{
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{
"NDCCode": "63654-600-68",
"PackageDescription": "20 TABLET in 1 BLISTER PACK (63654-600-68)",
"NDC11Code": "63654-0600-68",
"ProductNDC": "63654-600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold Medicine",
"ProprietaryNameSuffix": "Xl3",
"NonProprietaryName": "Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111115",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Selder, S.A. de C.V.",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 4; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63654-600-02",
"PackageDescription": "25 TABLET in 1 BLISTER PACK (63654-600-02)",
"NDC11Code": "63654-0600-02",
"ProductNDC": "63654-600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold Medicine",
"ProprietaryNameSuffix": "Xl3",
"NonProprietaryName": "Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111115",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Selder, S.A. de C.V.",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 4; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0093-5234-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0093-5234-56) ",
"NDC11Code": "00093-5234-56",
"ProductNDC": "0093-5234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091215",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "600; 200; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2024-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.",
"Description": "Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing EFV USP, FTC, and TDF. EFV, USP is a non-nucleoside reverse transcriptase inhibitor (NNRTI). FTC is a synthetic nucleoside analog of cytidine. TDF, which is converted in vivo to tenofovir, is an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration. Each tablet contains 600 mg of EFV USP, 200 mg of FTC, and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: carmine, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, povidone, sodium starch glycolate, talc, and titanium dioxide. Efavirenz, USP: EFV, USP is chemically described as (4S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its structural formula is:. C14H9ClF3NO2 M.W. 315.68. Efavirenz, USP is a white to slightly pink crystalline powder. It is freely soluble in methanol and practically insoluble in water (less than 10 mcg/mL). Emtricitabine: The chemical name of FTC is 5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has the following structural formula:. C8H10FN3O3S M.W. 247.24. Emtricitabine is a white to off-white colored crystalline powder. It is freely soluble in water and in methanol. Tenofovir DF: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of TDF is 9-[(R)-2[[bis[[(isopropoxycarbonyl)oxy]-methoxy]phosphinyl]methoxy]propyl]adenine fumarate. It has the following structural formula:. C19H30N5O10PC4H4O4 M.W. 635.52. TDF is a white to off-white crystalline powder. It is practically insoluble in water."
},
{
"NDCCode": "0113-2002-68",
"PackageDescription": "36 BLISTER PACK in 1 CARTON (0113-2002-68) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00113-2002-68",
"ProductNDC": "0113-2002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus D",
"NonProprietaryName": "Guaifenesin, Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091071",
"LabelerName": "L. Perrigo Company",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "600; 60",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160302",
"SamplePackage": "N"
},
{
"NDCCode": "0113-8307-68",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0113-8307-68) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "00113-8307-68",
"ProductNDC": "0113-8307",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus D",
"NonProprietaryName": "Guaifenesin And Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214407",
"LabelerName": "L. Perrigo Company",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "600; 60",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251003",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves nasal congestion due to:common coldhay feverupper respiratory allergies . temporarily restores freer breathing through the nose. promotes nasal and/or sinus drainage. temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "0363-0144-68",
"PackageDescription": "36 BLISTER PACK in 1 CARTON (0363-0144-68) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "00363-0144-68",
"ProductNDC": "0363-0144",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief D",
"NonProprietaryName": "Guaifenesin, Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091071",
"LabelerName": "Walgreen Company",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "600; 60",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-03-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20151217",
"SamplePackage": "N"
},
{
"NDCCode": "0363-8708-68",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0363-8708-68) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "00363-8708-68",
"ProductNDC": "0363-8708",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief D",
"NonProprietaryName": "Guaifenesin And Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214407",
"LabelerName": "Walgreen Company",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "600; 60",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240326",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves nasal congestion due to. common cold. hay fever. upper respiratory allergies . temporarily restores freer breathing through the nose. promotes nasal and/or sinus drainage. temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "0904-7253-68",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (0904-7253-68) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35) ",
"NDC11Code": "00904-7253-68",
"ProductNDC": "0904-7253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran Etexilate",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20250623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208040",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250623",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to pale yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran Etexilate Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: Butylated hydroxy toluene, citric acid monohydrate crystal, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, macrogol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol 600, polyvinyl alcohol, povidone (k-value-25), sodium bicarbonate, talc, tartaric acid and titanium dioxide. The capsule shell is composed of hypromellose, titanium dioxide, FD&C red #40 & FD&C blue #1 (150 mg and 110 mg), FD&C yellow #6 (75 mg and 150 mg). The imprinting ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide & potassium hydroxide."
