{
"NDC": [
{
"NDCCode": "31722-583-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-583-30) ",
"NDC11Code": "31722-0583-30",
"ProductNDC": "31722-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204343",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160811",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: Major Depressive Disorder [see Clinical Studies (14.1)] Generalized Anxiety Disorder [see Clinical Studies (14.2)] Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)] Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].",
"Description": "Duloxetine hydrochloride, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (γS)-N-Methyl-γ-(1-napthalenyloxy)-2-thiophenepropanamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.87. The structural formula is:. Duloxetine hydrochloride, USP is an off-white to white colored crystalline powder which is freely soluble in methanol and sparingly soluble in water Each capsule contains film-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. Inactive ingredients include carboxy methyl ethyl cellulose, crospovidone, FD & C Blue 2, gelatin, hypromellose, isopropyl alcohol, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sucrose, sugar spheres, talc and titanium dioxide. In addition, the 20 mg and 60 mg capsules also contain iron oxide yellow. The imprinting ink contains, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, and strong ammonia solution. The 20 mg capsule also contains black iron oxide and potassium hydroxide. The 30 mg capsule also contains yellow iron oxide. The 60 mg capsule also contains potassium hydroxide and titanium dioxide."
},
{
"NDCCode": "31722-583-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-583-01) ",
"NDC11Code": "31722-0583-01",
"ProductNDC": "31722-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204343",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160811",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: Major Depressive Disorder [see Clinical Studies (14.1)] Generalized Anxiety Disorder [see Clinical Studies (14.2)] Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)] Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].",
"Description": "Duloxetine hydrochloride, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (γS)-N-Methyl-γ-(1-napthalenyloxy)-2-thiophenepropanamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.87. The structural formula is:. Duloxetine hydrochloride, USP is an off-white to white colored crystalline powder which is freely soluble in methanol and sparingly soluble in water Each capsule contains film-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. Inactive ingredients include carboxy methyl ethyl cellulose, crospovidone, FD & C Blue 2, gelatin, hypromellose, isopropyl alcohol, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sucrose, sugar spheres, talc and titanium dioxide. In addition, the 20 mg and 60 mg capsules also contain iron oxide yellow. The imprinting ink contains, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, and strong ammonia solution. The 20 mg capsule also contains black iron oxide and potassium hydroxide. The 30 mg capsule also contains yellow iron oxide. The 60 mg capsule also contains potassium hydroxide and titanium dioxide."
},
{
"NDCCode": "31722-583-31",
"PackageDescription": "10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (31722-583-31) ",
"NDC11Code": "31722-0583-31",
"ProductNDC": "31722-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204343",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160811",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: Major Depressive Disorder [see Clinical Studies (14.1)] Generalized Anxiety Disorder [see Clinical Studies (14.2)] Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)] Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].",
"Description": "Duloxetine hydrochloride, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (γS)-N-Methyl-γ-(1-napthalenyloxy)-2-thiophenepropanamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.87. The structural formula is:. Duloxetine hydrochloride, USP is an off-white to white colored crystalline powder which is freely soluble in methanol and sparingly soluble in water Each capsule contains film-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. Inactive ingredients include carboxy methyl ethyl cellulose, crospovidone, FD & C Blue 2, gelatin, hypromellose, isopropyl alcohol, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sucrose, sugar spheres, talc and titanium dioxide. In addition, the 20 mg and 60 mg capsules also contain iron oxide yellow. The imprinting ink contains, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, and strong ammonia solution. The 20 mg capsule also contains black iron oxide and potassium hydroxide. The 30 mg capsule also contains yellow iron oxide. The 60 mg capsule also contains potassium hydroxide and titanium dioxide."
},
{
"NDCCode": "31722-583-32",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 CARTON (31722-583-32) ",
"NDC11Code": "31722-0583-32",
"ProductNDC": "31722-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204343",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160811",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: Major Depressive Disorder [see Clinical Studies (14.1)] Generalized Anxiety Disorder [see Clinical Studies (14.2)] Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)] Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].",
"Description": "Duloxetine hydrochloride, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (γS)-N-Methyl-γ-(1-napthalenyloxy)-2-thiophenepropanamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.87. The structural formula is:. Duloxetine hydrochloride, USP is an off-white to white colored crystalline powder which is freely soluble in methanol and sparingly soluble in water Each capsule contains film-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. Inactive ingredients include carboxy methyl ethyl cellulose, crospovidone, FD & C Blue 2, gelatin, hypromellose, isopropyl alcohol, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sucrose, sugar spheres, talc and titanium dioxide. In addition, the 20 mg and 60 mg capsules also contain iron oxide yellow. The imprinting ink contains, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, and strong ammonia solution. The 20 mg capsule also contains black iron oxide and potassium hydroxide. The 30 mg capsule also contains yellow iron oxide. The 60 mg capsule also contains potassium hydroxide and titanium dioxide."
