{
"NDC": [
{
"NDCCode": "43598-863-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-863-10) ",
"NDC11Code": "43598-0863-10",
"ProductNDC": "43598-863",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride (sr)",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206122",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160817",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets, USP (SR) are indicated as an aid to smoking cessation treatment.",
"Description": "Bupropion hydrochloride extended-release tablets, USP (SR) are a non-nicotine aid to smoking cessation. Bupropion is chemically unrelated to nicotine or other agents currently used in the treatment of nicotine addiction. Initially developed and marketed as an antidepressant (WELLBUTRIN [bupropion hydrochloride] tablets and WELLBUTRIN SR [bupropion hydrochloride] sustained-release tablets), Bupropion hydrochloride extended-release tablets, USP (SR) is also chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride USP is white powder, and soluble in 0.1N Hydrochloric acid, in alcohol (96.0%) and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR) are supplied for oral administration as 150-mg (purple), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, FD&C Blue No.2 Lake and FD&C Red No. 40 Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP dissolution Test 2."
},
{
"NDCCode": "43598-863-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-863-30) ",
"NDC11Code": "43598-0863-30",
"ProductNDC": "43598-863",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride (sr)",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206122",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160817",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets, USP (SR) are indicated as an aid to smoking cessation treatment.",
"Description": "Bupropion hydrochloride extended-release tablets, USP (SR) are a non-nicotine aid to smoking cessation. Bupropion is chemically unrelated to nicotine or other agents currently used in the treatment of nicotine addiction. Initially developed and marketed as an antidepressant (WELLBUTRIN [bupropion hydrochloride] tablets and WELLBUTRIN SR [bupropion hydrochloride] sustained-release tablets), Bupropion hydrochloride extended-release tablets, USP (SR) is also chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride USP is white powder, and soluble in 0.1N Hydrochloric acid, in alcohol (96.0%) and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR) are supplied for oral administration as 150-mg (purple), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, FD&C Blue No.2 Lake and FD&C Red No. 40 Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP dissolution Test 2."
},
{
"NDCCode": "43598-863-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-863-60) ",
"NDC11Code": "43598-0863-60",
"ProductNDC": "43598-863",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride (sr)",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206122",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160817",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets, USP (SR) are indicated as an aid to smoking cessation treatment.",
"Description": "Bupropion hydrochloride extended-release tablets, USP (SR) are a non-nicotine aid to smoking cessation. Bupropion is chemically unrelated to nicotine or other agents currently used in the treatment of nicotine addiction. Initially developed and marketed as an antidepressant (WELLBUTRIN [bupropion hydrochloride] tablets and WELLBUTRIN SR [bupropion hydrochloride] sustained-release tablets), Bupropion hydrochloride extended-release tablets, USP (SR) is also chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride USP is white powder, and soluble in 0.1N Hydrochloric acid, in alcohol (96.0%) and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR) are supplied for oral administration as 150-mg (purple), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, FD&C Blue No.2 Lake and FD&C Red No. 40 Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP dissolution Test 2."
},
{
"NDCCode": "16571-863-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-863-10) ",
"NDC11Code": "16571-0863-10",
"ProductNDC": "16571-863",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211020",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N"
},
{
"NDCCode": "21130-863-10",
"PackageDescription": "2 BOTTLE, SPRAY in 1 CARTON (21130-863-10) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "21130-0863-10",
"ProductNDC": "21130-863",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20250106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207957",
"LabelerName": "Safeway",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250304",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 itchy nose, 3 runny nose, 4 itchy, watery eyes, 5 sneezing."
},
{
"NDCCode": "50458-863-02",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-863-02) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "50458-0863-02",
"ProductNDC": "50458-863",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nucynta",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110825",
"EndMarketingDate": "20200331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200533",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2020-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110825",
"EndMarketingDatePackage": "20200331",
"SamplePackage": "N"
},
{
"NDCCode": "50594-863-10",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (50594-863-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "50594-0863-10",
"ProductNDC": "50594-863",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Reliever Pm",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hcl",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210820",
"EndMarketingDate": "20260820",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Big Lots",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210820",
"EndMarketingDatePackage": "20260820",
"SamplePackage": "N",
"IndicationAndUsage": "temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness."
