{
"NDC": [
{
"NDCCode": "45865-696-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (45865-696-60)",
"NDC11Code": "45865-0696-60",
"ProductNDC": "45865-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19950103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074342",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Anxiety Disorders. Alprazolam tablets, USP are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat'); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank' because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder. Alprazolam tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). 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. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, and 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored, and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&C yellow #6 aluminum lake (sunset yellow lake). The 1 mg tablet also contains FD&C blue #2 aluminum lake. The 2 mg tablet also contains D&C yellow #10 aluminum lake."
},
{
"NDCCode": "45865-696-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (45865-696-30)",
"NDC11Code": "45865-0696-30",
"ProductNDC": "45865-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19950103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074342",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Anxiety Disorders. Alprazolam tablets, USP are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat'); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank' because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder. Alprazolam tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). 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. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, and 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored, and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&C yellow #6 aluminum lake (sunset yellow lake). The 1 mg tablet also contains FD&C blue #2 aluminum lake. The 2 mg tablet also contains D&C yellow #10 aluminum lake."
},
{
"NDCCode": "45865-696-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (45865-696-90)",
"NDC11Code": "45865-0696-90",
"ProductNDC": "45865-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19950103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074342",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Anxiety Disorders. Alprazolam tablets, USP are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat'); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank' because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder. Alprazolam tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). 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. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, and 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored, and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&C yellow #6 aluminum lake (sunset yellow lake). The 1 mg tablet also contains FD&C blue #2 aluminum lake. The 2 mg tablet also contains D&C yellow #10 aluminum lake."
},
{
"NDCCode": "35356-696-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (35356-696-60) ",
"NDC11Code": "35356-0696-60",
"ProductNDC": "35356-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074754",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120518",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.",
"Description": "Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of non-steroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol. The structural formula is. C19H24N2O6 M.W. 376.41. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. Ketorolac tromethamine tablets are round, white, unscored, film-coated tablets. Each tablet, for oral administration, contains 10 mg ketorolac tromethamine, the active ingredient. In addition, each tablet contains the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "41250-696-33",
"PackageDescription": "1 BOTTLE in 1 CARTON (41250-696-33) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "41250-0696-33",
"ProductNDC": "41250-696",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Sleep Aid",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20200602",
"EndMarketingDate": "20250531",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M010",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210427",
"EndMarketingDatePackage": "20250501",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional sleeplessness."
},
{
"NDCCode": "43063-696-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (43063-696-60) ",
"NDC11Code": "43063-0696-60",
"ProductNDC": "43063-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010416",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075805",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160726",
"SamplePackage": "N"
},
{
"NDCCode": "43353-696-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (43353-696-60)",
"NDC11Code": "43353-0696-60",
"ProductNDC": "43353-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079162",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Topiramate is indicated for: : 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1), 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2).",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2, 3:4, 5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch (maize), sodium starch glycolate, magnesium stearate, opadry white (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80) for 25 mg tablets, opadry yellow (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80, iron oxide yellow) for 50 mg tablets, opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow, polysorbate 80, iron oxide red) for 100 mg tablets and, opadry pink (titanium dioxide, hypromellose 6cp, PEG 400,iron oxide red) for 200 mg tablets."
},
{
"NDCCode": "43744-696-60",
"PackageDescription": "750 g in 1 DRUM (43744-696-60)",
"NDC11Code": "43744-0696-60",
"ProductNDC": "43744-696",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Oxytocin Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120202",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "OXYTOCIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "51862-696-06",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (51862-696-06) ",
"NDC11Code": "51862-0696-06",
"ProductNDC": "51862-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208765",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170614",
"SamplePackage": "N",
"IndicationAndUsage": "Doxycycline hyclate tablets are tetracycline class drugs indicated for: 1 Rickettsial infections ( 1.1) , 2 Sexually transmitted infections ( 1.2) , 3 Respiratory tract infections ( 1.3) , 4 Specific bacterial infections ( 1.4) , 5 Ophthalmic infections ( 1.5) , 6 Anthrax, including inhalational anthrax (post-exposure) ( 1.6) , 7 Alternative treatment for selected infections when penicillin is contraindicated ( 1.7) , 8 Adjunctive therapy for acute intestinal amebiasis and severe acne ( 1.8) , 9 Prophylaxis of malaria ( 1.9) .",
"Description": "Doxycycline hyclate tablets contain doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral administration. The molecular formula of doxycycline hyclate is (C 22H 24N 2O 8∙ HCl) 2∙ C 2H 6O∙ H 2O and the molecular weight of doxycycline hyclate is 1025.87. The chemical name for doxycycline hyclate is: 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2 naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The structural formula for doxycycline hyclate is. Figure 1: Structure of Doxycycline Hyclate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates."
