{
"NDC": [
{
"NDCCode": "37205-825-75",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (37205-825-75) > 90 TABLET in 1 BOTTLE",
"NDC11Code": "37205-0825-75",
"ProductNDC": "37205-825",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader All Day Allergy",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078336",
"LabelerName": "Cardinal Health",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "37205-213-75",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (37205-213-75) ",
"NDC11Code": "37205-0213-75",
"ProductNDC": "37205-213",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Fiber",
"NonProprietaryName": "Calcium Polycarbophil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190819",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Cardinal Health",
"SubstanceName": "CALCIUM POLYCARBOPHIL",
"StrengthNumber": "625",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190819",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 constipation, 2 helps restore & maintain regularity, 3 promotes normal function of the bowel."
},
{
"NDCCode": "37205-346-75",
"PackageDescription": "90 TABLET in 1 BOTTLE (37205-346-75)",
"NDC11Code": "37205-0346-75",
"ProductNDC": "37205-346",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076134",
"LabelerName": "Cardinal Health",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "37205-820-75",
"PackageDescription": "90 TABLET in 1 BOTTLE (37205-820-75)",
"NDC11Code": "37205-0820-75",
"ProductNDC": "37205-820",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader All Day Allergy",
"NonProprietaryName": "Cetirizine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077498",
"LabelerName": "Cardinal Health",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "37205-825-65",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (37205-825-65) > 30 TABLET in 1 BOTTLE",
"NDC11Code": "37205-0825-65",
"ProductNDC": "37205-825",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader All Day Allergy",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078336",
"LabelerName": "Cardinal Health",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "37205-825-70",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (37205-825-70) > 45 TABLET in 1 BOTTLE",
"NDC11Code": "37205-0825-70",
"ProductNDC": "37205-825",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader All Day Allergy",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078336",
"LabelerName": "Cardinal Health",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "37205-825-74",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (37205-825-74) > 14 TABLET in 1 BLISTER PACK",
"NDC11Code": "37205-0825-74",
"ProductNDC": "37205-825",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader All Day Allergy",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078336",
"LabelerName": "Cardinal Health",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "10135-825-75",
"PackageDescription": "15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-825-75) ",
"NDC11Code": "10135-0825-75",
"ProductNDC": "10135-825",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201272",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 anic Disorder (PD) [see Clinical Studies (14.4)] .",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres, colloidal silicon dioxide, ethylcellulose, hypromellose, triethyl citrate, talc, polyethylene glycol, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the capsule of the 37.5 mg strength contains iron oxide yellow, iron oxide red and iron oxide black; the capsule of the 75 mg strength contains iron oxide yellow and iron oxide red; the capsule of the 150 mg strength contains D&C Yellow #10, FD&C Blue #1, and FD&C Red #40. The imprinting ink for all strengths’ capsules contains shellac, iron oxide black, propylene glycol, ammonia solution, and potassium hydroxide. Venlafaxine hydrochloride extended-release capsules, USP meets USP Dissolution Test 3."
},
{
"NDCCode": "71423-825-01",
"PackageDescription": "75 mL in 1 TUBE (71423-825-01)",
"NDC11Code": "71423-0825-01",
"ProductNDC": "71423-825",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Therapy",
"NonProprietaryName": "Camphor (synthetic), Menthol, Unspecified Form",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170509",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Hampshire Laboratories Inc",
"SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "31; 13",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-10-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231"
},
{
"NDCCode": "75109-506-09",
"PackageDescription": "12 CANISTER in 1 CARTON (75109-506-09) > 75 NOT APPLICABLE in 1 CANISTER > 258.825 mL in 1 NOT APPLICABLE",
"NDC11Code": "75109-0506-09",
"ProductNDC": "75109-506",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mascon Alcohol Wipes",
"NonProprietaryName": "Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200705",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Kangna (Zhejiang) Medical Supplies Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200705",
"SamplePackage": "N"
},
{
"NDCCode": "75109-513-09",
"PackageDescription": "12 CANISTER in 1 CARTON (75109-513-09) > 75 NOT APPLICABLE in 1 CANISTER > 258.825 mL in 1 NOT APPLICABLE",
"NDC11Code": "75109-0513-09",
"ProductNDC": "75109-513",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcosm Alcohol Wipes",
"NonProprietaryName": "Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200705",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Kangna (Zhejiang) Medical Supplies Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200705",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing to decrease bacteria on skin. Apply topically to skin to help prevent cross contamination. Not recommended for repeated use. Dries in seconds."
