of propylene glycol, purified water, cetyl alcohol, stearyl alcohol, isopropyl myristate, sorbitan monostearate, polysorbate 60, polysorbate 80, and sodium sulfite, anhydrous. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula. C26H28Cl2N4O4 M.W. 531.44.</Description>
</NDC>
<NDC>
<NDCCode>0093-4136-64</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (0093-4136-64) </PackageDescription>
<NDC11Code>00093-4136-64</NDC11Code>
<ProductNDC>0093-4136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefdinir</ProprietaryName>
<NonProprietaryName>Cefdinir</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065332</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>CEFDINIR MONOHYDRATE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension, USP and other antibacterial drugs, cefdinir for oral suspension, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir for oral suspension, USP is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.</IndicationAndUsage>
<Description>Cefdinir for oral suspension, USP contains the active ingredient cefdinir monohydrate, USP, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir monohydrate, USP is (6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. Cefdinir monohydrate, USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7 phosphate buffer. Cefdinir monohydrate, USP has the structural formula shown below. C14H13N5O5S2H2O M.W. 413.44. Cefdinir for oral suspension, USP, after reconstitution, contains 125 mg or 250 mg cefdinir per 5 mL and the following inactive ingredients: artificial cherry-mixed fruit flavor, anhydrous citric acid, colloidal silicon dioxide, guar gum, magnesium stearate, sodium benzoate, sodium citrate (anhydrous), sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0093-4136-73</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (0093-4136-73) </PackageDescription>
<NDC11Code>00093-4136-73</NDC11Code>
<ProductNDC>0093-4136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefdinir</ProprietaryName>
<NonProprietaryName>Cefdinir</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065332</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>CEFDINIR MONOHYDRATE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension, USP and other antibacterial drugs, cefdinir for oral suspension, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir for oral suspension, USP is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.</IndicationAndUsage>
<Description>Cefdinir for oral suspension, USP contains the active ingredient cefdinir monohydrate, USP, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir monohydrate, USP is (6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. Cefdinir monohydrate, USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7 phosphate buffer. Cefdinir monohydrate, USP has the structural formula shown below. C14H13N5O5S2H2O M.W. 413.44. Cefdinir for oral suspension, USP, after reconstitution, contains 125 mg or 250 mg cefdinir per 5 mL and the following inactive ingredients: artificial cherry-mixed fruit flavor, anhydrous citric acid, colloidal silicon dioxide, guar gum, magnesium stearate, sodium benzoate, sodium citrate (anhydrous), sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0093-4137-64</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (0093-4137-64) </PackageDescription>
<NDC11Code>00093-4137-64</NDC11Code>
<ProductNDC>0093-4137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefdinir</ProprietaryName>
<NonProprietaryName>Cefdinir</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065332</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>CEFDINIR MONOHYDRATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension, USP and other antibacterial drugs, cefdinir for oral suspension, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir for oral suspension, USP is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.</IndicationAndUsage>
<Description>Cefdinir for oral suspension, USP contains the active ingredient cefdinir monohydrate, USP, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir monohydrate, USP is (6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. Cefdinir monohydrate, USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7 phosphate buffer. Cefdinir monohydrate, USP has the structural formula shown below. C14H13N5O5S2H2O M.W. 413.44. Cefdinir for oral suspension, USP, after reconstitution, contains 125 mg or 250 mg cefdinir per 5 mL and the following inactive ingredients: artificial cherry-mixed fruit flavor, anhydrous citric acid, colloidal silicon dioxide, guar gum, magnesium stearate, sodium benzoate, sodium citrate (anhydrous), sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0093-4137-73</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (0093-4137-73) </PackageDescription>
<NDC11Code>00093-4137-73</NDC11Code>
<ProductNDC>0093-4137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefdinir</ProprietaryName>
<NonProprietaryName>Cefdinir</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065332</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>CEFDINIR MONOHYDRATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension, USP and other antibacterial drugs, cefdinir for oral suspension, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir for oral suspension, USP is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.</IndicationAndUsage>
<Description>Cefdinir for oral suspension, USP contains the active ingredient cefdinir monohydrate, USP, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir monohydrate, USP is (6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. Cefdinir monohydrate, USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7 phosphate buffer. Cefdinir monohydrate, USP has the structural formula shown below. C14H13N5O5S2H2O M.W. 413.44. Cefdinir for oral suspension, USP, after reconstitution, contains 125 mg or 250 mg cefdinir per 5 mL and the following inactive ingredients: artificial cherry-mixed fruit flavor, anhydrous citric acid, colloidal silicon dioxide, guar gum, magnesium stearate, sodium benzoate, sodium citrate (anhydrous), sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0093-4145-56</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0093-4145-56) > 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4145-45) > 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00093-4145-56</NDC11Code>
<ProductNDC>0093-4145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levalbuterol</ProprietaryName>
<NonProprietaryName>Levalbuterol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20130429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090297</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.31</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-10-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>Levalbuterol Inhalation Solution USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 188°C and is soluble in water and slightly soluble in ethanol. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg (0.0103%) of levalbuterol (as 0.36 mg of levalbuterol HCl) or 0.63 mg (0.021%) of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg (0.042%) of levalbuterol (as 1.44 mg of levalbuterol HCl), sodium chloride to adjust tonicity, 0.33 mg of edetate disodium dihydrate, 6 mg of trisodium citrate dihydrate and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).</Description>