},
{
"NDCCode": "13811-583-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (13811-583-30)",
"NDC11Code": "13811-0583-30",
"ProductNDC": "13811-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zatean-ch",
"NonProprietaryName": "Calcium Citrate, Iron, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Docusate Sodium, And Doconexent",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TRIGEN Laboratories, Inc.",
"SubstanceName": "CALCIUM CITRATE; IRON; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; DOCUSATE SODIUM; DOCONEXENT",
"StrengthNumber": "100; 27; 400; 30; 25; 1; 50; 250",
"StrengthUnit": "mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-08-15"
},
{
"NDCCode": "16714-583-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16714-583-01)",
"NDC11Code": "16714-0583-01",
"ProductNDC": "16714-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090382",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-05-29"
},
{
"NDCCode": "37808-583-39",
"PackageDescription": "1 BOTTLE in 1 CARTON (37808-583-39) / 30 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "37808-0583-39",
"ProductNDC": "37808-583",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078336",
"LabelerName": "H E B",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180126",
"SamplePackage": "N",
"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": "43353-583-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-583-30)",
"NDC11Code": "43353-0583-30",
"ProductNDC": "43353-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076862",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Metoprolol succinate is a beta1-selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets USP are indicated for the treatment of: : 1 Hypertension (1.1) , 2 Angina Pectoris (1.2) , 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.(1.3).",
"Description": "Metoprolol succinate is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: cellulose acetate butyrate, corn starch, crospovidone, glyceryl monostearate, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, poloxamer 188, polyethylene glycol, polysorbate 80, sucrose, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "43598-583-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (43598-583-30) ",
"NDC11Code": "43598-0583-30",
"ProductNDC": "43598-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe And Simvastatin",
"NonProprietaryName": "Ezetimibe And Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200909",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "EZETIMIBE; SIMVASTATIN",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170426",
"SamplePackage": "N"
},
{
"NDCCode": "43744-583-30",
"PackageDescription": "50 g in 1 DRUM (43744-583-30)",
"NDC11Code": "43744-0583-30",
"ProductNDC": "43744-583",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mepivacaine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130624",
"EndMarketingDate": "20130630",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "MEPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130630"
},
{
"NDCCode": "45865-583-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (45865-583-30) ",
"NDC11Code": "45865-0583-30",
"ProductNDC": "45865-583",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diphenhydramine Hcl",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100127",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "medsource pharmaceuticals",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies. Sneezing. Nasal congestion. Runny nose. Itchy, watery eyes. ."
},
{
"NDCCode": "47335-583-83",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (47335-583-83) ",
"NDC11Code": "47335-0583-83",
"ProductNDC": "47335-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079169",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230623",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor.",
"Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2- [methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white to off-white amorphous powder that is slightly soluble in water, and practically insoluble in ethanol and methanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, talc, titanium dioxide, iron oxide yellow (5 mg), iron oxide red (10 mg, 20 mg, 40 mg), and FD& C Red # 40 aluminum lake (10 mg, 20 mg, 40 mg). Meets USP dissolution test 2."
},
{
"NDCCode": "49349-583-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-583-02)",
"NDC11Code": "49349-0583-02",
"ProductNDC": "49349-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070178",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "51655-583-52",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (51655-583-52) ",
"NDC11Code": "51655-0583-52",
"ProductNDC": "51655-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230330",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021342",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230330",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'- tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous) and structural formula as shown:. Levothyroxine sodium tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients Magnesium Stearate, NF; Microcrystalline Cellulose, NF; Colloidal Silicone Dioxide, NF; and Sodium Starch Glycolate, NF. Each tablet strength meets USP Dissolution Test 2. Table 6provides a listing of the color additives by tablet strength:. Table 6. Levothyroxine Sodium Tablets Color Additives."
},
{
"NDCCode": "52125-583-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (52125-583-02) ",
"NDC11Code": "52125-0583-02",
"ProductNDC": "52125-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide",
"NonProprietaryName": "Glyburide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090937",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "GLYBURIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130311",
"SamplePackage": "N"
},
{
"NDCCode": "55700-583-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (55700-583-30) ",
"NDC11Code": "55700-0583-30",
"ProductNDC": "55700-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eszopiclone",
"NonProprietaryName": "Eszopiclone",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180202",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091024",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "ESZOPICLONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180202",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).",
"Description": "Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its molecular formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure. Eszopiclone is a white to slightly yellowish powder. Eszopiclone is soluble in methylene chloride, practically insoluble in water and alcohol. It dissolves in dilute mineral acids. Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcelac 100 (lactose monohydrate and cellulose, microcrystalline), polyethylene glycol and titanium dioxide. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2 and triacetin."