},
{
"NDCCode": "0904-7254-68",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (0904-7254-68) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7254-35) ",
"NDC11Code": "00904-7254-68",
"ProductNDC": "0904-7254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran Etexilate",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20250623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208040",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "110",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250623",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to pale yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran Etexilate Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: Butylated hydroxy toluene, citric acid monohydrate crystal, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, macrogol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol 600, polyvinyl alcohol, povidone (k-value-25), sodium bicarbonate, talc, tartaric acid and titanium dioxide. The capsule shell is composed of hypromellose, titanium dioxide, FD&C red #40 & FD&C blue #1 (150 mg and 110 mg), FD&C yellow #6 (75 mg and 150 mg). The imprinting ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide & potassium hydroxide."
},
{
"NDCCode": "0904-7255-68",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (0904-7255-68) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7255-35) ",
"NDC11Code": "00904-7255-68",
"ProductNDC": "0904-7255",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran Etexilate",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20250623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208040",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250623",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to pale yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran Etexilate Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: Butylated hydroxy toluene, citric acid monohydrate crystal, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, macrogol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol 600, polyvinyl alcohol, povidone (k-value-25), sodium bicarbonate, talc, tartaric acid and titanium dioxide. The capsule shell is composed of hypromellose, titanium dioxide, FD&C red #40 & FD&C blue #1 (150 mg and 110 mg), FD&C yellow #6 (75 mg and 150 mg). The imprinting ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide & potassium hydroxide."
},
{
"NDCCode": "11822-0731-6",
"PackageDescription": "68 BLISTER PACK in 1 CARTON (11822-0731-6) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "11822-0731-06",
"ProductNDC": "11822-0731",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190531",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207342",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190531",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive."
},
{
"NDCCode": "11822-0733-6",
"PackageDescription": "68 BLISTER PACK in 1 CARTON (11822-0733-6) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "11822-0733-06",
"ProductNDC": "11822-0733",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief Dm",
"NonProprietaryName": "Guaifenesin, Dextromethorphan Hbr",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190228",
"EndMarketingDate": "20261228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209692",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "600; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190228",
"EndMarketingDatePackage": "20261228",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relievescough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep."
},
{
"NDCCode": "30142-144-68",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (30142-144-68) > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "30142-0144-68",
"ProductNDC": "30142-144",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus D",
"NonProprietaryName": "Guaifenesin, Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091071",
"LabelerName": "Kroger Company",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "600; 60",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-02-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170420",
"SamplePackage": "N"
},
{
"NDCCode": "30142-739-68",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (30142-739-68) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "30142-0739-68",
"ProductNDC": "30142-739",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus D",
"NonProprietaryName": "Guaifenesin And Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214407",
"LabelerName": "Kroger Company",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "600; 60",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251104",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves nasal congestion due to:common coldhay feverupper respiratory allergies . temporarily restores freer breathing through the nose. promotes nasal and/or sinus drainage. temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "31722-504-25",
"PackageDescription": "250 TABLET, FILM COATED in 1 BOTTLE (31722-504-25) ",
"NDC11Code": "31722-0504-25",
"ProductNDC": "31722-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz",
"NonProprietaryName": "Efavirenz",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078886",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "EFAVIRENZ",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-05-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180427",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz tablets in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.",
"Description": "Efavirenz is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz USP is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its empirical formula is C 14H 9ClF 3NO 2 and its structural formula is:. Efavirenz USP is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (<10 microgram/mL). Tablets: Efavirenz are available as film-coated tablets for oral administration containing 600 mg of efavirenz USP and the following inactive ingredients: microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate. The film coating contains Opadry® Yellow (hypromellose, titanium dioxide, iron oxide yellow and polyethylene glycol)."
},
{
"NDCCode": "31722-504-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (31722-504-30) ",
"NDC11Code": "31722-0504-30",
"ProductNDC": "31722-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz",
"NonProprietaryName": "Efavirenz",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078886",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "EFAVIRENZ",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-05-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180427",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz tablets in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.",
"Description": "Efavirenz is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz USP is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its empirical formula is C 14H 9ClF 3NO 2 and its structural formula is:. Efavirenz USP is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (<10 microgram/mL). Tablets: Efavirenz are available as film-coated tablets for oral administration containing 600 mg of efavirenz USP and the following inactive ingredients: microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate. The film coating contains Opadry® Yellow (hypromellose, titanium dioxide, iron oxide yellow and polyethylene glycol)."
