{
"NDC": [
{
"NDCCode": "52427-274-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (52427-274-30) ",
"NDC11Code": "52427-0274-30",
"ProductNDC": "52427-274",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naprelan",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140117",
"EndMarketingDate": "20260401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020353",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140117",
"EndMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "NAPRELAN Tablets are indicated for the treatment of. rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain. [see Warnings and Precautions (5)].",
"Description": "NAPRELAN (naproxen sodium) Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug, available as controlled-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each NAPRELAN Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "52427-575-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (52427-575-30) ",
"NDC11Code": "52427-0575-30",
"ProductNDC": "52427-575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Forfivo",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170515",
"EndMarketingDate": "20250101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022497",
"LabelerName": "Almatica Pharma Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "450",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170515",
"EndMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "FORFIVO XL (bupropion hydrochloride extended-release tablets) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14)]. The physician who elects to use FORFIVO XL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
"Description": "FORFIVO XL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-2-(tert-Butylamino)-3'-chloropropiophenone hydrochloride. The molecular weight is 276.2. The empirical formula is C13H18ClNO·HCl. Bupropion hydrochloride powder is white or almost white, crystalline, and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. FORFIVO XL tablets are supplied for oral administration of 450 mg of bupropion hydrochloride as white to off-white extended-release tablets. Each film-coated tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: carboxymethyl cellulose sodium, colloidal silicon dioxide, hydrochloric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 8000, polyethylene oxide, polyvinyl pyrrolidone and polyvinyl acetate blend, stearic acid, talc, titanium dioxide and triacetin. The logo “Forfivo” is printed on one side of the tablet with edible black ink."
},
{
"NDCCode": "52427-576-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (52427-576-30) ",
"NDC11Code": "52427-0576-30",
"ProductNDC": "52427-576",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine Hcl",
"NonProprietaryName": "Fluoxetine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170901",
"EndMarketingDate": "20260401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202133",
"LabelerName": "Almatica Pharma Inc.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170901",
"EndMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine tablets are indicated for the treatment of: 1 Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age [see Clinical Studies (14.1)]., 2 Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age [see Clinical Studies (14.2)]., 3 Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine in Bulimia Nervosa was demonstrated in two 8-week trials and one 16-week trial in adults [see Clinical Studies (14.3)]., 4 Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine in Panic Disorder was demonstrated in two 12-week trials in adults [see Clinical Studies (14.4)].",
"Description": "Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each scored tablet contains fluoxetine hydrochloride equivalent to 60 mg (194 μmol) of fluoxetine. In addition, each scored tablet also contains the following inactive ingredients: mannitol, microcrystalline cellulose, maize starch, povidone, hypromellose, magnesium stearate, titanium dioxide, sucrose, glycerol, and polysorbate."
},
{
"NDCCode": "52427-632-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52427-632-30) ",
"NDC11Code": "52427-0632-30",
"ProductNDC": "52427-632",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215429",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "VENLAFAXINE BESYLATE MONOHYDRATE",
"StrengthNumber": "112.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine Extended-Release Tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD) , 2 Generalized Anxiety Disorder (GAD) .",
"Description": "Venlafaxine Extended-Release Tablets contains venlafaxine, an SNRI, present as venlafaxine besylate monohydrate salt. Venlafaxine besylate monohydrate is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol benzene sulfonate monohydrate or Cyclohexanol, 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-, benzenesulfonate, monohydrate and has the molecular formula of C23H33NO5S⸱H2O. Its molecular weight is 453.59. The structural formula is shown as follows. Venlafaxine besylate is a white to almost white crystalline powder, with a solubility of about 32 mg/ml in water. Its octanol:water partition coefficient is 0.154. Drug release is controlled by a combination of diffusion through the extended-release coating and erosion of the core tablets. The modified drug release is pH independent. Venlafaxine Extended-Release Tablets are intended for oral administration and contains 183.95 mg of venlafaxine besylate monohydrate equivalent to 112.5 mg of venlafaxine. Inactive ingredients: ammonio methacrylate copolymer, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, simethicone, talc, titanium dioxide, and triacetin. The tablet printing ink is composed of ammonium hydroxide, black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol, and shellac."
},
{
"NDCCode": "52427-658-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-658-30) ",
"NDC11Code": "52427-0658-30",
"ProductNDC": "52427-658",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loreev Xr",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214826",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210924",
"SamplePackage": "N",
"IndicationAndUsage": "LOREEV XR is indicated for the treatment of anxiety disorders in adults who are receiving stable, evenly divided, three times daily dosing with lorazepam tablets.",
"Description": "LOREEV XR contains lorazepam, a benzodiazepine. Lorazepam is a nearly white crystalline powder and is practically insoluble in water and slightly soluble in alcohol. It is a 1:1 mixture of (R) and (S) isomers. The chemical name is ±-7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one and its structural formula is. Molecular formula: C15H10Cl2N2O2; Molecular weight: 321.16. LOREEV XR is intended for oral administration. Each capsule contains 1 mg, 1.5 mg, 2 mg, or 3 mg of lorazepam. The inactive ingredients are colloidal silicon dioxide, corn starch, gelatin, glyceryl monostearate, hypromellose, lactose monohydrate, methyl acrylate methyl methacrylate and methacrylic acid (7:3:1) copolymer 280000 dispersion, microcrystalline cellulose, polysorbate 80, talc, titanium dioxide, and triethyl citrate. Additionally, the capsule shells contain the following colorants:. 1 mg capsules: FD&C Yellow No. 5. 1.5 mg capsules: FD&C Blue No. 1 and FD&C Red No. 3. 2 mg capsules: D&C Yellow No. 10 and FD&C Red No. 3. 3 mg capsules: D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6."
},
{
"NDCCode": "52427-661-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-661-30) ",
"NDC11Code": "52427-0661-30",
"ProductNDC": "52427-661",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loreev Xr",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214826",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "LOREEV XR is indicated for the treatment of anxiety disorders in adults who are receiving stable, evenly divided, three times daily dosing with lorazepam tablets.",
"Description": "LOREEV XR contains lorazepam, a benzodiazepine. Lorazepam is a nearly white crystalline powder and is practically insoluble in water and slightly soluble in alcohol. It is a 1:1 mixture of (R) and (S) isomers. The chemical name is ±-7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one and its structural formula is. Molecular formula: C15H10Cl2N2O2; Molecular weight: 321.16. LOREEV XR is intended for oral administration. Each capsule contains 1 mg, 1.5 mg, 2 mg, or 3 mg of lorazepam. The inactive ingredients are colloidal silicon dioxide, corn starch, gelatin, glyceryl monostearate, hypromellose, lactose monohydrate, methyl acrylate methyl methacrylate and methacrylic acid (7:3:1) copolymer 280000 dispersion, microcrystalline cellulose, polysorbate 80, talc, titanium dioxide, and triethyl citrate. Additionally, the capsule shells contain the following colorants:. 1 mg capsules: FD&C Yellow No. 5. 1.5 mg capsules: FD&C Blue No. 1 and FD&C Red No. 3. 2 mg capsules: D&C Yellow No. 10 and FD&C Red No. 3. 3 mg capsules: D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6."