},
{
"NDCCode": "55289-696-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (55289-696-60) ",
"NDC11Code": "55289-0696-60",
"ProductNDC": "55289-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076063",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100706",
"SamplePackage": "N"
},
{
"NDCCode": "55700-696-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-696-60) ",
"NDC11Code": "55700-0696-60",
"ProductNDC": "55700-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077797",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20181102",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C20H21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine Hydrochloride Tablets, USP are supplied as 5 mg and 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide; 5 mg tablets also contain FD&C Red #40 and 10 mg tablets contain D&C Yellow #10 and polysorbate."
},
{
"NDCCode": "60760-696-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-696-60)",
"NDC11Code": "60760-0696-60",
"ProductNDC": "60760-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nabumetone",
"NonProprietaryName": "Nabumetone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078671",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "NABUMETONE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63187-696-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (63187-696-60) ",
"NDC11Code": "63187-0696-60",
"ProductNDC": "63187-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076343",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160502",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate tablets USP is an antiepileptic (AED) agent indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1), 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2).",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets USP are available as 25mg, 50 mg and 100 mg circular tablets and 200 mg capsule shaped tablets for oral administration. Topiramate USP is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5Di-O-isopropylidene-ß-D-fructopyranose sulfamate and has the following structural formula:. Each tablet, for oral administration, contains 25 mg, 50 mg, 100 mg and 200 mg topiramate and has the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate and titanium dioxide. In addition, the 25 mg also contains FD&C Blue #2; the 50 mg and 100 mg also contain red iron oxide and yellow iron oxide; and the 200 mg also contains red iron oxide."
},
{
"NDCCode": "64896-696-13",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-696-13) ",
"NDC11Code": "64896-0696-13",
"ProductNDC": "64896-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxymorphone Hydrochloride",
"NonProprietaryName": "Oxymorphone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079087",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "OXYMORPHONE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130102",
"SamplePackage": "N",
"IndicationAndUsage": "Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Usage: 1 Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Oxymorphone Hydrochloride Extended-Release Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Oxymorphone Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Oxymorphone Hydrochloride Extended-Release Tablets, USP are for oral use and contain oxymorphone, an opioid agonist. Oxymorphone Hydrochloride Extended-Release Tablets, USP are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per tablet. The tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hypromellose, xanthan gum, magnesium stearate, polyvinyl alcohol - partially hydrolyzed, polyethylene glycol, talc, and titanium dioxide. The 5 mg, 7.5 mg, 10 mg, 20 mg and 40 mg tablets contain FD&C Yellow No. 6 Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue No. 2 and D&C Red No. 27. The 7.5 mg tablets contain FD&C Blue No. 2 and FD&C Red No. 40. The 10 mg tablets contain FD&C Red No. 40. The 20 mg tablets contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1, and FD&C Blue No. 2. The 30 mg tablets contain Iron Oxide Yellow and Iron Oxide Black. The 40 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The chemical name of oxymorphone hydrochloride is 4,5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride. Oxymorphone hydrochloride, USP is a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The pKa1 and pKa2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "71205-696-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71205-696-60) ",
"NDC11Code": "71205-0696-60",
"ProductNDC": "71205-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208677",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2023-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231030",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S )-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide."
},
{
"NDCCode": "71610-696-53",
"PackageDescription": "60 TABLET in 1 BOTTLE (71610-696-53) ",
"NDC11Code": "71610-0696-53",
"ProductNDC": "71610-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19951229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074112",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230320",
"SamplePackage": "N",
"IndicationAndUsage": "Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults. , 2 treatment of panic disorder (PD), with or without agoraphobia in adults.",
"Description": "Alprazolam, USP is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, USP, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam, USP. Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mg also contains FD&C Yellow #6 Aluminum Lake, and the 1 mg also contains FD&C Blue #2 Aluminum Lake."
},
{
"NDCCode": "71610-696-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (71610-696-60) ",
"NDC11Code": "71610-0696-60",
"ProductNDC": "71610-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19951229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074112",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230320",
"SamplePackage": "N",
"IndicationAndUsage": "Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults. , 2 treatment of panic disorder (PD), with or without agoraphobia in adults.",
"Description": "Alprazolam, USP is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, USP, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam, USP. Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mg also contains FD&C Yellow #6 Aluminum Lake, and the 1 mg also contains FD&C Blue #2 Aluminum Lake."
