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"ProductTypeName": "HUMAN OTC DRUG",
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"SubstanceName": "ALCOHOL",
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{
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Esomeprazole Magnesium",
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"StartMarketingDatePackage": "20200313",
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"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
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"NDC11Code": "21130-0753-03",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Safeway Signature Care No Breakout Sunscreen Face Spf 30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Safeway, Inc.",
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"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
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"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun ."
},
{
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"ProductNDC": "62195-753",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Water",
"DosageFormName": "INJECTION, SOLUTION",
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"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Vetter Pharma Fertigung GmbH & Co. KG",
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"ListingRecordCertifiedThrough": "20181231"
},
{
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"PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (63545-753-03) ",
"NDC11Code": "63545-0753-03",
"ProductNDC": "63545-753",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aesculus Hippocastanum",
"NonProprietaryName": "Aesculus Hippocastanum",
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"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20200113",
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},
{
"NDCCode": "64380-753-03",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
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"ApplicationNumber": "ANDA206943",
"LabelerName": "Strides Pharma Science Limited",
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"StrengthNumber": "100",
"StrengthUnit": "mg/1",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20260404",
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"IndicationAndUsage": "Gabapentin capsules, USP are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin capsules USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each Gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: Pregelatinized Maize starch, talc, gelatin, titanium dioxide, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (300 mg and 400 mg only), black iron oxide (300 mg and 400 mg only). Ingredients of Imprinting Ink (Black SW-9049) are Black Iron Oxide NF (E 172), Butyl Alcohol NF, Dehydrated Alcohol USP, Isopropyl Alcohol USP, Potassium Hydroxide NF, Propylene Glycol USP, Shellac NF, and Strong Ammonia Solution NF."
},
{
"NDCCode": "65162-753-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (65162-753-03) ",
"NDC11Code": "65162-0753-03",
"ProductNDC": "65162-753",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benazepril Hydrochloride",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076820",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100202",
"SamplePackage": "N",
"IndicationAndUsage": "Benazepril HCl tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.",
"Description": "Benazepril HCl, USP is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril HCl tablets, USP are supplied as white, round, biconvex tablets containing either 5 mg, 10 mg, 20 mg, or 40 mg of benazepril HCl, USP for oral administration. The inactive ingredients are crospovidone, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch and talc."
},
{
"NDCCode": "11673-753-01",
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"NDC11Code": "11673-0753-01",
"ProductNDC": "11673-753",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207193",
"LabelerName": "Target Corporation",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200313",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "24909-753-12",
"PackageDescription": "355 mL in 1 BOTTLE (24909-753-12) ",
"NDC11Code": "24909-0753-12",
"ProductNDC": "24909-753",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cbd Clinic Deep-rub Pain Relief - Level 3",
"NonProprietaryName": "Menthol",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191015",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Aidance Skincare & Topical Solutions, LLC",
"SubstanceName": "MENTHOL",
"StrengthNumber": "8",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191015",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pain of muscles and joints associated with: simple backache arthritis strains bruises sprains."
},
{
"NDCCode": "24909-753-28",
"PackageDescription": "3785 mL in 1 BOTTLE (24909-753-28) ",
"NDC11Code": "24909-0753-28",
"ProductNDC": "24909-753",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cbd Clinic Deep-rub Pain Relief - Level 3",
"NonProprietaryName": "Menthol",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191015",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Aidance Skincare & Topical Solutions, LLC",
"SubstanceName": "MENTHOL",
"StrengthNumber": "8",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191015",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pain of muscles and joints associated with: simple backache arthritis strains bruises sprains."
},
{
"NDCCode": "24909-753-64",
"PackageDescription": "1893 mL in 1 BOTTLE (24909-753-64) ",
"NDC11Code": "24909-0753-64",
"ProductNDC": "24909-753",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cbd Clinic Deep-rub Pain Relief - Level 3",
"NonProprietaryName": "Menthol",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191015",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Aidance Skincare & Topical Solutions, LLC",
"SubstanceName": "MENTHOL",
"StrengthNumber": "8",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191015",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pain of muscles and joints associated with: simple backache arthritis strains bruises sprains."