},
{
"NDCCode": "52427-663-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-663-30) ",
"NDC11Code": "52427-0663-30",
"ProductNDC": "52427-663",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loreev Xr",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214826",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210924",
"SamplePackage": "N",
"IndicationAndUsage": "LOREEV XR is indicated for the treatment of anxiety disorders in adults who are receiving stable, evenly divided, three times daily dosing with lorazepam tablets.",
"Description": "LOREEV XR contains lorazepam, a benzodiazepine. Lorazepam is a nearly white crystalline powder and is practically insoluble in water and slightly soluble in alcohol. It is a 1:1 mixture of (R) and (S) isomers. The chemical name is ±-7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one and its structural formula is. Molecular formula: C15H10Cl2N2O2; Molecular weight: 321.16. LOREEV XR is intended for oral administration. Each capsule contains 1 mg, 1.5 mg, 2 mg, or 3 mg of lorazepam. The inactive ingredients are colloidal silicon dioxide, corn starch, gelatin, glyceryl monostearate, hypromellose, lactose monohydrate, methyl acrylate methyl methacrylate and methacrylic acid (7:3:1) copolymer 280000 dispersion, microcrystalline cellulose, polysorbate 80, talc, titanium dioxide, and triethyl citrate. Additionally, the capsule shells contain the following colorants:. 1 mg capsules: FD&C Yellow No. 5. 1.5 mg capsules: FD&C Blue No. 1 and FD&C Red No. 3. 2 mg capsules: D&C Yellow No. 10 and FD&C Red No. 3. 3 mg capsules: D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6."
},
{
"NDCCode": "52427-664-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (52427-664-30) ",
"NDC11Code": "52427-0664-30",
"ProductNDC": "52427-664",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hcl",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20211004",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215133",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211101",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline Hydrochloride (HCl) Capsules is indicated for the treatment of the following [see Clinical Studies (14)]: 1 Major depressive disorder (MDD) in adults, 2 Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older.",
"Description": "Sertraline HCl Capsules contain sertraline HCl, a selective serotonin reuptake inhibitor (SSRI). Sertraline HCl has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-tetralin-1-amine hydrochloride. The empirical formula C17H17Cl2N HCl is represented by the following structural formula. Sertraline HCl is a white to almost white crystalline powder that is slightly soluble in water, acetone and isopropyl alcohol. Sertraline HCl Capsules is for oral administration and contain 168 mg and 224 mg sertraline HCl, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives."
},
{
"NDCCode": "52427-667-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-667-30) ",
"NDC11Code": "52427-0667-30",
"ProductNDC": "52427-667",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loreev Xr",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214826",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210924",
"SamplePackage": "N",
"IndicationAndUsage": "LOREEV XR is indicated for the treatment of anxiety disorders in adults who are receiving stable, evenly divided, three times daily dosing with lorazepam tablets.",
"Description": "LOREEV XR contains lorazepam, a benzodiazepine. Lorazepam is a nearly white crystalline powder and is practically insoluble in water and slightly soluble in alcohol. It is a 1:1 mixture of (R) and (S) isomers. The chemical name is ±-7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one and its structural formula is. Molecular formula: C15H10Cl2N2O2; Molecular weight: 321.16. LOREEV XR is intended for oral administration. Each capsule contains 1 mg, 1.5 mg, 2 mg, or 3 mg of lorazepam. The inactive ingredients are colloidal silicon dioxide, corn starch, gelatin, glyceryl monostearate, hypromellose, lactose monohydrate, methyl acrylate methyl methacrylate and methacrylic acid (7:3:1) copolymer 280000 dispersion, microcrystalline cellulose, polysorbate 80, talc, titanium dioxide, and triethyl citrate. Additionally, the capsule shells contain the following colorants:. 1 mg capsules: FD&C Yellow No. 5. 1.5 mg capsules: FD&C Blue No. 1 and FD&C Red No. 3. 2 mg capsules: D&C Yellow No. 10 and FD&C Red No. 3. 3 mg capsules: D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6."
},
{
"NDCCode": "52427-672-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (52427-672-30) ",
"NDC11Code": "52427-0672-30",
"ProductNDC": "52427-672",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hcl",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20211004",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215133",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211101",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline Hydrochloride (HCl) Capsules is indicated for the treatment of the following [see Clinical Studies (14)]: 1 Major depressive disorder (MDD) in adults, 2 Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older.",
"Description": "Sertraline HCl Capsules contain sertraline HCl, a selective serotonin reuptake inhibitor (SSRI). Sertraline HCl has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-tetralin-1-amine hydrochloride. The empirical formula C17H17Cl2N HCl is represented by the following structural formula. Sertraline HCl is a white to almost white crystalline powder that is slightly soluble in water, acetone and isopropyl alcohol. Sertraline HCl Capsules is for oral administration and contain 168 mg and 224 mg sertraline HCl, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives."
},
{
"NDCCode": "52427-691-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (52427-691-30) ",
"NDC11Code": "52427-0691-30",
"ProductNDC": "52427-691",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215428",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram Capsules are indicated for the treatment of Major Depressive Disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Citalopram Capsules contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5carbonitrile, hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide is a white to almost white crystalline powder. Citalopram hydrobromide is freely soluble in chloroform and sparingly soluble in ethanol and water. Citalopram Capsules is for oral administration and contains 30 mg of citalopram, equivalent to 37.5 mg of citalopram hydrobromide. The strengths reflect citalopram base equivalent content. Citalopram Capsules also contain the inactive ingredients copovidone, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. The capsule shells contain the colorants FD&C Blue #1 and FD&C Red #3."
