{
"NDC": [
{
"NDCCode": "49702-215-18",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (49702-215-18)",
"NDC11Code": "49702-0215-18",
"ProductNDC": "49702-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Selzentry",
"NonProprietaryName": "Maraviroc",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101013",
"EndMarketingDate": "20150131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022128",
"LabelerName": "ViiV Healthcare Company",
"SubstanceName": "MARAVIROC",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-02-06"
},
{
"NDCCode": "42582-215-18",
"PackageDescription": "500 TABLET, COATED in 1 BOTTLE (42582-215-18) ",
"NDC11Code": "42582-0215-18",
"ProductNDC": "42582-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211343",
"LabelerName": "Bi-Coastal Pharma International, LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200528",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline 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.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate tablets, USP. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8 ∙H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8∙HCl)2∙C2H6O∙H2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients for the tablet formulation are: croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose PH112, polyethylene glycol, silicon dioxide, titanium dioxide and water. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "57664-215-18",
"PackageDescription": "1000 TABLET in 1 BOTTLE (57664-215-18)",
"NDC11Code": "57664-0215-18",
"ProductNDC": "57664-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078036",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-04-11",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "72865-215-18",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (72865-215-18) ",
"NDC11Code": "72865-0215-18",
"ProductNDC": "72865-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215689",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211015",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.",
"Description": "The active ingredient in famotidine tablets USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Each famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine USP and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, silicon dioxide, povidone, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide and talc. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol."
},
{
"NDCCode": "49702-202-18",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (49702-202-18) ",
"NDC11Code": "49702-0202-18",
"ProductNDC": "49702-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Combivir",
"NonProprietaryName": "Lamivudine And Zidovudine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101019",
"EndMarketingDate": "20270228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020857",
"LabelerName": "ViiV Healthcare Company",
"SubstanceName": "LAMIVUDINE; ZIDOVUDINE",
"StrengthNumber": "150; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20101019",
"EndMarketingDatePackage": "20270228",
"SamplePackage": "N",
"IndicationAndUsage": "COMBIVIR, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection.",
"Description": "COMBIVIR tablets are combination tablets containing lamivudine and zidovudine. Lamivudine (EPIVIR) and zidovudine (RETROVIR, azidothymidine, AZT, or ZDV) are synthetic nucleoside analogues with activity against HIV‑1. COMBIVIR tablets are for oral administration. Each film‑coated tablet contains 150 mg of lamivudine, 300 mg of zidovudine, and the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. Lamivudine. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (‑)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (‑)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine is a white to off‑white crystalline solid and is soluble in water. Zidovudine. The chemical name of zidovudine is 3′-azido-3′-deoxythymidine. It has a molecular formula of C10H13N5O4 and a molecular weight of 267.24 g per mol. It has the following structural formula. Zidovudine is a white to beige, odorless, crystalline solid with a solubility of 20.1 mg per mL in water at 25°C."
},
{
"NDCCode": "49702-203-18",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (49702-203-18) ",
"NDC11Code": "49702-0203-18",
"ProductNDC": "49702-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epivir",
"NonProprietaryName": "Lamivudine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101004",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020564",
"LabelerName": "ViiV Healthcare Company",
"SubstanceName": "LAMIVUDINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101004",
"SamplePackage": "N",
"IndicationAndUsage": "EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection. Limitations of Use: 1 The dosage of this product is for HIV‑1 and not for HBV.",
"Description": "EPIVIR (also known as 3TC) is a brand name for lamivudine, a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg per mL in water at 20°C. EPIVIR tablets are for oral administration. Each scored 150-mg film-coated tablet contains 150 mg of lamivudine and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. Each 300-mg film-coated tablet contains 300 mg of lamivudine and the inactive ingredients black iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. EPIVIR oral solution is for oral administration. One milliliter (1 mL) of EPIVIR oral solution contains 10 mg of lamivudine (10 mg per mL) in an aqueous solution and the inactive ingredients artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg)."
},
{
"NDCCode": "49702-207-18",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (49702-207-18) ",
"NDC11Code": "49702-0207-18",
"ProductNDC": "49702-207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lexiva",
"NonProprietaryName": "Fosamprenavir Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101004",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021548",
"LabelerName": "ViiV Healthcare Company",
"SubstanceName": "FOSAMPRENAVIR CALCIUM",
"StrengthNumber": "700",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], P-Glycoprotein Inducers [MoA], Protease Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20101004",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "LEXIVA is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. The following points should be considered when initiating therapy with LEXIVA plus ritonavir in protease inhibitor-experienced patients: 1 The protease inhibitor-experienced patient trial was not large enough to reach a definitive conclusion that LEXIVA plus ritonavir and lopinavir plus ritonavir are clinically equivalent [see Clinical Studies (14.2)]., 2 Once-daily administration of LEXIVA plus ritonavir is not recommended for adult protease inhibitor-experienced patients or any pediatric patients [see Dosage and Administration (2.2, 2.3), Clinical Studies (14.2, 14.3)]., 3 Dosing of LEXIVA plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients younger than 6 months [see Clinical Pharmacology (12.3)].",
"Description": "LEXIVA (fosamprenavir calcium) is a prodrug of amprenavir, an inhibitor of HIV protease. The chemical name of fosamprenavir calcium is (3S)-tetrahydrofuran-3-yl (1S,2R)-3-[[(4-aminophenyl) sulfonyl](isobutyl)amino]-1-benzyl-2-(phosphonooxy) propylcarbamate monocalcium salt. Fosamprenavir calcium is a single stereoisomer with the (3S)(1S,2R) configuration. It has a molecular formula of C25H34CaN3O9PS and a molecular weight of 623.7. It has the following structural formula. Fosamprenavir calcium is a white to cream-colored solid with a solubility of approximately 0.31 mg per mL in water at 25°C. LEXIVA tablets are available for oral administration in a strength of 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir). Each 700-mg tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone K30. The tablet film-coating contains the inactive ingredients hypromellose, iron oxide red, titanium dioxide, and triacetin. LEXIVA oral suspension is available in a strength of 50 mg per mL of fosamprenavir as fosamprenavir calcium equivalent to approximately 43 mg of amprenavir. LEXIVA oral suspension is a white to off-white suspension with a grape-bubblegum-peppermint flavor. Each one milliliter (1 mL) contains the inactive ingredients artificial grape-bubblegum flavor, calcium chloride dihydrate, hypromellose, methylparaben, natural peppermint flavor, polysorbate 80, propylene glycol, propylparaben, purified water, and sucralose."
