RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "66582-315-52",
      "PackageDescription": "50 BLISTER PACK in 1 CARTON (66582-315-52)  > 1 TABLET in 1 BLISTER PACK (66582-315-01)",
      "NDC11Code": "66582-0315-52",
      "ProductNDC": "66582-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vytorin",
      "NonProprietaryName": "Ezetimibe And Simvastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040723",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021687",
      "LabelerName": "Merck Sharp & Dohme Corp.",
      "SubstanceName": "EZETIMIBE; SIMVASTATIN",
      "StrengthNumber": "10; 80",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "66582-313-52",
      "PackageDescription": "50 BLISTER PACK in 1 CARTON (66582-313-52)  > 1 TABLET in 1 BLISTER PACK (66582-313-01)",
      "NDC11Code": "66582-0313-52",
      "ProductNDC": "66582-313",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vytorin",
      "NonProprietaryName": "Ezetimibe And Simvastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040723",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021687",
      "LabelerName": "Merck Sharp & Dohme Corp.",
      "SubstanceName": "EZETIMIBE; SIMVASTATIN",
      "StrengthNumber": "10; 40",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "49884-315-91",
      "PackageDescription": "7 BLISTER PACK in 1 CARTON (49884-315-91)  / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-315-52) ",
      "NDC11Code": "49884-0315-91",
      "ProductNDC": "49884-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Risperidone",
      "NonProprietaryName": "Risperidone",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091026",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077494",
      "LabelerName": "Par Health USA, LLC",
      "SubstanceName": "RISPERIDONE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20091026",
      "SamplePackage": "N",
      "IndicationAndUsage": "Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
      "Description": "Risperidone Orally Disintegrating Tablets, USP contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCI. Risperidone Orally Disintegrating Tablets, USP are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths and are white in color. Risperidone Orally Disintegrating Tablets, USP contain the following inactive ingredients: aspartame, croscarmellose sodium, crospovidone, magnesium stearate, maltodextrin, mannitol, methacrylic acid polymer with divinylbenzene, modified food starch, silicon dioxide, sorbitol, talc, tartaric acid, and natural grapefruit flavor. This product meets USP Disintegration Test 2."
    },
    {
      "NDCCode": "51655-315-52",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (51655-315-52) ",
      "NDC11Code": "51655-0315-52",
      "ProductNDC": "51655-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Verapamil Hydrochloride",
      "NonProprietaryName": "Verapamil Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221123",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071881",
      "LabelerName": "Northwind Health Company, LLC",
      "SubstanceName": "VERAPAMIL HYDROCHLORIDE",
      "StrengthNumber": "120",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-01-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20221123",
      "SamplePackage": "N",
      "IndicationAndUsage": "Verapamil hydrochloride tablets, USP are indicated for the treatment of the following.",
      "Description": "Verapamil hydrochloride (verapamil HCl) tablets, USP is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) available for oral administration in film-coated tablets containing 40 mg, 80 mg or 120 mg of verapamil hydrochloride. The structural formula of verapamil HCl is. C 27H 38N 2O 4  HCl                                                                                   M.W. = 491.08. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil HCl is not chemically related to other cardioactive drugs. Inactive ingredients include colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, light mineral oil, sodium lauryl sulfate, titanium dioxide and hypromellose."