},
{
"NDCCode": "72319-696-60",
"PackageDescription": "60 APPLICATOR in 1 JAR (72319-696-60) / 1 mL in 1 APPLICATOR",
"NDC11Code": "72319-0696-60",
"ProductNDC": "72319-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate",
"NonProprietaryName": "Clindamycin Phosphate Topical",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250616",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065513",
"LabelerName": "i3 Pharmaceuticals, LLC",
"SubstanceName": "CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250616",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin Phosphate Topical Solution is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS, WARNINGSand ADVERSE REACTIONS.).",
"Description": "Clindamycin Phosphate Topical Solution contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Each Clindamycin Phosphate Topical Solution pledget applicator contains approximately 1 mL of topical solution. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The solution contains isopropyl alcohol 50% v/v, propylene glycol, sodium hydroxide (to adjust the pH to between 4.0 – 7.0) and purified water. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-α-D- galacto-octopyranoside 2-(dihydrogen phosphate)."
},
{
"NDCCode": "76420-696-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (76420-696-60) ",
"NDC11Code": "76420-0696-60",
"ProductNDC": "76420-696",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210526",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214548",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240302",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a, d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. C 20H 23N.HCl. M.W. 313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included. 10 mg-D&C Red #27 Phloxine Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;. 50 mg-D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake and FD&C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&C Yellow #10 Aluminum Lake and D&C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "45865-101-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (45865-101-60) ",
"NDC11Code": "45865-0101-60",
"ProductNDC": "45865-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203536",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200703",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablets are angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1) , 2 Treatment of heart failure (NYHA class II-IV); valsartan tablets significantly reduced hospitalization for heart failure ( 1.2) , 3 Post-myocardial infarction; for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction ( 1.3) .",
"Description": "Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)- N-[[2′-(1 H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24H 29N 5O 3, its molecular weight is 435.52, and its structural formula is. Valsartan USP is a white to off white hygroscopic powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg and 320 mg of valsartan USP. The inactive ingredients of the tablets are anhydrous lactose, crospovidone, dental-type silica, ferric oxide red (80 mg only), ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "45865-102-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (45865-102-60) ",
"NDC11Code": "45865-0102-60",
"ProductNDC": "45865-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20200703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205563",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200703",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole Magnesium Delayed-release Capsules is a proton pump inhibitor indicated for the following: 1 Treatment of gastroesophageal reflux disease (GERD). ( 1.1) , 2 Risk reduction of NSAID-associated gastric ulcer. ( 1.2) , 3 H. pylori eradication to reduce the risk of duodenal ulcer recurrence. ( 1.3) , 4 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome. ( 1.4) .",
"Description": "The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole-1-yl) magnesium dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17H 18N 3O 3S) 2Mg x 2 H 2O with molecular weight of 749.2 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is:. Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 2 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole Magnesium Delayed-release Capsules is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 21.7 mg, or 43.4 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets with the following inactive ingredients: diglycerin, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, monoglycerides, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, sodium lauryl sulfate, and titanium dioxide. In addition, the 20 mg capsule shell contains FD & C Red #40 and the 40 mg capsule shell contains FD&C Red #3. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. The 20 mg ink also contains titanium dioxide. The 40 mg ink may also contain n-butyl alcohol. Esomeprazole Magnesium Delayed-release Capsules meet USP Dissolution Test 4."
},
{
"NDCCode": "45865-111-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (45865-111-60) ",
"NDC11Code": "45865-0111-60",
"ProductNDC": "45865-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nabumetone",
"NonProprietaryName": "Nabumetone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078420",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "NABUMETONE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of nabumetone tablets, USP and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Nabumetone tablets, USP are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.",
"Description": "Nabumetone, USP is a naphthylalkanone designated chemically as 4-(6-methoxy-2- naphthalenyl)-2-butanone. It has the following structure. Nabumetone, USP is a white or almost white crystalline substance with a molecular weight of 228.3. It is nonacidic, freely soluble in acetone, sparingly soluble in alcohol and in methanol, practically insoluble in water. It has an n-octanol:phosphate buffer partition coefficient of 2400 at pH 7.4. Each tablet, for oral administration contains either 500 mg or 750 mg of nabumetone, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "45865-114-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (45865-114-60) ",
"NDC11Code": "45865-0114-60",
"ProductNDC": "45865-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091367",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"Description": "Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)- N-[[2'-(1 H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24H 29N 5O 3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red."
},
{
"NDCCode": "45865-115-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (45865-115-60) ",
"NDC11Code": "45865-0115-60",
"ProductNDC": "45865-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075964",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated. , 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia. .",
"Description": "Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadolhydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80."
},
{
"NDCCode": "45865-117-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (45865-117-60) ",
"NDC11Code": "45865-0117-60",
"ProductNDC": "45865-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090796",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N"
},
{
"NDCCode": "45865-120-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (45865-120-60) ",
"NDC11Code": "45865-0120-60",
"ProductNDC": "45865-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075964",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated. , 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia. .",
"Description": "Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadolhydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80."