},
{
"NDCCode": "54458-863-10",
"PackageDescription": "30 TABLET, COATED in 1 BLISTER PACK (54458-863-10) ",
"NDC11Code": "54458-0863-10",
"ProductNDC": "54458-863",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benazepril Hydrochloride",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076118",
"LabelerName": "International Laboratories, LLC",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140201",
"SamplePackage": "N",
"IndicationAndUsage": "Benazepril hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per 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. It may be used alone or in combination with thiazide diuretics.",
"Description": "Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril hydrochloride is supplied as film-coated tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide, and triacetin. The 10 mg tablet also contains FD&C Red No. 40 aluminum lake. The 20 mg tablet also contains black iron oxide and yellow iron oxide. The 40 mg tablet also contains FD&C Blue No. 2 aluminum lake. Benazepril hydrochloride tablets USP, 5 mg, 10 mg, 20 mg and 40 mg meet USP Dissolution Test 2."
},
{
"NDCCode": "55319-863-10",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (55319-863-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "55319-0863-10",
"ProductNDC": "55319-863",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Relief Pm",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hcl",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200228",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Family Dollar (FAMILY WELLNESS)",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200228",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness."
},
{
"NDCCode": "60429-863-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (60429-863-10) ",
"NDC11Code": "60429-0863-10",
"ProductNDC": "60429-863",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076958",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170309",
"SamplePackage": "N"
},
{
"NDCCode": "60687-863-56",
"PackageDescription": "10 TRAY in 1 CASE (60687-863-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-863-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-863-42) ",
"NDC11Code": "60687-0863-56",
"ProductNDC": "60687-863",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20241020",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "American Health Packaging",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2024-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241020",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive."
},
{
"NDCCode": "62037-863-20",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (62037-863-20) > 1 SYRINGE in 1 BLISTER PACK > 1 mL in 1 SYRINGE",
"NDC11Code": "62037-0863-20",
"ProductNDC": "62037-863",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enoxaparin Sodium",
"NonProprietaryName": "Enoxaparin Sodium",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20120213",
"EndMarketingDate": "20180630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076684",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "ENOXAPARIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120213",
"EndMarketingDatePackage": "20180630",
"SamplePackage": "N"
},
{
"NDCCode": "68382-863-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68382-863-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-863-30) ",
"NDC11Code": "68382-0863-77",
"ProductNDC": "68382-863",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207382",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180405",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate extended-release capsules are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules are available as 25 mg, 50 mg and 100 mg capsules for oral administration. Topiramate, USP is a white to off-white crystalline powder. Topiramate is freely soluble in dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate extended-release capsules contain 25 mg, 50 mg, 100 mg or 200 mg of. topiramate and contains following inactive ingredients: ethyl cellulose, hypromellose. microcrystalline cellulose, polyethylene glycol, talc and triethyl citrate. Additionally, each 25 mg, 50 mg and 100 mg capsule contain hydrogenated castor oil. and povidone and each 200 mg capsule contains hydroxypropyl cellulose. The capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide and water. The capsule is imprinted with black pharmaceutical ink and contains following. inactive ingredients: black iron oxide, potassium hydroxide and shellac."
},
{
"NDCCode": "68382-863-78",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68382-863-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-863-30) ",
"NDC11Code": "68382-0863-78",
"ProductNDC": "68382-863",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207382",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240910",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate extended-release capsules are indicated for: 1 Epilepsy:initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg and 200 mg capsules for oral administration. Topiramate, USP is a white to off-white crystalline powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate extended-release capsules, USP contain 25 mg, 50 mg ,100 mg or 200 mg of topiramate. Additionally, each capsule contains the following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and triethyl citrate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and water. All capsule shells are imprinted with black pharmaceutical ink that contains black iron oxide, potassium hydroxide, propylene glycol and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "68462-863-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (68462-863-10) ",
"NDC11Code": "68462-0863-10",
"ProductNDC": "68462-863",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorpromazine Hydrochloride",
"NonProprietaryName": "Chlorpromazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212144",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CHLORPROMAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2024-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210323",
"SamplePackage": "N",
"IndicationAndUsage": "For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.",
"Description": "Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chemical Name: C17H19ClN2S.HCl. Molecular Weight: 355.33 g/mol. Chlorpromazine hydrochloride, USP occurs as white or slightly creamy white crystalline powder. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive Ingredients:. 10 mg contains: corn starch, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. The coating material opadry brown contains diethyl phthalate, D&C yellow no 10, ethylcellulose, FD&C blue no 2, FD&C yellow no 6, hypromellose, red iron oxide, talc, and titanium dioxide. 25 mg contains: corn starch, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. The coating material opadry orange contains diethyl phthalate, D&C yellow no 10, ethylcellulose, FD&C yellow no 6, hypromellose, red iron oxide, talc, and titanium dioxide. 50 mg, 100 mg and 200 mg contains: corn starch, colloidal silicon dioxide, lactose monohydrate, anhydrous lactose, microcrystalline cellulose, magnesium stearate, poloxamer 188 micro, pregelatinized starch, povidone, and sodium starch glycolate. The coating material opadry brown contains diethyl phthalate, D&C yellow no 10, ethylcellulose, FD&C blue no 2, FD&C yellow no 6, hypromellose, red iron oxide, talc, and titanium dioxide."