},
{
"NDCCode": "58411-583-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (58411-583-10) / 30 mL in 1 BOTTLE",
"NDC11Code": "58411-0583-10",
"ProductNDC": "58411-583",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Synchro Skin Radiant Lifting Foundation",
"ProprietaryNameSuffix": "430",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200920",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "2.484; .36",
"StrengthUnit": "g/30mL; g/30mL",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200920",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "60429-583-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60429-583-30) ",
"NDC11Code": "60429-0583-30",
"ProductNDC": "60429-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Tramadol Hydrochloride Extended-release Tablets",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120627",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200491",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2022-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20161020",
"SamplePackage": "N"
},
{
"NDCCode": "60687-583-21",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-583-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-583-11) ",
"NDC11Code": "60687-0583-21",
"ProductNDC": "60687-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211623",
"LabelerName": "American Health Packaging",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220105",
"SamplePackage": "N",
"IndicationAndUsage": "Epilepsy Carbamazepine Extended-Release Tablet is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: : 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by Carbamazepine Extended-Release Tablets (see PRECAUTIONS, General). .",
"Description": "Before prescribing Carbamazepine Extended-Release Tablets, the physician should be thoroughly familiar with the details of this prescribing information, particularly regarding use with other drugs, especially those which accentuate toxicity potential."
},
{
"NDCCode": "61919-583-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (61919-583-30)",
"NDC11Code": "61919-0583-30",
"ProductNDC": "61919-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022370",
"LabelerName": "Direct Rx",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tramadol Hydrochloride Extended-Release is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.",
"Description": "Tramadol Hydrochloride Extended-Release capsules is a centrally acting synthetic analgesic in an extended-release oral formulation. The chemical name for tramadol hydrochloride USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.8. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Extended-Release capsules contain a total dose of tramadol hydrochloride USP 150 mg in a combination of immediate-release and extended-release components. Tramadol Hydrochloride Extended-Release capsules are white in color. Inactive ingredients include gelatin, titanium dioxide, shellac, yellow iron oxide, lactose monohydrate 200 mesh, microcrystalline cellulose, povidone K30, corn starch, sodium starch glycolate, magnesium stearate, sucrose stearate, hypromellose, talc, polysorbate 80, Eudragit NE 30D, and simethicone emulsion."
},
{
"NDCCode": "62135-583-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (62135-583-30) ",
"NDC11Code": "62135-0583-30",
"ProductNDC": "62135-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide",
"NonProprietaryName": "Glyburide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101005",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090937",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "GLYBURIDE",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230509",
"SamplePackage": "N",
"IndicationAndUsage": "Glyburide tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glyburide tablets, USP contain a smaller particle size glyburide, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound, formulated as glyburide tablets, USP of 1.25 mg, 2.5 mg, and 5 mg strengths for oral administration. Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate. In addition, the 2.5 mg contains FD&C Red No.40 and the 5 mg contains FD&C Blue No.1. The chemical name for glyburide is 1-[[p-[2-(5-chloro-o-anisamido)-ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. The structural formula is represented below."
},
{
"NDCCode": "63187-583-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (63187-583-30) ",
"NDC11Code": "63187-0583-30",
"ProductNDC": "63187-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077651",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2022-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Zonisamide capsules USP are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.",
"Description": "Zonisamide USP is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide USP, 1,2 benzisoxazole-3-methanesulfonamide. The empirical formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide USP is a white powder, pKa = 10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HCl (0.50 mg/mL). The chemical structure is:. Zonisamide USP is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide USP. Each capsule contains the labeled amount of zonisamide USP plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, and sodium lauryl sulfate. The printed capsule shell of the different strengths is made from the following ingredients. 25 mg – D&C Red #28, FD&C Blue #1, gelatin and titanium dioxide. 50 mg – D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. 100 mg - D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, gelatin and titanium dioxide. The dyes used in the printing ink are FD&C Blue #1, FD&C Blue #2, FD&C Red #40, D&C Yellow #10 aluminium lake and iron oxide black. Additionally, the printing ink also contains n-butyl alcohol, ethanol, propylene glycol and shellac."