},
{
"NDCCode": "45865-122-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (45865-122-60) ",
"NDC11Code": "45865-0122-60",
"ProductNDC": "45865-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203244",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140111",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin tablets are indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin tablets is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin and copovidone, hydroxyl propyl cellulose, magnesium stearate, mannitol, poloxamer, talc, low-substituted hydroxypropyl cellulose and opadry II (white). Opadry II (white) contains polyvinyl alcohol, polyethylene glycol, titanium dioxide, and talc."
},
{
"NDCCode": "45865-123-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-123-60) ",
"NDC11Code": "45865-0123-60",
"ProductNDC": "45865-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rabeprazole Sodium",
"NonProprietaryName": "Rabeprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208644",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "RABEPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180427",
"SamplePackage": "N",
"IndicationAndUsage": "Rabeprazole sodium delayed-release tablets is a proton pump inhibitor (PPI) indicated in adults for:. · Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) ( 1.1). · Maintenance of Healing of Erosive or Ulcerative GERD ( 1.2). · Treatment of Symptomatic GERD ( 1.3). · Healing of Duodenal Ulcers ( 1.4). · Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence ( 1.5). · Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome ( 1.6). In adolescent patients 12 years of age and older for:. · Short-term Treatment of Symptomatic GERD ( 1.7).",
"Description": "The active ingredient in rabeprazole sodium delayed-release tablets is rabeprazole sodium, which is a proton pump inhibitor. It is a substituted benzimidazole known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1 H–benzimidazole sodium salt. It has an empirical formula of C 18H 20N 3NaO 3S and a molecular weight of 381.42. Rabeprazole sodium is a white to slightly yellowish-white solid. It is very soluble in water and methanol, freely soluble in ethanol, chloroform, and ethyl acetate and insoluble in ether and n-hexane. The stability of rabeprazole sodium is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions. The structural figure is:. Rabeprazole sodium delayed-release tablets is available for oral administration as Delayed-Release, enteric-coated tablets containing 20 mg of rabeprazole sodium. Inactive ingredients of the 20 mg tablet are Mannitol, Crospovidone, Magnesium Oxide Light, Hydroxy Propyl Cellulose, Sodium Stearyl Fumarate, Magnesium Stearate, Ethyl Cellulose, Hypromellose phthalate, Carnauba Wax, Diacetylated Monoglyceride. The coating material contains Polyvinyl Alcohol, Talc, Titanium Dioxide, Macrogol, Lecithin and Iron Oxide Yellow. The printing ink contains Shellac, Ferrosoferric Oxide, Propylene Glycol and Ammonium Hydroxide 28%."
},
{
"NDCCode": "45865-130-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-130-60) ",
"NDC11Code": "45865-0130-60",
"ProductNDC": "45865-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202882",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180706",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole Sodium Delayed-Release Tablets are indicated for:.",
"Description": "The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP, a PPI, is a substituted benzimidazole, 5-(Difluoromethoxy) -2- [[(3,4-dimethoxy-2- pyridyl)methyl] sulfinyl]benzimidazole, sodium salt, sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S . 1.5 H 2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium sesquihydrate, USP is a white to off-white powder. Pantoprazole sodium sesquihydrate, USP is freely soluble in water, in methanol, in dehydrated alcohol, practically insoluble in hexane and dichloromethane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole Sodium is supplied as a Delayed-Release Tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet, USP contains 45.11 mg or 22.55 mg of pantoprazole sodium sesquihydrate, USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, ferric oxide yellow, hydroxy propyl cellulose, hypromellose, lactose monohydrate, methacrylic acid copolymer, polysorbate 80, propylene glycol, sodium carbonate anhydrous, sodium lauryl sulfate, titanium dioxide and triethyl citrate. The tablets are imprinted with opacode black containing ammonium hydroxide, iron oxide black, propylene glycol and shellac. Pantoprazole Sodium Delayed-Release Tablets, (40 mg and 20 mg) complies with USP dissolution test 2."