},
{
"NDCCode": "52427-692-03",
"PackageDescription": "30 POUCH in 1 CARTON (52427-692-03) > 1 FILM in 1 POUCH (52427-692-11) ",
"NDC11Code": "52427-0692-03",
"ProductNDC": "52427-692",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine And Naloxone",
"ProprietaryNameSuffix": "Sublingual Film",
"NonProprietaryName": "Buprenorphine And Naloxone",
"DosageFormName": "FILM",
"RouteName": "BUCCAL; SUBLINGUAL",
"StartMarketingDate": "20190211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205954",
"LabelerName": "Almatica Pharma Inc.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE",
"StrengthNumber": "2; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2022-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190211",
"SamplePackage": "N"
},
{
"NDCCode": "52427-694-03",
"PackageDescription": "30 POUCH in 1 CARTON (52427-694-03) > 1 FILM in 1 POUCH (52427-694-11) ",
"NDC11Code": "52427-0694-03",
"ProductNDC": "52427-694",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine And Naloxone",
"ProprietaryNameSuffix": "Sublingual Film",
"NonProprietaryName": "Buprenorphine And Naloxone",
"DosageFormName": "FILM",
"RouteName": "BUCCAL; SUBLINGUAL",
"StartMarketingDate": "20190211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205954",
"LabelerName": "Almatica Pharma Inc.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE",
"StrengthNumber": "4; 1",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2022-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190211",
"SamplePackage": "N"
},
{
"NDCCode": "52427-698-03",
"PackageDescription": "30 POUCH in 1 CARTON (52427-698-03) > 1 FILM in 1 POUCH (52427-698-11) ",
"NDC11Code": "52427-0698-03",
"ProductNDC": "52427-698",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine And Naloxone",
"ProprietaryNameSuffix": "Sublingual Film",
"NonProprietaryName": "Buprenorphine And Naloxone",
"DosageFormName": "FILM",
"RouteName": "BUCCAL; SUBLINGUAL",
"StartMarketingDate": "20190211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205954",
"LabelerName": "Almatica Pharma Inc.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE",
"StrengthNumber": "8; 2",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2022-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190211",
"SamplePackage": "N"
},
{
"NDCCode": "52427-712-03",
"PackageDescription": "30 POUCH in 1 CARTON (52427-712-03) > 1 FILM in 1 POUCH (52427-712-11) ",
"NDC11Code": "52427-0712-03",
"ProductNDC": "52427-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine And Naloxone",
"ProprietaryNameSuffix": "Sublingual Film",
"NonProprietaryName": "Buprenorphine And Naloxone",
"DosageFormName": "FILM",
"RouteName": "BUCCAL; SUBLINGUAL",
"StartMarketingDate": "20190211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205954",
"LabelerName": "Almatica Pharma Inc.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE",
"StrengthNumber": "12; 3",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2022-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190211",
"SamplePackage": "N"
},
{
"NDCCode": "52427-775-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (52427-775-30) ",
"NDC11Code": "52427-0775-30",
"ProductNDC": "52427-775",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230509",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215721",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230524",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem Tartrate Capsules are indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than 65 years of age [see Dosage and Administration (2.1) and Clinical Studies (14)].",
"Description": "Zolpidem Tartrate Capsules 7.5 mg contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate. It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder, hygroscopic that is slightly soluble in water, sparingly soluble in methanol alcohol, and practically insoluble in methylene chloride. It has a molecular formula of (C19H21N3O)2 · C4H6O6 and molecular weight of 764.87 g/mol. Zolpidem Tartrate Capsules are intended for oral administration and are available only in a 7.5 mg strength. The capsules contain 7.5 mg zolpidem tartrate, USP (equivalent to 6 mg zolpidem) and include the following inactive ingredients: gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and the colorants FD&C Blue #1, FD&C Red #40 and FD&C Yellow #6."
},
{
"NDCCode": "52427-791-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (52427-791-30) ",
"NDC11Code": "52427-0791-30",
"ProductNDC": "52427-791",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219131",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine Delayed-Release Capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older.",
"Description": "Duloxetine Delayed-Release Capsules contain duloxetine hydrochloride, a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to brownish-white solid, which is slightly soluble in water. Duloxetine Delayed-Release Capsules are intended for oral administration. Each capsule contains enteric-coated pellets of 80 mg, 90 mg, or 120 mg of duloxetine (equivalent to 89.8 mg, 101 mg, or 134.7 mg of duloxetine hydrochloride, USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the enteric-coated pellets include colloidal silicon dioxide, cysteine, hypromellose, hypromellose phthalate, sucrose, sugar spheres, talc, and triethyl citrate. The capsule shell ingredients for the 80 mg strength are D&C Yellow #10, gelatin, and titanium dioxide. The capsule shell ingredients for the 90 mg strength are D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, and titanium dioxide. The capsule shell ingredients for the 120 mg strength are D&C Yellow #10, FD&C Green #3, FD&C Red #40, gelatin, and titanium dioxide."
},
{
"NDCCode": "52427-795-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (52427-795-30) ",
"NDC11Code": "52427-0795-30",
"ProductNDC": "52427-795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitalopram",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20251006",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219130",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251006",
"SamplePackage": "N",
"IndicationAndUsage": "Escitalopram Capsules are indicated for the treatment of: : 1 Major depressive disorder (MDD) in adults younger than 65 years of age [see Dosage and Administration (2.1)] and pediatric patients 12 years of age and older., 2 Generalized anxiety disorder (GAD) in adults younger than 65 years of age [see Dosage and Administration (2.1)]. .",
"Description": "Escitalopram Capsules contain escitalopram, a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.43. Escitalopram oxalate occurs as a fine, white to slightly yellow powder and is freely soluble in methanol and in dimethyl sulphoxide, sparingly soluble in water and in alcohol, very slightly soluble in ethyl acetate and in isopropyl alcohol, and insoluble in heptane. Escitalopram Capsules are intended for oral administration and are available only in a 15 mg strength. The capsules contain 15 mg escitalopram (equivalent to 19.16 mg escitalopram oxalate) and the following inactive ingredients: croscarmellose sodium, copovidone, FD&C Blue #1, FD&C Red #40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, and titanium dioxide."
},
{
"NDCCode": "52427-821-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (52427-821-30) ",
"NDC11Code": "52427-0821-30",
"ProductNDC": "52427-821",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219131",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine Delayed-Release Capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older.",
"Description": "Duloxetine Delayed-Release Capsules contain duloxetine hydrochloride, a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to brownish-white solid, which is slightly soluble in water. Duloxetine Delayed-Release Capsules are intended for oral administration. Each capsule contains enteric-coated pellets of 80 mg, 90 mg, or 120 mg of duloxetine (equivalent to 89.8 mg, 101 mg, or 134.7 mg of duloxetine hydrochloride, USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the enteric-coated pellets include colloidal silicon dioxide, cysteine, hypromellose, hypromellose phthalate, sucrose, sugar spheres, talc, and triethyl citrate. The capsule shell ingredients for the 80 mg strength are D&C Yellow #10, gelatin, and titanium dioxide. The capsule shell ingredients for the 90 mg strength are D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, and titanium dioxide. The capsule shell ingredients for the 120 mg strength are D&C Yellow #10, FD&C Green #3, FD&C Red #40, gelatin, and titanium dioxide."
},
{
"NDCCode": "52427-913-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (52427-913-30) ",
"NDC11Code": "52427-0913-30",
"ProductNDC": "52427-913",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219131",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine Delayed-Release Capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older.",
"Description": "Duloxetine Delayed-Release Capsules contain duloxetine hydrochloride, a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to brownish-white solid, which is slightly soluble in water. Duloxetine Delayed-Release Capsules are intended for oral administration. Each capsule contains enteric-coated pellets of 80 mg, 90 mg, or 120 mg of duloxetine (equivalent to 89.8 mg, 101 mg, or 134.7 mg of duloxetine hydrochloride, USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the enteric-coated pellets include colloidal silicon dioxide, cysteine, hypromellose, hypromellose phthalate, sucrose, sugar spheres, talc, and triethyl citrate. The capsule shell ingredients for the 80 mg strength are D&C Yellow #10, gelatin, and titanium dioxide. The capsule shell ingredients for the 90 mg strength are D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, and titanium dioxide. The capsule shell ingredients for the 120 mg strength are D&C Yellow #10, FD&C Green #3, FD&C Red #40, gelatin, and titanium dioxide."