},
{
"NDCCode": "43353-753-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-30) ",
"NDC11Code": "43353-0753-30",
"ProductNDC": "43353-753",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075078",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150225",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following: OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.",
"Description": "Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose 2910 USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Povidone USP, and Sodium Starch Glycolate NF. Also, each 400 mg tablet contains Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol 400 NF, and Titanium Dioxide. Each 500 mg tablet contains Opadry Oy Blue (FD + C Blue #1 Aluminum Lake and D + C Yellow #10). Each Extended Release Tablet, for oral administration, contains 400 mg, 500 mg or 600mg of Etodolac. In addition, each tablet contains the following inactive ingredients: HPMC 2910, Hydroxypropyl Methylcellulose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, PEG 8000, Polydextrose FCC, Povidone, Titanium Dioxide and Triacetin. In addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F. Lake. In addition, the 500 mg tablets contain Yellow Iron Oxide."
},
{
"NDCCode": "43353-753-53",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-53) ",
"NDC11Code": "43353-0753-53",
"ProductNDC": "43353-753",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075078",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110811",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following: OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.",
"Description": "Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose 2910 USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Povidone USP, and Sodium Starch Glycolate NF. Also, each 400 mg tablet contains Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol 400 NF, and Titanium Dioxide. Each 500 mg tablet contains Opadry Oy Blue (FD + C Blue #1 Aluminum Lake and D + C Yellow #10). Each Extended Release Tablet, for oral administration, contains 400 mg, 500 mg or 600mg of Etodolac. In addition, each tablet contains the following inactive ingredients: HPMC 2910, Hydroxypropyl Methylcellulose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, PEG 8000, Polydextrose FCC, Povidone, Titanium Dioxide and Triacetin. In addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F. Lake. In addition, the 500 mg tablets contain Yellow Iron Oxide."
},
{
"NDCCode": "43353-753-60",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-60) ",
"NDC11Code": "43353-0753-60",
"ProductNDC": "43353-753",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075078",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110811",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following: OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.",
"Description": "Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose 2910 USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Povidone USP, and Sodium Starch Glycolate NF. Also, each 400 mg tablet contains Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol 400 NF, and Titanium Dioxide. Each 500 mg tablet contains Opadry Oy Blue (FD + C Blue #1 Aluminum Lake and D + C Yellow #10). Each Extended Release Tablet, for oral administration, contains 400 mg, 500 mg or 600mg of Etodolac. In addition, each tablet contains the following inactive ingredients: HPMC 2910, Hydroxypropyl Methylcellulose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, PEG 8000, Polydextrose FCC, Povidone, Titanium Dioxide and Triacetin. In addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F. Lake. In addition, the 500 mg tablets contain Yellow Iron Oxide."
},
{
"NDCCode": "43353-753-70",
"PackageDescription": "120 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-70) ",
"NDC11Code": "43353-0753-70",
"ProductNDC": "43353-753",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075078",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150225",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following: OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.",
"Description": "Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose 2910 USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Povidone USP, and Sodium Starch Glycolate NF. Also, each 400 mg tablet contains Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol 400 NF, and Titanium Dioxide. Each 500 mg tablet contains Opadry Oy Blue (FD + C Blue #1 Aluminum Lake and D + C Yellow #10). Each Extended Release Tablet, for oral administration, contains 400 mg, 500 mg or 600mg of Etodolac. In addition, each tablet contains the following inactive ingredients: HPMC 2910, Hydroxypropyl Methylcellulose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, PEG 8000, Polydextrose FCC, Povidone, Titanium Dioxide and Triacetin. In addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F. Lake. In addition, the 500 mg tablets contain Yellow Iron Oxide."
},
{
"NDCCode": "43353-753-80",
"PackageDescription": "180 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-80) ",
"NDC11Code": "43353-0753-80",
"ProductNDC": "43353-753",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075078",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150225",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following: OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.",
"Description": "Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose 2910 USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Povidone USP, and Sodium Starch Glycolate NF. Also, each 400 mg tablet contains Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol 400 NF, and Titanium Dioxide. Each 500 mg tablet contains Opadry Oy Blue (FD + C Blue #1 Aluminum Lake and D + C Yellow #10). Each Extended Release Tablet, for oral administration, contains 400 mg, 500 mg or 600mg of Etodolac. In addition, each tablet contains the following inactive ingredients: HPMC 2910, Hydroxypropyl Methylcellulose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, PEG 8000, Polydextrose FCC, Povidone, Titanium Dioxide and Triacetin. In addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F. Lake. In addition, the 500 mg tablets contain Yellow Iron Oxide."