},
{
"NDCCode": "49702-214-18",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (49702-214-18)",
"NDC11Code": "49702-0214-18",
"ProductNDC": "49702-214",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Retrovir",
"NonProprietaryName": "Zidovudine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101028",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020518",
"LabelerName": "ViiV Healthcare Company",
"SubstanceName": "ZIDOVUDINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-03-20"
},
{
"NDCCode": "49702-216-18",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (49702-216-18)",
"NDC11Code": "49702-0216-18",
"ProductNDC": "49702-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Selzentry",
"NonProprietaryName": "Maraviroc",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100901",
"EndMarketingDate": "20150331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022128",
"LabelerName": "ViiV Healthcare Company",
"SubstanceName": "MARAVIROC",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-04-03"
},
{
"NDCCode": "49702-217-18",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (49702-217-18) ",
"NDC11Code": "49702-0217-18",
"ProductNDC": "49702-217",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trizivir",
"NonProprietaryName": "Abacavir Sulfate, Lamivudine, And Zidovudine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101102",
"EndMarketingDate": "20241130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021205",
"LabelerName": "ViiV Healthcare Company",
"SubstanceName": "ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE",
"StrengthNumber": "300; 150; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 1A1 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20101102",
"EndMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "TRIZIVIR is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection. Limitations of Use: 1 Limited data exist on the use of TRIZIVIR alone in patients with higher baseline viral load levels (greater than 100,000 copies per mL) [see Clinical Studies (14)].",
"Description": "TRIZIVIR tablets contain the following 3 synthetic nucleoside analogues: abacavir (ZIAGEN), lamivudine (also known as EPIVIR or 3TC), and zidovudine (also known as RETROVIR, azidothymidine, or ZDV) with inhibitory activity against HIV-1. TRIZIVIR tablets are for oral administration. Each film-coated tablet contains the active ingredients 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine, and the inactive ingredients magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film (OPADRY green 03B11434) that is made of FD&C Blue No. 2, hypromellose, polyethylene glycol, titanium dioxide, and yellow iron oxide. Abacavir Sulfate: The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2H2SO4 and a molecular weight of 670.76 g per mol. It has the following structural formula. Abacavir sulfate is a white to off-white solid and soluble in water. Dosages are expressed in terms of abacavir. Lamivudine: The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine is a white to off-white crystalline solid and is soluble in water. Zidovudine: The chemical name of zidovudine is 3′-azido-3′-deoxythymidine. It has a molecular formula of C10H13N5O4 and a molecular weight of 267.24 g per mol. It has the following structural formula. Zidovudine is a white to beige, odorless, crystalline solid with a solubility of 20.1 mg per mL in water at 25°C."
},
{
"NDCCode": "49702-221-18",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (49702-221-18) ",
"NDC11Code": "49702-0221-18",
"ProductNDC": "49702-221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziagen",
"NonProprietaryName": "Abacavir Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19981229",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020977",
"LabelerName": "ViiV Healthcare Company",
"SubstanceName": "ABACAVIR SULFATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A1 Inhibitors [MoA], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19981229",
"SamplePackage": "N",
"IndicationAndUsage": "ZIAGEN tablets and oral solution, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.",
"Description": "ZIAGEN is the brand name for abacavir sulfate, a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1. The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2H2SO4 and a molecular weight of 670.76 g per mol. It has the following structural formula. Abacavir sulfate is a white to off-white solid and is soluble in water. ZIAGEN tablets are for oral administration. Each tablet contains abacavir sulfate equivalent to 300 mg of abacavir as active ingredient and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film that is made of hypromellose, polysorbate 80, synthetic yellow iron oxide, titanium dioxide, and triacetin. ZIAGEN oral solution is for oral administration. Each milliliter (1 mL) of ZIAGEN oral solution contains abacavir sulfate equivalent to 20 mg of abacavir (i.e., 20 mg per mL) as active ingredient and the following inactive ingredients: artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben and propylparaben (added as preservatives), propylene glycol, saccharin sodium, sodium citrate (dihydrate), sorbitol solution, and water. In vivo, abacavir sulfate dissociates to its free base, abacavir. Dosages are expressed in terms of abacavir."
},
{
"NDCCode": "49702-223-18",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (49702-223-18) ",
"NDC11Code": "49702-0223-18",
"ProductNDC": "49702-223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Selzentry",
"NonProprietaryName": "Maraviroc",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110516",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022128",
"LabelerName": "ViiV Healthcare Company",
"SubstanceName": "MARAVIROC",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "CCR5 Co-receptor Antagonist [EPC], Chemokine Co-receptor 5 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110516",
"SamplePackage": "N",
"IndicationAndUsage": "SELZENTRY is indicated in combination with other antiretroviral agents for the treatment of only CCR5‑tropic human immunodeficiency virus type 1 (HIV‑1) infection in adult and pediatric patients weighing at least 2 kg. Limitations of Use: 1 SELZENTRY is not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1 [see Microbiology (12.4)].",
"Description": "SELZENTRY (maraviroc) is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells. SELZENTRY film-coated tablets for oral administration contain 25, 75, 150, or 300 mg of maraviroc and the following inactive ingredients: dibasic calcium phosphate (anhydrous), magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coat (Opadry II Blue [85G20583]) contains FD&C blue #2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide. SELZENTRY oral solution contains 20 mg per mL of maraviroc and the following inactive ingredients: citric acid (anhydrous), purified water, sodium benzoate, sodium citrate dihydrate, strawberry flavoring (501440T), and sucralose. Maraviroc is chemically described as 4,4-difluoro-N-{(1S)-3-[exo-3-(3-isopropyl-5-methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1-phenylpropyl}cyclohexanecarboxamide. The molecular formula is C29H41F2N5O and the structural formula is. Maraviroc is a white to pale-colored powder with a molecular weight of 513.67. It is highly soluble across the physiological pH range (pH 1.0 to 7.5)."
},
{
"NDCCode": "49702-224-18",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (49702-224-18) ",
"NDC11Code": "49702-0224-18",
"ProductNDC": "49702-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Selzentry",
"NonProprietaryName": "Maraviroc",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110516",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022128",
"LabelerName": "ViiV Healthcare Company",
"SubstanceName": "MARAVIROC",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "CCR5 Co-receptor Antagonist [EPC], Chemokine Co-receptor 5 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110516",
"SamplePackage": "N",
"IndicationAndUsage": "SELZENTRY is indicated in combination with other antiretroviral agents for the treatment of only CCR5‑tropic human immunodeficiency virus type 1 (HIV‑1) infection in adult and pediatric patients weighing at least 2 kg. Limitations of Use: 1 SELZENTRY is not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1 [see Microbiology (12.4)].",
"Description": "SELZENTRY (maraviroc) is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells. SELZENTRY film-coated tablets for oral administration contain 25, 75, 150, or 300 mg of maraviroc and the following inactive ingredients: dibasic calcium phosphate (anhydrous), magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coat (Opadry II Blue [85G20583]) contains FD&C blue #2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide. SELZENTRY oral solution contains 20 mg per mL of maraviroc and the following inactive ingredients: citric acid (anhydrous), purified water, sodium benzoate, sodium citrate dihydrate, strawberry flavoring (501440T), and sucralose. Maraviroc is chemically described as 4,4-difluoro-N-{(1S)-3-[exo-3-(3-isopropyl-5-methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1-phenylpropyl}cyclohexanecarboxamide. The molecular formula is C29H41F2N5O and the structural formula is. Maraviroc is a white to pale-colored powder with a molecular weight of 513.67. It is highly soluble across the physiological pH range (pH 1.0 to 7.5)."