},
{
"NDCCode": "10544-274-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (10544-274-30)",
"NDC11Code": "10544-0274-30",
"ProductNDC": "10544-274",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040584",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer , 2 Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis , 3 Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis , 4 Dermatologic DiseasesPemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis , 5 Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions , 6 Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis , 7 Respiratory DiseasesSymptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Aspiration pneumonitis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy , 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia , 9 Neoplastic DiseasesFor palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood , 10 Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus, 11 Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis , 12 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement .",
"Description": "PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg."
},
{
"NDCCode": "13537-274-34",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (13537-274-34) > 30 mL in 1 BOTTLE, PLASTIC (13537-274-33)",
"NDC11Code": "13537-0274-34",
"ProductNDC": "13537-274",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Maximum Comfort And Long-lasting Foundation Spf 10",
"ProprietaryNameSuffix": "(obscure 9) - Brown",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": ".016",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14783-274-34",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (14783-274-34) > 30 mL in 1 BOTTLE, PLASTIC (14783-274-33)",
"NDC11Code": "14783-0274-34",
"ProductNDC": "14783-274",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Maximum Comfort And Long-lasting Foundation Spf 10",
"ProprietaryNameSuffix": "(obscure 9) - Brown",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": ".016",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16590-274-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (16590-274-30)",
"NDC11Code": "16590-0274-30",
"ProductNDC": "16590-274",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxazosin",
"NonProprietaryName": "Doxazosin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075509",
"LabelerName": "Stat Rx USA",
"SubstanceName": "DOXAZOSIN MESYLATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Doxazosin tablets are indicated for the treatment of both the urinary outflow obstruction and obstructive and irritative symptoms associated with BPH: obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning). Doxazosin may be used in all BPH patients whether hypertensive or normotensive. In patients with hypertension and BPH, both conditions were effectively treated with doxazosin monotherapy. Doxazosin provides rapid improvement in symptoms and urinary flow rate in 66 to 71% of patients. Sustained improvements with doxazosin were seen in patients treated for up to 14 weeks in double-blind studies and up to 2 years in open-label studies. Doxazosin tablets are also indicated for the treatment of hypertension. Doxazosin may be used alone or in combination with diuretics, beta-adrenergic blocking agents, calcium channel blockers or angiotensin-converting enzyme inhibitors.",
"Description": "Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha1 subtype of alpha adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The molecular formula for doxazosin mesylate is C23H25N5O5 CH4O3S and the molecular weight is 547.6. It has the following structure. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride."
},
{
"NDCCode": "21695-274-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (21695-274-30)",
"NDC11Code": "21695-0274-30",
"ProductNDC": "21695-274",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040757",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP contains. Hydrocodone Bitartrate, USP .......................... 10 mg. Acetaminophen, USP .................................. 650 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Meets USP Dissolution Test 1."
},
{
"NDCCode": "24236-274-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (24236-274-02) ",
"NDC11Code": "24236-0274-02",
"ProductNDC": "24236-274",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071207",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20070423",
"SamplePackage": "N"
},
{
"NDCCode": "27241-274-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-274-30) ",
"NDC11Code": "27241-0274-30",
"ProductNDC": "27241-274",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluvoxamine Maleate",
"NonProprietaryName": "Fluvoxamine Maleate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219055",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "FLUVOXAMINE MALEATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241017",
"SamplePackage": "N",
"IndicationAndUsage": "Fluvoxamine maleate extended-release capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) (1). Efficacy was demonstrated in: : 1 One 12-week study fluvoxamine maleate extended-release capsules in adults (14.1). , 2 Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents (14.1, 14.3)., 3 One maintenance study with IR fluvoxamine tablets (14.2).",
"Description": "Fluvoxamine maleate extended-release capsules, for oral administration, contain fluvoxamine maleate, USP a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate, USP is chemically designated as 5-methoxy-4'-(trifluoromethyl) valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the empirical formula C15H21O2N2F3C4H4O4. Its molecular weight is 434.41. The structural formula is. Fluvoxamine maleate, USP is a white to off-white, odorless, crystalline powder that is sparingly soluble in water, freely soluble in ethanol and chloroform, and practically insoluble in diethyl ether. Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate, USP each capsule contains the following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (which contain sucrose and corn starch), triethyl citrate, and talc. The capsule shell contains gelatin, titanium dioxide, black iron oxide, iron oxide yellow, FD&C Blue No. 1 and sodium lauryl sulfate. The capsule shell is printed with black ink. The black ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide. Fluvoxamine maleate extended-release capsules are gluten-free."
},
{
"NDCCode": "33342-274-07",
"PackageDescription": "30 FILM in 1 BOTTLE (33342-274-07) ",
"NDC11Code": "33342-0274-07",
"ProductNDC": "33342-274",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Febuxostat",
"NonProprietaryName": "Febuxostat Tablets 40 Mg",
"DosageFormName": "FILM",
"RouteName": "ORAL",
"StartMarketingDate": "20190404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207293",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "FEBUXOSTAT",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190404",
"SamplePackage": "N",
"IndicationAndUsage": "Febuxostat is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Limitations of Use: Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia.",
"Description": "Febuxostat is a xanthine oxidase inhibitor. The active ingredient in febuxostat is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid, with a molecular weight of 316.38. The empirical formula is C16H16N2O3S. The chemical structure is:. Febuxostat is a non-hygroscopic, white crystalline powder that is freely soluble in dimethylformamide; soluble in dimethylsulfoxide; sparingly soluble in ethanol; slightly soluble in methanol and acetonitrile; and practically insoluble in water. The melting range is 205°C to 208°C. Febuxostat tablets for oral use contain the active ingredient, febuxostat, and are available in two dosage strengths, 40 mg and 80 mg. Inactive ingredients include: colloidal silicon dioxide, FD&C red #40/ allura red AC aluminum lake, FD&C yellow #5/tartrazine aluminum lake, FD&C Blue # 1/Brilliant Blue FCF Aluminum Lake (11-13%), hydroxypropyl cellulose, lactose monohydrate, macrogol, microcrystalline cellulose, Polyvinyl alcohol-part hydrolyzed, purified water, magnesium stearate, sodium croscarmellose, talc, titanium dioxide."
