{
"NDC": [
{
"NDCCode": "0591-4104-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0591-4104-01) ",
"NDC11Code": "00591-4104-01",
"ProductNDC": "0591-4104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perphenazine",
"NonProprietaryName": "Perphenazine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207582",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "PERPHENAZINE",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170530",
"SamplePackage": "N",
"IndicationAndUsage": "Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.",
"Description": "Perphenazine (4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C21H26CIN3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine, USP. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, magnesium stearate, polyethylene glycol, starch (corn), titanium dioxide, hypromellose and polysorbate 80. Its structural formula is."
},
{
"NDCCode": "0591-4104-00",
"PackageDescription": "15000 TABLET, FILM COATED in 1 BOX (0591-4104-00) ",
"NDC11Code": "00591-4104-00",
"ProductNDC": "0591-4104",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Perphenazine",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "PERPHENAZINE",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-08-14",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "30-MAY-17"
},
{
"NDCCode": "0591-4104-77",
"PackageDescription": "18204 TABLET, FILM COATED in 1 CONTAINER (0591-4104-77) ",
"NDC11Code": "00591-4104-77",
"ProductNDC": "0591-4104",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Perphenazine",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20170530",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "PERPHENAZINE",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-08-14",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "04-JUL-24"
},
{
"NDCCode": "0498-4104-01",
"PackageDescription": "1 KIT in 1 KIT (0498-4104-01) * .9 g in 1 PACKET * .9 g in 1 PACKET (0498-0730-01) * 1.4 mL in 1 PACKET * .4 mL in 1 POUCH * 2 TABLET in 1 PACKET (0498-2001-01) ",
"NDC11Code": "00498-4104-01",
"ProductNDC": "0498-4104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4104 First Aid Kit",
"NonProprietaryName": "4104 First Aid Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20181018",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Honeywell Safety Products USA, INC",
"Status": "Deprecated",
"LastUpdate": "2019-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20181018",
"SamplePackage": "N"
},
{
"NDCCode": "37662-4104-1",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-4104-1) ",
"NDC11Code": "37662-4104-01",
"ProductNDC": "37662-4104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Titanium Muriaticum",
"NonProprietaryName": "Titanium Muriaticum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231006",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "TITANIUM DICHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231006",
"SamplePackage": "N"
},
{
"NDCCode": "48951-4104-1",
"PackageDescription": "10 AMPULE in 1 BOX (48951-4104-1) > 1 mL in 1 AMPULE",
"NDC11Code": "48951-4104-01",
"ProductNDC": "48951-4104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ferrum 8 Special Order",
"NonProprietaryName": "Ferrum 8 Special Order",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "IRON",
"StrengthNumber": "8",
"StrengthUnit": "[hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: FOR ORAL USE."
},
{
"NDCCode": "64552-4104-1",
"PackageDescription": "25 kg in 1 CONTAINER (64552-4104-1) ",
"NDC11Code": "64552-4104-01",
"ProductNDC": "64552-4104",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tapinarof",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Interquim, S.A.",
"SubstanceName": "TAPINAROF",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-12-16",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "01-JAN-23"
},
{
"NDCCode": "68071-4104-1",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (68071-4104-1) ",
"NDC11Code": "68071-4104-01",
"ProductNDC": "68071-4104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202446",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170929",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal anhydrous silica, croscarmellose sodium, lactose (monohydrate), lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, iron oxide red, talc, titanium dioxide and xanthan gum."
},
{
"NDCCode": "68210-4104-1",
"PackageDescription": "75 CAPSULE, LIQUID FILLED in 1 PACKAGE (68210-4104-1) ",
"NDC11Code": "68210-4104-01",
"ProductNDC": "68210-4104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Docusate Sodium",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20200702",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Spirit Pharmaceuticals LLC",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200702",
"SamplePackage": "N",
"IndicationAndUsage": "for temporary relief of occasional constipation and irregularity. this product generally produces a bowel movement within 12 to 72 hours."