},
{
"NDCCode": "45865-161-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (45865-161-60) ",
"NDC11Code": "45865-0161-60",
"ProductNDC": "45865-161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metaxalone",
"NonProprietaryName": "Metaxalone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208774",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "METAXALONE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210119",
"SamplePackage": "N",
"IndicationAndUsage": "Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.",
"Description": "Metaxalone tablets, USP are available as an 800 mg oval, scored pink tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C 12H 15NO 3, which corresponds to a molecular weight of 221.25. The structural formula is:. Metaxalone is a white crystalline powder, soluble in chloroform, acetonitrile and methanol, but insoluble in water. Each tablet contains 800 mg metaxalone and the following inactive ingredients: anhydrous citric acid, FD&C Red # 40, sodium alginate and magnesium stearate. USP Dissolution Test Pending."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>45865-696-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (45865-696-60)</PackageDescription>
<NDC11Code>45865-0696-60</NDC11Code>
<ProductNDC>45865-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074342</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Anxiety Disorders. Alprazolam tablets, USP are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat'); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank' because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder. Alprazolam tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). 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. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, and 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored, and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&C yellow #6 aluminum lake (sunset yellow lake). The 1 mg tablet also contains FD&C blue #2 aluminum lake. The 2 mg tablet also contains D&C yellow #10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>45865-696-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (45865-696-30)</PackageDescription>
<NDC11Code>45865-0696-30</NDC11Code>
<ProductNDC>45865-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074342</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Anxiety Disorders. Alprazolam tablets, USP are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat'); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank' because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder. Alprazolam tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). 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. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, and 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored, and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&C yellow #6 aluminum lake (sunset yellow lake). The 1 mg tablet also contains FD&C blue #2 aluminum lake. The 2 mg tablet also contains D&C yellow #10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>45865-696-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (45865-696-90)</PackageDescription>
<NDC11Code>45865-0696-90</NDC11Code>
<ProductNDC>45865-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074342</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Anxiety Disorders. Alprazolam tablets, USP are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat'); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank' because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder. Alprazolam tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). 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. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, and 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored, and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&C yellow #6 aluminum lake (sunset yellow lake). The 1 mg tablet also contains FD&C blue #2 aluminum lake. The 2 mg tablet also contains D&C yellow #10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>35356-696-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (35356-696-60) </PackageDescription>
<NDC11Code>35356-0696-60</NDC11Code>
<ProductNDC>35356-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074754</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.</IndicationAndUsage>
<Description>Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of non-steroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol. The structural formula is. C19H24N2O6 M.W. 376.41. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. Ketorolac tromethamine tablets are round, white, unscored, film-coated tablets. Each tablet, for oral administration, contains 10 mg ketorolac tromethamine, the active ingredient. In addition, each tablet contains the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>41250-696-33</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41250-696-33) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>41250-0696-33</NDC11Code>
<ProductNDC>41250-696</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Sleep Aid</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200602</StartMarketingDate>
<EndMarketingDate>20250531</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M010</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210427</StartMarketingDatePackage>
<EndMarketingDatePackage>20250501</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43063-696-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (43063-696-60) </PackageDescription>
<NDC11Code>43063-0696-60</NDC11Code>
<ProductNDC>43063-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010416</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075805</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43353-696-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (43353-696-60)</PackageDescription>
<NDC11Code>43353-0696-60</NDC11Code>
<ProductNDC>43353-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079162</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Topiramate is indicated for: : 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1), 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2).</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2, 3:4, 5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch (maize), sodium starch glycolate, magnesium stearate, opadry white (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80) for 25 mg tablets, opadry yellow (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80, iron oxide yellow) for 50 mg tablets, opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow, polysorbate 80, iron oxide red) for 100 mg tablets and, opadry pink (titanium dioxide, hypromellose 6cp, PEG 400,iron oxide red) for 200 mg tablets.</Description>
</NDC>
<NDC>
<NDCCode>43744-696-60</NDCCode>
<PackageDescription>750 g in 1 DRUM (43744-696-60)</PackageDescription>
<NDC11Code>43744-0696-60</NDC11Code>