},
{
"NDCCode": "71610-863-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (71610-863-10) ",
"NDC11Code": "71610-0863-10",
"ProductNDC": "71610-863",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077856",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"Description": "Clonazepam Tablets USP, a benzodiazepine, is available as scored tablets containing 0.5 mg of clonazepam and unscored tablets containing 1 mg or 2 mg of clonazepam. Each tablet also contains colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose, with the following colorants: 0.5 mg – D&C Yellow #10 aluminum lake; 1 mg – FD&C Blue #1 aluminum lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2 H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:."
},
{
"NDCCode": "43598-001-10",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-001-10) ",
"NDC11Code": "43598-0001-10",
"ProductNDC": "43598-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078421",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240909",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP."
},
{
"NDCCode": "43598-002-10",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-10) ",
"NDC11Code": "43598-0002-10",
"ProductNDC": "43598-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078421",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240909",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP."
},
{
"NDCCode": "43598-008-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-008-10) ",
"NDC11Code": "43598-0008-10",
"ProductNDC": "43598-008",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"StartMarketingDate": "20220315",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-07-30",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "15-MAR-22"
},
{
"NDCCode": "43598-009-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-009-10) ",
"NDC11Code": "43598-0009-10",
"ProductNDC": "43598-009",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"StartMarketingDate": "20220315",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "1200",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-07-30",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "15-MAR-22"
},
{
"NDCCode": "43598-027-48",
"PackageDescription": "1 KIT in 1 CARTON (43598-027-48) * 10 mL in 1 VIAL, SINGLE-DOSE (43598-029-50) * 10 mL in 1 VIAL, SINGLE-USE (43598-028-35) ",
"NDC11Code": "43598-0027-48",
"ProductNDC": "43598-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Melphalan Hydrochloride",
"NonProprietaryName": "Melphalan Hydrochloride",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203655",
"LabelerName": "Dr.Reddy's Laboratories Inc",
"Status": "Deprecated",
"LastUpdate": "2025-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210426",
"SamplePackage": "N",
"IndicationAndUsage": "Melphalan hydrochloride for injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.",
"Description": "Melphalan, also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent that is active against selected human neoplastic diseases. It is known chemically as 4-[bis(2-chloroethyl)amino]-L-phenylalanine monohydrochloride. The molecular formula is C13H18Cl2N2O2. HCl and the molecular weight is 341.67. The structural formula is:. Melphalan is the active L-isomer of the compound and was first synthesized in 1953 by Bergel and Stock; the D-isomer, known as medphalan, is less active against certain animal tumors, and the dose needed to produce effects on chromosomes is larger than that required with the L-isomer. The racemic (DL-) form is known as merphalan or sarcolysin. Melphalan is practically insoluble in water and has a pKa1 of∼2.5. Melphalan salt is practically insoluble in acetone and chlorinated organic solvents. Slightly soluble in methanol and ethanol. Soluble in water, 0.1 N HCl and 0.1 N NaOH. Melphalan hydrochloride for injection is supplied as a sterile,nonpyrogenic, freeze-dried powder. Each single-dose vial contains melphalan hydrochloride equivalent to 50 mg melphalan and 20 mg povidone. Melphalan hydrochloride for injection is reconstituted using the sterile diluent provided. Each vial of sterile diluent contains sodium citrate 0.2 g, propylene glycol 6 mL, ethanol (96%) 0.52 mL, and Water for Injection toa total of 10 mL. Melphalan hydrochloride for injection is administered intravenously."
