{
"NDC": [
{
"NDCCode": "62135-533-90",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-533-90) ",
"NDC11Code": "62135-0533-90",
"ProductNDC": "62135-533",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078281",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230405",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole Sodium Delayed-Release Tablets are indicated for.",
"Description": "The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1 H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S x 1.5 H 2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet contains 45.1 mg or 22.55 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, talc, titanium dioxide, and triethyl citrate. The 20 mg tablet also contains black iron oxide, isopropyl alcohol, and propylene glycol. Pantoprazole Sodium Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 4."
},
{
"NDCCode": "12634-533-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (12634-533-90)",
"NDC11Code": "12634-0533-90",
"ProductNDC": "12634-533",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077293",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"IndicationAndUsage": "FUROSEMIDE TABLET is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. FUROSEMIDE TABLET is particularly useful when an agent with greater diuretic potential is desired.",
"Description": "FUROSEMIDE TABLET is a diuretic which is an anthranilic acid derivative. FUROSEMIDE TABLET for oral administration contain furosemide as the active ingredient and the following inactive ingredients: lactose anhydrous NF, magnesium stearate NF, starch NF, microcrystalline cellulose NF, sodium starch Glycolate NF, and colloidal silicon dioxide NF. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. FUROSEMIDE TABLET is available as white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. It has a molecular formula of C 12H 11ClN 2O 5S and a molecular weight of 330.75. The molecular structure is as follows."
},
{
"NDCCode": "16252-533-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16252-533-90)",
"NDC11Code": "16252-0533-90",
"ProductNDC": "16252-533",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077663",
"LabelerName": "Cobalt Laboratories Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "21749-533-90",
"PackageDescription": "1250 mL in 1 BOTTLE (21749-533-90) ",
"NDC11Code": "21749-0533-90",
"ProductNDC": "21749-533",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Provon Antibacterial Foam Handwash",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130101",
"EndMarketingDate": "20211201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GOJO Industries, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".003",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130101",
"EndMarketingDatePackage": "20211201",
"SamplePackage": "N"
},
{
"NDCCode": "49999-533-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (49999-533-90)",
"NDC11Code": "49999-0533-90",
"ProductNDC": "49999-533",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Singulair",
"NonProprietaryName": "Montelukast Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120321",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020829",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "MONTELUKAST SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-03-23"
},
{
"NDCCode": "51655-533-26",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (51655-533-26) ",
"NDC11Code": "51655-0533-26",
"ProductNDC": "51655-533",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078512",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221228",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 atenolol. 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 1 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 mmHg 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. Atenolol tablets may be administered with other antihypertensive agents. Angina Pectoris Due to Coronary Atherosclerosis Atenolol tablets are indicated for the long-term management of patients with angina pectoris. Acute Myocardial Infarction Atenolol tablets are indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient’s clinical condition allows. (See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.) In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mmHg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta-blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mmHg) seemed less likely to benefit.",
"Description": "Atenolol, a synthetic, beta 1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The structural and molecular formulas are:. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol is available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: sodium starch glycolate, crospovidone, povidone, silicified microcrystalline cellulose, magnesium stearate."
},
{
"NDCCode": "61919-533-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (61919-533-90) ",
"NDC11Code": "61919-0533-90",
"ProductNDC": "61919-533",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078384",
"LabelerName": "DIRECT RX",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N",
"IndicationAndUsage": "1.2 Left Ventricular Dysfunction Following Myocardial Infarction. Carvedilol Tablet is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies ( 14.2)]. 1.3 Hypertension. Carvedilol Tablet is indicated for the management of essential hypertension [see Clinical Studies ( 14.3, 14.4)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions ( 7.2)].",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure. Carvedilol is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol Tablet is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5)."
},
{
"NDCCode": "68382-533-16",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-533-16) ",
"NDC11Code": "68382-0533-16",
"ProductNDC": "68382-533",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203553",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180307",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]., 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)].",
"Description": "Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. C23H27N3O7HCl M. W. 493.95. Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD & C blue #2 aluminum lake; the 80 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 90 mg tablets contain D & C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 115 mg tablets contain FD & C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D & C red #27 aluminum lake, D & C yellow #10 aluminum lake and FD & C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending."
},
{
"NDCCode": "71205-533-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (71205-533-90) ",
"NDC11Code": "71205-0533-90",
"ProductNDC": "71205-533",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205101",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2022-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210209",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is 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 and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 4.72±0.10 and a pK a2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400 mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc."
},
{
"NDCCode": "71610-533-60",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-60) ",
"NDC11Code": "71610-0533-60",
"ProductNDC": "71610-533",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078321",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2021-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210415",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride extended-release tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients carboxymethylcellulose sodium, copovidone, hypromellose, magnesium stearate and microcrystalline cellulose. The USP dissolution test is pending."