},
{
"NDCCode": "37205-531-65",
"PackageDescription": "1 BOTTLE in 1 CARTON (37205-531-65) > 30 TABLET in 1 BOTTLE",
"NDC11Code": "37205-0531-65",
"ProductNDC": "37205-531",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Acid Control",
"ProprietaryNameSuffix": "Acid Reducer",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076760",
"LabelerName": "Cardinal Health",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "37205-531-72",
"PackageDescription": "1 BOTTLE in 1 CARTON (37205-531-72) > 60 TABLET in 1 BOTTLE",
"NDC11Code": "37205-0531-72",
"ProductNDC": "37205-531",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Acid Control",
"ProprietaryNameSuffix": "Acid Reducer",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076760",
"LabelerName": "Cardinal Health",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "37205-724-30",
"PackageDescription": "177 mL in 1 CAN (37205-724-30) ",
"NDC11Code": "37205-0724-30",
"ProductNDC": "37205-724",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader",
"ProprietaryNameSuffix": "Kids Spf 90",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120115",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Cardinal Health",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "27.75; 138.75; 46.25; 92.5; 55.5",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-11-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20120115",
"SamplePackage": "N"
},
{
"NDCCode": "0480-0951-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0480-0951-01) ",
"NDC11Code": "00480-0951-01",
"ProductNDC": "0480-0951",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075416",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221101",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen sodium extended-release tablets are indicated for the treatment of: 1 rheumatoid arthritis (RA), 2 osteoarthritis (OA), 3 ankylosing spondylitis (AS), 4 tendinitis, bursitis, 5 acute gout, 6 primary dysmenorrhea (PD), 7 the relief of mild to moderate pain.",
"Description": "Naproxen sodium extended-release tablets are a nonsteroidal anti-inflammatory drug, available as extended-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium, USP is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. Naproxen sodium extended-release tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, USP equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each naproxen sodium extended-release tablet also contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, ethyl acrylate/methyl methacrylate copolymer, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, and propylene glycol. The tablet coating contains hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide."
},
{
"NDCCode": "0480-0952-58",
"PackageDescription": "75 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0480-0952-58) ",
"NDC11Code": "00480-0952-58",
"ProductNDC": "0480-0952",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075416",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221101",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen sodium extended-release tablets are indicated for the treatment of: 1 rheumatoid arthritis (RA), 2 osteoarthritis (OA), 3 ankylosing spondylitis (AS), 4 tendinitis, bursitis, 5 acute gout, 6 primary dysmenorrhea (PD), 7 the relief of mild to moderate pain.",
"Description": "Naproxen sodium extended-release tablets are a nonsteroidal anti-inflammatory drug, available as extended-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium, USP is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. Naproxen sodium extended-release tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, USP equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each naproxen sodium extended-release tablet also contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, ethyl acrylate/methyl methacrylate copolymer, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, and propylene glycol. The tablet coating contains hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide."
},
{
"NDCCode": "0480-0953-56",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0480-0953-56) ",
"NDC11Code": "00480-0953-56",
"ProductNDC": "0480-0953",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075416",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221101",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen sodium extended-release tablets are indicated for the treatment of: 1 rheumatoid arthritis (RA), 2 osteoarthritis (OA), 3 ankylosing spondylitis (AS), 4 tendinitis, bursitis, 5 acute gout, 6 primary dysmenorrhea (PD), 7 the relief of mild to moderate pain.",
"Description": "Naproxen sodium extended-release tablets are a nonsteroidal anti-inflammatory drug, available as extended-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium, USP is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. Naproxen sodium extended-release tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, USP equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each naproxen sodium extended-release tablet also contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, ethyl acrylate/methyl methacrylate copolymer, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, and propylene glycol. The tablet coating contains hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide."
