{
"NDC": [
{
"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": "52427-274-30",
"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": "52427-576-30",
"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": "13537-575-01",
"PackageDescription": "1 TUBE in 1 BOX (13537-575-01) > 30 g in 1 TUBE",
"NDC11Code": "13537-0575-01",
"ProductNDC": "13537-575",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cyzone Studio Look Base De Alta Cobertura Para El Rostro Con Fps 20",
"ProprietaryNameSuffix": "(medium 4) - Brown",
"NonProprietaryName": "Octinoxate And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150826",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": ".04; .024",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150826",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14141-575-01",
"PackageDescription": "1 TUBE in 1 BOX (14141-575-01) > 30 g in 1 TUBE",
"NDC11Code": "14141-0575-01",
"ProductNDC": "14141-575",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cyzone Studio Look Base De Alta Cobertura Para El Rostro Con Fps 20",
"ProprietaryNameSuffix": "(medium 4) - Brown",
"NonProprietaryName": "Octinoxate And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150826",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bel Star S.A. (Colombia)",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": ".04; .024",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150826",
"SamplePackage": "N"
},
{
"NDCCode": "21695-575-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-575-30)",
"NDC11Code": "21695-0575-30",
"ProductNDC": "21695-575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Mononitrate",
"NonProprietaryName": "Isosorbide Mononitrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19981030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075155",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "ISOSORBIDE MONONITRATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Isosorbide Mononitrate Extended-Release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. The molecular formula of ISMN is C6H9NO6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane."
},
{
"NDCCode": "21749-575-01",
"PackageDescription": "30 mL in 1 PACKAGE (21749-575-01) ",
"NDC11Code": "21749-0575-01",
"ProductNDC": "21749-575",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Purell Advanced Hand Sanitizer Warm Fall Spice",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160901",
"EndMarketingDate": "20190731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GOJO Industries, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160901",
"EndMarketingDatePackage": "20190731",
"SamplePackage": "N"
},
{
"NDCCode": "40032-575-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (40032-575-03)",
"NDC11Code": "40032-0575-03",
"ProductNDC": "40032-575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207884",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of 1 or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.",
"Description": "Methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white to off-white powder. Its solutions are acid to litmus. It is soluble in water, alcohol, and chloroform. Its molecular weight is 269.77. Inactive Ingredients. Methylphenidate hydrochloride tablets, USP: D&C Yellow No. 10 (5-mg and 20-mg tablets), lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Potato), magnesium stearate, and talc. USP Dissolution Testing pending."
},
{
"NDCCode": "43063-575-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (43063-575-30) ",
"NDC11Code": "43063-0575-30",
"ProductNDC": "43063-575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077637",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20120831",
"SamplePackage": "N"
},
{
"NDCCode": "43386-575-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (43386-575-03) ",
"NDC11Code": "43386-0575-03",
"ProductNDC": "43386-575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207884",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160120",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults, 2 Narcolepsy.",
"Description": "Methylphenidate hydrochloride tablets contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets contains the following inactive ingredients: D&C Yellow No. 10 (5-mg and 20-mg tablets), lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Potato), magnesium stearate, and talc."
},
{
"NDCCode": "43598-575-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (43598-575-30) ",
"NDC11Code": "43598-0575-30",
"ProductNDC": "43598-575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210069",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190326",
"SamplePackage": "N",
"Description": "Tadalafil USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil USP has the molecular formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a white or almost white powder that is freely soluble in dimethylsulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as oval-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, poloxamer, sodium lauryl sulfate, titanium dioxide, and triacetin. In addition 2.5, 10 and 20 mg tablets contain talc. USP Dissolution Test Pending."
},
{
"NDCCode": "43744-575-30",
"PackageDescription": "50 g in 1 DRUM (43744-575-30)",
"NDC11Code": "43744-0575-30",
"ProductNDC": "43744-575",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Melarsomine Dihydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120606",
"EndMarketingDate": "20130630",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "MELARSOMINE DIHYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130630"
},
{
"NDCCode": "45865-575-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (45865-575-30) ",
"NDC11Code": "45865-0575-30",
"ProductNDC": "45865-575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074869",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150903",
"SamplePackage": "N",
"IndicationAndUsage": "Seizure Disorders: Clonazepam tablets, USP are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy. Panic Disorder: Clonazepam tablets, USP are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLlNICAL PHARMACOLOGY: Clinical Trials). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clonazepam, USP a benzodiazepine, is available for oral administration as scored tablets containing 0.5 mg, 1 mg or 2 mg of clonazepam. In addition, each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 0.5 mg tablet also contains D&C Red #30 aluminum lake. The 1 mg tablet also contains D&C Yellow #10HT aluminum lake. Chemically, clonazepam is 5-( o-Chlorophenyl)-1,3-dihydro-7-nitro-2 H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:."