},
{
"NDCCode": "76420-533-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (76420-533-90) ",
"NDC11Code": "76420-0533-90",
"ProductNDC": "76420-533",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19861210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071321",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240308",
"SamplePackage": "N",
"IndicationAndUsage": "Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Diazepam tablets, USP are a benzodiazepine derivative. The chemical name of diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is an off-white to yellow crystalline powder, insoluble in water. The structural formula is as follows. C 16H 13ClN 2O M.W. 284.74. Diazepam tablets, USP are available as 2 mg, 5 mg, or 10 mg tablets for oral administration containing the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate."
},
{
"NDCCode": "62135-041-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-041-90) ",
"NDC11Code": "62135-0041-90",
"ProductNDC": "62135-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosinopril Sodium",
"NonProprietaryName": "Fosinopril Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076483",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "FOSINOPRIL SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230601",
"SamplePackage": "N",
"IndicationAndUsage": "Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION) . In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS). In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema).",
"Description": "Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl- 1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium, USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. Empirical formula: C 30H 45NNa0 7P Molecular weight: 585.65. Fosinopril Sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: carnauba wax, crospovidone, lactose anhydrous, microcrystalline cellulose, and zinc stearate."
},
{
"NDCCode": "62135-042-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-042-90) ",
"NDC11Code": "62135-0042-90",
"ProductNDC": "62135-042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosinopril Sodium",
"NonProprietaryName": "Fosinopril Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076483",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "FOSINOPRIL SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230601",
"SamplePackage": "N",
"IndicationAndUsage": "Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION) . In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS). In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema).",
"Description": "Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl- 1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium, USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. Empirical formula: C 30H 45NNa0 7P Molecular weight: 585.65. Fosinopril Sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: carnauba wax, crospovidone, lactose anhydrous, microcrystalline cellulose, and zinc stearate."
},
{
"NDCCode": "62135-043-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-043-90) ",
"NDC11Code": "62135-0043-90",
"ProductNDC": "62135-043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosinopril Sodium",
"NonProprietaryName": "Fosinopril Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076483",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "FOSINOPRIL SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230601",
"SamplePackage": "N",
"IndicationAndUsage": "Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION) . In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS). In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema).",
"Description": "Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl- 1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium, USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. Empirical formula: C 30H 45NNa0 7P Molecular weight: 585.65. Fosinopril Sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: carnauba wax, crospovidone, lactose anhydrous, microcrystalline cellulose, and zinc stearate."
},
{
"NDCCode": "62135-051-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-051-90) ",
"NDC11Code": "62135-0051-90",
"ProductNDC": "62135-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxazosin Mesylate",
"NonProprietaryName": "Doxazosin Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20001018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075646",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "DOXAZOSIN MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": "Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1) : 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.",
"Description": "Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23H 25N 5O 5 · CH 4O 3S and the molecular weight is 547.6. It has the following structure:. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "62135-052-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-052-90) ",
"NDC11Code": "62135-0052-90",
"ProductNDC": "62135-052",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxazosin Mesylate",
"NonProprietaryName": "Doxazosin Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20001018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075646",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "DOXAZOSIN MESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": "Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1) : 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.",
"Description": "Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23H 25N 5O 5 · CH 4O 3S and the molecular weight is 547.6. It has the following structure:. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "62135-053-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-053-90) ",
"NDC11Code": "62135-0053-90",
"ProductNDC": "62135-053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxazosin Mesylate",
"NonProprietaryName": "Doxazosin Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20001018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075646",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "DOXAZOSIN MESYLATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": "Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1) : 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.",
"Description": "Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23H 25N 5O 5 · CH 4O 3S and the molecular weight is 547.6. It has the following structure:. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "62135-054-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-054-90) ",
"NDC11Code": "62135-0054-90",
"ProductNDC": "62135-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxazosin Mesylate",
"NonProprietaryName": "Doxazosin Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20001018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075646",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "DOXAZOSIN MESYLATE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": "Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1) : 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.",
"Description": "Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23H 25N 5O 5 · CH 4O 3S and the molecular weight is 547.6. It has the following structure:. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "62135-067-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (62135-067-90) ",
"NDC11Code": "62135-0067-90",
"ProductNDC": "62135-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19840806",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018829",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220930",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules, USP and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see Warnings: Gastrointestinal Bleeding, Ulceration, and Perforation). Indomethacin has been found effective in active stages of the following. 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). 5. Acute gouty arthritis.",
"Description": "Indomethacin capsules, USP for oral administration contains 25 mg of indomethacin. Each capsule contains the following inactive ingredients: corn starch, croscarmellose sodium, lactose monohydrate, polyethylene glycol 4000, stearic acid, and talc. The capsule shell contains D&C Yellow #10, FD&C Green #3, gelatin, and titanium dioxide. The black imprinting ink contains alcohol, black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, ferrosoferric oxide, n-butyl alcohol, propylene glycol, and shellac glaze. Indomethacin is a nonsteroidal anti-inflammatory indole derivative designated chemically as 1 – (4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. The structural formula is. Indomethacin is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The molecular weight of indomethacin is 357.79 and its molecular formula is C 19H 16C 1NO 4."