},
{
"NDCCode": "10135-825-10",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-825-10) ",
"NDC11Code": "10135-0825-10",
"ProductNDC": "10135-825",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201272",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 anic Disorder (PD) [see Clinical Studies (14.4)] .",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres, colloidal silicon dioxide, ethylcellulose, hypromellose, triethyl citrate, talc, polyethylene glycol, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the capsule of the 37.5 mg strength contains iron oxide yellow, iron oxide red and iron oxide black; the capsule of the 75 mg strength contains iron oxide yellow and iron oxide red; the capsule of the 150 mg strength contains D&C Yellow #10, FD&C Blue #1, and FD&C Red #40. The imprinting ink for all strengths’ capsules contains shellac, iron oxide black, propylene glycol, ammonia solution, and potassium hydroxide. Venlafaxine hydrochloride extended-release capsules, USP meets USP Dissolution Test 3."
},
{
"NDCCode": "10135-825-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-825-30) ",
"NDC11Code": "10135-0825-30",
"ProductNDC": "10135-825",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201272",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 anic Disorder (PD) [see Clinical Studies (14.4)] .",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres, colloidal silicon dioxide, ethylcellulose, hypromellose, triethyl citrate, talc, polyethylene glycol, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the capsule of the 37.5 mg strength contains iron oxide yellow, iron oxide red and iron oxide black; the capsule of the 75 mg strength contains iron oxide yellow and iron oxide red; the capsule of the 150 mg strength contains D&C Yellow #10, FD&C Blue #1, and FD&C Red #40. The imprinting ink for all strengths’ capsules contains shellac, iron oxide black, propylene glycol, ammonia solution, and potassium hydroxide. Venlafaxine hydrochloride extended-release capsules, USP meets USP Dissolution Test 3."
},
{
"NDCCode": "10135-825-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-825-90) ",
"NDC11Code": "10135-0825-90",
"ProductNDC": "10135-825",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201272",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 anic Disorder (PD) [see Clinical Studies (14.4)] .",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres, colloidal silicon dioxide, ethylcellulose, hypromellose, triethyl citrate, talc, polyethylene glycol, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the capsule of the 37.5 mg strength contains iron oxide yellow, iron oxide red and iron oxide black; the capsule of the 75 mg strength contains iron oxide yellow and iron oxide red; the capsule of the 150 mg strength contains D&C Yellow #10, FD&C Blue #1, and FD&C Red #40. The imprinting ink for all strengths’ capsules contains shellac, iron oxide black, propylene glycol, ammonia solution, and potassium hydroxide. Venlafaxine hydrochloride extended-release capsules, USP meets USP Dissolution Test 3."
},
{
"NDCCode": "16590-242-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16590-242-30)",
"NDC11Code": "16590-0242-30",
"ProductNDC": "16590-242",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naprelan",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20081219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020353",
"LabelerName": "STAT RX USA",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of NAPRELAN® Tablets and other treatment options before deciding to use NAPRELAN® Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). NAPRELAN® Tablets are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis and acute gout. It is also indicated in the relief of mild to moderate pain and the treatment of primary dysmenorrhea.",
"Description": "NAPRELAN®* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN® Tablets use the proprietary IPDAS®** (Intestinal Protective Drug Absorption System) technology. It is a rapidly disintegrating tablet system combining an immediate release component and a sustained release component of microparticles that are widely dispersed, allowing absorption of the active ingredient throughout the gastrointestinal (GI) tract, maintaining blood levels over 24 hours. The chemical name for naproxen sodium is 2-naphthaleneacetic acid, 6-methoxy-a-methyl-sodium salt, (S)- with the following structural formula:. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN® Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen and 37.5, mg 50 mg, and 75 mg sodium respectively. Each NAPRELAN® Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "21695-905-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-905-60)",
"NDC11Code": "21695-0905-60",
"ProductNDC": "21695-905",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naprelan",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19960105",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020353",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of NAPRELAN® Tablets and other treatment options before deciding to use NAPRELAN® Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). NAPRELAN® Tablets are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis and acute gout. It is also indicated in the relief of mild to moderate pain and the treatment of primary dysmenorrhea.",
"Description": "NAPRELAN®* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN® Tablets use the proprietary IPDAS®** (Intestinal Protective Drug Absorption System) technology. It is a rapidly disintegrating tablet system combining an immediate release component and a sustained release component of microparticles that are widely dispersed, allowing absorption of the active ingredient throughout the gastrointestinal (GI) tract, maintaining blood levels over 24 hours. The chemical name for naproxen sodium is 2-naphthaleneacetic acid, 6-methoxy-a-methyl-sodium salt, (S)- with the following structural formula:. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN® Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen and 37.5, mg 50 mg, and 75 mg sodium respectively. Each NAPRELAN® Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "21695-906-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-906-60)",