},
{
"NDCCode": "68788-4104-1",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-4104-1) ",
"NDC11Code": "68788-4104-01",
"ProductNDC": "68788-4104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203270",
"LabelerName": "Preferred Phharmaceuticals Inc.",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260421",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-‑3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
},
{
"NDCCode": "50090-4104-0",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (50090-4104-0) > 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "50090-4104-00",
"ProductNDC": "50090-4104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xofluza",
"NonProprietaryName": "Baloxavir Marboxil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181024",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210854",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BALOXAVIR MARBOXIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190129",
"SamplePackage": "N",
"IndicationAndUsage": "XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 1 Treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are:otherwise healthy, orat high risk of developing influenza-related complications. (1.1), 2 Post-exposure prophylaxis of influenza in patients 12 years of age and older following contact with an individual who has influenza. (1.2).",
"Description": "XOFLUZA (baloxavir marboxil) is an antiviral PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water. XOFLUZA is supplied as tablets and as granules for oral suspension. XOFLUZA tablets are white to light yellow, film-coated tablets for oral administration. The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension is supplied as white to light yellow granules in an amber glass bottle. Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be constituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL suspension with strawberry flavor. The inactive ingredients are: colloidal silicon dioxide, hypromellose, maltitol, mannitol, povidone K25, sodium chloride, strawberry flavor, sucralose and talc."
},
{
"NDCCode": "0135-0591-01",
"PackageDescription": "1 TUBE in 1 CARTON (0135-0591-01) / 158.8 g in 1 TUBE",
"NDC11Code": "00135-0591-01",
"ProductNDC": "0135-0591",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aquafresh",
"ProprietaryNameSuffix": "Extra Fresh Plus Whitening",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE",
"RouteName": "DENTAL",
"StartMarketingDate": "20140509",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.15",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161001",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of dental cavities."
},
{
"NDCCode": "0591-0240-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0591-0240-01) ",
"NDC11Code": "00591-0240-01",
"ProductNDC": "0591-0240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19911031",
"EndMarketingDate": "20230430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072926",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19911031",
"EndMarketingDatePackage": "20230430",
"SamplePackage": "N"
},
{
"NDCCode": "0591-0241-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0591-0241-01) ",
"NDC11Code": "00591-0241-01",
"ProductNDC": "0591-0241",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19911031",
"EndMarketingDate": "20230430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072927",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19911031",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "0591-0242-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0591-0242-01) ",
"NDC11Code": "00591-0242-01",
"ProductNDC": "0591-0242",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19911031",
"EndMarketingDate": "20221130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072928",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19911031",
"EndMarketingDatePackage": "20221130",
"SamplePackage": "N"
},
{
"NDCCode": "0591-0338-01",
"PackageDescription": "24 BOTTLE, PLASTIC in 1 BOX (0591-0338-01) > 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC",
"NDC11Code": "00591-0338-01",
"ProductNDC": "0591-0338",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"ProprietaryNameSuffix": "Delayed Release",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19981113",
"EndMarketingDate": "20150228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075185",
"LabelerName": "Watson Pharma, Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-03-06"
},
{
"NDCCode": "0591-0339-01",
"PackageDescription": "24 BOTTLE, PLASTIC in 1 BOX (0591-0339-01) > 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC",
"NDC11Code": "00591-0339-01",
"ProductNDC": "0591-0339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"ProprietaryNameSuffix": "Delayed Release",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19981113",
"EndMarketingDate": "20150228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075185",
"LabelerName": "Watson Pharma, Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-03-06"
},
{
"NDCCode": "0591-0343-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0343-01) ",
"NDC11Code": "00591-0343-01",
"ProductNDC": "0591-0343",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19861001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070995",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "80",
"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": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19861001",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil Hydrochloride Tablets are indicated for the treatment of the following. Angina1. Angina at rest including: – Vasospastic (Prinzmetal’s variant) angina – Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina). Arrhythmias1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS: Accessory bypass tract) 2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia. Essential hypertension:Verapamil is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "Verapamil hydrochloride, 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, USP. The structural formula of verapamil hydrochloride, USP is. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil hydrochloride, USP is not chemically related to other cardioactive drugs. Inactive ingredients include anhydrous lactose, corn starch, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and polyethylene glycol 400. In addition the following coloring agents are used: FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose and titanium dioxide (40 mg light peach); hydroxypropyl cellulose and titanium dioxide (80 mg white and 120 mg white)."