},
{
"NDCCode": "43598-032-37",
"PackageDescription": "10 CARTON in 1 BOX (43598-032-37) / 1 SYRINGE, GLASS in 1 CARTON (43598-032-11) / .5 mL in 1 SYRINGE, GLASS",
"NDC11Code": "43598-0032-37",
"ProductNDC": "43598-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phytonadione",
"NonProprietaryName": "Phytonadione",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20261005",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215820",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "PHYTONADIONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261005",
"SamplePackage": "N",
"Description": "Phytonadione is a vitamin K replacement, which is an intense yellow viscous oily liquid. It is very soluble in ether, chloroform, and hexane; soluble in ethanol and very slightly soluble in water. It has a molecular weight of 450.7. Phytonadione is 2-Methyl-3’,7’,11’,15’-tetramethyl-hexadec-2’-enylnaphthalene-1,4-dione. Its molecular formula is C31H46O2 and its molecular structure is. Phytonadione Injectable Emulsion, USP injection is a clear yellow color, sterile solution of vitamin K1, with a pH of 3.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Phytonadione Injectable Emulsion, USP is available in 1 mg (1 mg/0.5 mL) single-dose prefilled syringes. Each 0.5 mL of Phytonadione Injectable Emulsion, USP contains the following inactive ingredients: 10 mg polysorbate 80, 10.4 mg propylene glycol, 0.17 mg sodium acetate anhydrous, and 0.00002 mL glacial acetic acid. Additional glacial acetic acid or sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 3.5 to 7.0."
},
{
"NDCCode": "43598-053-11",
"PackageDescription": "1 VIAL in 1 CARTON (43598-053-11) > 10 mL in 1 VIAL",
"NDC11Code": "43598-0053-11",
"ProductNDC": "43598-053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desmopressin Acetate",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20220912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215961",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2022-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220912",
"SamplePackage": "N",
"Description": "Desmopressin Acetate Injection, USP is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1068.4. Molecular Formula: C46H64N14O12S2 C2H4O2. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt). Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
},
{
"NDCCode": "43598-078-58",
"PackageDescription": "10 VIAL in 1 CARTON (43598-078-58) / 1 mL in 1 VIAL (43598-078-11) ",
"NDC11Code": "43598-0078-58",
"ProductNDC": "43598-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalaprilat",
"NonProprietaryName": "Enalaprilat",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075578",
"LabelerName": "Dr. Reddys Laboratories Inc",
"SubstanceName": "ENALAPRILAT",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2024-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": "Enalaprilat injection is indicated for the treatment of hypertension when oral therapy is not practical. Enalaprilat injection has been studied with only one other antihypertensive agent, furosemide, which showed approximately additive effects on blood pressure. Enalapril, the pro-drug of enalaprilat, has been used extensively with a variety of other antihypertensive agents, without apparent difficulty except for occasional hypotension. In using enalaprilat injection, 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, and that available data are insufficient to show that enalaprilat injection does not have a similar risk (see WARNINGS). In considering use of enalaprilat, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Angioedema).",
"Description": "Enalaprilat injection, USP is a sterile aqueous solution for intravenous administration. Enalaprilat is an angiotensin-converting enzyme inhibitor. It is chemically described as (S)-1-[N-(1-carboxy-3-phenylpropyl)-L-alanyl]-L-proline dihydrate. Its molecular formula is C18H24N2O52H2O and its structural formula is. Enalaprilat, USP is a white or almost white crystalline powder with a molecular weight of 384.43. It is sparingly soluble in methanol and slightly soluble in water. Each milliliter of enalaprilat injection, USP contains 1.25 mg enalaprilat, USP (anhydrous equivalent); sodium chloride to adjust tonicity; sodium hydroxide to adjust pH; water for injection, q.s.; with benzyl alcohol, 9 mg, added as a preservative."