},
{
"NDCCode": "63304-583-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (63304-583-30) ",
"NDC11Code": "63304-0583-30",
"ProductNDC": "63304-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosamprenavir Calcium",
"NonProprietaryName": "Fosamprenavir Calcium",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204024",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "FOSAMPRENAVIR CALCIUM",
"StrengthNumber": "700",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], P-Glycoprotein Inducers [MoA], Protease Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191128",
"SamplePackage": "N",
"IndicationAndUsage": "Fosamprenavir calcium tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. The following points should be considered when initiating therapy with fosamprenavir calcium tablets plus ritonavir in protease inhibitor-experienced patients: 1 The protease inhibitor-experienced patient trial was not large enough to reach a definitive conclusion that fosamprenavir calcium tablets plus ritonavir and lopinavir plus ritonavir are clinically equivalent [see Clinical Studies (14.2)]. , 2 Once-daily administration of fosamprenavir calcium tablets plus ritonavir is not recommended for adult protease inhibitor-experienced patients or any pediatric patients [see Dosage and Administration (2.2,2.3), Clinical Studies (14.2, 14.3)]. , 3 Dosing of fosamprenavir calcium tablets plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients younger than 6 months [see Clinical Pharmacology (12.3)]. .",
"Description": "Fosamprenavir calcium, USP is a prodrug of amprenavir, an inhibitor of HIV protease. The chemical name of fosamprenavir calcium, USP is (3S)-tetrahydrofuran-3-yl (1S,2R)-3-[[(4-aminophenyl) sulfonyl](isobutyl)amino]-1-benzyl-2-(phosphonooxy) propylcarbamate monocalcium salt. Fosamprenavir calcium, USP is a single stereoisomer with the (3S)(1S,2R) configuration. It has a molecular formula of C25H34CaN3O9PS and a molecular weight of 623.7. It has the following structural formula. Fosamprenavir calcium, USP is a white to cream color solid which is soluble in methanol. Fosamprenavir calcium tablets, USP are available for oral administration in a strength of 700 mg of fosamprenavir as fosamprenavir calcium, USP (equivalent to approximately 600 mg of amprenavir). Each 700 mg tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone. The tablet coating contains the inactive ingredients ethylcellulose, ferric oxide red, hypromellose, talc, and titanium dioxide. The imprinting ink contains the inactive ingredients ferric oxide black, propylene glycol, and shellac. Meets USP dissolution test 3."
},
{
"NDCCode": "63868-583-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (63868-583-30) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "63868-0583-30",
"ProductNDC": "63868-583",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077367",
"LabelerName": "Chain Drug Marketing Association INC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
},
{
"NDCCode": "65162-583-03",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (65162-583-03) ",
"NDC11Code": "65162-0583-03",
"ProductNDC": "65162-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160523",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203482",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160523",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam, USP is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is. C16H13ClN2O2 MW = 300.74. Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration. Each capsule for oral administration contains either 7.5 mg, 15 mg, 22.5 mg or 30 mg temazepam, USP. The inactive ingredients include: ammonia, black iron oxide, butyl alcohol, croscarmellose sodium, dehydrated alcohol, gelatin, isopropyl alcohol, lactose monohydrate, magnesium stearate, polyethylene glycol, potassium hydroxide, propylene glycol, shellac, and titanium dioxide. Additionally, the 7.5 mg capsule contains D&C Red #28 and FD&C Blue #1 and the 15 mg and 22.5 mg capsules contain FD&C Blue #1, FD&C Red #40 and FD&C Yellow #6."
},
{
"NDCCode": "65923-583-30",
"PackageDescription": "30 VIAL, SINGLE-USE in 1 BOX (65923-583-30) > .4 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "65923-0583-30",
"ProductNDC": "65923-583",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Family Care Single-use Eye",
"NonProprietaryName": "Carboxymethylcellulose Sodium",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20160328",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "United Exchange Corp.",
"SubstanceName": "CARBOXYMETHYLCELLULOSE SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-11-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "66267-583-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (66267-583-30) ",
"NDC11Code": "66267-0583-30",
"ProductNDC": "66267-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075994",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20161223",
"SamplePackage": "N"
},
{
"NDCCode": "69654-583-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69654-583-30) ",
"NDC11Code": "69654-0583-30",
"ProductNDC": "69654-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metadate Cd",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021259",
"LabelerName": "Aytu BioPharma, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240222",
"SamplePackage": "N",
"IndicationAndUsage": "METADATE CD is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of METADATE CD is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7). Use in Specific Populations ( 8.4)] .",
"Description": "METADATE CD contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. METADATE CD is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration. Chemically, methylphenidate HCl is d, l(racemic)- threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is:. Methylphenidate HCl USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. METADATE CD also contains the following inactive ingredients: Dibutyl sebacate, ethylcellulose aqueous dispersion, gelatin, hydroxypropylmethylcellulose, polyethylene glycol, povidone, sugar spheres, and titanium dioxide. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide. 20 mg capsules: FD&C Blue No. 2. 30 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide. 40 mg capsules: FDA/E172 Yellow Iron Oxide. 50 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide."