},
{
"NDCCode": "62135-068-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (62135-068-90) ",
"NDC11Code": "62135-0068-90",
"ProductNDC": "62135-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19860305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070651",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221001",
"SamplePackage": "N",
"IndicationAndUsage": "Indomethacin Capsules is indicated for. : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis, 3 Moderate to severe osteoarthritis, 4 Acute painful shoulder (bursitis and/or tendinitis), 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules are nonsteroidal anti-inflammatory drugs, available as capsules containing 50 mg of indomethacin, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C 19H 16C lNO 4, and it has the following chemical structure. Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in Indomethacin Capsules 50 mg include: lactose monohydrate, corn starch, croscarmellose sodium, polyethylene glycol, stearic acid, talc, gelatin, titanium dioxide, D&C Yellow #10, and FD&C Green #3. Black printing ink contains shellac, black iron oxide, n-butyl alcohol, ethanol, methanol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10, and FD&C Blue #1."
},
{
"NDCCode": "62135-205-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-205-90) ",
"NDC11Code": "62135-0205-90",
"ProductNDC": "62135-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methimazole",
"NonProprietaryName": "Methimazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040411",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211104",
"SamplePackage": "N",
"IndicationAndUsage": "Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
"Description": "Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:."
},
{
"NDCCode": "62135-206-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-206-90) ",
"NDC11Code": "62135-0206-90",
"ProductNDC": "62135-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methimazole",
"NonProprietaryName": "Methimazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040411",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211104",
"SamplePackage": "N",
"IndicationAndUsage": "Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
"Description": "Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:."
},
{
"NDCCode": "62135-210-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-210-90) ",
"NDC11Code": "62135-0210-90",
"ProductNDC": "62135-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folic Acid",
"NonProprietaryName": "Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090035",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "FOLIC ACID",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-10-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220303",
"SamplePackage": "N",
"IndicationAndUsage": "Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Folic acid, N-[ p-[[(2-amino-4-hydroxy-6-pteridinyl)methyl]-amino] benzoyl]L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid is prepared synthetically. Folic acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid (sodium folate). Aqueous solutions of folic acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light. The structural formula of folic acid is as follows. Each tablet, for oral administration, contains 1 mg folic acid. Folic acid tablets, USP 1 mg contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, lactose monohydrate, sodium starch glycolate and stearic acid."
},
{
"NDCCode": "62135-236-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-236-90) ",
"NDC11Code": "62135-0236-90",
"ProductNDC": "62135-236",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyproheptadine Hydrochloride",
"NonProprietaryName": "Cyproheptadine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830526",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088212",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "CYPROHEPTADINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230105",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Perennial and seasonal allergic rhinitis, Vasomotor rhinitis, Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Cold urticaria. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.",
"Description": "DESCRIPTION: Cyproheptadine HCl, is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride is a while to slightly yellowish, crystalline, solid. with a molecular weight of 350.89, which is slightly soluble in water, freely soluble in methanol, sparingly soluble in ethanol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5H-dibenzo (a, d) cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C 21H 21NHC1. and the structural formula of the anhydrous salt is:. Cyproheptadine hydrochloride is available in 4 mg tablets. Each tablet contains. Active Ingredient. Cyproheptad1ne Hydrochloride ...................... 4 mg. Each tablet contains. Inactive Ingredients:. Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), stearic acid."
},
{
"NDCCode": "62135-242-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (62135-242-90) ",
"NDC11Code": "62135-0242-90",
"ProductNDC": "62135-242",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naltrexone Hydrochloride",
"NonProprietaryName": "Naltrexone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207905",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "NALTREXONE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220105",
"SamplePackage": "N",
"IndicationAndUsage": "Naltrexone hydrochloride tablets are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride tablets have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.",
"Description": "Naltrexone hydrochloride tablets, USP an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl group. Naltrexone hydrochloride, USP is also related to the potent opioid antagonist, naloxone, or n-allylnoroxymorphone. Naltrexone hydrochloride. Naltrexone hydrochloride is a white or almost white powder. The hydrochloride salt is freely soluble in water. Naltrexone hydrochloride tablets, USP are available as film-coated tablets containing 50 mg of naltrexone hydrochloride. Naltrexone hydrochloride tablets, USP also contain: lactose monohydrate, hypromellose, magnesium stearate, polyethylene glycol, titanium dioxide, colloidal silicon dioxide, hydroxypropyl cellulose, yellow ferric oxide and red ferric oxide."