},
{
"NDCCode": "31722-736-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (31722-736-30) ",
"NDC11Code": "31722-0736-30",
"ProductNDC": "31722-736",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203053",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "600; 200; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2022-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220124",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.",
"Description": "Efavirenz, emtricitabine and tenofovir disoproxil fumarate is a fixed-dose combination tablet containing EFV, FTC, and TDF. EFV is a non-nucleoside reverse transcriptase inhibitor (NNRTI). FTC is a synthetic nucleoside analog of cytidine. TDF, which is converted in vivo to tenofovir, is an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration. Each tablet contains 600 mg of efavirenz USP, 200 mg of emtricitabine USP, and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film-coating contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Efavirenz: EFV is chemically described as ( S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2 H-3,1-benzoxazin-2-one. Its molecular formula is C 14H 9ClF 3NO 2 and its structural formula is:. Efavirenz USP is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is soluble in methanol and practically insoluble in water. Emtricitabine: The chemical name of FTC is 4-amino-5-fluoro-1-(2 R,5 S)-2-hydroxymethyl)-1,3-oxathiolan-5-yl]2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C 8H 10FN 3O 3S and a molecular weight of 247.25. It has the following structural formula:. Emtricitabine USP is a white to off-white powder with freely soluble in water and in methanol. Practically insoluble in methylene chloride. Tenofovir DF: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of TDF is [[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl] phosphonic acid disoproxil fumarate. It has a molecular formula of C 19H 30N 5O 10PC 4H 4O 4 and a molecular weight of 635.51. It has the following structural formula. TDF is a white to off-white crystalline powder with sparingly soluble in methanol and in ethanol."
},
{
"NDCCode": "33342-013-07",
"PackageDescription": "30 TABLET in 1 BOTTLE (33342-013-07) ",
"NDC11Code": "33342-0013-07",
"ProductNDC": "33342-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz",
"NonProprietaryName": "Efavirenz",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091579",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "EFAVIRENZ",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240510",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.",
"Description": "Efavirenz, USP is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as(S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro4(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its empirical formula is C14H9ClF3NO2 and its structural formula is: Efavirenz,USP is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (<10 microgram/mL). Tablets: Efavirenz USP is available as film-coated tablets for oral administration containing 600 mg of efavirenz and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coating contains Opadry Yellow,consisting of hydroxypropylmethyl cellulose, titanium dioxide, polyethylene glycol and iron oxide yellow."
},
{
"NDCCode": "33342-138-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-138-07) ",
"NDC11Code": "33342-0138-07",
"ProductNDC": "33342-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204287",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "600; 200; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2021-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210913",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.",
"Description": "Efavirenz, emtricitabine and tenofovir disoproxil fumarate is a fixed-dose combination tablet containing EFV, FTC, and TDF. EFV is a non-nucleoside reverse transcriptase inhibitor (NNRTI). FTC is a synthetic nucleoside analog of cytidine. TDF, which is converted in vivo to tenofovir, is an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Efavirenz, emtricitabine and tenofovir disoproxil fumarate are for oral administration. Each tablet contains 600 mg of EFV, 200 mg of FTC, and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregrelatinised starch, sodium lauryl sulfate. The tablets are film coated with a coating material containing black iron oxide, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, and titanium dioxide.Efavirenz: EFV is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1, 4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (less than 10 μg/mL).Emtricitabine: The chemical name of FTC is 5-fluoro-1-(2R,5S)-[2(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.24. It has the following structural formula. Emtricitabine is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25 oC. Tenofovir DF: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of TDF is 9-[(R)-2[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula. TDF is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25 °C."
},
{
"NDCCode": "37808-446-68",
"PackageDescription": "36 BLISTER PACK in 1 CARTON (37808-446-68) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "37808-0446-68",
"ProductNDC": "37808-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief D",
"NonProprietaryName": "Guaifenesin, Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091071",
"LabelerName": "H E B",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "600; 60",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160322",
"SamplePackage": "N"
},
{
"NDCCode": "37808-777-68",
"PackageDescription": "36 BLISTER PACK in 1 CARTON (37808-777-68) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "37808-0777-68",
"ProductNDC": "37808-777",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief D",
"NonProprietaryName": "Guaifenesin, Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091071",
"LabelerName": "H E B",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "600; 60",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180517",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves nasal congestion due to:. common cold. hay fever. upper respiratory allergies. temporarily restores freer breathing through the nose. promotes nasal and/or sinus drainage. temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "42543-889-04",
"PackageDescription": "30 TABLET in 1 BOTTLE (42543-889-04) ",
"NDC11Code": "42543-0889-04",
"ProductNDC": "42543-889",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz",
"NonProprietaryName": "Efavirenz",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204869",
"LabelerName": "Strides Pharma Inc.",
"SubstanceName": "EFAVIRENZ",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210111",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.",
"Description": "Efavirenz tablets USP are an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its empirical formula is C14H9ClF3NO2 and its structural formula is. Efavirenz is a white to off-white crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (<10 microgram/mL). Efavirenz tablet USP is available as capsule shaped film-coated tablets imprinted with \"600\" on one side and plain on other side for oral administration containing 600 mg of efavirenz and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coating contains Instacoat Universal. Instacoat Universal contains HPMC 2910/Hypromellose, titanium dioxide, polyethylene glycol, red iron oxide, black iron oxide and yellow iron oxide. Opacode black ink contains propylene glycol, shellac glaze and ferrosoferric oxide."