},
{
"NDCCode": "0591-0345-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0345-01) ",
"NDC11Code": "00591-0345-01",
"ProductNDC": "0591-0345",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19861001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070994",
"LabelerName": "Actavis Pharma, Inc.",
"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": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19861001",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil Hydrochloride Tablets are indicated for the treatment of the following. Angina1. Angina at rest including: – Vasospastic (Prinzmetal’s variant) angina – Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina). Arrhythmias1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS: Accessory bypass tract) 2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia. Essential hypertension:Verapamil is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "Verapamil hydrochloride, 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, USP. The structural formula of verapamil hydrochloride, USP is. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil hydrochloride, USP is not chemically related to other cardioactive drugs. Inactive ingredients include anhydrous lactose, corn starch, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and polyethylene glycol 400. In addition the following coloring agents are used: FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose and titanium dioxide (40 mg light peach); hydroxypropyl cellulose and titanium dioxide (80 mg white and 120 mg white)."
},
{
"NDCCode": "0591-0347-01",
"PackageDescription": "100 CAPSULE, GELATIN COATED in 1 BOTTLE (0591-0347-01) ",
"NDC11Code": "00591-0347-01",
"ProductNDC": "0591-0347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19961227",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020504",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19961227",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrochlorothiazide is indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.",
"Description": "Hydrochlorothiazide Capsules, USP, 12.5 mg is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2; its molecular weight is 297.74; and its structural formula is. It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate. Gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, gelatin, titanium dioxide. The capsules are printed with edible ink containing black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40."
},
{
"NDCCode": "0591-0348-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0591-0348-01) ",
"NDC11Code": "00591-0348-01",
"ProductNDC": "0591-0348",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamterene And Hydrochlorothiazide",
"NonProprietaryName": "Triamterene And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071851",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "TRIAMTERENE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "75; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2024-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930923",
"SamplePackage": "N",
"IndicationAndUsage": "This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone., 2 Triamterene and hydrochlorothiazide tablets are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.).",
"Description": "Triamterene and hydrochlorothiazide tablets, USP combine triamterene USP, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide, USP. Triamterene and hydrochlorothiazide tablets, USP are available in two strengths. Each triamterene and hydrochlorothiazide tablet USP, 75 mg/50 mg, contains triamterene USP, 75 mg and hydrochlorothiazide USP, 50 mg. Each triamterene and hydrochlorothiazide tablet USP, 37.5 mg/25 mg, contains triamterene USP, 37.5 mg and hydrochlorothiazide USP, 25 mg. Both strengths of triamterene and hydrochlorothiazide tablets, USP for oral administration contain the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol 8000, and povidone. Triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg also contain FD&C Blue No. 2 Aluminum Lake. Triamterene, USP is 2,4,7-triamino-6-phenylpteridine. Triamterene, USP is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene, USP is very slightly soluble in acetic acid, alcohol and dilute mineral acids. Its molecular weight is 253.27. Its structural formula is. C12H11N7. Triamterene, USP. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide, USP is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. Its structural formula is. C7H8ClN3O4S2. Hydrochlorothiazide, USP."
},
{
"NDCCode": "0591-0349-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0591-0349-01)",
"NDC11Code": "00591-0349-01",
"ProductNDC": "0591-0349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881201",
"EndMarketingDate": "20150831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089883",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "500; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2015-09-04"
},
{
"NDCCode": "0591-0369-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0591-0369-01) ",
"NDC11Code": "00591-0369-01",
"ProductNDC": "0591-0369",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19880615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072204",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880615",
"SamplePackage": "N",
"IndicationAndUsage": "Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
"Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.1 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, benzyl alcohol, butyl paraben, edetate calcium disodium, gelatin, magnesium stearate, methyl paraben, polacrilin potassium, propyl paraben, sodium lauryl sulfate, sodium propionate, talc, and titanium dioxide. The printing ink contains black iron oxide, propylene glycol, potassium hydroxide, shellac, strong ammonia solution. Additionally, the 10 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6, the 25 mg capsule contains D&C Yellow No. 10 and FD&C Blue No. 1, and the 50 mg capsule contains FD&C Blue No. 1."