},
{
"NDCCode": "49702-250-18",
"PackageDescription": "1 BOTTLE in 1 CARTON (49702-250-18) / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "49702-0250-18",
"ProductNDC": "49702-250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rukobia",
"NonProprietaryName": "Fostemsavir Tromethamine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200702",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212950",
"LabelerName": "ViiV Healthcare Company",
"SubstanceName": "FOSTEMSAVIR TROMETHAMINE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200702",
"SamplePackage": "N",
"IndicationAndUsage": "RUKOBIA, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations [see Clinical Studies (14)].",
"Description": "Fostemsavir tromethamine is a prodrug of temsavir, an HIV-1 gp120-directed attachment inhibitor. The chemical name of fostemsavir tromethamine is (3-((4-benzoyl-1-piperazinyl)(oxo)acetyl)-4-methoxy-7-(3-methyl-1H-1,2,4-triazol-1-yl)-1H-pyrrolo[2,3-c]pyridin-1-yl)methyl dihydrogen phosphate, 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). The empirical formula is C25H26N7O8PC4H11NO3. The molecular weight is 704.6 g/mol (583.5 as free acid). It has the following structural formula. Fostemsavir tromethamine is a white powder and is soluble to greater than 250 mg/mL in aqueous solutions with a pH greater than 3.7. RUKOBIA extended-release tablets are for oral administration. Each film-coated tablet contains 600 mg of fostemsavir (equivalent to 725 mg fostemsavir tromethamine), and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, and magnesium stearate. The tablet film-coating contains the inactive ingredients iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
},
{
"NDCCode": "0093-2140-62",
"PackageDescription": "3 POUCH in 1 CARTON (0093-2140-62) > 1 BLISTER PACK in 1 POUCH (0093-2140-28) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00093-2140-62",
"ProductNDC": "0093-2140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-lo-sprintec",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20151230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076784",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2022-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151230",
"SamplePackage": "N",
"IndicationAndUsage": "Tri-Lo-Sprintec® (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).",
"Description": "Tri-Lo-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)‑ (+)-) and ethinyl estradiol, USP is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active gray tablet contains 0.18 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, black iron oxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide., 2 Each active light blue tablet contains 0.215 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, croscarmellose sodium, FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide., 3 Each active blue tablet contains 0.25 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, croscarmellose sodium, FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide., 4 Each white tablet contains only inert ingredients, as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose."
},
{
"NDCCode": "0220-2727-41",
"PackageDescription": "6 [hp_C] in 1 TUBE (0220-2727-41) ",
"NDC11Code": "00220-2727-41",
"ProductNDC": "0220-2727",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Influenzinum",
"NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220816",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_C]/6[hp_C]; [hp_C]/6[hp_C]; [hp_C]/6[hp_C]; [hp_C]/6[hp_C]",
"Status": "Active",
"LastUpdate": "2022-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220816",
"SamplePackage": "N",
"IndicationAndUsage": "After effects of flu or flu-like symptoms*."
},
{
"NDCCode": "0220-2728-31",
"PackageDescription": "9 [hp_C] in 1 TUBE (0220-2728-31) ",
"NDC11Code": "00220-2728-31",
"ProductNDC": "0220-2728",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Influenzinum",
"NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220816",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "9; 9; 9; 9",
"StrengthUnit": "[hp_C]/9[hp_C]; [hp_C]/9[hp_C]; [hp_C]/9[hp_C]; [hp_C]/9[hp_C]",
"Status": "Active",
"LastUpdate": "2022-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220816",
"SamplePackage": "N",
"IndicationAndUsage": "After effects of flu or flu-like symptoms*."
},
{
"NDCCode": "0220-2728-41",
"PackageDescription": "9 [hp_C] in 1 TUBE (0220-2728-41) ",
"NDC11Code": "00220-2728-41",
"ProductNDC": "0220-2728",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Influenzinum",
"NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220816",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "9; 9; 9; 9",
"StrengthUnit": "[hp_C]/9[hp_C]; [hp_C]/9[hp_C]; [hp_C]/9[hp_C]; [hp_C]/9[hp_C]",
"Status": "Active",
"LastUpdate": "2022-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220816",
"SamplePackage": "N",
"IndicationAndUsage": "After effects of flu or flu-like symptoms*."
},
{
"NDCCode": "0220-2729-41",
"PackageDescription": "12 [hp_C] in 1 TUBE (0220-2729-41) ",
"NDC11Code": "00220-2729-41",
"ProductNDC": "0220-2729",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Influenzinum",
"NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220816",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "12; 12; 12; 12",
"StrengthUnit": "[hp_C]/12[hp_C]; [hp_C]/12[hp_C]; [hp_C]/12[hp_C]; [hp_C]/12[hp_C]",
"Status": "Active",
"LastUpdate": "2022-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220816",
"SamplePackage": "N",
"IndicationAndUsage": "After effects of flu or flu-like symptoms*."
},
{
"NDCCode": "0220-2730-41",
"PackageDescription": "15 [hp_C] in 1 TUBE (0220-2730-41) ",
"NDC11Code": "00220-2730-41",
"ProductNDC": "0220-2730",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Influenzinum",
"NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220816",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "15; 15; 15; 15",
"StrengthUnit": "[hp_C]/15[hp_C]; [hp_C]/15[hp_C]; [hp_C]/15[hp_C]; [hp_C]/15[hp_C]",
"Status": "Active",
"LastUpdate": "2022-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220816",
"SamplePackage": "N",
"IndicationAndUsage": "After effects of flu or flu-like symptoms*."
},
{
"NDCCode": "0220-2731-41",
"PackageDescription": "30 [hp_C] in 1 TUBE (0220-2731-41) ",
"NDC11Code": "00220-2731-41",
"ProductNDC": "0220-2731",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Influenzinum",
"NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220816",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "30; 30; 30; 30",
"StrengthUnit": "[hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]",
"Status": "Active",
"LastUpdate": "2022-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220816",
"SamplePackage": "N",
"IndicationAndUsage": "After effects of flu or flu-like symptoms*."
},
{
"NDCCode": "0220-2733-41",
"PackageDescription": "8 [hp_X] in 1 TUBE (0220-2733-41) ",
"NDC11Code": "00220-2733-41",
"ProductNDC": "0220-2733",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Influenzinum",
"NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220816",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "8; 8; 8; 8",
"StrengthUnit": "[hp_X]/8[hp_X]; [hp_X]/8[hp_X]; [hp_X]/8[hp_X]; [hp_X]/8[hp_X]",
"Status": "Active",
"LastUpdate": "2022-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220816",
"SamplePackage": "N",
"IndicationAndUsage": "After effects of flu or flu-like symptoms*."