},
{
"NDCCode": "43353-987-31",
"PackageDescription": "600 TABLET in 1 BOTTLE (43353-987-31) ",
"NDC11Code": "43353-0987-31",
"ProductNDC": "43353-987",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203769",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240610",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablet are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Tablets USP, are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride is a white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Each Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains hypromellose polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide."
},
{
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"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-704-05) ",
"NDC11Code": "43598-0704-05",
"ProductNDC": "43598-704",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Darunavir",
"NonProprietaryName": "Darunavir",
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"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211578",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "DARUNAVIR",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-02",
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"IndicationAndUsage": "Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].",
"Description": "Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir tablets contain the active ingredient darunavir, which has the following chemical name: (3R, 3aS, 6aR)-hexahydrofuro [2,3-b]furan-3-yl(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropylamino]-1-benzyl-2-hydroxy propyl]carbamate). Its molecular formula is C27H37N3O7S and its molecular weight is 547.68. Darunavir has the following structural formula. Darunavir is a white to pale yellow color solid with a solubility of approximately 0.08 mg per mL in water at ~37°C. It is freely soluble in dichloromethane and very slightly soluble in ethyl alcohol absolute. Darunavir 600 mg tablets are available as white colored, oval shaped, film-coated tablets for oral administration. Each tablet contains 600 mg of darunavir. Darunavir 800 mg tablets are available as blue colored, oval shaped, film-coated tablets for oral administration. Each tablet contains 800 mg of darunavir. Each tablet also contains the inactive ingredients colloidal silicon dioxide (colloidal anhydrous silica), croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The 600 mg tablet film coating, OPADRY® II White, contains polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablet film coating, OPADRY® II Blue, contains FD&C Blue No. 1/Brilliant Blue FCF Aluminium Lake, FD&C Blue No. 2/Indigo Caramine Aluminium Lake, FD&C Red No. 40/Alura Red AC Aluminium Lake, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. All strengths for darunavir are expressed in terms of the free form of darunavir."
},
{
"NDCCode": "43598-704-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (43598-704-60) ",
"NDC11Code": "43598-0704-60",
"ProductNDC": "43598-704",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211578",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "DARUNAVIR",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].",
"Description": "Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir tablets contain the active ingredient darunavir, which has the following chemical name: (3R, 3aS, 6aR)-hexahydrofuro [2,3-b]furan-3-yl(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropylamino]-1-benzyl-2-hydroxy propyl]carbamate). Its molecular formula is C27H37N3O7S and its molecular weight is 547.68. Darunavir has the following structural formula. Darunavir is a white to pale yellow color solid with a solubility of approximately 0.08 mg per mL in water at ~37°C. It is freely soluble in dichloromethane and very slightly soluble in ethyl alcohol absolute. Darunavir 600 mg tablets are available as white colored, oval shaped, film-coated tablets for oral administration. Each tablet contains 600 mg of darunavir. Darunavir 800 mg tablets are available as blue colored, oval shaped, film-coated tablets for oral administration. Each tablet contains 800 mg of darunavir. Each tablet also contains the inactive ingredients colloidal silicon dioxide (colloidal anhydrous silica), croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The 600 mg tablet film coating, OPADRY® II White, contains polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablet film coating, OPADRY® II Blue, contains FD&C Blue No. 1/Brilliant Blue FCF Aluminium Lake, FD&C Blue No. 2/Indigo Caramine Aluminium Lake, FD&C Red No. 40/Alura Red AC Aluminium Lake, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. All strengths for darunavir are expressed in terms of the free form of darunavir."
},
{
"NDCCode": "43598-705-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-705-05) ",
"NDC11Code": "43598-0705-05",
"ProductNDC": "43598-705",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Darunavir",
"NonProprietaryName": "Darunavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211578",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "DARUNAVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].",
"Description": "Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir tablets contain the active ingredient darunavir, which has the following chemical name: (3R, 3aS, 6aR)-hexahydrofuro [2,3-b]furan-3-yl(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropylamino]-1-benzyl-2-hydroxy propyl]carbamate). Its molecular formula is C27H37N3O7S and its molecular weight is 547.68. Darunavir has the following structural formula. Darunavir is a white to pale yellow color solid with a solubility of approximately 0.08 mg per mL in water at ~37°C. It is freely soluble in dichloromethane and very slightly soluble in ethyl alcohol absolute. Darunavir 600 mg tablets are available as white colored, oval shaped, film-coated tablets for oral administration. Each tablet contains 600 mg of darunavir. Darunavir 800 mg tablets are available as blue colored, oval shaped, film-coated tablets for oral administration. Each tablet contains 800 mg of darunavir. Each tablet also contains the inactive ingredients colloidal silicon dioxide (colloidal anhydrous silica), croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The 600 mg tablet film coating, OPADRY® II White, contains polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablet film coating, OPADRY® II Blue, contains FD&C Blue No. 1/Brilliant Blue FCF Aluminium Lake, FD&C Blue No. 2/Indigo Caramine Aluminium Lake, FD&C Red No. 40/Alura Red AC Aluminium Lake, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. All strengths for darunavir are expressed in terms of the free form of darunavir."