},
{
"NDCCode": "43063-274-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-274-30)",
"NDC11Code": "43063-0274-30",
"ProductNDC": "43063-274",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19870501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074862",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-04-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "43744-274-30",
"PackageDescription": "50 g in 1 DRUM (43744-274-30)",
"NDC11Code": "43744-0274-30",
"ProductNDC": "43744-274",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dichlorphenamide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130624",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "DICHLORPHENAMIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>52427-274-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (52427-274-30) </PackageDescription>
<NDC11Code>52427-0274-30</NDC11Code>
<ProductNDC>52427-274</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naprelan</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140117</StartMarketingDate>
<EndMarketingDate>20260401</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020353</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140117</StartMarketingDatePackage>
<EndMarketingDatePackage>20260401</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NAPRELAN Tablets are indicated for the treatment of. rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain. [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>NAPRELAN (naproxen sodium) Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug, available as controlled-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each NAPRELAN Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52427-575-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (52427-575-30) </PackageDescription>
<NDC11Code>52427-0575-30</NDC11Code>
<ProductNDC>52427-575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Forfivo</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170515</StartMarketingDate>
<EndMarketingDate>20250101</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022497</ApplicationNumber>
<LabelerName>Almatica Pharma Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>450</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170515</StartMarketingDatePackage>
<EndMarketingDatePackage>20250101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FORFIVO XL (bupropion hydrochloride extended-release tablets) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14)]. The physician who elects to use FORFIVO XL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>FORFIVO XL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-2-(tert-Butylamino)-3'-chloropropiophenone hydrochloride. The molecular weight is 276.2. The empirical formula is C13H18ClNO·HCl. Bupropion hydrochloride powder is white or almost white, crystalline, and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. FORFIVO XL tablets are supplied for oral administration of 450 mg of bupropion hydrochloride as white to off-white extended-release tablets. Each film-coated tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: carboxymethyl cellulose sodium, colloidal silicon dioxide, hydrochloric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 8000, polyethylene oxide, polyvinyl pyrrolidone and polyvinyl acetate blend, stearic acid, talc, titanium dioxide and triacetin. The logo “Forfivo” is printed on one side of the tablet with edible black ink.</Description>
</NDC>
<NDC>
<NDCCode>52427-576-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (52427-576-30) </PackageDescription>
<NDC11Code>52427-0576-30</NDC11Code>
<ProductNDC>52427-576</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine Hcl</ProprietaryName>
<NonProprietaryName>Fluoxetine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170901</StartMarketingDate>
<EndMarketingDate>20260401</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202133</ApplicationNumber>
<LabelerName>Almatica Pharma Inc.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170901</StartMarketingDatePackage>
<EndMarketingDatePackage>20260401</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine tablets are indicated for the treatment of: 1 Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age [see Clinical Studies (14.1)]., 2 Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age [see Clinical Studies (14.2)]., 3 Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine in Bulimia Nervosa was demonstrated in two 8-week trials and one 16-week trial in adults [see Clinical Studies (14.3)]., 4 Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine in Panic Disorder was demonstrated in two 12-week trials in adults [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each scored tablet contains fluoxetine hydrochloride equivalent to 60 mg (194 μmol) of fluoxetine. In addition, each scored tablet also contains the following inactive ingredients: mannitol, microcrystalline cellulose, maize starch, povidone, hypromellose, magnesium stearate, titanium dioxide, sucrose, glycerol, and polysorbate.</Description>
</NDC>
<NDC>
<NDCCode>52427-632-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52427-632-30) </PackageDescription>
<NDC11Code>52427-0632-30</NDC11Code>
<ProductNDC>52427-632</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220630</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215429</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>VENLAFAXINE BESYLATE MONOHYDRATE</SubstanceName>
<StrengthNumber>112.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine Extended-Release Tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD) , 2 Generalized Anxiety Disorder (GAD) .</IndicationAndUsage>
<Description>Venlafaxine Extended-Release Tablets contains venlafaxine, an SNRI, present as venlafaxine besylate monohydrate salt. Venlafaxine besylate monohydrate is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol benzene sulfonate monohydrate or Cyclohexanol, 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-, benzenesulfonate, monohydrate and has the molecular formula of C23H33NO5S⸱H2O. Its molecular weight is 453.59. The structural formula is shown as follows. Venlafaxine besylate is a white to almost white crystalline powder, with a solubility of about 32 mg/ml in water. Its octanol:water partition coefficient is 0.154. Drug release is controlled by a combination of diffusion through the extended-release coating and erosion of the core tablets. The modified drug release is pH independent. Venlafaxine Extended-Release Tablets are intended for oral administration and contains 183.95 mg of venlafaxine besylate monohydrate equivalent to 112.5 mg of venlafaxine. Inactive ingredients: ammonio methacrylate copolymer, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, simethicone, talc, titanium dioxide, and triacetin. The tablet printing ink is composed of ammonium hydroxide, black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>52427-658-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-658-30) </PackageDescription>
<NDC11Code>52427-0658-30</NDC11Code>
<ProductNDC>52427-658</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loreev Xr</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210831</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214826</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LOREEV XR is indicated for the treatment of anxiety disorders in adults who are receiving stable, evenly divided, three times daily dosing with lorazepam tablets.</IndicationAndUsage>
<Description>LOREEV XR contains lorazepam, a benzodiazepine. Lorazepam is a nearly white crystalline powder and is practically insoluble in water and slightly soluble in alcohol. It is a 1:1 mixture of (R) and (S) isomers. The chemical name is ±-7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one and its structural formula is. Molecular formula: C15H10Cl2N2O2; Molecular weight: 321.16. LOREEV XR is intended for oral administration. Each capsule contains 1 mg, 1.5 mg, 2 mg, or 3 mg of lorazepam. The inactive ingredients are colloidal silicon dioxide, corn starch, gelatin, glyceryl monostearate, hypromellose, lactose monohydrate, methyl acrylate methyl methacrylate and methacrylic acid (7:3:1) copolymer 280000 dispersion, microcrystalline cellulose, polysorbate 80, talc, titanium dioxide, and triethyl citrate. Additionally, the capsule shells contain the following colorants:. 1 mg capsules: FD&C Yellow No. 5. 1.5 mg capsules: FD&C Blue No. 1 and FD&C Red No. 3. 2 mg capsules: D&C Yellow No. 10 and FD&C Red No. 3. 3 mg capsules: D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>52427-661-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-661-30) </PackageDescription>
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<ProductNDC>52427-661</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loreev Xr</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214826</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LOREEV XR is indicated for the treatment of anxiety disorders in adults who are receiving stable, evenly divided, three times daily dosing with lorazepam tablets.</IndicationAndUsage>