"NDC11Code": "21695-0906-60",
"ProductNDC": "21695-906",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naprelan",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19960105",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020353",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of NAPRELAN® Tablets and other treatment options before deciding to use NAPRELAN® Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). NAPRELAN® Tablets are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis and acute gout. It is also indicated in the relief of mild to moderate pain and the treatment of primary dysmenorrhea.",
"Description": "NAPRELAN®* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN® Tablets use the proprietary IPDAS®** (Intestinal Protective Drug Absorption System) technology. It is a rapidly disintegrating tablet system combining an immediate release component and a sustained release component of microparticles that are widely dispersed, allowing absorption of the active ingredient throughout the gastrointestinal (GI) tract, maintaining blood levels over 24 hours. The chemical name for naproxen sodium is 2-naphthaleneacetic acid, 6-methoxy-a-methyl-sodium salt, (S)- with the following structural formula:. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN® Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen and 37.5, mg 50 mg, and 75 mg sodium respectively. Each NAPRELAN® Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "24979-249-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-249-01) ",
"NDC11Code": "24979-0249-01",
"ProductNDC": "24979-249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naprelan",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020353",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
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"SamplePackage": "N",
"IndicationAndUsage": "NAPRELAN Tablets are indicated for the treatment of. rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain. [see Warnings and Precautions (5)].",
"Description": "NAPRELAN (naproxen sodium) Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug, available as controlled-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each NAPRELAN Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "24979-250-68",
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"ProductNDC": "24979-250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naprelan",
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"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
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"LabelerName": "Upsher-Smith Laboratories, LLC",
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"IndicationAndUsage": "NAPRELAN Tablets are indicated for the treatment of. rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain. [see Warnings and Precautions (5)].",
"Description": "NAPRELAN (naproxen sodium) Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug, available as controlled-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each NAPRELAN Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naprelan",
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"RouteName": "ORAL",
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"LabelerName": "Upsher-Smith Laboratories, LLC",
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"IndicationAndUsage": "NAPRELAN Tablets are indicated for the treatment of. rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain. [see Warnings and Precautions (5)].",
"Description": "NAPRELAN (naproxen sodium) Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug, available as controlled-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each NAPRELAN Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
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"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
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"LabelerName": "Upsher-Smith Laboratories, LLC",
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"IndicationAndUsage": "Naproxen Sodium Controlled-Release Tablets are indicated for the treatment of: 1 rheumatoid arthritis (RA), 2 osteoarthritis (OA), 3 ankylosing spondylitis (AS), 4 tendinitis, bursitis, 5 acute gout, 6 primary dysmenorrhea (PD), 7 the relief of mild to moderate pain .",
"Description": "Naproxen Sodium Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug, available as controlled-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. Naproxen Sodium Controlled-Release Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each Naproxen Sodium Controlled-Release Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "24979-253-68",
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"NDC11Code": "24979-0253-68",
"ProductNDC": "24979-253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240425",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020353",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240425",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Sodium Controlled-Release Tablets are indicated for the treatment of: 1 rheumatoid arthritis (RA), 2 osteoarthritis (OA), 3 ankylosing spondylitis (AS), 4 tendinitis, bursitis, 5 acute gout, 6 primary dysmenorrhea (PD), 7 the relief of mild to moderate pain .",
"Description": "Naproxen Sodium Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug, available as controlled-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. Naproxen Sodium Controlled-Release Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each Naproxen Sodium Controlled-Release Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "24979-254-06",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-254-06) ",
"NDC11Code": "24979-0254-06",
"ProductNDC": "24979-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240425",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020353",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240425",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Sodium Controlled-Release Tablets are indicated for the treatment of: 1 rheumatoid arthritis (RA), 2 osteoarthritis (OA), 3 ankylosing spondylitis (AS), 4 tendinitis, bursitis, 5 acute gout, 6 primary dysmenorrhea (PD), 7 the relief of mild to moderate pain .",