},
{
"NDCCode": "43598-705-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (43598-705-30) ",
"NDC11Code": "43598-0705-30",
"ProductNDC": "43598-705",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Darunavir",
"NonProprietaryName": "Darunavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"ApplicationNumber": "ANDA211578",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "DARUNAVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].",
"Description": "Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir tablets contain the active ingredient darunavir, which has the following chemical name: (3R, 3aS, 6aR)-hexahydrofuro [2,3-b]furan-3-yl(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropylamino]-1-benzyl-2-hydroxy propyl]carbamate). Its molecular formula is C27H37N3O7S and its molecular weight is 547.68. Darunavir has the following structural formula. Darunavir is a white to pale yellow color solid with a solubility of approximately 0.08 mg per mL in water at ~37°C. It is freely soluble in dichloromethane and very slightly soluble in ethyl alcohol absolute. Darunavir 600 mg tablets are available as white colored, oval shaped, film-coated tablets for oral administration. Each tablet contains 600 mg of darunavir. Darunavir 800 mg tablets are available as blue colored, oval shaped, film-coated tablets for oral administration. Each tablet contains 800 mg of darunavir. Each tablet also contains the inactive ingredients colloidal silicon dioxide (colloidal anhydrous silica), croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The 600 mg tablet film coating, OPADRY® II White, contains polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablet film coating, OPADRY® II Blue, contains FD&C Blue No. 1/Brilliant Blue FCF Aluminium Lake, FD&C Blue No. 2/Indigo Caramine Aluminium Lake, FD&C Red No. 40/Alura Red AC Aluminium Lake, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. All strengths for darunavir are expressed in terms of the free form of darunavir."
},
{
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"PackageDescription": "18 BLISTER PACK in 1 CARTON (45802-230-68) > 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "45802-0230-68",
"ProductNDC": "45802-230",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin And Pseudoephedrine Hydrochloride Extended Release",
"NonProprietaryName": "Guaifenesin, Pseudoephedrine Hydrochloride",
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"ApplicationNumber": "ANDA091071",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "600; 60",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160129",
"EndMarketingDatePackage": "20220228",
"SamplePackage": "N"
},
{
"NDCCode": "46122-239-68",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (46122-239-68) > 18 TABLET in 1 BLISTER PACK",
"NDC11Code": "46122-0239-68",
"ProductNDC": "46122-239",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy Mucus D",
"NonProprietaryName": "Guaifenesin, Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091071",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "600; 60",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-11-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "49035-729-68",
"PackageDescription": "36 BLISTER PACK in 1 CARTON (49035-729-68) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "49035-0729-68",
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"ProductTypeName": "HUMAN OTC DRUG",
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"LabelerName": "Wal-Mart Stores Inc",
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<ProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</ProprietaryName>
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<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]</Pharm_Classes>
<Status>Active</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.</IndicationAndUsage>
<Description>Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing EFV USP, FTC, and TDF. EFV, USP is a non-nucleoside reverse transcriptase inhibitor (NNRTI). FTC is a synthetic nucleoside analog of cytidine. TDF, which is converted in vivo to tenofovir, is an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration. Each tablet contains 600 mg of EFV USP, 200 mg of FTC, and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: carmine, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, povidone, sodium starch glycolate, talc, and titanium dioxide. Efavirenz, USP: EFV, USP is chemically described as (4S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its structural formula is:. C14H9ClF3NO2 M.W. 315.68. Efavirenz, USP is a white to slightly pink crystalline powder. It is freely soluble in methanol and practically insoluble in water (less than 10 mcg/mL). Emtricitabine: The chemical name of FTC is 5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has the following structural formula:. C8H10FN3O3S M.W. 247.24. Emtricitabine is a white to off-white colored crystalline powder. It is freely soluble in water and in methanol. Tenofovir DF: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of TDF is 9-[(R)-2[[bis[[(isopropoxycarbonyl)oxy]-methoxy]phosphinyl]methoxy]propyl]adenine fumarate. It has the following structural formula:. C19H30N5O10PC4H4O4 M.W. 635.52. TDF is a white to off-white crystalline powder. It is practically insoluble in water.</Description>
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<SamplePackage>N</SamplePackage>
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<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves nasal congestion due to:common coldhay feverupper respiratory allergies . temporarily restores freer breathing through the nose. promotes nasal and/or sinus drainage. temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves nasal congestion due to. common cold. hay fever. upper respiratory allergies . temporarily restores freer breathing through the nose. promotes nasal and/or sinus drainage. temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