}
]
}
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<NDC>
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<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>
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<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
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<EndMarketingDate>20250101</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022497</ApplicationNumber>
<LabelerName>Almatica Pharma Inc.</LabelerName>
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<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>
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<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>
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<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>
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<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>
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<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>13537-575-01</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-575-01) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>13537-0575-01</NDC11Code>
<ProductNDC>13537-575</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cyzone Studio Look Base De Alta Cobertura Para El Rostro Con Fps 20</ProprietaryName>
<ProprietaryNameSuffix>(medium 4) - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150826</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.04; .024</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14141-575-01</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14141-575-01) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>14141-0575-01</NDC11Code>
<ProductNDC>14141-575</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cyzone Studio Look Base De Alta Cobertura Para El Rostro Con Fps 20</ProprietaryName>
<ProprietaryNameSuffix>(medium 4) - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150826</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bel Star S.A. (Colombia)</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.04; .024</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>21695-575-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-575-30)</PackageDescription>
<NDC11Code>21695-0575-30</NDC11Code>
<ProductNDC>21695-575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075155</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Isosorbide Mononitrate Extended-Release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. The molecular formula of ISMN is C6H9NO6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane.</Description>
</NDC>
<NDC>
<NDCCode>21749-575-01</NDCCode>
<PackageDescription>30 mL in 1 PACKAGE (21749-575-01) </PackageDescription>
<NDC11Code>21749-0575-01</NDC11Code>
<ProductNDC>21749-575</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Purell Advanced Hand Sanitizer Warm Fall Spice</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160901</StartMarketingDate>
<EndMarketingDate>20190731</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GOJO Industries, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160901</StartMarketingDatePackage>
<EndMarketingDatePackage>20190731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>40032-575-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (40032-575-03)</PackageDescription>
<NDC11Code>40032-0575-03</NDC11Code>
<ProductNDC>40032-575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207884</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of 1 or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white to off-white powder. Its solutions are acid to litmus. It is soluble in water, alcohol, and chloroform. Its molecular weight is 269.77. Inactive Ingredients. Methylphenidate hydrochloride tablets, USP: D&C Yellow No. 10 (5-mg and 20-mg tablets), lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Potato), magnesium stearate, and talc. USP Dissolution Testing pending.</Description>
</NDC>
<NDC>
<NDCCode>43063-575-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (43063-575-30) </PackageDescription>
<NDC11Code>43063-0575-30</NDC11Code>
<ProductNDC>43063-575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zonisamide</ProprietaryName>
<NonProprietaryName>Zonisamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077637</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43386-575-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43386-575-03) </PackageDescription>
<NDC11Code>43386-0575-03</NDC11Code>
<ProductNDC>43386-575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207884</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults, 2 Narcolepsy.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride tablets contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets contains the following inactive ingredients: D&C Yellow No. 10 (5-mg and 20-mg tablets), lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Potato), magnesium stearate, and talc.</Description>
</NDC>
<NDC>
<NDCCode>43598-575-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (43598-575-30) </PackageDescription>
<NDC11Code>43598-0575-30</NDC11Code>
<ProductNDC>43598-575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210069</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tadalafil USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil USP has the molecular formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a white or almost white powder that is freely soluble in dimethylsulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as oval-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, poloxamer, sodium lauryl sulfate, titanium dioxide, and triacetin. In addition 2.5, 10 and 20 mg tablets contain talc. USP Dissolution Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>43744-575-30</NDCCode>
<PackageDescription>50 g in 1 DRUM (43744-575-30)</PackageDescription>
<NDC11Code>43744-0575-30</NDC11Code>
<ProductNDC>43744-575</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Melarsomine Dihydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120606</StartMarketingDate>
<EndMarketingDate>20130630</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>MELARSOMINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130630</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>45865-575-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (45865-575-30) </PackageDescription>
<NDC11Code>45865-0575-30</NDC11Code>
<ProductNDC>45865-575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074869</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Seizure Disorders: Clonazepam tablets, USP are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy. Panic Disorder: Clonazepam tablets, USP are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLlNICAL PHARMACOLOGY: Clinical Trials). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clonazepam, USP a benzodiazepine, is available for oral administration as scored tablets containing 0.5 mg, 1 mg or 2 mg of clonazepam. In addition, each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 0.5 mg tablet also contains D&C Red #30 aluminum lake. The 1 mg tablet also contains D&C Yellow #10HT aluminum lake. Chemically, clonazepam is 5-( o-Chlorophenyl)-1,3-dihydro-7-nitro-2 H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:.</Description>
</NDC>
</NDCList>