"Description": "Naproxen Sodium Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug, available as controlled-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. Naproxen Sodium Controlled-Release Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each Naproxen Sodium Controlled-Release Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "43353-825-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (43353-825-30) ",
"NDC11Code": "43353-0825-30",
"ProductNDC": "43353-825",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19861210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071307",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2017-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130308",
"SamplePackage": "N",
"IndicationAndUsage": "Diazepam Tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Diazepam Tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam Tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of Diazepam Tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Diazepam Tablets USP are a benzodiazepine derivative. Chemically, diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, and is insoluble in water. Its structural formula is. C16H13ClN2O M.W. 284.75. Diazepam Tablets USP are available as 2 mg, 5 mg, and 10 mg tablets for oral administration and contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>37205-825-75</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (37205-825-75) > 90 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>37205-0825-75</NDC11Code>
<ProductNDC>37205-825</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader All Day Allergy</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078336</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>37205-213-75</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (37205-213-75) </PackageDescription>
<NDC11Code>37205-0213-75</NDC11Code>
<ProductNDC>37205-213</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Fiber</ProprietaryName>
<NonProprietaryName>Calcium Polycarbophil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190819</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>CALCIUM POLYCARBOPHIL</SubstanceName>
<StrengthNumber>625</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 constipation, 2 helps restore & maintain regularity, 3 promotes normal function of the bowel.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37205-346-75</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (37205-346-75)</PackageDescription>
<NDC11Code>37205-0346-75</NDC11Code>
<ProductNDC>37205-346</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076134</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>37205-820-75</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (37205-820-75)</PackageDescription>
<NDC11Code>37205-0820-75</NDC11Code>
<ProductNDC>37205-820</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader All Day Allergy</ProprietaryName>
<NonProprietaryName>Cetirizine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077498</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37205-825-65</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (37205-825-65) > 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>37205-0825-65</NDC11Code>
<ProductNDC>37205-825</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader All Day Allergy</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078336</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>37205-825-70</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (37205-825-70) > 45 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>37205-0825-70</NDC11Code>
<ProductNDC>37205-825</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader All Day Allergy</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078336</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>37205-825-74</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (37205-825-74) > 14 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>37205-0825-74</NDC11Code>
<ProductNDC>37205-825</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader All Day Allergy</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078336</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>10135-825-75</NDCCode>
<PackageDescription>15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-825-75) </PackageDescription>
<NDC11Code>10135-0825-75</NDC11Code>
<ProductNDC>10135-825</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201272</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 anic Disorder (PD) [see Clinical Studies (14.4)] .</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres, colloidal silicon dioxide, ethylcellulose, hypromellose, triethyl citrate, talc, polyethylene glycol, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the capsule of the 37.5 mg strength contains iron oxide yellow, iron oxide red and iron oxide black; the capsule of the 75 mg strength contains iron oxide yellow and iron oxide red; the capsule of the 150 mg strength contains D&C Yellow #10, FD&C Blue #1, and FD&C Red #40. The imprinting ink for all strengths’ capsules contains shellac, iron oxide black, propylene glycol, ammonia solution, and potassium hydroxide. Venlafaxine hydrochloride extended-release capsules, USP meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>71423-825-01</NDCCode>
<PackageDescription>75 mL in 1 TUBE (71423-825-01)</PackageDescription>
<NDC11Code>71423-0825-01</NDC11Code>
<ProductNDC>71423-825</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Therapy</ProprietaryName>
<NonProprietaryName>Camphor (synthetic), Menthol, Unspecified Form</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170509</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Hampshire Laboratories Inc</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>31; 13</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-10-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>75109-506-09</NDCCode>
<PackageDescription>12 CANISTER in 1 CARTON (75109-506-09) > 75 NOT APPLICABLE in 1 CANISTER > 258.825 mL in 1 NOT APPLICABLE</PackageDescription>
<NDC11Code>75109-0506-09</NDC11Code>
<ProductNDC>75109-506</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mascon Alcohol Wipes</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200705</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Kangna (Zhejiang) Medical Supplies Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75109-513-09</NDCCode>