},
{
"NDCCode": "0591-0370-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0591-0370-01) ",
"NDC11Code": "00591-0370-01",
"ProductNDC": "0591-0370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19880615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072205",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880615",
"SamplePackage": "N",
"IndicationAndUsage": "Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
"Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.1 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, benzyl alcohol, butyl paraben, edetate calcium disodium, gelatin, magnesium stearate, methyl paraben, polacrilin potassium, propyl paraben, sodium lauryl sulfate, sodium propionate, talc, and titanium dioxide. The printing ink contains black iron oxide, propylene glycol, potassium hydroxide, shellac, strong ammonia solution. Additionally, the 10 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6, the 25 mg capsule contains D&C Yellow No. 10 and FD&C Blue No. 1, and the 50 mg capsule contains FD&C Blue No. 1."
},
{
"NDCCode": "0591-0371-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0591-0371-01) ",
"NDC11Code": "00591-0371-01",
"ProductNDC": "0591-0371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19880615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072206",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880615",
"SamplePackage": "N",
"IndicationAndUsage": "Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
"Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.1 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, benzyl alcohol, butyl paraben, edetate calcium disodium, gelatin, magnesium stearate, methyl paraben, polacrilin potassium, propyl paraben, sodium lauryl sulfate, sodium propionate, talc, and titanium dioxide. The printing ink contains black iron oxide, propylene glycol, potassium hydroxide, shellac, strong ammonia solution. Additionally, the 10 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6, the 25 mg capsule contains D&C Yellow No. 10 and FD&C Blue No. 1, and the 50 mg capsule contains FD&C Blue No. 1."
},
{
"NDCCode": "0591-0372-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0591-0372-01) ",
"NDC11Code": "00591-0372-01",
"ProductNDC": "0591-0372",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19880615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072062",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880615",
"SamplePackage": "N",
"IndicationAndUsage": "Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
"Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.1 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, benzyl alcohol, butyl paraben, edetate calcium disodium, gelatin, magnesium stearate, methyl paraben, polacrilin potassium, propyl paraben, sodium lauryl sulfate, sodium propionate, talc, and titanium dioxide. The printing ink contains black iron oxide, propylene glycol, potassium hydroxide, shellac, strong ammonia solution. Additionally, the 10 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6, the 25 mg capsule contains D&C Yellow No. 10 and FD&C Blue No. 1, and the 50 mg capsule contains FD&C Blue No. 1."
},
{
"NDCCode": "0591-0385-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0591-0385-01)",
"NDC11Code": "00591-0385-01",
"ProductNDC": "0591-0385",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19910830",
"EndMarketingDate": "20150930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081080",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "500; 7.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "0591-0387-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0591-0387-01)",
"NDC11Code": "00591-0387-01",
"ProductNDC": "0591-0387",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19910830",
"EndMarketingDate": "20150930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081083",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "750; 7.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "0591-0388-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0591-0388-01)",
"NDC11Code": "00591-0388-01",
"ProductNDC": "0591-0388",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19910830",
"EndMarketingDate": "20150831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081079",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "500; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2015-09-04"
},
{
"NDCCode": "0591-0395-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0591-0395-01) ",
"NDC11Code": "00591-0395-01",
"ProductNDC": "0591-0395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pentazocine And Naloxone",
"NonProprietaryName": "Pentazocine Hydrochloride And Naloxone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074736",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
"StrengthNumber": "50; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Competitive Opioid Antagonists [MoA], Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19970521",
"SamplePackage": "N",
"IndicationAndUsage": "Pentazocine and Naloxone Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including Pentazocine and Naloxone Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Pentazocine and Naloxone Tablets, USP contain pentazocine hydrochloride, USP, a partial opioid agonist, equivalent to 50 mg base and is a member of the benzazocine series (also known as the benzomorphan series), and naloxone hydrochloride, USP, an opioid antagonist equivalent to 0.5 mg base. Pentazocine and Naloxone Tablets, USP are an analgesic for oral administration. Chemically, pentazocine hydrochloride, USP is (2R*,6R*,11R*)-1,2,3,4,5,6-Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a white, crystalline substance soluble in acidic aqueous solutions, and has the following structural formula. C19H27NO·HCl Molecular Weight: 321.88. Chemically, naloxone hydrochloride, USP is Morphinan-6-one,4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, hydrochloride, (5α)-. It is a slightly off-white powder, and is soluble in water and dilute acids, and has the following structural formula:. C19H21NO4·HCl Molecular Weight: 363.84. Inactive Ingredients: colloidal silicon dioxide, dibasic calcium phosphate, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium lauryl sulfate."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0591-4104-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0591-4104-01) </PackageDescription>