},
{
"NDCCode": "70186-583-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (70186-583-01) > 30 mL in 1 BOTTLE",
"NDC11Code": "70186-0583-01",
"ProductNDC": "70186-583",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Magic Foundation Flawless Long-lasting Coverage Sunscreen Broad Spectrum Spf 15",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "SUSPENSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Charlotte Tilbury Beauty Ltd.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "1.83; .287",
"StrengthUnit": "g/30mL; g/30mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N",
"IndicationAndUsage": " Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "70934-583-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (70934-583-30) ",
"NDC11Code": "70934-0583-30",
"ProductNDC": "70934-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078627",
"LabelerName": "Denton Pharma, Inc. dba Northwind Pharmaceuticals",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200225",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>31722-583-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-583-30) </PackageDescription>
<NDC11Code>31722-0583-30</NDC11Code>
<ProductNDC>31722-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204343</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: Major Depressive Disorder [see Clinical Studies (14.1)] Generalized Anxiety Disorder [see Clinical Studies (14.2)] Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)] Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].</IndicationAndUsage>
<Description>Duloxetine hydrochloride, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (γS)-N-Methyl-γ-(1-napthalenyloxy)-2-thiophenepropanamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.87. The structural formula is:. Duloxetine hydrochloride, USP is an off-white to white colored crystalline powder which is freely soluble in methanol and sparingly soluble in water Each capsule contains film-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. Inactive ingredients include carboxy methyl ethyl cellulose, crospovidone, FD & C Blue 2, gelatin, hypromellose, isopropyl alcohol, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sucrose, sugar spheres, talc and titanium dioxide. In addition, the 20 mg and 60 mg capsules also contain iron oxide yellow. The imprinting ink contains, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, and strong ammonia solution. The 20 mg capsule also contains black iron oxide and potassium hydroxide. The 30 mg capsule also contains yellow iron oxide. The 60 mg capsule also contains potassium hydroxide and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-583-01</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-583-01) </PackageDescription>
<NDC11Code>31722-0583-01</NDC11Code>
<ProductNDC>31722-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204343</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: Major Depressive Disorder [see Clinical Studies (14.1)] Generalized Anxiety Disorder [see Clinical Studies (14.2)] Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)] Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].</IndicationAndUsage>
<Description>Duloxetine hydrochloride, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (γS)-N-Methyl-γ-(1-napthalenyloxy)-2-thiophenepropanamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.87. The structural formula is:. Duloxetine hydrochloride, USP is an off-white to white colored crystalline powder which is freely soluble in methanol and sparingly soluble in water Each capsule contains film-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. Inactive ingredients include carboxy methyl ethyl cellulose, crospovidone, FD & C Blue 2, gelatin, hypromellose, isopropyl alcohol, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sucrose, sugar spheres, talc and titanium dioxide. In addition, the 20 mg and 60 mg capsules also contain iron oxide yellow. The imprinting ink contains, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, and strong ammonia solution. The 20 mg capsule also contains black iron oxide and potassium hydroxide. The 30 mg capsule also contains yellow iron oxide. The 60 mg capsule also contains potassium hydroxide and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-583-31</NDCCode>
<PackageDescription>10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (31722-583-31) </PackageDescription>
<NDC11Code>31722-0583-31</NDC11Code>
<ProductNDC>31722-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204343</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: Major Depressive Disorder [see Clinical Studies (14.1)] Generalized Anxiety Disorder [see Clinical Studies (14.2)] Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)] Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].</IndicationAndUsage>
<Description>Duloxetine hydrochloride, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (γS)-N-Methyl-γ-(1-napthalenyloxy)-2-thiophenepropanamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.87. The structural formula is:. Duloxetine hydrochloride, USP is an off-white to white colored crystalline powder which is freely soluble in methanol and sparingly soluble in water Each capsule contains film-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. Inactive ingredients include carboxy methyl ethyl cellulose, crospovidone, FD & C Blue 2, gelatin, hypromellose, isopropyl alcohol, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sucrose, sugar spheres, talc and titanium dioxide. In addition, the 20 mg and 60 mg capsules also contain iron oxide yellow. The imprinting ink contains, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, and strong ammonia solution. The 20 mg capsule also contains black iron oxide and potassium hydroxide. The 30 mg capsule also contains yellow iron oxide. The 60 mg capsule also contains potassium hydroxide and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-583-32</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 CARTON (31722-583-32) </PackageDescription>
<NDC11Code>31722-0583-32</NDC11Code>
<ProductNDC>31722-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204343</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: Major Depressive Disorder [see Clinical Studies (14.1)] Generalized Anxiety Disorder [see Clinical Studies (14.2)] Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)] Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].</IndicationAndUsage>