<PackageDescription>12 CANISTER in 1 CARTON (75109-513-09) > 75 NOT APPLICABLE in 1 CANISTER > 258.825 mL in 1 NOT APPLICABLE</PackageDescription>
<NDC11Code>75109-0513-09</NDC11Code>
<ProductNDC>75109-513</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcosm Alcohol Wipes</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200705</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Kangna (Zhejiang) Medical Supplies Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand sanitizing to decrease bacteria on skin. Apply topically to skin to help prevent cross contamination. Not recommended for repeated use. Dries in seconds.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37205-531-65</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (37205-531-65) > 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>37205-0531-65</NDC11Code>
<ProductNDC>37205-531</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Acid Control</ProprietaryName>
<ProprietaryNameSuffix>Acid Reducer</ProprietaryNameSuffix>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076760</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>37205-531-72</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (37205-531-72) > 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>37205-0531-72</NDC11Code>
<ProductNDC>37205-531</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Acid Control</ProprietaryName>
<ProprietaryNameSuffix>Acid Reducer</ProprietaryNameSuffix>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076760</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>37205-724-30</NDCCode>
<PackageDescription>177 mL in 1 CAN (37205-724-30) </PackageDescription>
<NDC11Code>37205-0724-30</NDC11Code>
<ProductNDC>37205-724</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader</ProprietaryName>
<ProprietaryNameSuffix>Kids Spf 90</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>27.75; 138.75; 46.25; 92.5; 55.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0480-0951-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0480-0951-01) </PackageDescription>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075416</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>375</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen sodium extended-release tablets are indicated for the treatment of: 1 rheumatoid arthritis (RA), 2 osteoarthritis (OA), 3 ankylosing spondylitis (AS), 4 tendinitis, bursitis, 5 acute gout, 6 primary dysmenorrhea (PD), 7 the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Naproxen sodium extended-release tablets are a nonsteroidal anti-inflammatory drug, available as extended-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium, USP is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. Naproxen sodium extended-release tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, USP equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each naproxen sodium extended-release tablet also contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, ethyl acrylate/methyl methacrylate copolymer, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, and propylene glycol. The tablet coating contains hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
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<ApplicationNumber>ANDA075416</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen sodium extended-release tablets are indicated for the treatment of: 1 rheumatoid arthritis (RA), 2 osteoarthritis (OA), 3 ankylosing spondylitis (AS), 4 tendinitis, bursitis, 5 acute gout, 6 primary dysmenorrhea (PD), 7 the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Naproxen sodium extended-release tablets are a nonsteroidal anti-inflammatory drug, available as extended-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium, USP is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. Naproxen sodium extended-release tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, USP equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each naproxen sodium extended-release tablet also contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, ethyl acrylate/methyl methacrylate copolymer, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, and propylene glycol. The tablet coating contains hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide.</Description>
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<NDC>
<NDCCode>0480-0953-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0480-0953-56) </PackageDescription>
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<ProductNDC>0480-0953</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075416</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
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<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen sodium extended-release tablets are indicated for the treatment of: 1 rheumatoid arthritis (RA), 2 osteoarthritis (OA), 3 ankylosing spondylitis (AS), 4 tendinitis, bursitis, 5 acute gout, 6 primary dysmenorrhea (PD), 7 the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Naproxen sodium extended-release tablets are a nonsteroidal anti-inflammatory drug, available as extended-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium, USP is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. Naproxen sodium extended-release tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, USP equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each naproxen sodium extended-release tablet also contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, ethyl acrylate/methyl methacrylate copolymer, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, and propylene glycol. The tablet coating contains hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide.</Description>
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<NDC>
<NDCCode>10135-825-10</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-825-10) </PackageDescription>
<NDC11Code>10135-0825-10</NDC11Code>