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<IndicationAndUsage>Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to pale yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran Etexilate Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: Butylated hydroxy toluene, citric acid monohydrate crystal, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, macrogol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol 600, polyvinyl alcohol, povidone (k-value-25), sodium bicarbonate, talc, tartaric acid and titanium dioxide. The capsule shell is composed of hypromellose, titanium dioxide, FD&C red #40 & FD&C blue #1 (150 mg and 110 mg), FD&C yellow #6 (75 mg and 150 mg). The imprinting ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide & potassium hydroxide.</Description>
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<IndicationAndUsage>Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to pale yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran Etexilate Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: Butylated hydroxy toluene, citric acid monohydrate crystal, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, macrogol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol 600, polyvinyl alcohol, povidone (k-value-25), sodium bicarbonate, talc, tartaric acid and titanium dioxide. The capsule shell is composed of hypromellose, titanium dioxide, FD&C red #40 & FD&C blue #1 (150 mg and 110 mg), FD&C yellow #6 (75 mg and 150 mg). The imprinting ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide & potassium hydroxide.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to pale yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran Etexilate Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: Butylated hydroxy toluene, citric acid monohydrate crystal, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, macrogol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol 600, polyvinyl alcohol, povidone (k-value-25), sodium bicarbonate, talc, tartaric acid and titanium dioxide. The capsule shell is composed of hypromellose, titanium dioxide, FD&C red #40 & FD&C blue #1 (150 mg and 110 mg), FD&C yellow #6 (75 mg and 150 mg). The imprinting ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide & potassium hydroxide.</Description>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190531</StartMarketingDatePackage>
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<IndicationAndUsage>Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.</IndicationAndUsage>
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<NDC>
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<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relievescough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep.</IndicationAndUsage>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves nasal congestion due to:common coldhay feverupper respiratory allergies . temporarily restores freer breathing through the nose. promotes nasal and/or sinus drainage. temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Efavirenz</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078886</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>EFAVIRENZ</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Efavirenz tablets in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.</IndicationAndUsage>
<Description>Efavirenz is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz USP is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its empirical formula is C 14H 9ClF 3NO 2 and its structural formula is:. Efavirenz USP is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (<10 microgram/mL). Tablets: Efavirenz are available as film-coated tablets for oral administration containing 600 mg of efavirenz USP and the following inactive ingredients: microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate. The film coating contains Opadry® Yellow (hypromellose, titanium dioxide, iron oxide yellow and polyethylene glycol).</Description>
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<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>EFAVIRENZ</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Efavirenz tablets in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.</IndicationAndUsage>
<Description>Efavirenz is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz USP is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its empirical formula is C 14H 9ClF 3NO 2 and its structural formula is:. Efavirenz USP is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (<10 microgram/mL). Tablets: Efavirenz are available as film-coated tablets for oral administration containing 600 mg of efavirenz USP and the following inactive ingredients: microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate. The film coating contains Opadry® Yellow (hypromellose, titanium dioxide, iron oxide yellow and polyethylene glycol).</Description>
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<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (31722-736-30) </PackageDescription>
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<ProductNDC>31722-736</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</ProprietaryName>
<NonProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203053</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
<StrengthNumber>600; 200; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.</IndicationAndUsage>
<Description>Efavirenz, emtricitabine and tenofovir disoproxil fumarate is a fixed-dose combination tablet containing EFV, FTC, and TDF. EFV is a non-nucleoside reverse transcriptase inhibitor (NNRTI). FTC is a synthetic nucleoside analog of cytidine. TDF, which is converted in vivo to tenofovir, is an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration. Each tablet contains 600 mg of efavirenz USP, 200 mg of emtricitabine USP, and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film-coating contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Efavirenz: EFV is chemically described as ( S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2 H-3,1-benzoxazin-2-one. Its molecular formula is C 14H 9ClF 3NO 2 and its structural formula is:. Efavirenz USP is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is soluble in methanol and practically insoluble in water. Emtricitabine: The chemical name of FTC is 4-amino-5-fluoro-1-(2 R,5 S)-2-hydroxymethyl)-1,3-oxathiolan-5-yl]2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C 8H 10FN 3O 3S and a molecular weight of 247.25. It has the following structural formula:. Emtricitabine USP is a white to off-white powder with freely soluble in water and in methanol. Practically insoluble in methylene chloride. Tenofovir DF: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of TDF is [[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl] phosphonic acid disoproxil fumarate. It has a molecular formula of C 19H 30N 5O 10PC 4H 4O 4 and a molecular weight of 635.51. It has the following structural formula. TDF is a white to off-white crystalline powder with sparingly soluble in methanol and in ethanol.</Description>