},
{
"NDCCode": "62135-271-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (62135-271-90) ",
"NDC11Code": "62135-0271-90",
"ProductNDC": "62135-271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200826",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078745",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260102",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor 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. It may be used alone or in combination with thiazide diuretics ( 1.1). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3).",
"Description": "Ramipril, USP is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2 S, 3a S, 6a S)-1 [( S)- N-[( S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [ b]pyrrole-2-carboxylic acid, 1-ethyl ester. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains D&C Yellow # 10 and FD&C Yellow # 6 the 2.5 mg capsule shell contains D&C Red # 28, D&C Yellow # 10 and FD&C Red #40, the 5 mg capsule shell contains D&C Red # 28, D&C Red # 33, D&C Yellow # 10 and FD&C Blue #1, and the 10 mg capsule shell contains D&C Red # 28, and FD&C Blue #1. Capsule shells are imprinted with black ink containing shellac, black iron oxide, n-butyl alcohol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10 and FD&C Blue #1. The structural formula for ramipril is. Its molecular formula is C 23H 32N 2O 5and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group."
},
{
"NDCCode": "62135-272-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (62135-272-90) ",
"NDC11Code": "62135-0272-90",
"ProductNDC": "62135-272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200826",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078745",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260102",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor 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. It may be used alone or in combination with thiazide diuretics ( 1.1). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3).",
"Description": "Ramipril, USP is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2 S, 3a S, 6a S)-1 [( S)- N-[( S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [ b]pyrrole-2-carboxylic acid, 1-ethyl ester. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains D&C Yellow # 10 and FD&C Yellow # 6 the 2.5 mg capsule shell contains D&C Red # 28, D&C Yellow # 10 and FD&C Red #40, the 5 mg capsule shell contains D&C Red # 28, D&C Red # 33, D&C Yellow # 10 and FD&C Blue #1, and the 10 mg capsule shell contains D&C Red # 28, and FD&C Blue #1. Capsule shells are imprinted with black ink containing shellac, black iron oxide, n-butyl alcohol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10 and FD&C Blue #1. The structural formula for ramipril is. Its molecular formula is C 23H 32N 2O 5and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group."
},
{
"NDCCode": "62135-273-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (62135-273-90) ",
"NDC11Code": "62135-0273-90",
"ProductNDC": "62135-273",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200826",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078745",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260102",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor 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. It may be used alone or in combination with thiazide diuretics ( 1.1). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3).",
"Description": "Ramipril, USP is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2 S, 3a S, 6a S)-1 [( S)- N-[( S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [ b]pyrrole-2-carboxylic acid, 1-ethyl ester. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains D&C Yellow # 10 and FD&C Yellow # 6 the 2.5 mg capsule shell contains D&C Red # 28, D&C Yellow # 10 and FD&C Red #40, the 5 mg capsule shell contains D&C Red # 28, D&C Red # 33, D&C Yellow # 10 and FD&C Blue #1, and the 10 mg capsule shell contains D&C Red # 28, and FD&C Blue #1. Capsule shells are imprinted with black ink containing shellac, black iron oxide, n-butyl alcohol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10 and FD&C Blue #1. The structural formula for ramipril is. Its molecular formula is C 23H 32N 2O 5and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group."
},
{
"NDCCode": "62135-274-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (62135-274-90) ",
"NDC11Code": "62135-0274-90",
"ProductNDC": "62135-274",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200826",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078745",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260102",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor 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. It may be used alone or in combination with thiazide diuretics ( 1.1). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3).",
"Description": "Ramipril, USP is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2 S, 3a S, 6a S)-1 [( S)- N-[( S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [ b]pyrrole-2-carboxylic acid, 1-ethyl ester. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains D&C Yellow # 10 and FD&C Yellow # 6 the 2.5 mg capsule shell contains D&C Red # 28, D&C Yellow # 10 and FD&C Red #40, the 5 mg capsule shell contains D&C Red # 28, D&C Red # 33, D&C Yellow # 10 and FD&C Blue #1, and the 10 mg capsule shell contains D&C Red # 28, and FD&C Blue #1. Capsule shells are imprinted with black ink containing shellac, black iron oxide, n-butyl alcohol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10 and FD&C Blue #1. The structural formula for ramipril is. Its molecular formula is C 23H 32N 2O 5and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group."