<Description>Duloxetine hydrochloride, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (γS)-N-Methyl-γ-(1-napthalenyloxy)-2-thiophenepropanamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.87. The structural formula is:. Duloxetine hydrochloride, USP is an off-white to white colored crystalline powder which is freely soluble in methanol and sparingly soluble in water Each capsule contains film-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. Inactive ingredients include carboxy methyl ethyl cellulose, crospovidone, FD & C Blue 2, gelatin, hypromellose, isopropyl alcohol, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sucrose, sugar spheres, talc and titanium dioxide. In addition, the 20 mg and 60 mg capsules also contain iron oxide yellow. The imprinting ink contains, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, and strong ammonia solution. The 20 mg capsule also contains black iron oxide and potassium hydroxide. The 30 mg capsule also contains yellow iron oxide. The 60 mg capsule also contains potassium hydroxide and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>13811-583-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (13811-583-30)</PackageDescription>
<NDC11Code>13811-0583-30</NDC11Code>
<ProductNDC>13811-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zatean-ch</ProprietaryName>
<NonProprietaryName>Calcium Citrate, Iron, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Docusate Sodium, And Doconexent</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>TRIGEN Laboratories, Inc.</LabelerName>
<SubstanceName>CALCIUM CITRATE; IRON; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; DOCUSATE SODIUM; DOCONEXENT</SubstanceName>
<StrengthNumber>100; 27; 400; 30; 25; 1; 50; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>16714-583-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16714-583-01)</PackageDescription>
<NDC11Code>16714-0583-01</NDC11Code>
<ProductNDC>16714-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090382</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>37808-583-39</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (37808-583-39) / 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>37808-0583-39</NDC11Code>
<ProductNDC>37808-583</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078336</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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>43353-583-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-583-30)</PackageDescription>
<NDC11Code>43353-0583-30</NDC11Code>
<ProductNDC>43353-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076862</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metoprolol succinate is a beta1-selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets USP are indicated for the treatment of: : 1 Hypertension (1.1) , 2 Angina Pectoris (1.2) , 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.(1.3).</IndicationAndUsage>
<Description>Metoprolol succinate is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: cellulose acetate butyrate, corn starch, crospovidone, glyceryl monostearate, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, poloxamer 188, polyethylene glycol, polysorbate 80, sucrose, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-583-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43598-583-30) </PackageDescription>
<NDC11Code>43598-0583-30</NDC11Code>
<ProductNDC>43598-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
<NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200909</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43744-583-30</NDCCode>
<PackageDescription>50 g in 1 DRUM (43744-583-30)</PackageDescription>
<NDC11Code>43744-0583-30</NDC11Code>
<ProductNDC>43744-583</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mepivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130624</StartMarketingDate>
<EndMarketingDate>20130630</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>MEPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130630</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>45865-583-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (45865-583-30) </PackageDescription>
<NDC11Code>45865-0583-30</NDC11Code>
<ProductNDC>45865-583</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diphenhydramine Hcl</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100127</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>medsource pharmaceuticals</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies. Sneezing. Nasal congestion. Runny nose. Itchy, watery eyes. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47335-583-83</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (47335-583-83) </PackageDescription>
<NDC11Code>47335-0583-83</NDC11Code>
<ProductNDC>47335-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079169</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor.</IndicationAndUsage>
<Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2- [methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white to off-white amorphous powder that is slightly soluble in water, and practically insoluble in ethanol and methanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, talc, titanium dioxide, iron oxide yellow (5 mg), iron oxide red (10 mg, 20 mg, 40 mg), and FD& C Red # 40 aluminum lake (10 mg, 20 mg, 40 mg). Meets USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>49349-583-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (49349-583-02)</PackageDescription>
<NDC11Code>49349-0583-02</NDC11Code>
<ProductNDC>49349-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070178</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>51655-583-52</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (51655-583-52) </PackageDescription>
<NDC11Code>51655-0583-52</NDC11Code>
<ProductNDC>51655-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230330</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021342</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'- tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous) and structural formula as shown:. Levothyroxine sodium tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients Magnesium Stearate, NF; Microcrystalline Cellulose, NF; Colloidal Silicone Dioxide, NF; and Sodium Starch Glycolate, NF. Each tablet strength meets USP Dissolution Test 2. Table 6provides a listing of the color additives by tablet strength:. Table 6. Levothyroxine Sodium Tablets Color Additives.</Description>
</NDC>
<NDC>
<NDCCode>52125-583-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (52125-583-02) </PackageDescription>
<NDC11Code>52125-0583-02</NDC11Code>
<ProductNDC>52125-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide</ProprietaryName>
<NonProprietaryName>Glyburide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090937</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>GLYBURIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55700-583-30</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (55700-583-30) </PackageDescription>
<NDC11Code>55700-0583-30</NDC11Code>
<ProductNDC>55700-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eszopiclone</ProprietaryName>
<NonProprietaryName>Eszopiclone</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180202</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091024</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>ESZOPICLONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180202</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).</IndicationAndUsage>