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<NDCCode>33342-013-07</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (33342-013-07) </PackageDescription>
<NDC11Code>33342-0013-07</NDC11Code>
<ProductNDC>33342-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Efavirenz</ProprietaryName>
<NonProprietaryName>Efavirenz</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091579</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>EFAVIRENZ</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Efavirenz in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.</IndicationAndUsage>
<Description>Efavirenz, USP is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as(S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro4(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its empirical formula is C14H9ClF3NO2 and its structural formula is: Efavirenz,USP is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (<10 microgram/mL). Tablets: Efavirenz USP is available as film-coated tablets for oral administration containing 600 mg of efavirenz and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coating contains Opadry Yellow,consisting of hydroxypropylmethyl cellulose, titanium dioxide, polyethylene glycol and iron oxide yellow.</Description>
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<NDCCode>33342-138-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-138-07) </PackageDescription>
<NDC11Code>33342-0138-07</NDC11Code>
<ProductNDC>33342-138</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</ProprietaryName>
<NonProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204287</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
<StrengthNumber>600; 200; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.</IndicationAndUsage>
<Description>Efavirenz, emtricitabine and tenofovir disoproxil fumarate is a fixed-dose combination tablet containing EFV, FTC, and TDF. EFV is a non-nucleoside reverse transcriptase inhibitor (NNRTI). FTC is a synthetic nucleoside analog of cytidine. TDF, which is converted in vivo to tenofovir, is an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Efavirenz, emtricitabine and tenofovir disoproxil fumarate are for oral administration. Each tablet contains 600 mg of EFV, 200 mg of FTC, and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregrelatinised starch, sodium lauryl sulfate. The tablets are film coated with a coating material containing black iron oxide, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, and titanium dioxide.Efavirenz: EFV is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1, 4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (less than 10 μg/mL).Emtricitabine: The chemical name of FTC is 5-fluoro-1-(2R,5S)-[2(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.24. It has the following structural formula. Emtricitabine is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25 oC. Tenofovir DF: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of TDF is 9-[(R)-2[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula. TDF is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25 °C.</Description>
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<NDC>
<NDCCode>37808-446-68</NDCCode>
<PackageDescription>36 BLISTER PACK in 1 CARTON (37808-446-68) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>37808-0446-68</NDC11Code>
<ProductNDC>37808-446</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief D</ProprietaryName>
<NonProprietaryName>Guaifenesin, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091071</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>600; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>36 BLISTER PACK in 1 CARTON (37808-777-68) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>37808-0777-68</NDC11Code>
<ProductNDC>37808-777</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief D</ProprietaryName>
<NonProprietaryName>Guaifenesin, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091071</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>600; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves nasal congestion due to:. common cold. hay fever. upper respiratory allergies. temporarily restores freer breathing through the nose. promotes nasal and/or sinus drainage. temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
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<NDC>
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<PackageDescription>30 TABLET in 1 BOTTLE (42543-889-04) </PackageDescription>
<NDC11Code>42543-0889-04</NDC11Code>
<ProductNDC>42543-889</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Efavirenz</ProprietaryName>
<NonProprietaryName>Efavirenz</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204869</ApplicationNumber>
<LabelerName>Strides Pharma Inc.</LabelerName>
<SubstanceName>EFAVIRENZ</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Efavirenz in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.</IndicationAndUsage>
<Description>Efavirenz tablets USP are an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its empirical formula is C14H9ClF3NO2 and its structural formula is. Efavirenz is a white to off-white crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (<10 microgram/mL). Efavirenz tablet USP is available as capsule shaped film-coated tablets imprinted with "600" on one side and plain on other side for oral administration containing 600 mg of efavirenz and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coating contains Instacoat Universal. Instacoat Universal contains HPMC 2910/Hypromellose, titanium dioxide, polyethylene glycol, red iron oxide, black iron oxide and yellow iron oxide. Opacode black ink contains propylene glycol, shellac glaze and ferrosoferric oxide.</Description>