},
{
"NDCCode": "62135-321-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (62135-321-90) ",
"NDC11Code": "62135-0321-90",
"ProductNDC": "62135-321",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methyldopa",
"NonProprietaryName": "Methyldopa",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19840629",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018934",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METHYLDOPA",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221122",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension.",
"Description": "Methyldopa is an antihypertensive drug. Methyldopa, the L-isomer of alpha-methyldopa, is levo-3-(3,4-dihydroxyphenyl)-2-methylalanine. Its empirical formula is C 10H 13NO 4, with a molecular weight of 211.22, and its structural formula is:. Methyldopa is a white to yellowish white, odorless fine powder, and is soluble in water. Methyldopa Tablets, USP is supplied as tablets, for oral use, in two strengths: 250 mg and 500 mg of methyldopa per tablet. Inactive ingredients in the tablets are: lactose monohydrate, hypromellose , citric acid, corn starch, colloidal silicon dioxide, microcrystalline cellulose, ethyl cellulose, magnesium stearate, and polyethylene glycol."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>62135-533-90</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-533-90) </PackageDescription>
<NDC11Code>62135-0533-90</NDC11Code>
<ProductNDC>62135-533</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078281</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole Sodium Delayed-Release Tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1 H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S x 1.5 H 2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet contains 45.1 mg or 22.55 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, talc, titanium dioxide, and triethyl citrate. The 20 mg tablet also contains black iron oxide, isopropyl alcohol, and propylene glycol. Pantoprazole Sodium Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 4.</Description>
</NDC>
<NDC>
<NDCCode>12634-533-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (12634-533-90)</PackageDescription>
<NDC11Code>12634-0533-90</NDC11Code>
<ProductNDC>12634-533</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077293</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FUROSEMIDE TABLET is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. FUROSEMIDE TABLET is particularly useful when an agent with greater diuretic potential is desired.</IndicationAndUsage>
<Description>FUROSEMIDE TABLET is a diuretic which is an anthranilic acid derivative. FUROSEMIDE TABLET for oral administration contain furosemide as the active ingredient and the following inactive ingredients: lactose anhydrous NF, magnesium stearate NF, starch NF, microcrystalline cellulose NF, sodium starch Glycolate NF, and colloidal silicon dioxide NF. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. FUROSEMIDE TABLET is available as white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. It has a molecular formula of C 12H 11ClN 2O 5S and a molecular weight of 330.75. The molecular structure is as follows.</Description>
</NDC>
<NDC>
<NDCCode>16252-533-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16252-533-90)</PackageDescription>
<NDC11Code>16252-0533-90</NDC11Code>
<ProductNDC>16252-533</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077663</ApplicationNumber>
<LabelerName>Cobalt Laboratories Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>21749-533-90</NDCCode>
<PackageDescription>1250 mL in 1 BOTTLE (21749-533-90) </PackageDescription>
<NDC11Code>21749-0533-90</NDC11Code>
<ProductNDC>21749-533</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Provon Antibacterial Foam Handwash</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<EndMarketingDate>20211201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GOJO Industries, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.003</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130101</StartMarketingDatePackage>
<EndMarketingDatePackage>20211201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49999-533-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (49999-533-90)</PackageDescription>
<NDC11Code>49999-0533-90</NDC11Code>
<ProductNDC>49999-533</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Singulair</ProprietaryName>
<NonProprietaryName>Montelukast Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120321</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020829</ApplicationNumber>
<LabelerName>Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>MONTELUKAST SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-03-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>51655-533-26</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (51655-533-26) </PackageDescription>
<NDC11Code>51655-0533-26</NDC11Code>
<ProductNDC>51655-533</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078512</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 atenolol. 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 1 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 mmHg 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. Atenolol tablets may be administered with other antihypertensive agents. Angina Pectoris Due to Coronary Atherosclerosis Atenolol tablets are indicated for the long-term management of patients with angina pectoris. Acute Myocardial Infarction Atenolol tablets are indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient’s clinical condition allows. (See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.) In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mmHg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta-blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mmHg) seemed less likely to benefit.</IndicationAndUsage>
<Description>Atenolol, a synthetic, beta 1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The structural and molecular formulas are:. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol is available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: sodium starch glycolate, crospovidone, povidone, silicified microcrystalline cellulose, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>61919-533-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (61919-533-90) </PackageDescription>
<NDC11Code>61919-0533-90</NDC11Code>
<ProductNDC>61919-533</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078384</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.2 Left Ventricular Dysfunction Following Myocardial Infarction. Carvedilol Tablet is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies ( 14.2)]. 1.3 Hypertension. Carvedilol Tablet is indicated for the management of essential hypertension [see Clinical Studies ( 14.3, 14.4)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions ( 7.2)].</IndicationAndUsage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure. Carvedilol is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol Tablet is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5).</Description>
</NDC>
<NDC>
<NDCCode>68382-533-16</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-533-16) </PackageDescription>
<NDC11Code>68382-0533-16</NDC11Code>
<ProductNDC>68382-533</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203553</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]., 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)].</IndicationAndUsage>