<NDC11Code>00591-4104-01</NDC11Code>
<ProductNDC>0591-4104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine</ProprietaryName>
<NonProprietaryName>Perphenazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207582</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>PERPHENAZINE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Perphenazine (4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C21H26CIN3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine, USP. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, magnesium stearate, polyethylene glycol, starch (corn), titanium dioxide, hypromellose and polysorbate 80. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0591-4104-00</NDCCode>
<PackageDescription>15000 TABLET, FILM COATED in 1 BOX (0591-4104-00) </PackageDescription>
<NDC11Code>00591-4104-00</NDC11Code>
<ProductNDC>0591-4104</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Perphenazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>PERPHENAZINE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-08-14</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-MAY-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0591-4104-77</NDCCode>
<PackageDescription>18204 TABLET, FILM COATED in 1 CONTAINER (0591-4104-77) </PackageDescription>
<NDC11Code>00591-4104-77</NDC11Code>
<ProductNDC>0591-4104</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Perphenazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20170530</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>PERPHENAZINE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-08-14</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-JUL-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0498-4104-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0498-4104-01) * .9 g in 1 PACKET * .9 g in 1 PACKET (0498-0730-01) * 1.4 mL in 1 PACKET * .4 mL in 1 POUCH * 2 TABLET in 1 PACKET (0498-2001-01) </PackageDescription>
<NDC11Code>00498-4104-01</NDC11Code>
<ProductNDC>0498-4104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4104 First Aid Kit</ProprietaryName>
<NonProprietaryName>4104 First Aid Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20181018</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Honeywell Safety Products USA, INC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-4104-1</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-4104-1) </PackageDescription>
<NDC11Code>37662-4104-01</NDC11Code>
<ProductNDC>37662-4104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Titanium Muriaticum</ProprietaryName>
<NonProprietaryName>Titanium Muriaticum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231006</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>TITANIUM DICHLORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48951-4104-1</NDCCode>
<PackageDescription>10 AMPULE in 1 BOX (48951-4104-1) > 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>48951-4104-01</NDC11Code>
<ProductNDC>48951-4104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ferrum 8 Special Order</ProprietaryName>
<NonProprietaryName>Ferrum 8 Special Order</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>IRON</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: FOR ORAL USE.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64552-4104-1</NDCCode>
<PackageDescription>25 kg in 1 CONTAINER (64552-4104-1) </PackageDescription>
<NDC11Code>64552-4104-01</NDC11Code>
<ProductNDC>64552-4104</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tapinarof</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Interquim, S.A.</LabelerName>
<SubstanceName>TAPINAROF</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-12-16</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68071-4104-1</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (68071-4104-1) </PackageDescription>
<NDC11Code>68071-4104-01</NDC11Code>
<ProductNDC>68071-4104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202446</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal anhydrous silica, croscarmellose sodium, lactose (monohydrate), lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, iron oxide red, talc, titanium dioxide and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>68210-4104-1</NDCCode>
<PackageDescription>75 CAPSULE, LIQUID FILLED in 1 PACKAGE (68210-4104-1) </PackageDescription>
<NDC11Code>68210-4104-01</NDC11Code>
<ProductNDC>68210-4104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Docusate Sodium</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200702</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Spirit Pharmaceuticals LLC</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for temporary relief of occasional constipation and irregularity. this product generally produces a bowel movement within 12 to 72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68788-4104-1</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-4104-1) </PackageDescription>
<NDC11Code>68788-4104-01</NDC11Code>
<ProductNDC>68788-4104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203270</ApplicationNumber>
<LabelerName>Preferred Phharmaceuticals Inc.</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-‑3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>50090-4104-0</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (50090-4104-0) > 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50090-4104-00</NDC11Code>
<ProductNDC>50090-4104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xofluza</ProprietaryName>