<ProductNDC>43744-696</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Oxytocin Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120202</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>OXYTOCIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51862-696-06</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (51862-696-06) </PackageDescription>
<NDC11Code>51862-0696-06</NDC11Code>
<ProductNDC>51862-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208765</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxycycline hyclate tablets are tetracycline class drugs indicated for: 1 Rickettsial infections ( 1.1) , 2 Sexually transmitted infections ( 1.2) , 3 Respiratory tract infections ( 1.3) , 4 Specific bacterial infections ( 1.4) , 5 Ophthalmic infections ( 1.5) , 6 Anthrax, including inhalational anthrax (post-exposure) ( 1.6) , 7 Alternative treatment for selected infections when penicillin is contraindicated ( 1.7) , 8 Adjunctive therapy for acute intestinal amebiasis and severe acne ( 1.8) , 9 Prophylaxis of malaria ( 1.9) .</IndicationAndUsage>
<Description>Doxycycline hyclate tablets contain doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral administration. The molecular formula of doxycycline hyclate is (C 22H 24N 2O 8∙ HCl) 2∙ C 2H 6O∙ H 2O and the molecular weight of doxycycline hyclate is 1025.87. The chemical name for doxycycline hyclate is: 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2 naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The structural formula for doxycycline hyclate is. Figure 1: Structure of Doxycycline Hyclate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates.</Description>
</NDC>
<NDC>
<NDCCode>55289-696-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (55289-696-60) </PackageDescription>
<NDC11Code>55289-0696-60</NDC11Code>
<ProductNDC>55289-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076063</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55700-696-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-696-60) </PackageDescription>
<NDC11Code>55700-0696-60</NDC11Code>
<ProductNDC>55700-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077797</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C20H21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine Hydrochloride Tablets, USP are supplied as 5 mg and 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide; 5 mg tablets also contain FD&C Red #40 and 10 mg tablets contain D&C Yellow #10 and polysorbate.</Description>
</NDC>
<NDC>
<NDCCode>60760-696-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-696-60)</PackageDescription>
<NDC11Code>60760-0696-60</NDC11Code>
<ProductNDC>60760-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nabumetone</ProprietaryName>
<NonProprietaryName>Nabumetone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078671</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>NABUMETONE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63187-696-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (63187-696-60) </PackageDescription>
<NDC11Code>63187-0696-60</NDC11Code>
<ProductNDC>63187-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076343</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablets USP is an antiepileptic (AED) agent indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1), 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2).</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets USP are available as 25mg, 50 mg and 100 mg circular tablets and 200 mg capsule shaped tablets for oral administration. Topiramate USP is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5Di-O-isopropylidene-ß-D-fructopyranose sulfamate and has the following structural formula:. Each tablet, for oral administration, contains 25 mg, 50 mg, 100 mg and 200 mg topiramate and has the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate and titanium dioxide. In addition, the 25 mg also contains FD&C Blue #2; the 50 mg and 100 mg also contain red iron oxide and yellow iron oxide; and the 200 mg also contains red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>64896-696-13</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64896-696-13) </PackageDescription>
<NDC11Code>64896-0696-13</NDC11Code>
<ProductNDC>64896-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079087</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Usage: 1 Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Oxymorphone Hydrochloride Extended-Release Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Oxymorphone Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Oxymorphone Hydrochloride Extended-Release Tablets, USP are for oral use and contain oxymorphone, an opioid agonist. Oxymorphone Hydrochloride Extended-Release Tablets, USP are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per tablet. The tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hypromellose, xanthan gum, magnesium stearate, polyvinyl alcohol - partially hydrolyzed, polyethylene glycol, talc, and titanium dioxide. The 5 mg, 7.5 mg, 10 mg, 20 mg and 40 mg tablets contain FD&C Yellow No. 6 Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue No. 2 and D&C Red No. 27. The 7.5 mg tablets contain FD&C Blue No. 2 and FD&C Red No. 40. The 10 mg tablets contain FD&C Red No. 40. The 20 mg tablets contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1, and FD&C Blue No. 2. The 30 mg tablets contain Iron Oxide Yellow and Iron Oxide Black. The 40 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The chemical name of oxymorphone hydrochloride is 4,5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride. Oxymorphone hydrochloride, USP is a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The pKa1 and pKa2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>71205-696-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71205-696-60) </PackageDescription>
<NDC11Code>71205-0696-60</NDC11Code>
<ProductNDC>71205-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208677</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S )-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-696-53</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71610-696-53) </PackageDescription>
<NDC11Code>71610-0696-53</NDC11Code>
<ProductNDC>71610-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074112</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults. , 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
<Description>Alprazolam, USP is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, USP, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam, USP. Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mg also contains FD&C Yellow #6 Aluminum Lake, and the 1 mg also contains FD&C Blue #2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>71610-696-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71610-696-60) </PackageDescription>
<NDC11Code>71610-0696-60</NDC11Code>
<ProductNDC>71610-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074112</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults. , 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