<Description>LOREEV XR contains lorazepam, a benzodiazepine. Lorazepam is a nearly white crystalline powder and is practically insoluble in water and slightly soluble in alcohol. It is a 1:1 mixture of (R) and (S) isomers. The chemical name is ±-7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one and its structural formula is. Molecular formula: C15H10Cl2N2O2; Molecular weight: 321.16. LOREEV XR is intended for oral administration. Each capsule contains 1 mg, 1.5 mg, 2 mg, or 3 mg of lorazepam. The inactive ingredients are colloidal silicon dioxide, corn starch, gelatin, glyceryl monostearate, hypromellose, lactose monohydrate, methyl acrylate methyl methacrylate and methacrylic acid (7:3:1) copolymer 280000 dispersion, microcrystalline cellulose, polysorbate 80, talc, titanium dioxide, and triethyl citrate. Additionally, the capsule shells contain the following colorants:. 1 mg capsules: FD&C Yellow No. 5. 1.5 mg capsules: FD&C Blue No. 1 and FD&C Red No. 3. 2 mg capsules: D&C Yellow No. 10 and FD&C Red No. 3. 3 mg capsules: D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>52427-663-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-663-30) </PackageDescription>
<NDC11Code>52427-0663-30</NDC11Code>
<ProductNDC>52427-663</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loreev Xr</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210831</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214826</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LOREEV XR is indicated for the treatment of anxiety disorders in adults who are receiving stable, evenly divided, three times daily dosing with lorazepam tablets.</IndicationAndUsage>
<Description>LOREEV XR contains lorazepam, a benzodiazepine. Lorazepam is a nearly white crystalline powder and is practically insoluble in water and slightly soluble in alcohol. It is a 1:1 mixture of (R) and (S) isomers. The chemical name is ±-7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one and its structural formula is. Molecular formula: C15H10Cl2N2O2; Molecular weight: 321.16. LOREEV XR is intended for oral administration. Each capsule contains 1 mg, 1.5 mg, 2 mg, or 3 mg of lorazepam. The inactive ingredients are colloidal silicon dioxide, corn starch, gelatin, glyceryl monostearate, hypromellose, lactose monohydrate, methyl acrylate methyl methacrylate and methacrylic acid (7:3:1) copolymer 280000 dispersion, microcrystalline cellulose, polysorbate 80, talc, titanium dioxide, and triethyl citrate. Additionally, the capsule shells contain the following colorants:. 1 mg capsules: FD&C Yellow No. 5. 1.5 mg capsules: FD&C Blue No. 1 and FD&C Red No. 3. 2 mg capsules: D&C Yellow No. 10 and FD&C Red No. 3. 3 mg capsules: D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>52427-664-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (52427-664-30) </PackageDescription>
<NDC11Code>52427-0664-30</NDC11Code>
<ProductNDC>52427-664</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hcl</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211004</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215133</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline Hydrochloride (HCl) Capsules is indicated for the treatment of the following [see Clinical Studies (14)]: 1 Major depressive disorder (MDD) in adults, 2 Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older.</IndicationAndUsage>
<Description>Sertraline HCl Capsules contain sertraline HCl, a selective serotonin reuptake inhibitor (SSRI). Sertraline HCl has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-tetralin-1-amine hydrochloride. The empirical formula C17H17Cl2N HCl is represented by the following structural formula. Sertraline HCl is a white to almost white crystalline powder that is slightly soluble in water, acetone and isopropyl alcohol. Sertraline HCl Capsules is for oral administration and contain 168 mg and 224 mg sertraline HCl, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives.</Description>
</NDC>
<NDC>
<NDCCode>52427-667-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52427-667-30) </PackageDescription>
<NDC11Code>52427-0667-30</NDC11Code>
<ProductNDC>52427-667</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loreev Xr</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210831</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214826</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LOREEV XR is indicated for the treatment of anxiety disorders in adults who are receiving stable, evenly divided, three times daily dosing with lorazepam tablets.</IndicationAndUsage>
<Description>LOREEV XR contains lorazepam, a benzodiazepine. Lorazepam is a nearly white crystalline powder and is practically insoluble in water and slightly soluble in alcohol. It is a 1:1 mixture of (R) and (S) isomers. The chemical name is ±-7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one and its structural formula is. Molecular formula: C15H10Cl2N2O2; Molecular weight: 321.16. LOREEV XR is intended for oral administration. Each capsule contains 1 mg, 1.5 mg, 2 mg, or 3 mg of lorazepam. The inactive ingredients are colloidal silicon dioxide, corn starch, gelatin, glyceryl monostearate, hypromellose, lactose monohydrate, methyl acrylate methyl methacrylate and methacrylic acid (7:3:1) copolymer 280000 dispersion, microcrystalline cellulose, polysorbate 80, talc, titanium dioxide, and triethyl citrate. Additionally, the capsule shells contain the following colorants:. 1 mg capsules: FD&C Yellow No. 5. 1.5 mg capsules: FD&C Blue No. 1 and FD&C Red No. 3. 2 mg capsules: D&C Yellow No. 10 and FD&C Red No. 3. 3 mg capsules: D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>52427-672-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (52427-672-30) </PackageDescription>
<NDC11Code>52427-0672-30</NDC11Code>
<ProductNDC>52427-672</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hcl</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211004</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215133</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline Hydrochloride (HCl) Capsules is indicated for the treatment of the following [see Clinical Studies (14)]: 1 Major depressive disorder (MDD) in adults, 2 Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older.</IndicationAndUsage>
<Description>Sertraline HCl Capsules contain sertraline HCl, a selective serotonin reuptake inhibitor (SSRI). Sertraline HCl has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-tetralin-1-amine hydrochloride. The empirical formula C17H17Cl2N HCl is represented by the following structural formula. Sertraline HCl is a white to almost white crystalline powder that is slightly soluble in water, acetone and isopropyl alcohol. Sertraline HCl Capsules is for oral administration and contain 168 mg and 224 mg sertraline HCl, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives.</Description>
</NDC>
<NDC>
<NDCCode>52427-691-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (52427-691-30) </PackageDescription>
<NDC11Code>52427-0691-30</NDC11Code>
<ProductNDC>52427-691</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220131</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215428</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram Capsules are indicated for the treatment of Major Depressive Disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Citalopram Capsules contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5carbonitrile, hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide is a white to almost white crystalline powder. Citalopram hydrobromide is freely soluble in chloroform and sparingly soluble in ethanol and water. Citalopram Capsules is for oral administration and contains 30 mg of citalopram, equivalent to 37.5 mg of citalopram hydrobromide. The strengths reflect citalopram base equivalent content. Citalopram Capsules also contain the inactive ingredients copovidone, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. The capsule shells contain the colorants FD&C Blue #1 and FD&C Red #3.</Description>
</NDC>
<NDC>
<NDCCode>52427-692-03</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (52427-692-03) > 1 FILM in 1 POUCH (52427-692-11) </PackageDescription>
<NDC11Code>52427-0692-03</NDC11Code>
<ProductNDC>52427-692</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine And Naloxone</ProprietaryName>
<ProprietaryNameSuffix>Sublingual Film</ProprietaryNameSuffix>
<NonProprietaryName>Buprenorphine And Naloxone</NonProprietaryName>
<DosageFormName>FILM</DosageFormName>
<RouteName>BUCCAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20190211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205954</ApplicationNumber>
<LabelerName>Almatica Pharma Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE</SubstanceName>
<StrengthNumber>2; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52427-694-03</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (52427-694-03) > 1 FILM in 1 POUCH (52427-694-11) </PackageDescription>
<NDC11Code>52427-0694-03</NDC11Code>
<ProductNDC>52427-694</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine And Naloxone</ProprietaryName>