},
{
"NDCCode": "0220-2734-41",
"PackageDescription": "30 [hp_X] in 1 TRAY (0220-2734-41) ",
"NDC11Code": "00220-2734-41",
"ProductNDC": "0220-2734",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Influenzinum",
"NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220816",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "30; 30; 30; 30",
"StrengthUnit": "[hp_X]/30[hp_X]; [hp_X]/30[hp_X]; [hp_X]/30[hp_X]; [hp_X]/30[hp_X]",
"Status": "Active",
"LastUpdate": "2022-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220816",
"SamplePackage": "N",
"IndicationAndUsage": "After effects of flu or flu-like symptoms*."
},
{
"NDCCode": "0555-9018-58",
"PackageDescription": "6 POUCH in 1 CARTON (0555-9018-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00555-9018-58",
"ProductNDC": "0555-9018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-sprintec",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20031229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075808",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20031229",
"SamplePackage": "N",
"IndicationAndUsage": "Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1). Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).",
"Description": "Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and ethinyl estradiol, USP is designated as (19-Nor-17α-pregna,1,3,5(10)-trien-20-yne-3, 17-diol). Each active gray tablet contains 0.18 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, lactose monohydrate, lake blend black LB 636 (which consists of FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, and FD&C Yellow No. 6 Aluminum Lake), magnesium stearate, and pregelatinized corn starch. Each active light blue tablet contains 0.215 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each active blue tablet contains 0.25 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each white placebo tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formulas are as follows. C23H31NO3 M.W. 369.50. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "12497-1041-1",
"PackageDescription": "1 BAG in 1 DRUM (12497-1041-1) > 50 kg in 1 BAG",
"NDC11Code": "12497-1041-01",
"ProductNDC": "12497-1041",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Amino Acid Mixture Kiiir",
"DosageFormName": "POWDER",
"StartMarketingDate": "19871118",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Kyowa Hakko Bio Co., Ltd.",
"SubstanceName": "SERINE; METHIONINE; LEUCINE; ISOLEUCINE; ARGININE; HISTIDINE; VALINE; THREONINE; GLYCINE; ALANINE; PROLINE",
"StrengthNumber": "3.57; 3.215; 5.5; 4.215; 5.785; 1.715; 4; 2.43; 8.5; 4.285; 6.785",
"StrengthUnit": "kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "18-NOV-87"
},
{
"NDCCode": "17314-215-00",
"PackageDescription": "15202 TABLET, FILM COATED in 1 DRUM (17314-215-00) ",
"NDC11Code": "17314-0215-00",
"ProductNDC": "17314-215",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Apalutamide",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20180214",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Janssen Ortho LLC",
"SubstanceName": "APALUTAMIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-04-05",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "14-FEB-18"
},
{
"NDCCode": "21695-407-01",
"PackageDescription": "6 DIALPACK in 1 CARTON (21695-407-01) > 1 KIT in 1 DIALPACK",
"NDC11Code": "21695-0407-01",
"ProductNDC": "21695-407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trinessa",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20070817",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019697",
"LabelerName": "Rebel Distributors Corp",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "TriNessa® is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. TriNessa is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy, and have achieved menarche. TriNessa should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. Oral contraceptives are highly effective for pregnancy prevention. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TriNessa has not been studied for and is not indicated for use in emergency contraception. In four clinical trials with TriNessa, a total of 4,756 subjects completed 45,244 cycles, and the use-efficacy pregnancy rate was approximately 1 pregnancy per 100 womenyears. TriNessa was evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies.221 patients received TriNessa and 234 patients received placebo. Mean age at enrollment for both groups was 28 years. At the end of 6 months, the mean total lesion count changes from 55 to 31 (42% reduction) in patients treated with TriNessa and from 54 to 38 (27% reduction) in patients similarly treated with placebo.Table III summarizes the changes in lesion count for each type of lesion in the ITT population. Based on the investigator’s global assessment conducted at the final visit, patients treated with TriNessa showed a statistically significant improvement in total lesions compared to those treated with placebo.",
"Description": "The following product is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. TriNessa® Tablets. Each white tablet contains 0.180 mg of the progestational compound, norgestimate (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include carnauba wax, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, purified water and titanium dioxide. Each light blue tablet contains 0.215 mg of the progestational compound norgestimate (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD & C Blue No.2 Aluminum Lake, carnauba wax, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, purified water and titanium dioxide. Each blue tablet contains 0.250 mg of the progestational compound norgestimate (18,19-Dinor-17-pregn-4-en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD & C Blue No.2 Aluminum Lake, carnauba wax, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, purified water and titanium dioxide. Each dark green tablet contains only inert ingredients, as follows: FD & C Blue No. 2 Aluminum Lake, ferric oxide, hypromellose, lactose, magnesium stearate, polyethylene glycol, pregelatinized corn starch, purified water, talc and titanium dioxide."
},
{
"NDCCode": "21695-770-01",
"PackageDescription": "1 BLISTER PACK in 1 POUCH (21695-770-01) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "21695-0770-01",
"ProductNDC": "21695-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-sprintec",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20110125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075808",
"LabelerName": "Rebel Distributors Corp",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tri-Sprintec Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tri-Sprintec Tablets are indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche and are unresponsive to topical anti-acne medications. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In four clinical trials with norgestimate and ethinyl estradiol, the use-efficacy pregnancy rate ranged from 0.68 to 1.47 per 100 women-years. In total, 4,756 subjects completed 45,244 cycles and a total of 42 pregnancies were reported. This represents an overall use-efficacy rate of 1.21 per 100 women-years. One of these 4 studies was a randomized comparative clinical trial in which 4,633 subjects completed 22,312 cycles. Of the 2,312 patients on norgestimate and ethinyl estradiol, 8 pregnancies were reported. This represents an overall use-efficacy pregnancy rate of 0.94 per 100 women-years. In two double-blind, placebo-controlled, six month, multicenter clinical trials, norgestimate and ethinyl estradiol showed a statistically significant decrease in inflammatory lesion count and total lesion count (TABLE II). The adverse reaction profile of norgestimate and ethinyl estradiol from these two controlled clinical trials is consistent with what has been noted from previous studies involving norgestimate and ethinyl estradiol and are the known risks associated with oral contraceptives.",
"Description": "Tri-Sprintec® Tablets are a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Each gray tablet contains 0.18 mg of the progestational compound, norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, lactose monohydrate, lake blend black LB 636 (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, sodium bicarbonate and sodium carbonate), magnesium stearate, and pregelatinized starch. Each light blue tablet contains 0.215 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, (ingredients include aluminum sulfate solution, aluminum-chloride solution, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized starch. Each blue tablet contains 0.25 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, (ingredients include aluminum sulfate solution, aluminum-chloride solution, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized starch. Each white tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formula is as follows."