},
{
"NDCCode": "43353-753-87",
"PackageDescription": "2400 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-87) ",
"NDC11Code": "43353-0753-87",
"ProductNDC": "43353-753",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075078",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140211",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following: OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.",
"Description": "Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose 2910 USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Povidone USP, and Sodium Starch Glycolate NF. Also, each 400 mg tablet contains Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol 400 NF, and Titanium Dioxide. Each 500 mg tablet contains Opadry Oy Blue (FD + C Blue #1 Aluminum Lake and D + C Yellow #10). Each Extended Release Tablet, for oral administration, contains 400 mg, 500 mg or 600mg of Etodolac. In addition, each tablet contains the following inactive ingredients: HPMC 2910, Hydroxypropyl Methylcellulose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, PEG 8000, Polydextrose FCC, Povidone, Titanium Dioxide and Triacetin. In addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F. Lake. In addition, the 500 mg tablets contain Yellow Iron Oxide."
},
{
"NDCCode": "54305-753-01",
"PackageDescription": "800 kg in 1 BAG (54305-753-01) ",
"NDC11Code": "54305-0753-01",
"ProductNDC": "54305-753",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOZENGE",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Ricola Ag",
"SubstanceName": "MENTHOL",
"StrengthNumber": "3809.6",
"StrengthUnit": "mg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-01-03",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-JUN-18"
},
{
"NDCCode": "66096-753-02",
"PackageDescription": "30 mL in 1 PACKAGE (66096-753-02) ",
"NDC11Code": "66096-0753-02",
"ProductNDC": "66096-753",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ohm-cir",
"NonProprietaryName": "Baryta Iodata, Cactus Grandiflorus, Carbo Vegetabilis, Crataegus Oxyacantha, Curare, Kali Carbonicum, Kalmia Latifolia, Melilotus Officinale, Naja Tripudians, Secale Cornutum, Solanum Nigrum, Spigelia Anthelmia",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20181219",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "BARIUM IODIDE; SELENICEREUS GRANDIFLORUS STEM; ACTIVATED CHARCOAL; HAWTHORN LEAF WITH FLOWER; TUBOCURARINE CHLORIDE; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; MELILOTUS OFFICINALIS TOP; NAJA NAJA VENOM; CLAVICEPS PURPUREA SCLEROTIUM; SOLANUM NIGRUM TOP; SPIGELIA ANTHELMIA",
"StrengthNumber": "12; 6; 12; 6; 12; 7; 6; 6; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Active",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181219",
"SamplePackage": "N",
"IndicationAndUsage": "Contraindicaciones: Ninguna reportada."
},
{
"NDCCode": "67684-2000-0",
"PackageDescription": "10 VIAL in 1 PACKAGE (67684-2000-0) / 5 mL in 1 VIAL",
"NDC11Code": "67684-2000-00",
"ProductNDC": "67684-2000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dotarem",
"NonProprietaryName": "Gadoterate Meglumine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130320",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204781",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOTERATE MEGLUMINE",
"StrengthNumber": "376.9",
"StrengthUnit": "mg/mL",
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"Description": "DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively."
},
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"Description": "DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively."
}
]
}
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<StartMarketingDatePackage>20260404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin capsules, USP are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each Gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: Pregelatinized Maize starch, talc, gelatin, titanium dioxide, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (300 mg and 400 mg only), black iron oxide (300 mg and 400 mg only). Ingredients of Imprinting Ink (Black SW-9049) are Black Iron Oxide NF (E 172), Butyl Alcohol NF, Dehydrated Alcohol USP, Isopropyl Alcohol USP, Potassium Hydroxide NF, Propylene Glycol USP, Shellac NF, and Strong Ammonia Solution NF.</Description>
</NDC>
<NDC>
<NDCCode>65162-753-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (65162-753-03) </PackageDescription>
<NDC11Code>65162-0753-03</NDC11Code>
<ProductNDC>65162-753</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076820</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benazepril HCl tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
<Description>Benazepril HCl, USP is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril HCl tablets, USP are supplied as white, round, biconvex tablets containing either 5 mg, 10 mg, 20 mg, or 40 mg of benazepril HCl, USP for oral administration. The inactive ingredients are crospovidone, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch and talc.</Description>
</NDC>
<NDC>
<NDCCode>11673-753-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11673-753-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>11673-0753-01</NDC11Code>
<ProductNDC>11673-753</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207193</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM DIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24909-753-12</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (24909-753-12) </PackageDescription>
<NDC11Code>24909-0753-12</NDC11Code>
<ProductNDC>24909-753</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cbd Clinic Deep-rub Pain Relief - Level 3</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191015</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Aidance Skincare & Topical Solutions, LLC</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pain of muscles and joints associated with: simple backache arthritis strains bruises sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24909-753-28</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE (24909-753-28) </PackageDescription>