    },
    {
      "NDCCode": "51862-315-78",
      "PackageDescription": "5 POUCH in 1 CARTON (51862-315-78)  > 1 PATCH in 1 POUCH (51862-315-52)  > 72 h in 1 PATCH",
      "NDC11Code": "51862-0315-78",
      "ProductNDC": "51862-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fentanyl",
      "NonProprietaryName": "Fentanyl",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20171002",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077062",
      "LabelerName": "Mayne Pharma",
      "SubstanceName": "FENTANYL",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/h",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2020-05-07",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "66582-315-31",
      "PackageDescription": "30 TABLET in 1 BOTTLE (66582-315-31) ",
      "NDC11Code": "66582-0315-31",
      "ProductNDC": "66582-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vytorin",
      "NonProprietaryName": "Ezetimibe And Simvastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040723",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021687",
      "LabelerName": "Merck Sharp & Dohme Corp.",
      "SubstanceName": "EZETIMIBE; SIMVASTATIN",
      "StrengthNumber": "10; 80",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20040723",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "66582-315-54",
      "PackageDescription": "90 TABLET in 1 BOTTLE (66582-315-54) ",
      "NDC11Code": "66582-0315-54",
      "ProductNDC": "66582-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vytorin",
      "NonProprietaryName": "Ezetimibe And Simvastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040723",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021687",
      "LabelerName": "Merck Sharp & Dohme Corp.",
      "SubstanceName": "EZETIMIBE; SIMVASTATIN",
      "StrengthNumber": "10; 80",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20040723",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "66582-315-66",
      "PackageDescription": "2500 TABLET in 1 BOTTLE (66582-315-66) ",
      "NDC11Code": "66582-0315-66",
      "ProductNDC": "66582-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vytorin",
      "NonProprietaryName": "Ezetimibe And Simvastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040723",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021687",
      "LabelerName": "Merck Sharp & Dohme Corp.",
      "SubstanceName": "EZETIMIBE; SIMVASTATIN",
      "StrengthNumber": "10; 80",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-04-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20040723",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "66582-315-74",
      "PackageDescription": "500 TABLET in 1 BOTTLE (66582-315-74) ",
      "NDC11Code": "66582-0315-74",
      "ProductNDC": "66582-315",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vytorin",
      "NonProprietaryName": "Ezetimibe And Simvastatin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040723",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021687",
      "LabelerName": "Merck Sharp & Dohme Corp.",
      "SubstanceName": "EZETIMIBE; SIMVASTATIN",
      "StrengthNumber": "10; 80",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-04-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20040723",
      "SamplePackage": "N"
    },
    {
      "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": "23155-216-31",
      "PackageDescription": "5 mL in 1 VIAL, GLASS (23155-216-31) ",
      "NDC11Code": "23155-0216-31",
      "ProductNDC": "23155-216",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cidofovir Dihydrate",
      "NonProprietaryName": "Cidofovir Dihydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20120806",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202501",
      "LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
      "SubstanceName": "CIDOFOVIR",
      "StrengthNumber": "375",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog [EXT]",
      "Status": "Active",
      "LastUpdate": "2023-10-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120806",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cidofovir injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF CIDOFOVIR INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS. DESCRIPTION OF CLINICAL TRIALS. Three phase II/III controlled trials of cidofovir injection have been conducted in HIV-infected patients with CMV retinitis. Delayed Versus Immediate Therapy (Study 105). In stage 1 of this open-label trial, conducted by the Studies of the Ocular Complications of AIDS (SOCA) Clinical Research Group, 29 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 3 mg/kg every other week) or to have cidofovir injection delayed until progression of CMV retinitis13. In stage 2 of this trial, an additional 35 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 5 mg/kg every other week), immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 3 mg/kg every other week), or to have cidofovir injection delayed until progression of CMV retinitis. Of the 64 patients in this study, 12 were randomized to 5 mg/kg maintenance therapy, 26 to 3 mg/kg maintenance therapy, and 26 to delayed therapy. Of the 12 patients enrolled in the 5 mg/kg maintenance group, 5 patients progressed, 5 patients discontinued therapy and 2 patients had no progression at study completion. Based on masked readings of retinal photographs, the median [95% confidence interval (CI)] time to retinitis progression was not reached (25, not reached) for the 5 mg/kg maintenance group. Median (95% CI) time to the alternative endpoint of retinitis progression or study drug discontinuation was 44 days (24, 207) for the 5 mg/kg maintenance group. Patients receiving 5 mg/kg maintenance had delayed time to retinitis progression compared to patients receiving 3 mg/kg maintenance or deferred therapy. Delayed Versus Immediate Therapy (Study 106). In an open-label trial, 48 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 5 mg/kg every other week), or to have cidofovir injection delayed until progression of CMV retinitis14. Patient baseline characteristics and disposition are shown in Table 3. Of 25 and 23 patients in the immediate and delayed groups respectively, 23 and 21 were evaluable for retinitis progression as determined by retinal photography. Based on masked readings of retinal photographs, the median [95% confidence interval (CI)] times to retinitis progression were 120 days (40, 134) and 22 days (10, 27) for the immediate and delayed therapy groups, respectively. This difference was statistically significant. However, because of the limited number of patients remaining on treatment over time (3 of 25 patients received cidofovir injection for 120 days or longer), the median time to progression for the immediate therapy group was difficult to precisely estimate. Median (95% CI) times to the alternative endpoint of retinitis progression or study drug discontinuation (including adverse events, withdrawn consent, and systemic CMV disease) were 52 days (37, 85) and 22 days (13, 27) for the immediate and delayed therapy groups, respectively. This difference was statistically significant. Time to progression estimates from this study may not be directly comparable to estimates reported for other therapies. Dose-response study of cidofovir injection (Study 107). In an open-label trial, 100 patients with relapsing CMV retinitis were randomized to receive 5 mg/kg once a week for 2 weeks and then either 5 mg/kg (n = 49) or 3 mg/kg (n   = 51) every other week. Enrolled patients had been diagnosed with CMV retinitis an average of 390 days prior to randomization and had received a median of 3.8 prior courses of systemic CMV therapy. Eighty four of the 100 patients were considered evaluable for progression by serial retinal photographs (43 randomized to 5 mg/kg and 41 randomized to 3 mg/kg). Twenty-six and 21 patients discontinued therapy due to either an adverse event, intercurrent illness, excluded medication, or withdrawn consent in the 5 mg/kg and 3 mg/kg groups, respectively. Thirty-eight of the 100 randomized patients had progressed according to masked assessment of serial retinal photographs (13 randomized to 5 mg/kg and 25 randomized to 3 mg/kg). Using retinal photographs, the median (95% CI) times to retinitis progression for the 5 mg/kg and 3 mg/kg groups were 115 days (70, not reached) and 49 days (35, 52), respectively. This difference was statistically significant. Similar to Study 106, the median time to retinitis progression for the 5 mg/kg group was difficult to precisely estimate due to the limited number of patients remaining on treatment over time (4 of the 49 patients in the 5 mg/kg group were treated for 115 days or longer). Median (95% CI) times to the alternative endpoint of retinitis progression or study drug discontinuation were 49 days (38, 63) and 35 days (27, 39) for the 5 mg/kg and 3 mg/kg groups, respectively. This difference was statistically significant.",
      "Description": "The chemical name of cidofovir USP is 1-[(S)-3-hydroxy-2-(phosphonomethoxy)propyl]cytosine dihydrate (HPMPC), with the molecular formula of C8H14N3O6P2H2O and a molecular weight of 315.22 (279.19 for anhydrous). The chemical structure is. Cidofovir USP is a white crystalline powder with an aqueous solubility of ≥ 170 mg/mL at pH 6 to 8 and a log P (octanol/aqueous buffer, pH 7.1) value of -3.3. Cidofovir Injection, USP is a sterile, hypertonic aqueous solution for intravenous infusion only. The solution is clear and colorless. It is supplied in clear glass vials, each containing 375 mg of anhydrous cidofovir USP in 5 mL aqueous solution at a concentration of 75 mg/mL. The formulation is pH-adjusted to 7.4 (range 7.1 to 7.7)  with sodium hydroxide and/or hydrochloric acid and contains no preservatives. The appropriate volume of Cidofovir Injection must be removed from the single-dose vial and diluted prior to administration (see DOSAGE AND ADMINISTRATION). MICROBIOLOGY. Mechanism of Action. Cidofovir suppresses cytomegalovirus (CMV) replication by selective inhibition of viral DNA synthesis. Biochemical data support selective inhibition of CMV DNA polymerase by cidofovir diphosphate, the active intracellular metabolite of cidofovir. Cidofovir diphosphate inhibits herpesvirus polymerases at concentrations that are 8- to 600-fold lower than those needed to inhibit human cellular DNA polymerases alpha, beta, and gamma1, 2, 3. Incorporation of cidofovir into the growing viral DNA chain results in reductions in the rate of viral DNA synthesis. In Vitro Susceptibility. Cidofovir is active in vitro against a variety of laboratory and clinical isolates of CMV and other herpesviruses (Table 1). Controlled clinical studies of efficacy have been limited to patients with AIDS and CMV retinitis. Table 1. Cidofovir Inhibition of Virus Multiplication in Cell Culture. Resistance. CMV isolates with reduced susceptibility to cidofovir have been selected in vitro in the presence of high concentrations of cidofovir4. IC50 values for selected resistant isolates ranged from 7 to 15 μM. There are insufficient data at this time to assess the frequency or the clinical significance of the development of resistant isolates following cidofovir injection administration to patients. The possibility of viral resistance should be considered for patients who show a poor clinical response or experience recurrent retinitis progression during therapy. Cross Resistance. Cidofovir-resistant isolates selected in vitro following exposure to increasing concentrations of cidofovir were assessed for susceptibility to ganciclovir and foscarnet4. All were cross resistant to ganciclovir, but remained susceptible to foscarnet. Ganciclovir or ganciclovir/foscarnet-resistant isolates that are cross resistant to cidofovir have been obtained from drug naive patients and from patients following ganciclovir or ganciclovir/ foscarnet therapy. To date, the majority of ganciclovir-resistant isolates are UL97 gene product (phosphokinase) mutants and remain susceptible to cidofovir5. Reduced susceptibility to cidofovir, however, has been reported for DNA polymerase mutants of CMV which are resistant to ganciclovir6–9. To date, all clinical isolates which exhibit high level resistance to ganciclovir, due to mutations in both the DNA polymerase and UL97 genes, have been shown to be cross resistant to cidofovir. Cidofovir is active against some, but not all, CMV isolates which are resistant to foscarnet10–12. The incidence of foscarnet-resistant isolates that are resistant to cidofovir is not known. A few triple-drug resistant isolates have been described. Genotypic analysis of two of these triple-resistant isolates revealed several point mutations in the CMV DNA polymerase gene. The clinical significance of the development of these cross-resistant isolates is not known."