<Description>Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its molecular formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure. Eszopiclone is a white to slightly yellowish powder. Eszopiclone is soluble in methylene chloride, practically insoluble in water and alcohol. It dissolves in dilute mineral acids. Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcelac 100 (lactose monohydrate and cellulose, microcrystalline), polyethylene glycol and titanium dioxide. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2 and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>58411-583-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (58411-583-10) / 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58411-0583-10</NDC11Code>
<ProductNDC>58411-583</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Synchro Skin Radiant Lifting Foundation</ProprietaryName>
<ProprietaryNameSuffix>430</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200920</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>2.484; .36</StrengthNumber>
<StrengthUnit>g/30mL; g/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60429-583-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60429-583-30) </PackageDescription>
<NDC11Code>60429-0583-30</NDC11Code>
<ProductNDC>60429-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Tramadol Hydrochloride Extended-release Tablets</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120627</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200491</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60687-583-21</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-583-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-583-11) </PackageDescription>
<NDC11Code>60687-0583-21</NDC11Code>
<ProductNDC>60687-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211623</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Epilepsy Carbamazepine Extended-Release Tablet is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: : 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by Carbamazepine Extended-Release Tablets (see PRECAUTIONS, General). .</IndicationAndUsage>
<Description>Before prescribing Carbamazepine Extended-Release Tablets, the physician should be thoroughly familiar with the details of this prescribing information, particularly regarding use with other drugs, especially those which accentuate toxicity potential.</Description>
</NDC>
<NDC>
<NDCCode>61919-583-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (61919-583-30)</PackageDescription>
<NDC11Code>61919-0583-30</NDC11Code>
<ProductNDC>61919-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022370</ApplicationNumber>
<LabelerName>Direct Rx</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tramadol Hydrochloride Extended-Release is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.</IndicationAndUsage>
<Description>Tramadol Hydrochloride Extended-Release capsules is a centrally acting synthetic analgesic in an extended-release oral formulation. The chemical name for tramadol hydrochloride USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.8. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Extended-Release capsules contain a total dose of tramadol hydrochloride USP 150 mg in a combination of immediate-release and extended-release components. Tramadol Hydrochloride Extended-Release capsules are white in color. Inactive ingredients include gelatin, titanium dioxide, shellac, yellow iron oxide, lactose monohydrate 200 mesh, microcrystalline cellulose, povidone K30, corn starch, sodium starch glycolate, magnesium stearate, sucrose stearate, hypromellose, talc, polysorbate 80, Eudragit NE 30D, and simethicone emulsion.</Description>
</NDC>
<NDC>
<NDCCode>62135-583-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (62135-583-30) </PackageDescription>
<NDC11Code>62135-0583-30</NDC11Code>
<ProductNDC>62135-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide</ProprietaryName>
<NonProprietaryName>Glyburide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101005</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090937</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>GLYBURIDE</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glyburide tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glyburide tablets, USP contain a smaller particle size glyburide, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound, formulated as glyburide tablets, USP of 1.25 mg, 2.5 mg, and 5 mg strengths for oral administration. Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate. In addition, the 2.5 mg contains FD&C Red No.40 and the 5 mg contains FD&C Blue No.1. The chemical name for glyburide is 1-[[p-[2-(5-chloro-o-anisamido)-ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. The structural formula is represented below.</Description>
</NDC>
<NDC>
<NDCCode>63187-583-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (63187-583-30) </PackageDescription>
<NDC11Code>63187-0583-30</NDC11Code>
<ProductNDC>63187-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zonisamide</ProprietaryName>
<NonProprietaryName>Zonisamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077651</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zonisamide capsules USP are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.</IndicationAndUsage>
<Description>Zonisamide USP is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide USP, 1,2 benzisoxazole-3-methanesulfonamide. The empirical formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide USP is a white powder, pKa = 10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HCl (0.50 mg/mL). The chemical structure is:. Zonisamide USP is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide USP. Each capsule contains the labeled amount of zonisamide USP plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, and sodium lauryl sulfate. The printed capsule shell of the different strengths is made from the following ingredients. 25 mg – D&C Red #28, FD&C Blue #1, gelatin and titanium dioxide. 50 mg – D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. 100 mg - D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, gelatin and titanium dioxide. The dyes used in the printing ink are FD&C Blue #1, FD&C Blue #2, FD&C Red #40, D&C Yellow #10 aluminium lake and iron oxide black. Additionally, the printing ink also contains n-butyl alcohol, ethanol, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>63304-583-30</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (63304-583-30) </PackageDescription>
<NDC11Code>63304-0583-30</NDC11Code>
<ProductNDC>63304-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosamprenavir Calcium</ProprietaryName>
<NonProprietaryName>Fosamprenavir Calcium</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204024</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>FOSAMPRENAVIR CALCIUM</SubstanceName>