<NDC11Code>24909-0753-28</NDC11Code>
<ProductNDC>24909-753</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cbd Clinic Deep-rub Pain Relief - Level 3</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191015</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Aidance Skincare & Topical Solutions, LLC</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pain of muscles and joints associated with: simple backache arthritis strains bruises sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24909-753-64</NDCCode>
<PackageDescription>1893 mL in 1 BOTTLE (24909-753-64) </PackageDescription>
<NDC11Code>24909-0753-64</NDC11Code>
<ProductNDC>24909-753</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cbd Clinic Deep-rub Pain Relief - Level 3</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191015</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Aidance Skincare & Topical Solutions, LLC</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pain of muscles and joints associated with: simple backache arthritis strains bruises sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43353-753-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-30) </PackageDescription>
<NDC11Code>43353-0753-30</NDC11Code>
<ProductNDC>43353-753</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etodolac</ProprietaryName>
<NonProprietaryName>Etodolac</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075078</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following: OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.</IndicationAndUsage>
<Description>Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose 2910 USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Povidone USP, and Sodium Starch Glycolate NF. Also, each 400 mg tablet contains Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol 400 NF, and Titanium Dioxide. Each 500 mg tablet contains Opadry Oy Blue (FD + C Blue #1 Aluminum Lake and D + C Yellow #10). Each Extended Release Tablet, for oral administration, contains 400 mg, 500 mg or 600mg of Etodolac. In addition, each tablet contains the following inactive ingredients: HPMC 2910, Hydroxypropyl Methylcellulose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, PEG 8000, Polydextrose FCC, Povidone, Titanium Dioxide and Triacetin. In addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F. Lake. In addition, the 500 mg tablets contain Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-753-53</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-53) </PackageDescription>
<NDC11Code>43353-0753-53</NDC11Code>
<ProductNDC>43353-753</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etodolac</ProprietaryName>
<NonProprietaryName>Etodolac</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075078</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following: OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.</IndicationAndUsage>
<Description>Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose 2910 USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Povidone USP, and Sodium Starch Glycolate NF. Also, each 400 mg tablet contains Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol 400 NF, and Titanium Dioxide. Each 500 mg tablet contains Opadry Oy Blue (FD + C Blue #1 Aluminum Lake and D + C Yellow #10). Each Extended Release Tablet, for oral administration, contains 400 mg, 500 mg or 600mg of Etodolac. In addition, each tablet contains the following inactive ingredients: HPMC 2910, Hydroxypropyl Methylcellulose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, PEG 8000, Polydextrose FCC, Povidone, Titanium Dioxide and Triacetin. In addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F. Lake. In addition, the 500 mg tablets contain Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-753-60</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-60) </PackageDescription>
<NDC11Code>43353-0753-60</NDC11Code>
<ProductNDC>43353-753</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etodolac</ProprietaryName>
<NonProprietaryName>Etodolac</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075078</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following: OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.</IndicationAndUsage>
<Description>Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose 2910 USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Povidone USP, and Sodium Starch Glycolate NF. Also, each 400 mg tablet contains Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol 400 NF, and Titanium Dioxide. Each 500 mg tablet contains Opadry Oy Blue (FD + C Blue #1 Aluminum Lake and D + C Yellow #10). Each Extended Release Tablet, for oral administration, contains 400 mg, 500 mg or 600mg of Etodolac. In addition, each tablet contains the following inactive ingredients: HPMC 2910, Hydroxypropyl Methylcellulose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, PEG 8000, Polydextrose FCC, Povidone, Titanium Dioxide and Triacetin. In addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F. Lake. In addition, the 500 mg tablets contain Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-753-70</NDCCode>
<PackageDescription>120 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-70) </PackageDescription>
<NDC11Code>43353-0753-70</NDC11Code>
<ProductNDC>43353-753</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etodolac</ProprietaryName>
<NonProprietaryName>Etodolac</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075078</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following: OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.</IndicationAndUsage>
<Description>Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose 2910 USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Povidone USP, and Sodium Starch Glycolate NF. Also, each 400 mg tablet contains Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol 400 NF, and Titanium Dioxide. Each 500 mg tablet contains Opadry Oy Blue (FD + C Blue #1 Aluminum Lake and D + C Yellow #10). Each Extended Release Tablet, for oral administration, contains 400 mg, 500 mg or 600mg of Etodolac. In addition, each tablet contains the following inactive ingredients: HPMC 2910, Hydroxypropyl Methylcellulose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, PEG 8000, Polydextrose FCC, Povidone, Titanium Dioxide and Triacetin. In addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F. Lake. In addition, the 500 mg tablets contain Yellow Iron Oxide.</Description>