},
{
"NDCCode": "35356-215-30",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (35356-215-30) > 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "35356-0215-30",
"ProductNDC": "35356-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spiriva",
"NonProprietaryName": "Tiotropium Bromide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL; RESPIRATORY (INHALATION)",
"StartMarketingDate": "20051011",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021395",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "TIOTROPIUM BROMIDE MONOHYDRATE",
"StrengthNumber": "18",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-09-26"
},
{
"NDCCode": "37000-504-76",
"PackageDescription": "1 TUBE in 1 CARTON (37000-504-76) > 215 g in 1 TUBE",
"NDC11Code": "37000-0504-76",
"ProductNDC": "37000-504",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crest Complete Multi Benefit",
"ProprietaryNameSuffix": "Whitening Plus Scope Outlast",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20090908",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20090908",
"SamplePackage": "N"
}
]
}
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<NDCList>
<NDC>
<NDCCode>49702-215-18</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (49702-215-18)</PackageDescription>
<NDC11Code>49702-0215-18</NDC11Code>
<ProductNDC>49702-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Selzentry</ProprietaryName>
<NonProprietaryName>Maraviroc</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101013</StartMarketingDate>
<EndMarketingDate>20150131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022128</ApplicationNumber>
<LabelerName>ViiV Healthcare Company</LabelerName>
<SubstanceName>MARAVIROC</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>42582-215-18</NDCCode>
<PackageDescription>500 TABLET, COATED in 1 BOTTLE (42582-215-18) </PackageDescription>
<NDC11Code>42582-0215-18</NDC11Code>
<ProductNDC>42582-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211343</ApplicationNumber>
<LabelerName>Bi-Coastal Pharma International, LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline 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.</IndicationAndUsage>
<Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate tablets, USP. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8 ∙H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8∙HCl)2∙C2H6O∙H2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients for the tablet formulation are: croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose PH112, polyethylene glycol, silicon dioxide, titanium dioxide and water. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>57664-215-18</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (57664-215-18)</PackageDescription>
<NDC11Code>57664-0215-18</NDC11Code>
<ProductNDC>57664-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078036</ApplicationNumber>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-11</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>72865-215-18</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (72865-215-18) </PackageDescription>
<NDC11Code>72865-0215-18</NDC11Code>
<ProductNDC>72865-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215689</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.</IndicationAndUsage>
<Description>The active ingredient in famotidine tablets USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Each famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine USP and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, silicon dioxide, povidone, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide and talc. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>49702-202-18</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (49702-202-18) </PackageDescription>
<NDC11Code>49702-0202-18</NDC11Code>
<ProductNDC>49702-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Combivir</ProprietaryName>
<NonProprietaryName>Lamivudine And Zidovudine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101019</StartMarketingDate>
<EndMarketingDate>20270228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020857</ApplicationNumber>
<LabelerName>ViiV Healthcare Company</LabelerName>
<SubstanceName>LAMIVUDINE; ZIDOVUDINE</SubstanceName>
<StrengthNumber>150; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20101019</StartMarketingDatePackage>
<EndMarketingDatePackage>20270228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COMBIVIR, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection.</IndicationAndUsage>
<Description>COMBIVIR tablets are combination tablets containing lamivudine and zidovudine. Lamivudine (EPIVIR) and zidovudine (RETROVIR, azidothymidine, AZT, or ZDV) are synthetic nucleoside analogues with activity against HIV‑1. COMBIVIR tablets are for oral administration. Each film‑coated tablet contains 150 mg of lamivudine, 300 mg of zidovudine, and the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. Lamivudine. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (‑)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (‑)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine is a white to off‑white crystalline solid and is soluble in water. Zidovudine. The chemical name of zidovudine is 3′-azido-3′-deoxythymidine. It has a molecular formula of C10H13N5O4 and a molecular weight of 267.24 g per mol. It has the following structural formula. Zidovudine is a white to beige, odorless, crystalline solid with a solubility of 20.1 mg per mL in water at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>49702-203-18</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (49702-203-18) </PackageDescription>
<NDC11Code>49702-0203-18</NDC11Code>
<ProductNDC>49702-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epivir</ProprietaryName>
<NonProprietaryName>Lamivudine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101004</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020564</ApplicationNumber>
<LabelerName>ViiV Healthcare Company</LabelerName>
<SubstanceName>LAMIVUDINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection. Limitations of Use: 1 The dosage of this product is for HIV‑1 and not for HBV.</IndicationAndUsage>
<Description>EPIVIR (also known as 3TC) is a brand name for lamivudine, a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg per mL in water at 20°C. EPIVIR tablets are for oral administration. Each scored 150-mg film-coated tablet contains 150 mg of lamivudine and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. Each 300-mg film-coated tablet contains 300 mg of lamivudine and the inactive ingredients black iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. EPIVIR oral solution is for oral administration. One milliliter (1 mL) of EPIVIR oral solution contains 10 mg of lamivudine (10 mg per mL) in an aqueous solution and the inactive ingredients artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg).</Description>
</NDC>
<NDC>
<NDCCode>49702-207-18</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (49702-207-18) </PackageDescription>
<NDC11Code>49702-0207-18</NDC11Code>
<ProductNDC>49702-207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lexiva</ProprietaryName>
<NonProprietaryName>Fosamprenavir Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101004</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021548</ApplicationNumber>
<LabelerName>ViiV Healthcare Company</LabelerName>
<SubstanceName>FOSAMPRENAVIR CALCIUM</SubstanceName>
<StrengthNumber>700</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], P-Glycoprotein Inducers [MoA], Protease Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20101004</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LEXIVA is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. The following points should be considered when initiating therapy with LEXIVA plus ritonavir in protease inhibitor-experienced patients: 1 The protease inhibitor-experienced patient trial was not large enough to reach a definitive conclusion that LEXIVA plus ritonavir and lopinavir plus ritonavir are clinically equivalent [see Clinical Studies (14.2)]., 2 Once-daily administration of LEXIVA plus ritonavir is not recommended for adult protease inhibitor-experienced patients or any pediatric patients [see Dosage and Administration (2.2, 2.3), Clinical Studies (14.2, 14.3)]., 3 Dosing of LEXIVA plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients younger than 6 months [see Clinical Pharmacology (12.3)].</IndicationAndUsage>