    },
    {
      "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",
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      "StartMarketingDatePackage": "20210913",
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      "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": "42385-915-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42385-915-30) ",
      "NDC11Code": "42385-0915-30",
      "ProductNDC": "42385-915",
      "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": "20211222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213541",
      "LabelerName": "Laurus Labs 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": "2025-07-30",
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      "StartMarketingDatePackage": "20211222",
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      "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 film coated tablet contains efavirenz, USP 600 mg; emtricitabine, USP 200 mg and tenofovir disoproxil fumarate 300 mg 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 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, USP is a white to off white powder with a molecular mass of 315.67. It is 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 a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula:Emtricitabine, USP is a white to almost white crystalline powder. It is freely soluble in water. 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 C19H30N5O10P●C4H4O4 and a molecular weight of 635.52. It has the following structural formula:TDF is a white to off white powder. It is slightly soluble in water at 25°C."
    },
    {
      "NDCCode": "42385-915-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-915-90) ",
      "NDC11Code": "42385-0915-90",
      "ProductNDC": "42385-915",
      "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": "20211222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213541",
      "LabelerName": "Laurus Labs 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": "2025-07-30",
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      "StartMarketingDatePackage": "20211222",
      "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 film coated tablet contains efavirenz, USP 600 mg; emtricitabine, USP 200 mg and tenofovir disoproxil fumarate 300 mg 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 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, USP is a white to off white powder with a molecular mass of 315.67. It is 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 a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula:Emtricitabine, USP is a white to almost white crystalline powder. It is freely soluble in water. 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 C19H30N5O10P●C4H4O4 and a molecular weight of 635.52. It has the following structural formula:TDF is a white to off white powder. It is slightly soluble in water at 25°C."
    },
    {
      "NDCCode": "42385-928-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42385-928-30) ",
      "NDC11Code": "42385-0928-30",
      "ProductNDC": "42385-928",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
      "NonProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200514",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212786",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
      "StrengthNumber": "600; 300; 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], 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]",
      "Status": "Active",
      "LastUpdate": "2023-11-17",
      "PackageNdcExcludeFlag": "N",
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      "StartMarketingDatePackage": "20200514",
      "SamplePackage": "N",
      "IndicationAndUsage": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.",
      "Description": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets contain efavirenz (EFV), an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI), lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir), a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are for oral administration. Each film coated tablet contains efavirenz USP 600 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz: The chemical name of efavirenz is (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 USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL).Lamivudine: The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water.Tenofovir Disoproxil Fumarate: The chemical name of tenofovir DF 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: Tenofovir DF is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75."
    },
    {
      "NDCCode": "42385-928-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-928-90) ",
      "NDC11Code": "42385-0928-90",
      "ProductNDC": "42385-928",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
      "NonProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200514",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212786",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
      "StrengthNumber": "600; 300; 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], 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]",
      "Status": "Active",
      "LastUpdate": "2023-11-17",
      "PackageNdcExcludeFlag": "N",
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      "StartMarketingDatePackage": "20200514",
      "SamplePackage": "N",
      "IndicationAndUsage": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.",
      "Description": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets contain efavirenz (EFV), an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI), lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir), a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are for oral administration. Each film coated tablet contains efavirenz USP 600 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz: The chemical name of efavirenz is (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 USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL).Lamivudine: The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water.Tenofovir Disoproxil Fumarate: The chemical name of tenofovir DF 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: Tenofovir DF is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75."