<Description>Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. C23H27N3O7HCl M. W. 493.95. Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD & C blue #2 aluminum lake; the 80 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 90 mg tablets contain D & C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 115 mg tablets contain FD & C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D & C red #27 aluminum lake, D & C yellow #10 aluminum lake and FD & C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending.</Description>
</NDC>
<NDC>
<NDCCode>71205-533-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71205-533-90) </PackageDescription>
<NDC11Code>71205-0533-90</NDC11Code>
<ProductNDC>71205-533</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205101</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is 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 and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 4.72±0.10 and a pK a2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400 mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc.</Description>
</NDC>
<NDC>
<NDCCode>71610-533-60</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-60) </PackageDescription>
<NDC11Code>71610-0533-60</NDC11Code>
<ProductNDC>71610-533</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078321</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients carboxymethylcellulose sodium, copovidone, hypromellose, magnesium stearate and microcrystalline cellulose. The USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>76420-533-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (76420-533-90) </PackageDescription>
<NDC11Code>76420-0533-90</NDC11Code>
<ProductNDC>76420-533</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19861210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071321</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240308</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Diazepam tablets, USP are a benzodiazepine derivative. The chemical name of diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is an off-white to yellow crystalline powder, insoluble in water. The structural formula is as follows. C 16H 13ClN 2O M.W. 284.74. Diazepam tablets, USP are available as 2 mg, 5 mg, or 10 mg tablets for oral administration containing the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>62135-041-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-041-90) </PackageDescription>
<NDC11Code>62135-0041-90</NDC11Code>
<ProductNDC>62135-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosinopril Sodium</ProprietaryName>
<NonProprietaryName>Fosinopril Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076483</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>FOSINOPRIL SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION) . In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS). In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema).</IndicationAndUsage>
<Description>Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl- 1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium, USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. Empirical formula: C 30H 45NNa0 7P Molecular weight: 585.65. Fosinopril Sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: carnauba wax, crospovidone, lactose anhydrous, microcrystalline cellulose, and zinc stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-042-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-042-90) </PackageDescription>
<NDC11Code>62135-0042-90</NDC11Code>
<ProductNDC>62135-042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosinopril Sodium</ProprietaryName>
<NonProprietaryName>Fosinopril Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076483</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>FOSINOPRIL SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION) . In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS). In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema).</IndicationAndUsage>
<Description>Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl- 1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium, USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. Empirical formula: C 30H 45NNa0 7P Molecular weight: 585.65. Fosinopril Sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: carnauba wax, crospovidone, lactose anhydrous, microcrystalline cellulose, and zinc stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-043-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-043-90) </PackageDescription>
<NDC11Code>62135-0043-90</NDC11Code>
<ProductNDC>62135-043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosinopril Sodium</ProprietaryName>
<NonProprietaryName>Fosinopril Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076483</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>FOSINOPRIL SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION) . In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS). In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema).</IndicationAndUsage>
<Description>Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl- 1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium, USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. Empirical formula: C 30H 45NNa0 7P Molecular weight: 585.65. Fosinopril Sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: carnauba wax, crospovidone, lactose anhydrous, microcrystalline cellulose, and zinc stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-051-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-051-90) </PackageDescription>
<NDC11Code>62135-0051-90</NDC11Code>
<ProductNDC>62135-051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxazosin Mesylate</ProprietaryName>
<NonProprietaryName>Doxazosin Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075646</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1) : 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.</IndicationAndUsage>
<Description>Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23H 25N 5O 5 · CH 4O 3S and the molecular weight is 547.6. It has the following structure:. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-052-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-052-90) </PackageDescription>
<NDC11Code>62135-0052-90</NDC11Code>
<ProductNDC>62135-052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxazosin Mesylate</ProprietaryName>
<NonProprietaryName>Doxazosin Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075646</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1) : 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.</IndicationAndUsage>
<Description>Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23H 25N 5O 5 · CH 4O 3S and the molecular weight is 547.6. It has the following structure:. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-053-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-053-90) </PackageDescription>
<NDC11Code>62135-0053-90</NDC11Code>
<ProductNDC>62135-053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxazosin Mesylate</ProprietaryName>
<NonProprietaryName>Doxazosin Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075646</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1) : 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.</IndicationAndUsage>
<Description>Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23H 25N 5O 5 · CH 4O 3S and the molecular weight is 547.6. It has the following structure:. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-054-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-054-90) </PackageDescription>
<NDC11Code>62135-0054-90</NDC11Code>
<ProductNDC>62135-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxazosin Mesylate</ProprietaryName>