<Description>LEXIVA (fosamprenavir calcium) is a prodrug of amprenavir, an inhibitor of HIV protease. The chemical name of fosamprenavir calcium is (3S)-tetrahydrofuran-3-yl (1S,2R)-3-[[(4-aminophenyl) sulfonyl](isobutyl)amino]-1-benzyl-2-(phosphonooxy) propylcarbamate monocalcium salt. Fosamprenavir calcium is a single stereoisomer with the (3S)(1S,2R) configuration. It has a molecular formula of C25H34CaN3O9PS and a molecular weight of 623.7. It has the following structural formula. Fosamprenavir calcium is a white to cream-colored solid with a solubility of approximately 0.31 mg per mL in water at 25°C. LEXIVA tablets are available for oral administration in a strength of 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir). Each 700-mg tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone K30. The tablet film-coating contains the inactive ingredients hypromellose, iron oxide red, titanium dioxide, and triacetin. LEXIVA oral suspension is available in a strength of 50 mg per mL of fosamprenavir as fosamprenavir calcium equivalent to approximately 43 mg of amprenavir. LEXIVA oral suspension is a white to off-white suspension with a grape-bubblegum-peppermint flavor. Each one milliliter (1 mL) contains the inactive ingredients artificial grape-bubblegum flavor, calcium chloride dihydrate, hypromellose, methylparaben, natural peppermint flavor, polysorbate 80, propylene glycol, propylparaben, purified water, and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>49702-214-18</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (49702-214-18)</PackageDescription>
<NDC11Code>49702-0214-18</NDC11Code>
<ProductNDC>49702-214</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Retrovir</ProprietaryName>
<NonProprietaryName>Zidovudine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101028</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020518</ApplicationNumber>
<LabelerName>ViiV Healthcare Company</LabelerName>
<SubstanceName>ZIDOVUDINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-03-20</LastUpdate>
</NDC>
<NDC>
<NDCCode>49702-216-18</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (49702-216-18)</PackageDescription>
<NDC11Code>49702-0216-18</NDC11Code>
<ProductNDC>49702-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Selzentry</ProprietaryName>
<NonProprietaryName>Maraviroc</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100901</StartMarketingDate>
<EndMarketingDate>20150331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022128</ApplicationNumber>
<LabelerName>ViiV Healthcare Company</LabelerName>
<SubstanceName>MARAVIROC</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>49702-217-18</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (49702-217-18) </PackageDescription>
<NDC11Code>49702-0217-18</NDC11Code>
<ProductNDC>49702-217</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trizivir</ProprietaryName>
<NonProprietaryName>Abacavir Sulfate, Lamivudine, And Zidovudine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101102</StartMarketingDate>
<EndMarketingDate>20241130</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021205</ApplicationNumber>
<LabelerName>ViiV Healthcare Company</LabelerName>
<SubstanceName>ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE</SubstanceName>
<StrengthNumber>300; 150; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A1 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20101102</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRIZIVIR is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection. Limitations of Use: 1 Limited data exist on the use of TRIZIVIR alone in patients with higher baseline viral load levels (greater than 100,000 copies per mL) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>TRIZIVIR tablets contain the following 3 synthetic nucleoside analogues: abacavir (ZIAGEN), lamivudine (also known as EPIVIR or 3TC), and zidovudine (also known as RETROVIR, azidothymidine, or ZDV) with inhibitory activity against HIV-1. TRIZIVIR tablets are for oral administration. Each film-coated tablet contains the active ingredients 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine, and the inactive ingredients magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film (OPADRY green 03B11434) that is made of FD&C Blue No. 2, hypromellose, polyethylene glycol, titanium dioxide, and yellow iron oxide. Abacavir Sulfate: The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2H2SO4 and a molecular weight of 670.76 g per mol. It has the following structural formula. Abacavir sulfate is a white to off-white solid and soluble in water. Dosages are expressed in terms of abacavir. Lamivudine: The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine is a white to off-white crystalline solid and is soluble in water. Zidovudine: The chemical name of zidovudine is 3′-azido-3′-deoxythymidine. It has a molecular formula of C10H13N5O4 and a molecular weight of 267.24 g per mol. It has the following structural formula. Zidovudine is a white to beige, odorless, crystalline solid with a solubility of 20.1 mg per mL in water at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>49702-221-18</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (49702-221-18) </PackageDescription>
<NDC11Code>49702-0221-18</NDC11Code>
<ProductNDC>49702-221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziagen</ProprietaryName>
<NonProprietaryName>Abacavir Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981229</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020977</ApplicationNumber>
<LabelerName>ViiV Healthcare Company</LabelerName>
<SubstanceName>ABACAVIR SULFATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A1 Inhibitors [MoA], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19981229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZIAGEN tablets and oral solution, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.</IndicationAndUsage>
<Description>ZIAGEN is the brand name for abacavir sulfate, a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1. The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2H2SO4 and a molecular weight of 670.76 g per mol. It has the following structural formula. Abacavir sulfate is a white to off-white solid and is soluble in water. ZIAGEN tablets are for oral administration. Each tablet contains abacavir sulfate equivalent to 300 mg of abacavir as active ingredient and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film that is made of hypromellose, polysorbate 80, synthetic yellow iron oxide, titanium dioxide, and triacetin. ZIAGEN oral solution is for oral administration. Each milliliter (1 mL) of ZIAGEN oral solution contains abacavir sulfate equivalent to 20 mg of abacavir (i.e., 20 mg per mL) as active ingredient and the following inactive ingredients: artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben and propylparaben (added as preservatives), propylene glycol, saccharin sodium, sodium citrate (dihydrate), sorbitol solution, and water. In vivo, abacavir sulfate dissociates to its free base, abacavir. Dosages are expressed in terms of abacavir.</Description>
</NDC>
<NDC>
<NDCCode>49702-223-18</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (49702-223-18) </PackageDescription>
<NDC11Code>49702-0223-18</NDC11Code>
<ProductNDC>49702-223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Selzentry</ProprietaryName>
<NonProprietaryName>Maraviroc</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110516</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022128</ApplicationNumber>
<LabelerName>ViiV Healthcare Company</LabelerName>
<SubstanceName>MARAVIROC</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>CCR5 Co-receptor Antagonist [EPC], Chemokine Co-receptor 5 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SELZENTRY is indicated in combination with other antiretroviral agents for the treatment of only CCR5‑tropic human immunodeficiency virus type 1 (HIV‑1) infection in adult and pediatric patients weighing at least 2 kg. Limitations of Use: 1 SELZENTRY is not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1 [see Microbiology (12.4)].</IndicationAndUsage>
<Description>SELZENTRY (maraviroc) is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells. SELZENTRY film-coated tablets for oral administration contain 25, 75, 150, or 300 mg of maraviroc and the following inactive ingredients: dibasic calcium phosphate (anhydrous), magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coat (Opadry II Blue [85G20583]) contains FD&C blue #2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide. SELZENTRY oral solution contains 20 mg per mL of maraviroc and the following inactive ingredients: citric acid (anhydrous), purified water, sodium benzoate, sodium citrate dihydrate, strawberry flavoring (501440T), and sucralose. Maraviroc is chemically described as 4,4-difluoro-N-{(1S)-3-[exo-3-(3-isopropyl-5-methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1-phenylpropyl}cyclohexanecarboxamide. The molecular formula is C29H41F2N5O and the structural formula is. Maraviroc is a white to pale-colored powder with a molecular weight of 513.67. It is highly soluble across the physiological pH range (pH 1.0 to 7.5).</Description>
</NDC>
<NDC>
<NDCCode>49702-224-18</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (49702-224-18) </PackageDescription>
<NDC11Code>49702-0224-18</NDC11Code>
<ProductNDC>49702-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Selzentry</ProprietaryName>
<NonProprietaryName>Maraviroc</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110516</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022128</ApplicationNumber>
<LabelerName>ViiV Healthcare Company</LabelerName>