    },
    {
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      "IndicationAndUsage": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.",
      "Description": "Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is 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 molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 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. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75."
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      "IndicationAndUsage": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.",
      "Description": "Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is 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 molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 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. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75."
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      "IndicationAndUsage": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.",
      "Description": "Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is 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 molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 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. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75."
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      "IndicationAndUsage": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.",
      "Description": "Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is 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 molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 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. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75."
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      "IndicationAndUsage": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.",
      "Description": "Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is 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 molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 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. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75."
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      "SamplePackage": "N",
      "IndicationAndUsage": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.",
      "Description": "Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is 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 molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 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. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75."
    },
    {
      "NDCCode": "42571-420-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (42571-420-01) ",
      "NDC11Code": "42571-0420-01",
      "ProductNDC": "42571-420",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxepin Hydrochloride",
      "NonProprietaryName": "Doxepin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217688",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "DOXEPIN HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
      "Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride, USP is C 19H 21NOHCl with a molecular weight of 315.84. It is a white crystalline solid soluble in water, lower alcohols and chloroform. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[ b, e]oxepin-11(6 H)ylidene- N, N-dimethyl-, hydrochloride. It structural formula of doxepin is shown below. Doxepin hydrochloride capsules, USP are for oral administration. Active ingredients for the capsules include: 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg of doxepin (equivalent to 11.30 mg, 28.26 mg, 56.52 mg, 84.78 mg, and 113.05 mg of doxepin hydrochloride, respectively). Inactive ingredients: magnesium stearate, pregelatinised starch, silicified microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg capsule shells contains FD&C Yellow No. 5 and FD&C Red 40; and 75 mg and 100 mg capsules shells contains D&C Yellow 10 and FD&C Green 3. The imprinting black ink contains black iron oxide, potassium hydroxide and shellac. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "42571-420-13",
      "PackageDescription": "1000 CAPSULE in 1 BOTTLE (42571-420-13) ",
      "NDC11Code": "42571-0420-13",
      "ProductNDC": "42571-420",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxepin Hydrochloride",
      "NonProprietaryName": "Doxepin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217688",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "DOXEPIN HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
      "Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride, USP is C 19H 21NOHCl with a molecular weight of 315.84. It is a white crystalline solid soluble in water, lower alcohols and chloroform. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[ b, e]oxepin-11(6 H)ylidene- N, N-dimethyl-, hydrochloride. It structural formula of doxepin is shown below. Doxepin hydrochloride capsules, USP are for oral administration. Active ingredients for the capsules include: 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg of doxepin (equivalent to 11.30 mg, 28.26 mg, 56.52 mg, 84.78 mg, and 113.05 mg of doxepin hydrochloride, respectively). Inactive ingredients: magnesium stearate, pregelatinised starch, silicified microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg capsule shells contains FD&C Yellow No. 5 and FD&C Red 40; and 75 mg and 100 mg capsules shells contains D&C Yellow 10 and FD&C Green 3. The imprinting black ink contains black iron oxide, potassium hydroxide and shellac. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "42571-421-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (42571-421-01) ",