</NDC>
<NDC>
<NDCCode>0093-4146-56</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0093-4146-56) > 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4146-45) > 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00093-4146-56</NDC11Code>
<ProductNDC>0093-4146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levalbuterol</ProprietaryName>
<NonProprietaryName>Levalbuterol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20130429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090297</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.63</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-10-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>Levalbuterol Inhalation Solution USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 188°C and is soluble in water and slightly soluble in ethanol. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg (0.0103%) of levalbuterol (as 0.36 mg of levalbuterol HCl) or 0.63 mg (0.021%) of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg (0.042%) of levalbuterol (as 1.44 mg of levalbuterol HCl), sodium chloride to adjust tonicity, 0.33 mg of edetate disodium dihydrate, 6 mg of trisodium citrate dihydrate and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).</Description>
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<StartMarketingDate>20141216</StartMarketingDate>
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<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
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<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-16</LastUpdate>
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<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levalbuterol inhalation solution (concentrate) is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>Levalbuterol Inhalation Solution USP (Concentrate) is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol hydrochloride, USP is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol hydrochloride, USP is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol hydrochloride, USP is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 188°C and is soluble in water and slightly soluble in ethanol. Levalbuterol hydrochloride, USP is the USAN modified name for (R)-albuterol hydrochloride in the United States. Levalbuterol Inhalation Solution USP (Concentrate) is supplied in 0.5 mL unit-dose vials that must be diluted with normal saline before administration by nebulization. Each 0.5 mL unit-dose vial contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol hydrochloride, USP), 4 mg sodium chloride to adjust tonicity, and 0.055 mg edetate sodium dihydrate, 1 mg of trisodium citrate dihydrate, and sulfuric acid to adjust pH to 4.0 (3.3 to 4.5).</Description>
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<RouteName>RESPIRATORY (INHALATION)</RouteName>
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<ApplicationNumber>ANDA090297</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-10-21</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>Levalbuterol Inhalation Solution USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 188°C and is soluble in water and slightly soluble in ethanol. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg (0.0103%) of levalbuterol (as 0.36 mg of levalbuterol HCl) or 0.63 mg (0.021%) of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg (0.042%) of levalbuterol (as 1.44 mg of levalbuterol HCl), sodium chloride to adjust tonicity, 0.33 mg of edetate disodium dihydrate, 6 mg of trisodium citrate dihydrate and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).</Description>
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<PackageDescription>30 BLISTER PACK in 1 CARTON (0093-5245-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5245-19) </PackageDescription>
<NDC11Code>00093-5245-65</NDC11Code>
<ProductNDC>0093-5245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077243</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
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<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1).</IndicationAndUsage>
<Description>Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine and has the following chemical structure:. C17H20N4S M.W. 312.44. Olanzapine, USP is a yellow crystalline powder, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg (16 micromol), 10 mg (32 micromol), 15 mg (48 micromol) or 20 mg (64 micromol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, sodium stearyl fumarate, strawberry flavor and xylitol. Meets USP Disintegration Test 2.</Description>
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<PackageDescription>30 BLISTER PACK in 1 CARTON (0093-5246-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5246-19) </PackageDescription>
<NDC11Code>00093-5246-65</NDC11Code>
<ProductNDC>0093-5246</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077243</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1).</IndicationAndUsage>
<Description>Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine and has the following chemical structure:. C17H20N4S M.W. 312.44. Olanzapine, USP is a yellow crystalline powder, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg (16 micromol), 10 mg (32 micromol), 15 mg (48 micromol) or 20 mg (64 micromol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, sodium stearyl fumarate, strawberry flavor and xylitol. Meets USP Disintegration Test 2.</Description>
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<PackageDescription>30 BLISTER PACK in 1 CARTON (0093-5247-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5247-19) </PackageDescription>
<NDC11Code>00093-5247-65</NDC11Code>
<ProductNDC>0093-5247</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077243</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1).</IndicationAndUsage>
<Description>Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine and has the following chemical structure:. C17H20N4S M.W. 312.44. Olanzapine, USP is a yellow crystalline powder, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg (16 micromol), 10 mg (32 micromol), 15 mg (48 micromol) or 20 mg (64 micromol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, sodium stearyl fumarate, strawberry flavor and xylitol. Meets USP Disintegration Test 2.</Description>
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<NDCCode>0093-5248-65</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (0093-5248-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5248-19) </PackageDescription>
<NDC11Code>00093-5248-65</NDC11Code>
<ProductNDC>0093-5248</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077243</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1).</IndicationAndUsage>
<Description>Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine and has the following chemical structure:. C17H20N4S M.W. 312.44. Olanzapine, USP is a yellow crystalline powder, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg (16 micromol), 10 mg (32 micromol), 15 mg (48 micromol) or 20 mg (64 micromol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, sodium stearyl fumarate, strawberry flavor and xylitol. Meets USP Disintegration Test 2.</Description>