<SubstanceName>MARAVIROC</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>CCR5 Co-receptor Antagonist [EPC], Chemokine Co-receptor 5 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SELZENTRY is indicated in combination with other antiretroviral agents for the treatment of only CCR5‑tropic human immunodeficiency virus type 1 (HIV‑1) infection in adult and pediatric patients weighing at least 2 kg. Limitations of Use: 1 SELZENTRY is not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1 [see Microbiology (12.4)].</IndicationAndUsage>
<Description>SELZENTRY (maraviroc) is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells. SELZENTRY film-coated tablets for oral administration contain 25, 75, 150, or 300 mg of maraviroc and the following inactive ingredients: dibasic calcium phosphate (anhydrous), magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coat (Opadry II Blue [85G20583]) contains FD&C blue #2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide. SELZENTRY oral solution contains 20 mg per mL of maraviroc and the following inactive ingredients: citric acid (anhydrous), purified water, sodium benzoate, sodium citrate dihydrate, strawberry flavoring (501440T), and sucralose. Maraviroc is chemically described as 4,4-difluoro-N-{(1S)-3-[exo-3-(3-isopropyl-5-methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1-phenylpropyl}cyclohexanecarboxamide. The molecular formula is C29H41F2N5O and the structural formula is. Maraviroc is a white to pale-colored powder with a molecular weight of 513.67. It is highly soluble across the physiological pH range (pH 1.0 to 7.5).</Description>
</NDC>
<NDC>
<NDCCode>49702-250-18</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49702-250-18) / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>49702-0250-18</NDC11Code>
<ProductNDC>49702-250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rukobia</ProprietaryName>
<NonProprietaryName>Fostemsavir Tromethamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200702</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212950</ApplicationNumber>
<LabelerName>ViiV Healthcare Company</LabelerName>
<SubstanceName>FOSTEMSAVIR TROMETHAMINE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RUKOBIA, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Fostemsavir tromethamine is a prodrug of temsavir, an HIV-1 gp120-directed attachment inhibitor. The chemical name of fostemsavir tromethamine is (3-((4-benzoyl-1-piperazinyl)(oxo)acetyl)-4-methoxy-7-(3-methyl-1H-1,2,4-triazol-1-yl)-1H-pyrrolo[2,3-c]pyridin-1-yl)methyl dihydrogen phosphate, 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). The empirical formula is C25H26N7O8PC4H11NO3. The molecular weight is 704.6 g/mol (583.5 as free acid). It has the following structural formula. Fostemsavir tromethamine is a white powder and is soluble to greater than 250 mg/mL in aqueous solutions with a pH greater than 3.7. RUKOBIA extended-release tablets are for oral administration. Each film-coated tablet contains 600 mg of fostemsavir (equivalent to 725 mg fostemsavir tromethamine), and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, and magnesium stearate. The tablet film-coating contains the inactive ingredients iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0093-2140-62</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (0093-2140-62) > 1 BLISTER PACK in 1 POUCH (0093-2140-28) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00093-2140-62</NDC11Code>
<ProductNDC>0093-2140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-lo-sprintec</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076784</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tri-Lo-Sprintec® (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1).</IndicationAndUsage>
<Description>Tri-Lo-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)‑ (+)-) and ethinyl estradiol, USP is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active gray tablet contains 0.18 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, black iron oxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide., 2 Each active light blue tablet contains 0.215 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, croscarmellose sodium, FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide., 3 Each active blue tablet contains 0.25 mg of norgestimate, USP and 0.025 mg of ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, croscarmellose sodium, FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide., 4 Each white tablet contains only inert ingredients, as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>0220-2727-41</NDCCode>
<PackageDescription>6 [hp_C] in 1 TUBE (0220-2727-41) </PackageDescription>
<NDC11Code>00220-2727-41</NDC11Code>
<ProductNDC>0220-2727</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenzinum</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220816</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/6[hp_C]; [hp_C]/6[hp_C]; [hp_C]/6[hp_C]; [hp_C]/6[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>After effects of flu or flu-like symptoms*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0220-2728-31</NDCCode>
<PackageDescription>9 [hp_C] in 1 TUBE (0220-2728-31) </PackageDescription>
<NDC11Code>00220-2728-31</NDC11Code>
<ProductNDC>0220-2728</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenzinum</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220816</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>9; 9; 9; 9</StrengthNumber>
<StrengthUnit>[hp_C]/9[hp_C]; [hp_C]/9[hp_C]; [hp_C]/9[hp_C]; [hp_C]/9[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>After effects of flu or flu-like symptoms*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0220-2728-41</NDCCode>
<PackageDescription>9 [hp_C] in 1 TUBE (0220-2728-41) </PackageDescription>
<NDC11Code>00220-2728-41</NDC11Code>
<ProductNDC>0220-2728</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenzinum</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220816</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>9; 9; 9; 9</StrengthNumber>
<StrengthUnit>[hp_C]/9[hp_C]; [hp_C]/9[hp_C]; [hp_C]/9[hp_C]; [hp_C]/9[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>After effects of flu or flu-like symptoms*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0220-2729-41</NDCCode>
<PackageDescription>12 [hp_C] in 1 TUBE (0220-2729-41) </PackageDescription>
<NDC11Code>00220-2729-41</NDC11Code>
<ProductNDC>0220-2729</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenzinum</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220816</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_C]/12[hp_C]; [hp_C]/12[hp_C]; [hp_C]/12[hp_C]; [hp_C]/12[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>After effects of flu or flu-like symptoms*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0220-2730-41</NDCCode>
<PackageDescription>15 [hp_C] in 1 TUBE (0220-2730-41) </PackageDescription>
<NDC11Code>00220-2730-41</NDC11Code>
<ProductNDC>0220-2730</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenzinum</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220816</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>[hp_C]/15[hp_C]; [hp_C]/15[hp_C]; [hp_C]/15[hp_C]; [hp_C]/15[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>After effects of flu or flu-like symptoms*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0220-2731-41</NDCCode>
<PackageDescription>30 [hp_C] in 1 TUBE (0220-2731-41) </PackageDescription>
<NDC11Code>00220-2731-41</NDC11Code>
<ProductNDC>0220-2731</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenzinum</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220816</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>After effects of flu or flu-like symptoms*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0220-2733-41</NDCCode>
<PackageDescription>8 [hp_X] in 1 TUBE (0220-2733-41) </PackageDescription>
<NDC11Code>00220-2733-41</NDC11Code>
<ProductNDC>0220-2733</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenzinum</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220816</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/8[hp_X]; [hp_X]/8[hp_X]; [hp_X]/8[hp_X]; [hp_X]/8[hp_X]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>After effects of flu or flu-like symptoms*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0220-2734-41</NDCCode>
<PackageDescription>30 [hp_X] in 1 TRAY (0220-2734-41) </PackageDescription>
<NDC11Code>00220-2734-41</NDC11Code>
<ProductNDC>0220-2734</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenzinum</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220816</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/30[hp_X]; [hp_X]/30[hp_X]; [hp_X]/30[hp_X]; [hp_X]/30[hp_X]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>After effects of flu or flu-like symptoms*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0555-9018-58</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0555-9018-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9018-58</NDC11Code>
<ProductNDC>0555-9018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-sprintec</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20031229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075808</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20031229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1). Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).</IndicationAndUsage>