      "NDC11Code": "42571-0421-01",
      "ProductNDC": "42571-421",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxepin Hydrochloride",
      "NonProprietaryName": "Doxepin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217688",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "DOXEPIN HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
      "Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride, USP is C 19H 21NOHCl with a molecular weight of 315.84. It is a white crystalline solid soluble in water, lower alcohols and chloroform. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[ b, e]oxepin-11(6 H)ylidene- N, N-dimethyl-, hydrochloride. It structural formula of doxepin is shown below. Doxepin hydrochloride capsules, USP are for oral administration. Active ingredients for the capsules include: 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg of doxepin (equivalent to 11.30 mg, 28.26 mg, 56.52 mg, 84.78 mg, and 113.05 mg of doxepin hydrochloride, respectively). Inactive ingredients: magnesium stearate, pregelatinised starch, silicified microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg capsule shells contains FD&C Yellow No. 5 and FD&C Red 40; and 75 mg and 100 mg capsules shells contains D&C Yellow 10 and FD&C Green 3. The imprinting black ink contains black iron oxide, potassium hydroxide and shellac. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "42571-421-13",
      "PackageDescription": "1000 CAPSULE in 1 BOTTLE (42571-421-13) ",
      "NDC11Code": "42571-0421-13",
      "ProductNDC": "42571-421",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxepin Hydrochloride",
      "NonProprietaryName": "Doxepin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217688",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "DOXEPIN HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
      "Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride, USP is C 19H 21NOHCl with a molecular weight of 315.84. It is a white crystalline solid soluble in water, lower alcohols and chloroform. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[ b, e]oxepin-11(6 H)ylidene- N, N-dimethyl-, hydrochloride. It structural formula of doxepin is shown below. Doxepin hydrochloride capsules, USP are for oral administration. Active ingredients for the capsules include: 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg of doxepin (equivalent to 11.30 mg, 28.26 mg, 56.52 mg, 84.78 mg, and 113.05 mg of doxepin hydrochloride, respectively). Inactive ingredients: magnesium stearate, pregelatinised starch, silicified microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg capsule shells contains FD&C Yellow No. 5 and FD&C Red 40; and 75 mg and 100 mg capsules shells contains D&C Yellow 10 and FD&C Green 3. The imprinting black ink contains black iron oxide, potassium hydroxide and shellac. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "42571-422-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (42571-422-01) ",
      "NDC11Code": "42571-0422-01",
      "ProductNDC": "42571-422",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxepin Hydrochloride",
      "NonProprietaryName": "Doxepin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217688",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "DOXEPIN HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
      "Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride, USP is C 19H 21NOHCl with a molecular weight of 315.84. It is a white crystalline solid soluble in water, lower alcohols and chloroform. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[ b, e]oxepin-11(6 H)ylidene- N, N-dimethyl-, hydrochloride. It structural formula of doxepin is shown below. Doxepin hydrochloride capsules, USP are for oral administration. Active ingredients for the capsules include: 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg of doxepin (equivalent to 11.30 mg, 28.26 mg, 56.52 mg, 84.78 mg, and 113.05 mg of doxepin hydrochloride, respectively). Inactive ingredients: magnesium stearate, pregelatinised starch, silicified microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg capsule shells contains FD&C Yellow No. 5 and FD&C Red 40; and 75 mg and 100 mg capsules shells contains D&C Yellow 10 and FD&C Green 3. The imprinting black ink contains black iron oxide, potassium hydroxide and shellac. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "42571-422-13",
      "PackageDescription": "1000 CAPSULE in 1 BOTTLE (42571-422-13) ",
      "NDC11Code": "42571-0422-13",
      "ProductNDC": "42571-422",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxepin Hydrochloride",
      "NonProprietaryName": "Doxepin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217688",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "DOXEPIN HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
      "Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride, USP is C 19H 21NOHCl with a molecular weight of 315.84. It is a white crystalline solid soluble in water, lower alcohols and chloroform. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[ b, e]oxepin-11(6 H)ylidene- N, N-dimethyl-, hydrochloride. It structural formula of doxepin is shown below. Doxepin hydrochloride capsules, USP are for oral administration. Active ingredients for the capsules include: 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg of doxepin (equivalent to 11.30 mg, 28.26 mg, 56.52 mg, 84.78 mg, and 113.05 mg of doxepin hydrochloride, respectively). Inactive ingredients: magnesium stearate, pregelatinised starch, silicified microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg capsule shells contains FD&C Yellow No. 5 and FD&C Red 40; and 75 mg and 100 mg capsules shells contains D&C Yellow 10 and FD&C Green 3. The imprinting black ink contains black iron oxide, potassium hydroxide and shellac. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "42571-423-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (42571-423-01) ",