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<NDC>
<NDCCode>43353-987-31</NDCCode>
<PackageDescription>600 TABLET in 1 BOTTLE (43353-987-31) </PackageDescription>
<NDC11Code>43353-0987-31</NDC11Code>
<ProductNDC>43353-987</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203769</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablet are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin Hydrochloride Tablets USP, are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride is a white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Each Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains hypromellose polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide.</Description>
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<NDC>
<NDCCode>43598-704-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-704-05) </PackageDescription>
<NDC11Code>43598-0704-05</NDC11Code>
<ProductNDC>43598-704</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Darunavir</ProprietaryName>
<NonProprietaryName>Darunavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211578</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>DARUNAVIR</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231129</StartMarketingDatePackage>
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<IndicationAndUsage>Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].</IndicationAndUsage>
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<Description>Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir tablets contain the active ingredient darunavir, which has the following chemical name: (3R, 3aS, 6aR)-hexahydrofuro [2,3-b]furan-3-yl(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropylamino]-1-benzyl-2-hydroxy propyl]carbamate). Its molecular formula is C27H37N3O7S and its molecular weight is 547.68. Darunavir has the following structural formula. Darunavir is a white to pale yellow color solid with a solubility of approximately 0.08 mg per mL in water at ~37°C. It is freely soluble in dichloromethane and very slightly soluble in ethyl alcohol absolute. Darunavir 600 mg tablets are available as white colored, oval shaped, film-coated tablets for oral administration. Each tablet contains 600 mg of darunavir. Darunavir 800 mg tablets are available as blue colored, oval shaped, film-coated tablets for oral administration. Each tablet contains 800 mg of darunavir. Each tablet also contains the inactive ingredients colloidal silicon dioxide (colloidal anhydrous silica), croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The 600 mg tablet film coating, OPADRY® II White, contains polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablet film coating, OPADRY® II Blue, contains FD&C Blue No. 1/Brilliant Blue FCF Aluminium Lake, FD&C Blue No. 2/Indigo Caramine Aluminium Lake, FD&C Red No. 40/Alura Red AC Aluminium Lake, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. All strengths for darunavir are expressed in terms of the free form of darunavir.</Description>
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<Description>Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir tablets contain the active ingredient darunavir, which has the following chemical name: (3R, 3aS, 6aR)-hexahydrofuro [2,3-b]furan-3-yl(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropylamino]-1-benzyl-2-hydroxy propyl]carbamate). Its molecular formula is C27H37N3O7S and its molecular weight is 547.68. Darunavir has the following structural formula. Darunavir is a white to pale yellow color solid with a solubility of approximately 0.08 mg per mL in water at ~37°C. It is freely soluble in dichloromethane and very slightly soluble in ethyl alcohol absolute. Darunavir 600 mg tablets are available as white colored, oval shaped, film-coated tablets for oral administration. Each tablet contains 600 mg of darunavir. Darunavir 800 mg tablets are available as blue colored, oval shaped, film-coated tablets for oral administration. Each tablet contains 800 mg of darunavir. Each tablet also contains the inactive ingredients colloidal silicon dioxide (colloidal anhydrous silica), croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The 600 mg tablet film coating, OPADRY® II White, contains polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablet film coating, OPADRY® II Blue, contains FD&C Blue No. 1/Brilliant Blue FCF Aluminium Lake, FD&C Blue No. 2/Indigo Caramine Aluminium Lake, FD&C Red No. 40/Alura Red AC Aluminium Lake, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. All strengths for darunavir are expressed in terms of the free form of darunavir.</Description>
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<Description>Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir tablets contain the active ingredient darunavir, which has the following chemical name: (3R, 3aS, 6aR)-hexahydrofuro [2,3-b]furan-3-yl(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropylamino]-1-benzyl-2-hydroxy propyl]carbamate). Its molecular formula is C27H37N3O7S and its molecular weight is 547.68. Darunavir has the following structural formula. Darunavir is a white to pale yellow color solid with a solubility of approximately 0.08 mg per mL in water at ~37°C. It is freely soluble in dichloromethane and very slightly soluble in ethyl alcohol absolute. Darunavir 600 mg tablets are available as white colored, oval shaped, film-coated tablets for oral administration. Each tablet contains 600 mg of darunavir. Darunavir 800 mg tablets are available as blue colored, oval shaped, film-coated tablets for oral administration. Each tablet contains 800 mg of darunavir. Each tablet also contains the inactive ingredients colloidal silicon dioxide (colloidal anhydrous silica), croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The 600 mg tablet film coating, OPADRY® II White, contains polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablet film coating, OPADRY® II Blue, contains FD&C Blue No. 1/Brilliant Blue FCF Aluminium Lake, FD&C Blue No. 2/Indigo Caramine Aluminium Lake, FD&C Red No. 40/Alura Red AC Aluminium Lake, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. All strengths for darunavir are expressed in terms of the free form of darunavir.</Description>
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