</NDC>
<NDC>
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<PackageDescription>180 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-80) </PackageDescription>
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<ProductNDC>43353-753</ProductNDC>
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<ApplicationNumber>ANDA075078</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following: OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.</IndicationAndUsage>
<Description>Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose 2910 USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Povidone USP, and Sodium Starch Glycolate NF. Also, each 400 mg tablet contains Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol 400 NF, and Titanium Dioxide. Each 500 mg tablet contains Opadry Oy Blue (FD + C Blue #1 Aluminum Lake and D + C Yellow #10). Each Extended Release Tablet, for oral administration, contains 400 mg, 500 mg or 600mg of Etodolac. In addition, each tablet contains the following inactive ingredients: HPMC 2910, Hydroxypropyl Methylcellulose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, PEG 8000, Polydextrose FCC, Povidone, Titanium Dioxide and Triacetin. In addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F. Lake. In addition, the 500 mg tablets contain Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-753-87</NDCCode>
<PackageDescription>2400 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-87) </PackageDescription>
<NDC11Code>43353-0753-87</NDC11Code>
<ProductNDC>43353-753</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etodolac</ProprietaryName>
<NonProprietaryName>Etodolac</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075078</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac Capsules and Tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following: OsteoarthritisRheumatoid arthritis, 2 For the management of acute pain.</IndicationAndUsage>
<Description>Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose 2910 USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Povidone USP, and Sodium Starch Glycolate NF. Also, each 400 mg tablet contains Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol 400 NF, and Titanium Dioxide. Each 500 mg tablet contains Opadry Oy Blue (FD + C Blue #1 Aluminum Lake and D + C Yellow #10). Each Extended Release Tablet, for oral administration, contains 400 mg, 500 mg or 600mg of Etodolac. In addition, each tablet contains the following inactive ingredients: HPMC 2910, Hydroxypropyl Methylcellulose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, PEG 8000, Polydextrose FCC, Povidone, Titanium Dioxide and Triacetin. In addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F. Lake. In addition, the 500 mg tablets contain Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>54305-753-01</NDCCode>
<PackageDescription>800 kg in 1 BAG (54305-753-01) </PackageDescription>
<NDC11Code>54305-0753-01</NDC11Code>
<ProductNDC>54305-753</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<StartMarketingDate>20180601</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Ricola Ag</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>3809.6</StrengthNumber>
<StrengthUnit>mg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-03</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JUN-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>66096-753-02</NDCCode>
<PackageDescription>30 mL in 1 PACKAGE (66096-753-02) </PackageDescription>
<NDC11Code>66096-0753-02</NDC11Code>
<ProductNDC>66096-753</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ohm-cir</ProprietaryName>
<NonProprietaryName>Baryta Iodata, Cactus Grandiflorus, Carbo Vegetabilis, Crataegus Oxyacantha, Curare, Kali Carbonicum, Kalmia Latifolia, Melilotus Officinale, Naja Tripudians, Secale Cornutum, Solanum Nigrum, Spigelia Anthelmia</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>BARIUM IODIDE; SELENICEREUS GRANDIFLORUS STEM; ACTIVATED CHARCOAL; HAWTHORN LEAF WITH FLOWER; TUBOCURARINE CHLORIDE; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; MELILOTUS OFFICINALIS TOP; NAJA NAJA VENOM; CLAVICEPS PURPUREA SCLEROTIUM; SOLANUM NIGRUM TOP; SPIGELIA ANTHELMIA</SubstanceName>
<StrengthNumber>12; 6; 12; 6; 12; 7; 6; 6; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Contraindicaciones: Ninguna reportada.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67684-2000-0</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (67684-2000-0) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>67684-2000-00</NDC11Code>
<ProductNDC>67684-2000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dotarem</ProprietaryName>
<NonProprietaryName>Gadoterate Meglumine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130320</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204781</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOTERATE MEGLUMINE</SubstanceName>
<StrengthNumber>376.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.</IndicationAndUsage>
<Description>DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively.</Description>
</NDC>
<NDC>
<NDCCode>67684-2000-1</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (67684-2000-1) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>67684-2000-01</NDC11Code>
<ProductNDC>67684-2000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dotarem</ProprietaryName>
<NonProprietaryName>Gadoterate Meglumine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130320</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204781</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOTERATE MEGLUMINE</SubstanceName>
<StrengthNumber>376.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.</IndicationAndUsage>
<Description>DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively.</Description>
</NDC>
</NDCList>