      "NDC11Code": "42571-0423-01",
      "ProductNDC": "42571-423",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxepin Hydrochloride",
      "NonProprietaryName": "Doxepin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217688",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "DOXEPIN HYDROCHLORIDE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
      "Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride, USP is C 19H 21NOHCl with a molecular weight of 315.84. It is a white crystalline solid soluble in water, lower alcohols and chloroform. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[ b, e]oxepin-11(6 H)ylidene- N, N-dimethyl-, hydrochloride. It structural formula of doxepin is shown below. Doxepin hydrochloride capsules, USP are for oral administration. Active ingredients for the capsules include: 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg of doxepin (equivalent to 11.30 mg, 28.26 mg, 56.52 mg, 84.78 mg, and 113.05 mg of doxepin hydrochloride, respectively). Inactive ingredients: magnesium stearate, pregelatinised starch, silicified microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg capsule shells contains FD&C Yellow No. 5 and FD&C Red 40; and 75 mg and 100 mg capsules shells contains D&C Yellow 10 and FD&C Green 3. The imprinting black ink contains black iron oxide, potassium hydroxide and shellac. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "42571-423-13",
      "PackageDescription": "1000 CAPSULE in 1 BOTTLE (42571-423-13) ",
      "NDC11Code": "42571-0423-13",
      "ProductNDC": "42571-423",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxepin Hydrochloride",
      "NonProprietaryName": "Doxepin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217688",
      "LabelerName": "Micro Labs Limited",
      "SubstanceName": "DOXEPIN HYDROCHLORIDE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
      "Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride, USP is C 19H 21NOHCl with a molecular weight of 315.84. It is a white crystalline solid soluble in water, lower alcohols and chloroform. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[ b, e]oxepin-11(6 H)ylidene- N, N-dimethyl-, hydrochloride. It structural formula of doxepin is shown below. Doxepin hydrochloride capsules, USP are for oral administration. Active ingredients for the capsules include: 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg of doxepin (equivalent to 11.30 mg, 28.26 mg, 56.52 mg, 84.78 mg, and 113.05 mg of doxepin hydrochloride, respectively). Inactive ingredients: magnesium stearate, pregelatinised starch, silicified microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg capsule shells contains FD&C Yellow No. 5 and FD&C Red 40; and 75 mg and 100 mg capsules shells contains D&C Yellow 10 and FD&C Green 3. The imprinting black ink contains black iron oxide, potassium hydroxide and shellac. Meets USP Dissolution Test 3."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"66582-315-52","ProprietaryName":"Vytorin","NonProprietaryName":"Ezetimibe And Simvastatin"},{"NDCCode":"66582-313-52","ProprietaryName":"Vytorin","NonProprietaryName":"Ezetimibe And Simvastatin"},{"NDCCode":"49884-315-91","ProprietaryName":"Risperidone","NonProprietaryName":"Risperidone"},{"NDCCode":"51655-315-52","ProprietaryName":"Verapamil Hydrochloride","NonProprietaryName":"Verapamil Hydrochloride"},{"NDCCode":"51862-315-78","ProprietaryName":"Fentanyl","NonProprietaryName":"Fentanyl"},{"NDCCode":"66582-315-31","ProprietaryName":"Vytorin","NonProprietaryName":"Ezetimibe And Simvastatin"},{"NDCCode":"66582-315-54","ProprietaryName":"Vytorin","NonProprietaryName":"Ezetimibe And Simvastatin"},{"NDCCode":"66582-315-66","ProprietaryName":"Vytorin","NonProprietaryName":"Ezetimibe And Simvastatin"},{"NDCCode":"66582-315-74","ProprietaryName":"Vytorin","NonProprietaryName":"Ezetimibe And Simvastatin"},{"NDCCode":"0093-5234-56","ProprietaryName":"Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate","NonProprietaryName":"Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate"},{"NDCCode":"23155-216-31","ProprietaryName":"Cidofovir Dihydrate","NonProprietaryName":"Cidofovir Dihydrate"},{"NDCCode":"33342-138-07","ProprietaryName":"Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate","NonProprietaryName":"Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate"},{"NDCCode":"42385-915-30","ProprietaryName":"Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate","NonProprietaryName":"Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate"},{"NDCCode":"42385-915-90","ProprietaryName":"Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate","NonProprietaryName":"Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate"},{"NDCCode":"42385-928-30","ProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate","NonProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate"},{"NDCCode":"42385-928-90","ProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate","NonProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate"},{"NDCCode":"42385-929-18","ProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate","NonProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate"},{"NDCCode":"42385-929-30","ProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate","NonProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate"},{"NDCCode":"42385-929-31","ProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate","NonProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate"},{"NDCCode":"42385-929-82","ProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate","NonProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate"},{"NDCCode":"42385-929-90","ProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate","NonProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate"},{"NDCCode":"42385-929-91","ProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate","NonProprietaryName":"Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate"},{"NDCCode":"42571-420-01","ProprietaryName":"Doxepin