<NonProprietaryName>Baloxavir Marboxil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181024</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210854</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>BALOXAVIR MARBOXIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Chelating Activity [MoA], Polymerase Acidic Endonuclease Inhibitor [EPC], Polymerase Acidic Endonuclease Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 1 Treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are:otherwise healthy, orat high risk of developing influenza-related complications. (1.1), 2 Post-exposure prophylaxis of influenza in patients 12 years of age and older following contact with an individual who has influenza. (1.2).</IndicationAndUsage>
<Description>XOFLUZA (baloxavir marboxil) is an antiviral PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water. XOFLUZA is supplied as tablets and as granules for oral suspension. XOFLUZA tablets are white to light yellow, film-coated tablets for oral administration. The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension is supplied as white to light yellow granules in an amber glass bottle. Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be constituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL suspension with strawberry flavor. The inactive ingredients are: colloidal silicon dioxide, hypromellose, maltitol, mannitol, povidone K25, sodium chloride, strawberry flavor, sucralose and talc.</Description>
</NDC>
<NDC>
<NDCCode>0135-0591-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0135-0591-01) / 158.8 g in 1 TUBE</PackageDescription>
<NDC11Code>00135-0591-01</NDC11Code>
<ProductNDC>0135-0591</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aquafresh</ProprietaryName>
<ProprietaryNameSuffix>Extra Fresh Plus Whitening</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20140509</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.15</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0591-0240-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0591-0240-01) </PackageDescription>
<NDC11Code>00591-0240-01</NDC11Code>
<ProductNDC>0591-0240</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19911031</StartMarketingDate>
<EndMarketingDate>20230430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072926</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19911031</StartMarketingDatePackage>
<EndMarketingDatePackage>20230430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0591-0241-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0591-0241-01) </PackageDescription>
<NDC11Code>00591-0241-01</NDC11Code>
<ProductNDC>0591-0241</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19911031</StartMarketingDate>
<EndMarketingDate>20230430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072927</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19911031</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0591-0242-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0591-0242-01) </PackageDescription>
<NDC11Code>00591-0242-01</NDC11Code>
<ProductNDC>0591-0242</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19911031</StartMarketingDate>
<EndMarketingDate>20221130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072928</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19911031</StartMarketingDatePackage>
<EndMarketingDatePackage>20221130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0591-0338-01</NDCCode>
<PackageDescription>24 BOTTLE, PLASTIC in 1 BOX (0591-0338-01) > 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00591-0338-01</NDC11Code>
<ProductNDC>0591-0338</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed Release</ProprietaryNameSuffix>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981113</StartMarketingDate>
<EndMarketingDate>20150228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075185</ApplicationNumber>
<LabelerName>Watson Pharma, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-03-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>0591-0339-01</NDCCode>
<PackageDescription>24 BOTTLE, PLASTIC in 1 BOX (0591-0339-01) > 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00591-0339-01</NDC11Code>
<ProductNDC>0591-0339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed Release</ProprietaryNameSuffix>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981113</StartMarketingDate>
<EndMarketingDate>20150228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075185</ApplicationNumber>
<LabelerName>Watson Pharma, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-03-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>0591-0343-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0343-01) </PackageDescription>
<NDC11Code>00591-0343-01</NDC11Code>
<ProductNDC>0591-0343</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19861001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070995</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19861001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil Hydrochloride Tablets are indicated for the treatment of the following. Angina1. Angina at rest including: – Vasospastic (Prinzmetal’s variant) angina – Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina). Arrhythmias1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS: Accessory bypass tract) 2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia. Essential hypertension:Verapamil is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>Verapamil hydrochloride, 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, USP. The structural formula of verapamil hydrochloride, USP is. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil hydrochloride, USP is not chemically related to other cardioactive drugs. Inactive ingredients include anhydrous lactose, corn starch, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and polyethylene glycol 400. In addition the following coloring agents are used: FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose and titanium dioxide (40 mg light peach); hydroxypropyl cellulose and titanium dioxide (80 mg white and 120 mg white).</Description>
</NDC>
<NDC>
<NDCCode>0591-0345-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0345-01) </PackageDescription>
<NDC11Code>00591-0345-01</NDC11Code>