<NonProprietaryName>Doxazosin Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075646</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1) : 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.</IndicationAndUsage>
<Description>Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23H 25N 5O 5 · CH 4O 3S and the molecular weight is 547.6. It has the following structure:. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-067-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (62135-067-90) </PackageDescription>
<NDC11Code>62135-0067-90</NDC11Code>
<ProductNDC>62135-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840806</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018829</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules, USP and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see Warnings: Gastrointestinal Bleeding, Ulceration, and Perforation). Indomethacin has been found effective in active stages of the following. 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). 5. Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin capsules, USP for oral administration contains 25 mg of indomethacin. Each capsule contains the following inactive ingredients: corn starch, croscarmellose sodium, lactose monohydrate, polyethylene glycol 4000, stearic acid, and talc. The capsule shell contains D&C Yellow #10, FD&C Green #3, gelatin, and titanium dioxide. The black imprinting ink contains alcohol, black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, ferrosoferric oxide, n-butyl alcohol, propylene glycol, and shellac glaze. Indomethacin is a nonsteroidal anti-inflammatory indole derivative designated chemically as 1 – (4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. The structural formula is. Indomethacin is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The molecular weight of indomethacin is 357.79 and its molecular formula is C 19H 16C 1NO 4.</Description>
</NDC>
<NDC>
<NDCCode>62135-068-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (62135-068-90) </PackageDescription>
<NDC11Code>62135-0068-90</NDC11Code>
<ProductNDC>62135-068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070651</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin Capsules is indicated for. : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis, 3 Moderate to severe osteoarthritis, 4 Acute painful shoulder (bursitis and/or tendinitis), 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules are nonsteroidal anti-inflammatory drugs, available as capsules containing 50 mg of indomethacin, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C 19H 16C lNO 4, and it has the following chemical structure. Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in Indomethacin Capsules 50 mg include: lactose monohydrate, corn starch, croscarmellose sodium, polyethylene glycol, stearic acid, talc, gelatin, titanium dioxide, D&C Yellow #10, and FD&C Green #3. Black printing ink contains shellac, black iron oxide, n-butyl alcohol, ethanol, methanol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10, and FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>62135-205-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-205-90) </PackageDescription>
<NDC11Code>62135-0205-90</NDC11Code>
<ProductNDC>62135-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methimazole</ProprietaryName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040411</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
<Description>Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>62135-206-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-206-90) </PackageDescription>
<NDC11Code>62135-0206-90</NDC11Code>
<ProductNDC>62135-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methimazole</ProprietaryName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040411</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
<Description>Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>62135-210-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-210-90) </PackageDescription>
<NDC11Code>62135-0210-90</NDC11Code>
<ProductNDC>62135-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folic Acid</ProprietaryName>
<NonProprietaryName>Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090035</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>FOLIC ACID</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Folic acid, N-[ p-[[(2-amino-4-hydroxy-6-pteridinyl)methyl]-amino] benzoyl]L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid is prepared synthetically. Folic acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid (sodium folate). Aqueous solutions of folic acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light. The structural formula of folic acid is as follows. Each tablet, for oral administration, contains 1 mg folic acid. Folic acid tablets, USP 1 mg contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, lactose monohydrate, sodium starch glycolate and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>62135-236-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-236-90) </PackageDescription>
<NDC11Code>62135-0236-90</NDC11Code>
<ProductNDC>62135-236</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyproheptadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyproheptadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830526</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088212</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>CYPROHEPTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Perennial and seasonal allergic rhinitis, Vasomotor rhinitis, Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Cold urticaria. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.</IndicationAndUsage>
<Description>DESCRIPTION: Cyproheptadine HCl, is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride is a while to slightly yellowish, crystalline, solid. with a molecular weight of 350.89, which is slightly soluble in water, freely soluble in methanol, sparingly soluble in ethanol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5H-dibenzo (a, d) cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C 21H 21NHC1. and the structural formula of the anhydrous salt is:. Cyproheptadine hydrochloride is available in 4 mg tablets. Each tablet contains. Active Ingredient. Cyproheptad1ne Hydrochloride ...................... 4 mg. Each tablet contains. Inactive Ingredients:. Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>62135-242-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (62135-242-90) </PackageDescription>
<NDC11Code>62135-0242-90</NDC11Code>
<ProductNDC>62135-242</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naltrexone Hydrochloride</ProprietaryName>
<NonProprietaryName>Naltrexone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207905</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>NALTREXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naltrexone hydrochloride tablets are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride tablets have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.</IndicationAndUsage>
<Description>Naltrexone hydrochloride tablets, USP an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl group. Naltrexone hydrochloride, USP is also related to the potent opioid antagonist, naloxone, or n-allylnoroxymorphone. Naltrexone hydrochloride. Naltrexone hydrochloride is a white or almost white powder. The hydrochloride salt is freely soluble in water. Naltrexone hydrochloride tablets, USP are available as film-coated tablets containing 50 mg of naltrexone hydrochloride. Naltrexone hydrochloride tablets, USP also contain: lactose monohydrate, hypromellose, magnesium stearate, polyethylene glycol, titanium dioxide, colloidal silicon dioxide, hydroxypropyl cellulose, yellow ferric oxide and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>62135-271-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (62135-271-90) </PackageDescription>