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<NDC>
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<PackageDescription>30 CAPSULE in 1 BOTTLE (0093-5503-56) </PackageDescription>
<NDC11Code>00093-5503-56</NDC11Code>
<ProductNDC>0093-5503</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName>
<NonProprietaryName>Olanzapine And Fluoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202074</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>OLANZAPINE; FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]., 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Olanzapine and Fluoxetine Capsules, USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa®, and Zyprexa® Zydis®) and fluoxetine hydrochloride, USP (the active ingredient in Prozac® and Sarafem®). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The chemical structures are. C17H20N4S M.W. 312.44. C17H18F3NOHCl M.W. 345.79. Olanzapine, USP is a pale yellow to yellow crystalline powder, which is practically insoluble in water. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40.</Description>
</NDC>
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<PackageDescription>30 CAPSULE in 1 BOTTLE (0093-5504-56) </PackageDescription>
<NDC11Code>00093-5504-56</NDC11Code>
<ProductNDC>0093-5504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName>
<NonProprietaryName>Olanzapine And Fluoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077528</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>OLANZAPINE; FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]., 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Olanzapine and Fluoxetine Capsules, USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa®, and Zyprexa® Zydis®) and fluoxetine hydrochloride, USP (the active ingredient in Prozac® and Sarafem®). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The chemical structures are. C17H20N4S M.W. 312.44. C17H18F3NOHCl M.W. 345.79. Olanzapine, USP is a pale yellow to yellow crystalline powder, which is practically insoluble in water. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40.</Description>
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<PackageDescription>30 CAPSULE in 1 BOTTLE (0093-5505-56) </PackageDescription>
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<ProductNDC>0093-5505</ProductNDC>
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<ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName>
<NonProprietaryName>Olanzapine And Fluoxetine</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20120619</StartMarketingDate>
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<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
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<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]., 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Olanzapine and Fluoxetine Capsules, USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa®, and Zyprexa® Zydis®) and fluoxetine hydrochloride, USP (the active ingredient in Prozac® and Sarafem®). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The chemical structures are. C17H20N4S M.W. 312.44. C17H18F3NOHCl M.W. 345.79. Olanzapine, USP is a pale yellow to yellow crystalline powder, which is practically insoluble in water. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40.</Description>
</NDC>
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<NDCCode>0093-5506-56</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0093-5506-56) </PackageDescription>
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<ProductNDC>0093-5506</ProductNDC>
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<ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName>
<NonProprietaryName>Olanzapine And Fluoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077528</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
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<StrengthNumber>12; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]., 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Olanzapine and Fluoxetine Capsules, USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa®, and Zyprexa® Zydis®) and fluoxetine hydrochloride, USP (the active ingredient in Prozac® and Sarafem®). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The chemical structures are. C17H20N4S M.W. 312.44. C17H18F3NOHCl M.W. 345.79. Olanzapine, USP is a pale yellow to yellow crystalline powder, which is practically insoluble in water. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40.</Description>
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<PackageDescription>30 CAPSULE in 1 BOTTLE (0093-5507-56) </PackageDescription>
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<ProductNDC>0093-5507</ProductNDC>
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<ProprietaryName>Olanzapine And Fluoxetine</ProprietaryName>
<NonProprietaryName>Olanzapine And Fluoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077528</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
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<StrengthNumber>12; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine and fluoxetine capsules are indicated for the treatment of: 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]., 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Olanzapine and Fluoxetine Capsules, USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa®, and Zyprexa® Zydis®) and fluoxetine hydrochloride, USP (the active ingredient in Prozac® and Sarafem®). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The chemical structures are. C17H20N4S M.W. 312.44. C17H18F3NOHCl M.W. 345.79. Olanzapine, USP is a pale yellow to yellow crystalline powder, which is practically insoluble in water. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations. Each capsule also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40.</Description>
</NDC>
<NDC>
<NDCCode>0093-9609-95</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0093-9609-95) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>00093-9609-95</NDC11Code>
<ProductNDC>0093-9609</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215408</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride cream, 5% is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Doxepin hydrochloride cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride, USP (equivalent to 44.3 mg of doxepin). Doxepin hydrochloride, USP is one of a class of agents known as dibenzoxepin tricyclic antidepressant compounds. It is an isomeric mixture of N,N-dimethyldibenz[b,e]oxepin-∆11(6H),γ-propylaminehydrochloride. Doxepin hydrochloride, USP has a molecular formula of C19H21NOHCl and a molecular weight of 315.84. Doxepin hydrochloride cream, 5% is a white cream and contains the following inactive ingredients: sorbitol solution, cetyl alcohol, isopropyl myristate, glyceryl stearate, PEG-100 stearate, white petrolatum, benzyl alcohol, titanium dioxide, and purified water.</Description>
</NDC>
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