<ProductNDC>0591-0345</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19861001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070994</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19861001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil Hydrochloride Tablets are indicated for the treatment of the following. Angina1. Angina at rest including: – Vasospastic (Prinzmetal’s variant) angina – Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina). Arrhythmias1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS: Accessory bypass tract) 2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia. Essential hypertension:Verapamil is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>Verapamil hydrochloride, 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, USP. The structural formula of verapamil hydrochloride, USP is. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil hydrochloride, USP is not chemically related to other cardioactive drugs. Inactive ingredients include anhydrous lactose, corn starch, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and polyethylene glycol 400. In addition the following coloring agents are used: FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose and titanium dioxide (40 mg light peach); hydroxypropyl cellulose and titanium dioxide (80 mg white and 120 mg white).</Description>
</NDC>
<NDC>
<NDCCode>0591-0347-01</NDCCode>
<PackageDescription>100 CAPSULE, GELATIN COATED in 1 BOTTLE (0591-0347-01) </PackageDescription>
<NDC11Code>00591-0347-01</NDC11Code>
<ProductNDC>0591-0347</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961227</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020504</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrochlorothiazide is indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.</IndicationAndUsage>
<Description>Hydrochlorothiazide Capsules, USP, 12.5 mg is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2; its molecular weight is 297.74; and its structural formula is. It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate. Gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, gelatin, titanium dioxide. The capsules are printed with edible ink containing black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40.</Description>
</NDC>
<NDC>
<NDCCode>0591-0348-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0591-0348-01) </PackageDescription>
<NDC11Code>00591-0348-01</NDC11Code>
<ProductNDC>0591-0348</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamterene And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071851</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>TRIAMTERENE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>75; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone., 2 Triamterene and hydrochlorothiazide tablets are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.).</IndicationAndUsage>
<Description>Triamterene and hydrochlorothiazide tablets, USP combine triamterene USP, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide, USP. Triamterene and hydrochlorothiazide tablets, USP are available in two strengths. Each triamterene and hydrochlorothiazide tablet USP, 75 mg/50 mg, contains triamterene USP, 75 mg and hydrochlorothiazide USP, 50 mg. Each triamterene and hydrochlorothiazide tablet USP, 37.5 mg/25 mg, contains triamterene USP, 37.5 mg and hydrochlorothiazide USP, 25 mg. Both strengths of triamterene and hydrochlorothiazide tablets, USP for oral administration contain the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol 8000, and povidone. Triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg also contain FD&C Blue No. 2 Aluminum Lake. Triamterene, USP is 2,4,7-triamino-6-phenylpteridine. Triamterene, USP is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene, USP is very slightly soluble in acetic acid, alcohol and dilute mineral acids. Its molecular weight is 253.27. Its structural formula is. C12H11N7. Triamterene, USP. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide, USP is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. Its structural formula is. C7H8ClN3O4S2. Hydrochlorothiazide, USP.</Description>
</NDC>
<NDC>
<NDCCode>0591-0349-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0591-0349-01)</PackageDescription>
<NDC11Code>00591-0349-01</NDC11Code>
<ProductNDC>0591-0349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881201</StartMarketingDate>
<EndMarketingDate>20150831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089883</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>500; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-09-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>0591-0369-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0591-0369-01) </PackageDescription>
<NDC11Code>00591-0369-01</NDC11Code>
<ProductNDC>0591-0369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loxapine</ProprietaryName>
<NonProprietaryName>Loxapine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072204</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>LOXAPINE SUCCINATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.</IndicationAndUsage>
<Description>Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.1 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, benzyl alcohol, butyl paraben, edetate calcium disodium, gelatin, magnesium stearate, methyl paraben, polacrilin potassium, propyl paraben, sodium lauryl sulfate, sodium propionate, talc, and titanium dioxide. The printing ink contains black iron oxide, propylene glycol, potassium hydroxide, shellac, strong ammonia solution. Additionally, the 10 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6, the 25 mg capsule contains D&C Yellow No. 10 and FD&C Blue No. 1, and the 50 mg capsule contains FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>0591-0370-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0591-0370-01) </PackageDescription>
<NDC11Code>00591-0370-01</NDC11Code>
<ProductNDC>0591-0370</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loxapine</ProprietaryName>
<NonProprietaryName>Loxapine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072205</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>LOXAPINE SUCCINATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.</IndicationAndUsage>