<StrengthNumber>700</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], P-Glycoprotein Inducers [MoA], Protease Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosamprenavir calcium tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. The following points should be considered when initiating therapy with fosamprenavir calcium tablets plus ritonavir in protease inhibitor-experienced patients: 1 The protease inhibitor-experienced patient trial was not large enough to reach a definitive conclusion that fosamprenavir calcium tablets plus ritonavir and lopinavir plus ritonavir are clinically equivalent [see Clinical Studies (14.2)]. , 2 Once-daily administration of fosamprenavir calcium tablets plus ritonavir is not recommended for adult protease inhibitor-experienced patients or any pediatric patients [see Dosage and Administration (2.2,2.3), Clinical Studies (14.2, 14.3)]. , 3 Dosing of fosamprenavir calcium tablets plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients younger than 6 months [see Clinical Pharmacology (12.3)]. .</IndicationAndUsage>
<Description>Fosamprenavir calcium, USP is a prodrug of amprenavir, an inhibitor of HIV protease. The chemical name of fosamprenavir calcium, USP is (3S)-tetrahydrofuran-3-yl (1S,2R)-3-[[(4-aminophenyl) sulfonyl](isobutyl)amino]-1-benzyl-2-(phosphonooxy) propylcarbamate monocalcium salt. Fosamprenavir calcium, USP is a single stereoisomer with the (3S)(1S,2R) configuration. It has a molecular formula of C25H34CaN3O9PS and a molecular weight of 623.7. It has the following structural formula. Fosamprenavir calcium, USP is a white to cream color solid which is soluble in methanol. Fosamprenavir calcium tablets, USP are available for oral administration in a strength of 700 mg of fosamprenavir as fosamprenavir calcium, USP (equivalent to approximately 600 mg of amprenavir). Each 700 mg tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone. The tablet coating contains the inactive ingredients ethylcellulose, ferric oxide red, hypromellose, talc, and titanium dioxide. The imprinting ink contains the inactive ingredients ferric oxide black, propylene glycol, and shellac. Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>63868-583-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (63868-583-30) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>63868-0583-30</NDC11Code>
<ProductNDC>63868-583</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077367</ApplicationNumber>
<LabelerName>Chain Drug Marketing Association INC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65162-583-03</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (65162-583-03) </PackageDescription>
<NDC11Code>65162-0583-03</NDC11Code>
<ProductNDC>65162-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temazepam</ProprietaryName>
<NonProprietaryName>Temazepam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203482</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam, USP is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is. C16H13ClN2O2 MW = 300.74. Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration. Each capsule for oral administration contains either 7.5 mg, 15 mg, 22.5 mg or 30 mg temazepam, USP. The inactive ingredients include: ammonia, black iron oxide, butyl alcohol, croscarmellose sodium, dehydrated alcohol, gelatin, isopropyl alcohol, lactose monohydrate, magnesium stearate, polyethylene glycol, potassium hydroxide, propylene glycol, shellac, and titanium dioxide. Additionally, the 7.5 mg capsule contains D&C Red #28 and FD&C Blue #1 and the 15 mg and 22.5 mg capsules contain FD&C Blue #1, FD&C Red #40 and FD&C Yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>65923-583-30</NDCCode>
<PackageDescription>30 VIAL, SINGLE-USE in 1 BOX (65923-583-30) > .4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>65923-0583-30</NDC11Code>
<ProductNDC>65923-583</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Family Care Single-use Eye</ProprietaryName>
<NonProprietaryName>Carboxymethylcellulose Sodium</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20160328</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>United Exchange Corp.</LabelerName>
<SubstanceName>CARBOXYMETHYLCELLULOSE SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-11-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>66267-583-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (66267-583-30) </PackageDescription>
<NDC11Code>66267-0583-30</NDC11Code>
<ProductNDC>66267-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075994</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69654-583-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69654-583-30) </PackageDescription>
<NDC11Code>69654-0583-30</NDC11Code>
<ProductNDC>69654-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metadate Cd</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021259</ApplicationNumber>
<LabelerName>Aytu BioPharma, Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>METADATE CD is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of METADATE CD is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7). Use in Specific Populations ( 8.4)] .</IndicationAndUsage>
<Description>METADATE CD contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. METADATE CD is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration. Chemically, methylphenidate HCl is d, l(racemic)- threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is:. Methylphenidate HCl USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. METADATE CD also contains the following inactive ingredients: Dibutyl sebacate, ethylcellulose aqueous dispersion, gelatin, hydroxypropylmethylcellulose, polyethylene glycol, povidone, sugar spheres, and titanium dioxide. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide. 20 mg capsules: FD&C Blue No. 2. 30 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide. 40 mg capsules: FDA/E172 Yellow Iron Oxide. 50 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>70186-583-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70186-583-01) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70186-0583-01</NDC11Code>
<ProductNDC>70186-583</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Magic Foundation Flawless Long-lasting Coverage Sunscreen Broad Spectrum Spf 15</ProprietaryName>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Charlotte Tilbury Beauty Ltd.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>1.83; .287</StrengthNumber>
<StrengthUnit>g/30mL; g/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70934-583-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (70934-583-30) </PackageDescription>
<NDC11Code>70934-0583-30</NDC11Code>
<ProductNDC>70934-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078627</ApplicationNumber>
<LabelerName>Denton Pharma, Inc. dba Northwind Pharmaceuticals</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>