<ProductNDC>10135-825</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201272</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 anic Disorder (PD) [see Clinical Studies (14.4)] .</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres, colloidal silicon dioxide, ethylcellulose, hypromellose, triethyl citrate, talc, polyethylene glycol, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the capsule of the 37.5 mg strength contains iron oxide yellow, iron oxide red and iron oxide black; the capsule of the 75 mg strength contains iron oxide yellow and iron oxide red; the capsule of the 150 mg strength contains D&C Yellow #10, FD&C Blue #1, and FD&C Red #40. The imprinting ink for all strengths’ capsules contains shellac, iron oxide black, propylene glycol, ammonia solution, and potassium hydroxide. Venlafaxine hydrochloride extended-release capsules, USP meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>10135-825-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-825-30) </PackageDescription>
<NDC11Code>10135-0825-30</NDC11Code>
<ProductNDC>10135-825</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201272</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 anic Disorder (PD) [see Clinical Studies (14.4)] .</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres, colloidal silicon dioxide, ethylcellulose, hypromellose, triethyl citrate, talc, polyethylene glycol, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the capsule of the 37.5 mg strength contains iron oxide yellow, iron oxide red and iron oxide black; the capsule of the 75 mg strength contains iron oxide yellow and iron oxide red; the capsule of the 150 mg strength contains D&C Yellow #10, FD&C Blue #1, and FD&C Red #40. The imprinting ink for all strengths’ capsules contains shellac, iron oxide black, propylene glycol, ammonia solution, and potassium hydroxide. Venlafaxine hydrochloride extended-release capsules, USP meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>10135-825-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-825-90) </PackageDescription>
<NDC11Code>10135-0825-90</NDC11Code>
<ProductNDC>10135-825</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201272</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 anic Disorder (PD) [see Clinical Studies (14.4)] .</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres, colloidal silicon dioxide, ethylcellulose, hypromellose, triethyl citrate, talc, polyethylene glycol, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the capsule of the 37.5 mg strength contains iron oxide yellow, iron oxide red and iron oxide black; the capsule of the 75 mg strength contains iron oxide yellow and iron oxide red; the capsule of the 150 mg strength contains D&C Yellow #10, FD&C Blue #1, and FD&C Red #40. The imprinting ink for all strengths’ capsules contains shellac, iron oxide black, propylene glycol, ammonia solution, and potassium hydroxide. Venlafaxine hydrochloride extended-release capsules, USP meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>16590-242-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16590-242-30)</PackageDescription>
<NDC11Code>16590-0242-30</NDC11Code>
<ProductNDC>16590-242</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naprelan</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020353</ApplicationNumber>
<LabelerName>STAT RX USA</LabelerName>
<SubstanceName>NAPROXEN SODIUM</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>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of NAPRELAN® Tablets and other treatment options before deciding to use NAPRELAN® Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). NAPRELAN® Tablets are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis and acute gout. It is also indicated in the relief of mild to moderate pain and the treatment of primary dysmenorrhea.</IndicationAndUsage>
<Description>NAPRELAN®* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN® Tablets use the proprietary IPDAS®** (Intestinal Protective Drug Absorption System) technology. It is a rapidly disintegrating tablet system combining an immediate release component and a sustained release component of microparticles that are widely dispersed, allowing absorption of the active ingredient throughout the gastrointestinal (GI) tract, maintaining blood levels over 24 hours. The chemical name for naproxen sodium is 2-naphthaleneacetic acid, 6-methoxy-a-methyl-sodium salt, (S)- with the following structural formula:. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN® Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen and 37.5, mg 50 mg, and 75 mg sodium respectively. Each NAPRELAN® Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-905-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-905-60)</PackageDescription>
<NDC11Code>21695-0905-60</NDC11Code>
<ProductNDC>21695-905</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naprelan</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960105</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020353</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>375</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>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of NAPRELAN® Tablets and other treatment options before deciding to use NAPRELAN® Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). NAPRELAN® Tablets are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis and acute gout. It is also indicated in the relief of mild to moderate pain and the treatment of primary dysmenorrhea.</IndicationAndUsage>
<Description>NAPRELAN®* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN® Tablets use the proprietary IPDAS®** (Intestinal Protective Drug Absorption System) technology. It is a rapidly disintegrating tablet system combining an immediate release component and a sustained release component of microparticles that are widely dispersed, allowing absorption of the active ingredient throughout the gastrointestinal (GI) tract, maintaining blood levels over 24 hours. The chemical name for naproxen sodium is 2-naphthaleneacetic acid, 6-methoxy-a-methyl-sodium salt, (S)- with the following structural formula:. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN® Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen and 37.5, mg 50 mg, and 75 mg sodium respectively. Each NAPRELAN® Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-906-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-906-60)</PackageDescription>
<NDC11Code>21695-0906-60</NDC11Code>