<Description>Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and ethinyl estradiol, USP is designated as (19-Nor-17α-pregna,1,3,5(10)-trien-20-yne-3, 17-diol). Each active gray tablet contains 0.18 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, lactose monohydrate, lake blend black LB 636 (which consists of FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, and FD&C Yellow No. 6 Aluminum Lake), magnesium stearate, and pregelatinized corn starch. Each active light blue tablet contains 0.215 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each active blue tablet contains 0.25 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each white placebo tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formulas are as follows. C23H31NO3 M.W. 369.50. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>12497-1041-1</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (12497-1041-1) > 50 kg in 1 BAG</PackageDescription>
<NDC11Code>12497-1041-01</NDC11Code>
<ProductNDC>12497-1041</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Amino Acid Mixture Kiiir</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19871118</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Kyowa Hakko Bio Co., Ltd.</LabelerName>
<SubstanceName>SERINE; METHIONINE; LEUCINE; ISOLEUCINE; ARGININE; HISTIDINE; VALINE; THREONINE; GLYCINE; ALANINE; PROLINE</SubstanceName>
<StrengthNumber>3.57; 3.215; 5.5; 4.215; 5.785; 1.715; 4; 2.43; 8.5; 4.285; 6.785</StrengthNumber>
<StrengthUnit>kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-NOV-87</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>17314-215-00</NDCCode>
<PackageDescription>15202 TABLET, FILM COATED in 1 DRUM (17314-215-00) </PackageDescription>
<NDC11Code>17314-0215-00</NDC11Code>
<ProductNDC>17314-215</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Apalutamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20180214</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Janssen Ortho LLC</LabelerName>
<SubstanceName>APALUTAMIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-04-05</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>14-FEB-18</StartMarketingDatePackage>
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<NDC>
<NDCCode>21695-407-01</NDCCode>
<PackageDescription>6 DIALPACK in 1 CARTON (21695-407-01) > 1 KIT in 1 DIALPACK</PackageDescription>
<NDC11Code>21695-0407-01</NDC11Code>
<ProductNDC>21695-407</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trinessa</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20070817</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019697</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>TriNessa® is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. TriNessa is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy, and have achieved menarche. TriNessa should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. Oral contraceptives are highly effective for pregnancy prevention. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TriNessa has not been studied for and is not indicated for use in emergency contraception. In four clinical trials with TriNessa, a total of 4,756 subjects completed 45,244 cycles, and the use-efficacy pregnancy rate was approximately 1 pregnancy per 100 womenyears. TriNessa was evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies.221 patients received TriNessa and 234 patients received placebo. Mean age at enrollment for both groups was 28 years. At the end of 6 months, the mean total lesion count changes from 55 to 31 (42% reduction) in patients treated with TriNessa and from 54 to 38 (27% reduction) in patients similarly treated with placebo.Table III summarizes the changes in lesion count for each type of lesion in the ITT population. Based on the investigator’s global assessment conducted at the final visit, patients treated with TriNessa showed a statistically significant improvement in total lesions compared to those treated with placebo.</IndicationAndUsage>
<Description>The following product is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. TriNessa® Tablets. Each white tablet contains 0.180 mg of the progestational compound, norgestimate (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include carnauba wax, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, purified water and titanium dioxide. Each light blue tablet contains 0.215 mg of the progestational compound norgestimate (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD & C Blue No.2 Aluminum Lake, carnauba wax, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, purified water and titanium dioxide. Each blue tablet contains 0.250 mg of the progestational compound norgestimate (18,19-Dinor-17-pregn-4-en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD & C Blue No.2 Aluminum Lake, carnauba wax, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, purified water and titanium dioxide. Each dark green tablet contains only inert ingredients, as follows: FD & C Blue No. 2 Aluminum Lake, ferric oxide, hypromellose, lactose, magnesium stearate, polyethylene glycol, pregelatinized corn starch, purified water, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-770-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 POUCH (21695-770-01) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21695-0770-01</NDC11Code>
<ProductNDC>21695-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-sprintec</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20110125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075808</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tri-Sprintec Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tri-Sprintec Tablets are indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche and are unresponsive to topical anti-acne medications. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In four clinical trials with norgestimate and ethinyl estradiol, the use-efficacy pregnancy rate ranged from 0.68 to 1.47 per 100 women-years. In total, 4,756 subjects completed 45,244 cycles and a total of 42 pregnancies were reported. This represents an overall use-efficacy rate of 1.21 per 100 women-years. One of these 4 studies was a randomized comparative clinical trial in which 4,633 subjects completed 22,312 cycles. Of the 2,312 patients on norgestimate and ethinyl estradiol, 8 pregnancies were reported. This represents an overall use-efficacy pregnancy rate of 0.94 per 100 women-years. In two double-blind, placebo-controlled, six month, multicenter clinical trials, norgestimate and ethinyl estradiol showed a statistically significant decrease in inflammatory lesion count and total lesion count (TABLE II). The adverse reaction profile of norgestimate and ethinyl estradiol from these two controlled clinical trials is consistent with what has been noted from previous studies involving norgestimate and ethinyl estradiol and are the known risks associated with oral contraceptives.</IndicationAndUsage>
<Description>Tri-Sprintec® Tablets are a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Each gray tablet contains 0.18 mg of the progestational compound, norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, lactose monohydrate, lake blend black LB 636 (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, sodium bicarbonate and sodium carbonate), magnesium stearate, and pregelatinized starch. Each light blue tablet contains 0.215 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, (ingredients include aluminum sulfate solution, aluminum-chloride solution, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized starch. Each blue tablet contains 0.25 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, (ingredients include aluminum sulfate solution, aluminum-chloride solution, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized starch. Each white tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formula is as follows.</Description>
</NDC>
<NDC>
<NDCCode>35356-215-30</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (35356-215-30) > 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>35356-0215-30</NDC11Code>
<ProductNDC>35356-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spiriva</ProprietaryName>
<NonProprietaryName>Tiotropium Bromide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL; RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20051011</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021395</ApplicationNumber>
<LabelerName>Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>TIOTROPIUM BROMIDE MONOHYDRATE</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>37000-504-76</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (37000-504-76) > 215 g in 1 TUBE</PackageDescription>
<NDC11Code>37000-0504-76</NDC11Code>
<ProductNDC>37000-504</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crest Complete Multi Benefit</ProprietaryName>
<ProprietaryNameSuffix>Whitening Plus Scope Outlast</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20090908</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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