<Description>Alprazolam, USP is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, USP, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam, USP. Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mg also contains FD&C Yellow #6 Aluminum Lake, and the 1 mg also contains FD&C Blue #2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>72319-696-60</NDCCode>
<PackageDescription>60 APPLICATOR in 1 JAR (72319-696-60) / 1 mL in 1 APPLICATOR</PackageDescription>
<NDC11Code>72319-0696-60</NDC11Code>
<ProductNDC>72319-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate Topical</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250616</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065513</ApplicationNumber>
<LabelerName>i3 Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin Phosphate Topical Solution is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS, WARNINGSand ADVERSE REACTIONS.).</IndicationAndUsage>
<Description>Clindamycin Phosphate Topical Solution contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Each Clindamycin Phosphate Topical Solution pledget applicator contains approximately 1 mL of topical solution. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The solution contains isopropyl alcohol 50% v/v, propylene glycol, sodium hydroxide (to adjust the pH to between 4.0 – 7.0) and purified water. The structural formula is represented below. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-α-D- galacto-octopyranoside 2-(dihydrogen phosphate).</Description>
</NDC>
<NDC>
<NDCCode>76420-696-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (76420-696-60) </PackageDescription>
<NDC11Code>76420-0696-60</NDC11Code>
<ProductNDC>76420-696</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210526</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214548</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a, d] cycloheptene-Δ 5, γ-propylamine hydrochloride. It has the following structural formula:. C 20H 23N.HCl. M.W. 313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included. 10 mg-D&C Red #27 Phloxine Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;. 50 mg-D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake and FD&C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&C Yellow #10 Aluminum Lake and D&C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>45865-101-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (45865-101-60) </PackageDescription>
<NDC11Code>45865-0101-60</NDC11Code>
<ProductNDC>45865-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203536</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1) , 2 Treatment of heart failure (NYHA class II-IV); valsartan tablets significantly reduced hospitalization for heart failure ( 1.2) , 3 Post-myocardial infarction; for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction ( 1.3) .</IndicationAndUsage>
<Description>Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)- N-[[2′-(1 H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24H 29N 5O 3, its molecular weight is 435.52, and its structural formula is. Valsartan USP is a white to off white hygroscopic powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg and 320 mg of valsartan USP. The inactive ingredients of the tablets are anhydrous lactose, crospovidone, dental-type silica, ferric oxide red (80 mg only), ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>45865-102-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (45865-102-60) </PackageDescription>
<NDC11Code>45865-0102-60</NDC11Code>
<ProductNDC>45865-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205563</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole Magnesium Delayed-release Capsules is a proton pump inhibitor indicated for the following: 1 Treatment of gastroesophageal reflux disease (GERD). ( 1.1) , 2 Risk reduction of NSAID-associated gastric ulcer. ( 1.2) , 3 H. pylori eradication to reduce the risk of duodenal ulcer recurrence. ( 1.3) , 4 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome. ( 1.4) .</IndicationAndUsage>
<Description>The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole-1-yl) magnesium dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17H 18N 3O 3S) 2Mg x 2 H 2O with molecular weight of 749.2 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is:. Figure 1. The magnesium salt is a white to slightly colored crystalline powder. It contains 2 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole Magnesium Delayed-release Capsules is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 21.7 mg, or 43.4 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets with the following inactive ingredients: diglycerin, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, monoglycerides, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, sodium lauryl sulfate, and titanium dioxide. In addition, the 20 mg capsule shell contains FD & C Red #40 and the 40 mg capsule shell contains FD&C Red #3. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. The 20 mg ink also contains titanium dioxide. The 40 mg ink may also contain n-butyl alcohol. Esomeprazole Magnesium Delayed-release Capsules meet USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>45865-111-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (45865-111-60) </PackageDescription>
<NDC11Code>45865-0111-60</NDC11Code>
<ProductNDC>45865-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nabumetone</ProprietaryName>
<NonProprietaryName>Nabumetone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078420</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>NABUMETONE</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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of nabumetone tablets, USP and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Nabumetone tablets, USP are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.</IndicationAndUsage>
<Description>Nabumetone, USP is a naphthylalkanone designated chemically as 4-(6-methoxy-2- naphthalenyl)-2-butanone. It has the following structure. Nabumetone, USP is a white or almost white crystalline substance with a molecular weight of 228.3. It is nonacidic, freely soluble in acetone, sparingly soluble in alcohol and in methanol, practically insoluble in water. It has an n-octanol:phosphate buffer partition coefficient of 2400 at pH 7.4. Each tablet, for oral administration contains either 500 mg or 750 mg of nabumetone, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>45865-114-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (45865-114-60) </PackageDescription>
<NDC11Code>45865-0114-60</NDC11Code>
<ProductNDC>45865-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091367</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)- N-[[2'-(1 H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24H 29N 5O 3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red.</Description>
</NDC>