<Description>Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.1 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, benzyl alcohol, butyl paraben, edetate calcium disodium, gelatin, magnesium stearate, methyl paraben, polacrilin potassium, propyl paraben, sodium lauryl sulfate, sodium propionate, talc, and titanium dioxide. The printing ink contains black iron oxide, propylene glycol, potassium hydroxide, shellac, strong ammonia solution. Additionally, the 10 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6, the 25 mg capsule contains D&C Yellow No. 10 and FD&C Blue No. 1, and the 50 mg capsule contains FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>0591-0371-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0591-0371-01) </PackageDescription>
<NDC11Code>00591-0371-01</NDC11Code>
<ProductNDC>0591-0371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loxapine</ProprietaryName>
<NonProprietaryName>Loxapine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072206</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>LOXAPINE SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.</IndicationAndUsage>
<Description>Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.1 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, benzyl alcohol, butyl paraben, edetate calcium disodium, gelatin, magnesium stearate, methyl paraben, polacrilin potassium, propyl paraben, sodium lauryl sulfate, sodium propionate, talc, and titanium dioxide. The printing ink contains black iron oxide, propylene glycol, potassium hydroxide, shellac, strong ammonia solution. Additionally, the 10 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6, the 25 mg capsule contains D&C Yellow No. 10 and FD&C Blue No. 1, and the 50 mg capsule contains FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>0591-0372-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0591-0372-01) </PackageDescription>
<NDC11Code>00591-0372-01</NDC11Code>
<ProductNDC>0591-0372</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loxapine</ProprietaryName>
<NonProprietaryName>Loxapine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072062</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>LOXAPINE SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.</IndicationAndUsage>
<Description>Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.1 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, benzyl alcohol, butyl paraben, edetate calcium disodium, gelatin, magnesium stearate, methyl paraben, polacrilin potassium, propyl paraben, sodium lauryl sulfate, sodium propionate, talc, and titanium dioxide. The printing ink contains black iron oxide, propylene glycol, potassium hydroxide, shellac, strong ammonia solution. Additionally, the 10 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6, the 25 mg capsule contains D&C Yellow No. 10 and FD&C Blue No. 1, and the 50 mg capsule contains FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>0591-0385-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0591-0385-01)</PackageDescription>
<NDC11Code>00591-0385-01</NDC11Code>
<ProductNDC>0591-0385</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19910830</StartMarketingDate>
<EndMarketingDate>20150930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081080</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>500; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>0591-0387-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0591-0387-01)</PackageDescription>
<NDC11Code>00591-0387-01</NDC11Code>
<ProductNDC>0591-0387</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19910830</StartMarketingDate>
<EndMarketingDate>20150930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081083</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>750; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>0591-0388-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0591-0388-01)</PackageDescription>
<NDC11Code>00591-0388-01</NDC11Code>
<ProductNDC>0591-0388</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19910830</StartMarketingDate>
<EndMarketingDate>20150831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081079</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>500; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-09-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>0591-0395-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0591-0395-01) </PackageDescription>
<NDC11Code>00591-0395-01</NDC11Code>
<ProductNDC>0591-0395</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pentazocine And Naloxone</ProprietaryName>
<NonProprietaryName>Pentazocine Hydrochloride And Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074736</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Competitive Opioid Antagonists [MoA], Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pentazocine and Naloxone Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including Pentazocine and Naloxone Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Pentazocine and Naloxone Tablets, USP contain pentazocine hydrochloride, USP, a partial opioid agonist, equivalent to 50 mg base and is a member of the benzazocine series (also known as the benzomorphan series), and naloxone hydrochloride, USP, an opioid antagonist equivalent to 0.5 mg base. Pentazocine and Naloxone Tablets, USP are an analgesic for oral administration. Chemically, pentazocine hydrochloride, USP is (2R*,6R*,11R*)-1,2,3,4,5,6-Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a white, crystalline substance soluble in acidic aqueous solutions, and has the following structural formula. C19H27NO·HCl Molecular Weight: 321.88. Chemically, naloxone hydrochloride, USP is Morphinan-6-one,4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, hydrochloride, (5α)-. It is a slightly off-white powder, and is soluble in water and dilute acids, and has the following structural formula:. C19H21NO4·HCl Molecular Weight: 363.84. Inactive Ingredients: colloidal silicon dioxide, dibasic calcium phosphate, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium lauryl sulfate.</Description>
</NDC>
</NDCList>