<NDC11Code>62135-0271-90</NDC11Code>
<ProductNDC>62135-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramipril</ProprietaryName>
<NonProprietaryName>Ramipril</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200826</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078745</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>RAMIPRIL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor 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. It may be used alone or in combination with thiazide diuretics ( 1.1). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3).</IndicationAndUsage>
<Description>Ramipril, USP is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2 S, 3a S, 6a S)-1 [( S)- N-[( S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [ b]pyrrole-2-carboxylic acid, 1-ethyl ester. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains D&C Yellow # 10 and FD&C Yellow # 6 the 2.5 mg capsule shell contains D&C Red # 28, D&C Yellow # 10 and FD&C Red #40, the 5 mg capsule shell contains D&C Red # 28, D&C Red # 33, D&C Yellow # 10 and FD&C Blue #1, and the 10 mg capsule shell contains D&C Red # 28, and FD&C Blue #1. Capsule shells are imprinted with black ink containing shellac, black iron oxide, n-butyl alcohol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10 and FD&C Blue #1. The structural formula for ramipril is. Its molecular formula is C 23H 32N 2O 5and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
</NDC>
<NDC>
<NDCCode>62135-272-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (62135-272-90) </PackageDescription>
<NDC11Code>62135-0272-90</NDC11Code>
<ProductNDC>62135-272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramipril</ProprietaryName>
<NonProprietaryName>Ramipril</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200826</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078745</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>RAMIPRIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor 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. It may be used alone or in combination with thiazide diuretics ( 1.1). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3).</IndicationAndUsage>
<Description>Ramipril, USP is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2 S, 3a S, 6a S)-1 [( S)- N-[( S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [ b]pyrrole-2-carboxylic acid, 1-ethyl ester. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains D&C Yellow # 10 and FD&C Yellow # 6 the 2.5 mg capsule shell contains D&C Red # 28, D&C Yellow # 10 and FD&C Red #40, the 5 mg capsule shell contains D&C Red # 28, D&C Red # 33, D&C Yellow # 10 and FD&C Blue #1, and the 10 mg capsule shell contains D&C Red # 28, and FD&C Blue #1. Capsule shells are imprinted with black ink containing shellac, black iron oxide, n-butyl alcohol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10 and FD&C Blue #1. The structural formula for ramipril is. Its molecular formula is C 23H 32N 2O 5and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
</NDC>
<NDC>
<NDCCode>62135-273-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (62135-273-90) </PackageDescription>
<NDC11Code>62135-0273-90</NDC11Code>
<ProductNDC>62135-273</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramipril</ProprietaryName>
<NonProprietaryName>Ramipril</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200826</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078745</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>RAMIPRIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor 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. It may be used alone or in combination with thiazide diuretics ( 1.1). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3).</IndicationAndUsage>
<Description>Ramipril, USP is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2 S, 3a S, 6a S)-1 [( S)- N-[( S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [ b]pyrrole-2-carboxylic acid, 1-ethyl ester. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains D&C Yellow # 10 and FD&C Yellow # 6 the 2.5 mg capsule shell contains D&C Red # 28, D&C Yellow # 10 and FD&C Red #40, the 5 mg capsule shell contains D&C Red # 28, D&C Red # 33, D&C Yellow # 10 and FD&C Blue #1, and the 10 mg capsule shell contains D&C Red # 28, and FD&C Blue #1. Capsule shells are imprinted with black ink containing shellac, black iron oxide, n-butyl alcohol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10 and FD&C Blue #1. The structural formula for ramipril is. Its molecular formula is C 23H 32N 2O 5and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
</NDC>
<NDC>
<NDCCode>62135-274-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (62135-274-90) </PackageDescription>
<NDC11Code>62135-0274-90</NDC11Code>
<ProductNDC>62135-274</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramipril</ProprietaryName>
<NonProprietaryName>Ramipril</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200826</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078745</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>RAMIPRIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor 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. It may be used alone or in combination with thiazide diuretics ( 1.1). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3).</IndicationAndUsage>
<Description>Ramipril, USP is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2 S, 3a S, 6a S)-1 [( S)- N-[( S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [ b]pyrrole-2-carboxylic acid, 1-ethyl ester. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains D&C Yellow # 10 and FD&C Yellow # 6 the 2.5 mg capsule shell contains D&C Red # 28, D&C Yellow # 10 and FD&C Red #40, the 5 mg capsule shell contains D&C Red # 28, D&C Red # 33, D&C Yellow # 10 and FD&C Blue #1, and the 10 mg capsule shell contains D&C Red # 28, and FD&C Blue #1. Capsule shells are imprinted with black ink containing shellac, black iron oxide, n-butyl alcohol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10 and FD&C Blue #1. The structural formula for ramipril is. Its molecular formula is C 23H 32N 2O 5and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
</NDC>
<NDC>
<NDCCode>62135-321-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (62135-321-90) </PackageDescription>
<NDC11Code>62135-0321-90</NDC11Code>
<ProductNDC>62135-321</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methyldopa</ProprietaryName>
<NonProprietaryName>Methyldopa</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840629</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018934</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METHYLDOPA</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension.</IndicationAndUsage>
<Description>Methyldopa is an antihypertensive drug. Methyldopa, the L-isomer of alpha-methyldopa, is levo-3-(3,4-dihydroxyphenyl)-2-methylalanine. Its empirical formula is C 10H 13NO 4, with a molecular weight of 211.22, and its structural formula is:. Methyldopa is a white to yellowish white, odorless fine powder, and is soluble in water. Methyldopa Tablets, USP is supplied as tablets, for oral use, in two strengths: 250 mg and 500 mg of methyldopa per tablet. Inactive ingredients in the tablets are: lactose monohydrate, hypromellose , citric acid, corn starch, colloidal silicon dioxide, microcrystalline cellulose, ethyl cellulose, magnesium stearate, and polyethylene glycol.</Description>
</NDC>
</NDCList>