<ProprietaryNameSuffix>Sublingual Film</ProprietaryNameSuffix>
<NonProprietaryName>Buprenorphine And Naloxone</NonProprietaryName>
<DosageFormName>FILM</DosageFormName>
<RouteName>BUCCAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20190211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205954</ApplicationNumber>
<LabelerName>Almatica Pharma Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE</SubstanceName>
<StrengthNumber>4; 1</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52427-698-03</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (52427-698-03) > 1 FILM in 1 POUCH (52427-698-11) </PackageDescription>
<NDC11Code>52427-0698-03</NDC11Code>
<ProductNDC>52427-698</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine And Naloxone</ProprietaryName>
<ProprietaryNameSuffix>Sublingual Film</ProprietaryNameSuffix>
<NonProprietaryName>Buprenorphine And Naloxone</NonProprietaryName>
<DosageFormName>FILM</DosageFormName>
<RouteName>BUCCAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20190211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205954</ApplicationNumber>
<LabelerName>Almatica Pharma Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE</SubstanceName>
<StrengthNumber>8; 2</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52427-712-03</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (52427-712-03) > 1 FILM in 1 POUCH (52427-712-11) </PackageDescription>
<NDC11Code>52427-0712-03</NDC11Code>
<ProductNDC>52427-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine And Naloxone</ProprietaryName>
<ProprietaryNameSuffix>Sublingual Film</ProprietaryNameSuffix>
<NonProprietaryName>Buprenorphine And Naloxone</NonProprietaryName>
<DosageFormName>FILM</DosageFormName>
<RouteName>BUCCAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20190211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205954</ApplicationNumber>
<LabelerName>Almatica Pharma Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE</SubstanceName>
<StrengthNumber>12; 3</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52427-775-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (52427-775-30) </PackageDescription>
<NDC11Code>52427-0775-30</NDC11Code>
<ProductNDC>52427-775</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230509</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215721</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem Tartrate Capsules are indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than 65 years of age [see Dosage and Administration (2.1) and Clinical Studies (14)].</IndicationAndUsage>
<Description>Zolpidem Tartrate Capsules 7.5 mg contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate. It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder, hygroscopic that is slightly soluble in water, sparingly soluble in methanol alcohol, and practically insoluble in methylene chloride. It has a molecular formula of (C19H21N3O)2 · C4H6O6 and molecular weight of 764.87 g/mol. Zolpidem Tartrate Capsules are intended for oral administration and are available only in a 7.5 mg strength. The capsules contain 7.5 mg zolpidem tartrate, USP (equivalent to 6 mg zolpidem) and include the following inactive ingredients: gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and the colorants FD&C Blue #1, FD&C Red #40 and FD&C Yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>52427-791-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (52427-791-30) </PackageDescription>
<NDC11Code>52427-0791-30</NDC11Code>
<ProductNDC>52427-791</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219131</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine Delayed-Release Capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older.</IndicationAndUsage>
<Description>Duloxetine Delayed-Release Capsules contain duloxetine hydrochloride, a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to brownish-white solid, which is slightly soluble in water. Duloxetine Delayed-Release Capsules are intended for oral administration. Each capsule contains enteric-coated pellets of 80 mg, 90 mg, or 120 mg of duloxetine (equivalent to 89.8 mg, 101 mg, or 134.7 mg of duloxetine hydrochloride, USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the enteric-coated pellets include colloidal silicon dioxide, cysteine, hypromellose, hypromellose phthalate, sucrose, sugar spheres, talc, and triethyl citrate. The capsule shell ingredients for the 80 mg strength are D&C Yellow #10, gelatin, and titanium dioxide. The capsule shell ingredients for the 90 mg strength are D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, and titanium dioxide. The capsule shell ingredients for the 120 mg strength are D&C Yellow #10, FD&C Green #3, FD&C Red #40, gelatin, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52427-795-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (52427-795-30) </PackageDescription>
<NDC11Code>52427-0795-30</NDC11Code>
<ProductNDC>52427-795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251006</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219130</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Escitalopram Capsules are indicated for the treatment of: : 1 Major depressive disorder (MDD) in adults younger than 65 years of age [see Dosage and Administration (2.1)] and pediatric patients 12 years of age and older., 2 Generalized anxiety disorder (GAD) in adults younger than 65 years of age [see Dosage and Administration (2.1)]. .</IndicationAndUsage>
<Description>Escitalopram Capsules contain escitalopram, a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.43. Escitalopram oxalate occurs as a fine, white to slightly yellow powder and is freely soluble in methanol and in dimethyl sulphoxide, sparingly soluble in water and in alcohol, very slightly soluble in ethyl acetate and in isopropyl alcohol, and insoluble in heptane. Escitalopram Capsules are intended for oral administration and are available only in a 15 mg strength. The capsules contain 15 mg escitalopram (equivalent to 19.16 mg escitalopram oxalate) and the following inactive ingredients: croscarmellose sodium, copovidone, FD&C Blue #1, FD&C Red #40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52427-821-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (52427-821-30) </PackageDescription>
<NDC11Code>52427-0821-30</NDC11Code>
<ProductNDC>52427-821</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219131</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine Delayed-Release Capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older.</IndicationAndUsage>
<Description>Duloxetine Delayed-Release Capsules contain duloxetine hydrochloride, a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to brownish-white solid, which is slightly soluble in water. Duloxetine Delayed-Release Capsules are intended for oral administration. Each capsule contains enteric-coated pellets of 80 mg, 90 mg, or 120 mg of duloxetine (equivalent to 89.8 mg, 101 mg, or 134.7 mg of duloxetine hydrochloride, USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the enteric-coated pellets include colloidal silicon dioxide, cysteine, hypromellose, hypromellose phthalate, sucrose, sugar spheres, talc, and triethyl citrate. The capsule shell ingredients for the 80 mg strength are D&C Yellow #10, gelatin, and titanium dioxide. The capsule shell ingredients for the 90 mg strength are D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, and titanium dioxide. The capsule shell ingredients for the 120 mg strength are D&C Yellow #10, FD&C Green #3, FD&C Red #40, gelatin, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52427-913-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (52427-913-30) </PackageDescription>
<NDC11Code>52427-0913-30</NDC11Code>
<ProductNDC>52427-913</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219131</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine Delayed-Release Capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older.</IndicationAndUsage>
<Description>Duloxetine Delayed-Release Capsules contain duloxetine hydrochloride, a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to brownish-white solid, which is slightly soluble in water. Duloxetine Delayed-Release Capsules are intended for oral administration. Each capsule contains enteric-coated pellets of 80 mg, 90 mg, or 120 mg of duloxetine (equivalent to 89.8 mg, 101 mg, or 134.7 mg of duloxetine hydrochloride, USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the enteric-coated pellets include colloidal silicon dioxide, cysteine, hypromellose, hypromellose phthalate, sucrose, sugar spheres, talc, and triethyl citrate. The capsule shell ingredients for the 80 mg strength are D&C Yellow #10, gelatin, and titanium dioxide. The capsule shell ingredients for the 90 mg strength are D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, and titanium dioxide. The capsule shell ingredients for the 120 mg strength are D&C Yellow #10, FD&C Green #3, FD&C Red #40, gelatin, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>10544-274-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (10544-274-30)</PackageDescription>
<NDC11Code>10544-0274-30</NDC11Code>