<NDC>
<NDCCode>45865-115-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (45865-115-60) </PackageDescription>
<NDC11Code>45865-0115-60</NDC11Code>
<ProductNDC>45865-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075964</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated. , 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia. .</IndicationAndUsage>
<Description>Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadolhydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>45865-117-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (45865-117-60) </PackageDescription>
<NDC11Code>45865-0117-60</NDC11Code>
<ProductNDC>45865-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090796</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>600</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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45865-120-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (45865-120-60) </PackageDescription>
<NDC11Code>45865-0120-60</NDC11Code>
<ProductNDC>45865-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075964</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated. , 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia. .</IndicationAndUsage>
<Description>Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadolhydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>45865-122-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (45865-122-60) </PackageDescription>
<NDC11Code>45865-0122-60</NDC11Code>
<ProductNDC>45865-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203244</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin tablets are indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin and copovidone, hydroxyl propyl cellulose, magnesium stearate, mannitol, poloxamer, talc, low-substituted hydroxypropyl cellulose and opadry II (white). Opadry II (white) contains polyvinyl alcohol, polyethylene glycol, titanium dioxide, and talc.</Description>
</NDC>
<NDC>
<NDCCode>45865-123-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-123-60) </PackageDescription>
<NDC11Code>45865-0123-60</NDC11Code>
<ProductNDC>45865-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rabeprazole Sodium</ProprietaryName>
<NonProprietaryName>Rabeprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208644</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>RABEPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rabeprazole sodium delayed-release tablets is a proton pump inhibitor (PPI) indicated in adults for:. · Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) ( 1.1). · Maintenance of Healing of Erosive or Ulcerative GERD ( 1.2). · Treatment of Symptomatic GERD ( 1.3). · Healing of Duodenal Ulcers ( 1.4). · Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence ( 1.5). · Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome ( 1.6). In adolescent patients 12 years of age and older for:. · Short-term Treatment of Symptomatic GERD ( 1.7).</IndicationAndUsage>
<Description>The active ingredient in rabeprazole sodium delayed-release tablets is rabeprazole sodium, which is a proton pump inhibitor. It is a substituted benzimidazole known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1 H–benzimidazole sodium salt. It has an empirical formula of C 18H 20N 3NaO 3S and a molecular weight of 381.42. Rabeprazole sodium is a white to slightly yellowish-white solid. It is very soluble in water and methanol, freely soluble in ethanol, chloroform, and ethyl acetate and insoluble in ether and n-hexane. The stability of rabeprazole sodium is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions. The structural figure is:. Rabeprazole sodium delayed-release tablets is available for oral administration as Delayed-Release, enteric-coated tablets containing 20 mg of rabeprazole sodium. Inactive ingredients of the 20 mg tablet are Mannitol, Crospovidone, Magnesium Oxide Light, Hydroxy Propyl Cellulose, Sodium Stearyl Fumarate, Magnesium Stearate, Ethyl Cellulose, Hypromellose phthalate, Carnauba Wax, Diacetylated Monoglyceride. The coating material contains Polyvinyl Alcohol, Talc, Titanium Dioxide, Macrogol, Lecithin and Iron Oxide Yellow. The printing ink contains Shellac, Ferrosoferric Oxide, Propylene Glycol and Ammonium Hydroxide 28%.</Description>
</NDC>
<NDC>
<NDCCode>45865-130-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-130-60) </PackageDescription>
<NDC11Code>45865-0130-60</NDC11Code>
<ProductNDC>45865-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202882</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole Sodium Delayed-Release Tablets are indicated for:.</IndicationAndUsage>
<Description>The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP, a PPI, is a substituted benzimidazole, 5-(Difluoromethoxy) -2- [[(3,4-dimethoxy-2- pyridyl)methyl] sulfinyl]benzimidazole, sodium salt, sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S . 1.5 H 2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium sesquihydrate, USP is a white to off-white powder. Pantoprazole sodium sesquihydrate, USP is freely soluble in water, in methanol, in dehydrated alcohol, practically insoluble in hexane and dichloromethane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole Sodium is supplied as a Delayed-Release Tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet, USP contains 45.11 mg or 22.55 mg of pantoprazole sodium sesquihydrate, USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, ferric oxide yellow, hydroxy propyl cellulose, hypromellose, lactose monohydrate, methacrylic acid copolymer, polysorbate 80, propylene glycol, sodium carbonate anhydrous, sodium lauryl sulfate, titanium dioxide and triethyl citrate. The tablets are imprinted with opacode black containing ammonium hydroxide, iron oxide black, propylene glycol and shellac. Pantoprazole Sodium Delayed-Release Tablets, (40 mg and 20 mg) complies with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>45865-161-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (45865-161-60) </PackageDescription>
<NDC11Code>45865-0161-60</NDC11Code>
<ProductNDC>45865-161</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metaxalone</ProprietaryName>
<NonProprietaryName>Metaxalone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180924</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208774</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>METAXALONE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Metaxalone tablets, USP are available as an 800 mg oval, scored pink tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C 12H 15NO 3, which corresponds to a molecular weight of 221.25. The structural formula is:. Metaxalone is a white crystalline powder, soluble in chloroform, acetonitrile and methanol, but insoluble in water. Each tablet contains 800 mg metaxalone and the following inactive ingredients: anhydrous citric acid, FD&C Red # 40, sodium alginate and magnesium stearate. USP Dissolution Test Pending.</Description>
</NDC>
</NDCList>