<ProductNDC>21695-906</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naprelan</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960105</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020353</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>500</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>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of NAPRELAN® Tablets and other treatment options before deciding to use NAPRELAN® Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). NAPRELAN® Tablets are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis and acute gout. It is also indicated in the relief of mild to moderate pain and the treatment of primary dysmenorrhea.</IndicationAndUsage>
<Description>NAPRELAN®* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN® Tablets use the proprietary IPDAS®** (Intestinal Protective Drug Absorption System) technology. It is a rapidly disintegrating tablet system combining an immediate release component and a sustained release component of microparticles that are widely dispersed, allowing absorption of the active ingredient throughout the gastrointestinal (GI) tract, maintaining blood levels over 24 hours. The chemical name for naproxen sodium is 2-naphthaleneacetic acid, 6-methoxy-a-methyl-sodium salt, (S)- with the following structural formula:. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN® Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen and 37.5, mg 50 mg, and 75 mg sodium respectively. Each NAPRELAN® Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.</Description>
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<IndicationAndUsage>NAPRELAN Tablets are indicated for the treatment of. rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain. [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>NAPRELAN (naproxen sodium) Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug, available as controlled-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each NAPRELAN Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.</Description>
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<IndicationAndUsage>NAPRELAN Tablets are indicated for the treatment of. rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain. [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>NAPRELAN (naproxen sodium) Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug, available as controlled-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each NAPRELAN Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.</Description>
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<IndicationAndUsage>NAPRELAN Tablets are indicated for the treatment of. rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain. [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>NAPRELAN (naproxen sodium) Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug, available as controlled-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each NAPRELAN Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.</Description>
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<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
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<IndicationAndUsage>Naproxen Sodium Controlled-Release Tablets are indicated for the treatment of: 1 rheumatoid arthritis (RA), 2 osteoarthritis (OA), 3 ankylosing spondylitis (AS), 4 tendinitis, bursitis, 5 acute gout, 6 primary dysmenorrhea (PD), 7 the relief of mild to moderate pain .</IndicationAndUsage>
<Description>Naproxen Sodium Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug, available as controlled-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. Naproxen Sodium Controlled-Release Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each Naproxen Sodium Controlled-Release Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.</Description>
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<IndicationAndUsage>Naproxen Sodium Controlled-Release Tablets are indicated for the treatment of: 1 rheumatoid arthritis (RA), 2 osteoarthritis (OA), 3 ankylosing spondylitis (AS), 4 tendinitis, bursitis, 5 acute gout, 6 primary dysmenorrhea (PD), 7 the relief of mild to moderate pain .</IndicationAndUsage>
<Description>Naproxen Sodium Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug, available as controlled-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. Naproxen Sodium Controlled-Release Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each Naproxen Sodium Controlled-Release Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.</Description>
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<IndicationAndUsage>Naproxen Sodium Controlled-Release Tablets are indicated for the treatment of: 1 rheumatoid arthritis (RA), 2 osteoarthritis (OA), 3 ankylosing spondylitis (AS), 4 tendinitis, bursitis, 5 acute gout, 6 primary dysmenorrhea (PD), 7 the relief of mild to moderate pain .</IndicationAndUsage>
<Description>Naproxen Sodium Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug, available as controlled-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. Naproxen Sodium Controlled-Release Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each Naproxen Sodium Controlled-Release Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.</Description>
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<NDC>
<NDCCode>43353-825-30</NDCCode>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>19861210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071307</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2017-12-13</LastUpdate>
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<IndicationAndUsage>Diazepam Tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Diazepam Tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam Tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of Diazepam Tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Diazepam Tablets USP are a benzodiazepine derivative. Chemically, diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, and is insoluble in water. Its structural formula is. C16H13ClN2O M.W. 284.75. Diazepam Tablets USP are available as 2 mg, 5 mg, and 10 mg tablets for oral administration and contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate.</Description>
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