<ProductNDC>10544-274</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040584</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer , 2 Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis , 3 Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis , 4 Dermatologic DiseasesPemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis , 5 Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions , 6 Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis , 7 Respiratory DiseasesSymptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Aspiration pneumonitis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy , 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia , 9 Neoplastic DiseasesFor palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood , 10 Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus, 11 Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis , 12 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement .</IndicationAndUsage>
<Description>PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg.</Description>
</NDC>
<NDC>
<NDCCode>13537-274-34</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (13537-274-34) > 30 mL in 1 BOTTLE, PLASTIC (13537-274-33)</PackageDescription>
<NDC11Code>13537-0274-34</NDC11Code>
<ProductNDC>13537-274</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Maximum Comfort And Long-lasting Foundation Spf 10</ProprietaryName>
<ProprietaryNameSuffix>(obscure 9) - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131216</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>.016</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14783-274-34</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (14783-274-34) > 30 mL in 1 BOTTLE, PLASTIC (14783-274-33)</PackageDescription>
<NDC11Code>14783-0274-34</NDC11Code>
<ProductNDC>14783-274</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Maximum Comfort And Long-lasting Foundation Spf 10</ProprietaryName>
<ProprietaryNameSuffix>(obscure 9) - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131216</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>.016</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16590-274-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16590-274-30)</PackageDescription>
<NDC11Code>16590-0274-30</NDC11Code>
<ProductNDC>16590-274</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxazosin</ProprietaryName>
<NonProprietaryName>Doxazosin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075509</ApplicationNumber>
<LabelerName>Stat Rx USA</LabelerName>
<SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Doxazosin tablets are indicated for the treatment of both the urinary outflow obstruction and obstructive and irritative symptoms associated with BPH: obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning). Doxazosin may be used in all BPH patients whether hypertensive or normotensive. In patients with hypertension and BPH, both conditions were effectively treated with doxazosin monotherapy. Doxazosin provides rapid improvement in symptoms and urinary flow rate in 66 to 71% of patients. Sustained improvements with doxazosin were seen in patients treated for up to 14 weeks in double-blind studies and up to 2 years in open-label studies. Doxazosin tablets are also indicated for the treatment of hypertension. Doxazosin may be used alone or in combination with diuretics, beta-adrenergic blocking agents, calcium channel blockers or angiotensin-converting enzyme inhibitors.</IndicationAndUsage>
<Description>Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha1 subtype of alpha adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The molecular formula for doxazosin mesylate is C23H25N5O5 CH4O3S and the molecular weight is 547.6. It has the following structure. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride.</Description>
</NDC>
<NDC>
<NDCCode>21695-274-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (21695-274-30)</PackageDescription>
<NDC11Code>21695-0274-30</NDC11Code>
<ProductNDC>21695-274</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>20100218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040757</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP contains. Hydrocodone Bitartrate, USP .......................... 10 mg. Acetaminophen, USP .................................. 650 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>24236-274-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (24236-274-02) </PackageDescription>
<NDC11Code>24236-0274-02</NDC11Code>
<ProductNDC>24236-274</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071207</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>27241-274-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-274-30) </PackageDescription>
<NDC11Code>27241-0274-30</NDC11Code>
<ProductNDC>27241-274</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluvoxamine Maleate</ProprietaryName>
<NonProprietaryName>Fluvoxamine Maleate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219055</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>FLUVOXAMINE MALEATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluvoxamine maleate extended-release capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) (1). Efficacy was demonstrated in: : 1 One 12-week study fluvoxamine maleate extended-release capsules in adults (14.1). , 2 Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents (14.1, 14.3)., 3 One maintenance study with IR fluvoxamine tablets (14.2).</IndicationAndUsage>
<Description>Fluvoxamine maleate extended-release capsules, for oral administration, contain fluvoxamine maleate, USP a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate, USP is chemically designated as 5-methoxy-4'-(trifluoromethyl) valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the empirical formula C15H21O2N2F3C4H4O4. Its molecular weight is 434.41. The structural formula is. Fluvoxamine maleate, USP is a white to off-white, odorless, crystalline powder that is sparingly soluble in water, freely soluble in ethanol and chloroform, and practically insoluble in diethyl ether. Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate, USP each capsule contains the following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (which contain sucrose and corn starch), triethyl citrate, and talc. The capsule shell contains gelatin, titanium dioxide, black iron oxide, iron oxide yellow, FD&C Blue No. 1 and sodium lauryl sulfate. The capsule shell is printed with black ink. The black ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide. Fluvoxamine maleate extended-release capsules are gluten-free.</Description>
</NDC>
<NDC>
<NDCCode>33342-274-07</NDCCode>
<PackageDescription>30 FILM in 1 BOTTLE (33342-274-07) </PackageDescription>
<NDC11Code>33342-0274-07</NDC11Code>
<ProductNDC>33342-274</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Febuxostat</ProprietaryName>
<NonProprietaryName>Febuxostat Tablets 40 Mg</NonProprietaryName>
<DosageFormName>FILM</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207293</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>FEBUXOSTAT</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Febuxostat is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Limitations of Use: Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia.</IndicationAndUsage>
<Description>Febuxostat is a xanthine oxidase inhibitor. The active ingredient in febuxostat is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid, with a molecular weight of 316.38. The empirical formula is C16H16N2O3S. The chemical structure is:. Febuxostat is a non-hygroscopic, white crystalline powder that is freely soluble in dimethylformamide; soluble in dimethylsulfoxide; sparingly soluble in ethanol; slightly soluble in methanol and acetonitrile; and practically insoluble in water. The melting range is 205°C to 208°C. Febuxostat tablets for oral use contain the active ingredient, febuxostat, and are available in two dosage strengths, 40 mg and 80 mg. Inactive ingredients include: colloidal silicon dioxide, FD&C red #40/ allura red AC aluminum lake, FD&C yellow #5/tartrazine aluminum lake, FD&C Blue # 1/Brilliant Blue FCF Aluminum Lake (11-13%), hydroxypropyl cellulose, lactose monohydrate, macrogol, microcrystalline cellulose, Polyvinyl alcohol-part hydrolyzed, purified water, magnesium stearate, sodium croscarmellose, talc, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43063-274-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-274-30)</PackageDescription>
<NDC11Code>43063-0274-30</NDC11Code>
<ProductNDC>43063-274</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074862</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-04-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43744-274-30</NDCCode>
<PackageDescription>50 g in 1 DRUM (43744-274-30)</PackageDescription>
<NDC11Code>43744-0274-30</NDC11Code>
<ProductNDC>43744-274</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dichlorphenamide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130624</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>DICHLORPHENAMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
</NDCList>