Hydrochloride","NonProprietaryName":"Doxepin Hydrochloride"},{"NDCCode":"42571-420-13","ProprietaryName":"Doxepin Hydrochloride","NonProprietaryName":"Doxepin Hydrochloride"},{"NDCCode":"42571-421-01","ProprietaryName":"Doxepin Hydrochloride","NonProprietaryName":"Doxepin Hydrochloride"},{"NDCCode":"42571-421-13","ProprietaryName":"Doxepin Hydrochloride","NonProprietaryName":"Doxepin Hydrochloride"},{"NDCCode":"42571-422-01","ProprietaryName":"Doxepin Hydrochloride","NonProprietaryName":"Doxepin Hydrochloride"},{"NDCCode":"42571-422-13","ProprietaryName":"Doxepin Hydrochloride","NonProprietaryName":"Doxepin Hydrochloride"},{"NDCCode":"42571-423-01","ProprietaryName":"Doxepin Hydrochloride","NonProprietaryName":"Doxepin Hydrochloride"},{"NDCCode":"42571-423-13","ProprietaryName":"Doxepin Hydrochloride","NonProprietaryName":"Doxepin Hydrochloride"}]}
                    

<NDCList><NDC><NDCCode>66582-315-52</NDCCode><ProprietaryName>Vytorin</ProprietaryName><NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>66582-313-52</NDCCode><ProprietaryName>Vytorin</ProprietaryName><NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>49884-315-91</NDCCode><ProprietaryName>Risperidone</ProprietaryName><NonProprietaryName>Risperidone</NonProprietaryName></NDC><NDC><NDCCode>51655-315-52</NDCCode><ProprietaryName>Verapamil Hydrochloride</ProprietaryName><NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>51862-315-78</NDCCode><ProprietaryName>Fentanyl</ProprietaryName><NonProprietaryName>Fentanyl</NonProprietaryName></NDC><NDC><NDCCode>66582-315-31</NDCCode><ProprietaryName>Vytorin</ProprietaryName><NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>66582-315-54</NDCCode><ProprietaryName>Vytorin</ProprietaryName><NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>66582-315-66</NDCCode><ProprietaryName>Vytorin</ProprietaryName><NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>66582-315-74</NDCCode><ProprietaryName>Vytorin</ProprietaryName><NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>0093-5234-56</NDCCode><ProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</ProprietaryName><NonProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>23155-216-31</NDCCode><ProprietaryName>Cidofovir Dihydrate</ProprietaryName><NonProprietaryName>Cidofovir Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>33342-138-07</NDCCode><ProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</ProprietaryName><NonProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>42385-915-30</NDCCode><ProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</ProprietaryName><NonProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>42385-915-90</NDCCode><ProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</ProprietaryName><NonProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>42385-928-30</NDCCode><ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName><NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>42385-928-90</NDCCode><ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName><NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>42385-929-18</NDCCode><ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName><NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>42385-929-30</NDCCode><ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName><NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>42385-929-31</NDCCode><ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName><NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>42385-929-82</NDCCode><ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName><NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>42385-929-90</NDCCode><ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName><NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>42385-929-91</NDCCode><ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName><NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName></NDC><NDC><NDCCode>42571-420-01</NDCCode><ProprietaryName>Doxepin Hydrochloride</ProprietaryName><NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42571-420-13</NDCCode><ProprietaryName>Doxepin Hydrochloride</ProprietaryName><NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42571-421-01</NDCCode><ProprietaryName>Doxepin Hydrochloride</ProprietaryName><NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42571-421-13</NDCCode><ProprietaryName>Doxepin Hydrochloride</ProprietaryName><NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42571-422-01</NDCCode><ProprietaryName>Doxepin Hydrochloride</ProprietaryName><NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42571-422-13</NDCCode><ProprietaryName>Doxepin Hydrochloride</ProprietaryName><NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42571-423-01</NDCCode><ProprietaryName>Doxepin Hydrochloride</ProprietaryName><NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42571-423-13</NDCCode><ProprietaryName>Doxepin Hydrochloride</ProprietaryName><NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName></NDC></NDCList>