},
{
"NDCCode": "43598-086-58",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (43598-086-58) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "43598-0086-58",
"ProductNDC": "43598-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"ProprietaryNameSuffix": "Doxycycline",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218753",
"LabelerName": "Dr. Reddy's Laboratories, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250718",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline for injection and other antibacterial drugs, doxycycline for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated in infections caused by the following microorganisms: 1 Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, , 2 Q fever, rickettsial pox and tick fevers)., 3 Mycoplasma pneumoniae (PPLO, Eaton Agent). , 4 Agents of psittacosis and ornithosis., 5 Agents of lymphogranuloma venereum and granuloma inguinale., 6 The spirochetal agent of relapsing fever (Borrelia recurrentis).",
"Description": "Doxycycline for Injection, USP is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate, USP, ascorbic acid and mannitol in Water for Injection. Doxycycline hyclate, USP is a broad spectrum antibiotic derived from oxytetracycline. It is meant for INTRAVENOUS use only after reconstitution. Doxycycline hyclate, USP is a yellow to light yellow powder which is chemically designated 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11- dioxo-2-naphthacenecarboxamide, monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. It has the following structural formula. (C22H24N2O8·HCl)2·C2H6O·H2O M.W.1025.89. Doxycycline hyclate, USP is soluble in water and chars at 201°C without melting. The base doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Each 100 mg vial contains: Doxycycline hyclate, USP equivalent to 100 mg doxycycline; ascorbic acid 480 mg; mannitol 300 mg. pH of the reconstituted solution (10 mg/mL) is between 1.8 and 3.3."
},
{
"NDCCode": "43598-087-58",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (43598-087-58) / 20 mL in 1 VIAL, SINGLE-DOSE (43598-087-11) ",
"NDC11Code": "43598-0087-58",
"ProductNDC": "43598-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217718",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240422",
"SamplePackage": "N",
"Description": "The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "43598-098-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (43598-098-78) / 10 TABLET in 1 BLISTER PACK (43598-098-10) ",
"NDC11Code": "43598-0098-78",
"ProductNDC": "43598-098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214659",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5."
},
{
"NDCCode": "43598-099-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (43598-099-78) / 10 TABLET in 1 BLISTER PACK (43598-099-10) ",
"NDC11Code": "43598-0099-78",
"ProductNDC": "43598-099",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214659",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5."
},
{
"NDCCode": "43598-101-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (43598-101-78) / 10 TABLET in 1 BLISTER PACK (43598-101-10) ",
"NDC11Code": "43598-0101-78",
"ProductNDC": "43598-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214659",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5."
},
{
"NDCCode": "43598-103-81",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (43598-103-81) / 10 TABLET in 1 BLISTER PACK (43598-103-10) ",
"NDC11Code": "43598-0103-81",
"ProductNDC": "43598-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214659",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>43598-863-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-863-10) </PackageDescription>
<NDC11Code>43598-0863-10</NDC11Code>
<ProductNDC>43598-863</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride (sr)</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206122</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets, USP (SR) are indicated as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets, USP (SR) are a non-nicotine aid to smoking cessation. Bupropion is chemically unrelated to nicotine or other agents currently used in the treatment of nicotine addiction. Initially developed and marketed as an antidepressant (WELLBUTRIN [bupropion hydrochloride] tablets and WELLBUTRIN SR [bupropion hydrochloride] sustained-release tablets), Bupropion hydrochloride extended-release tablets, USP (SR) is also chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride USP is white powder, and soluble in 0.1N Hydrochloric acid, in alcohol (96.0%) and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR) are supplied for oral administration as 150-mg (purple), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, FD&C Blue No.2 Lake and FD&C Red No. 40 Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-863-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-863-30) </PackageDescription>
<NDC11Code>43598-0863-30</NDC11Code>
<ProductNDC>43598-863</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride (sr)</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206122</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets, USP (SR) are indicated as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets, USP (SR) are a non-nicotine aid to smoking cessation. Bupropion is chemically unrelated to nicotine or other agents currently used in the treatment of nicotine addiction. Initially developed and marketed as an antidepressant (WELLBUTRIN [bupropion hydrochloride] tablets and WELLBUTRIN SR [bupropion hydrochloride] sustained-release tablets), Bupropion hydrochloride extended-release tablets, USP (SR) is also chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride USP is white powder, and soluble in 0.1N Hydrochloric acid, in alcohol (96.0%) and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR) are supplied for oral administration as 150-mg (purple), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, FD&C Blue No.2 Lake and FD&C Red No. 40 Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-863-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-863-60) </PackageDescription>
<NDC11Code>43598-0863-60</NDC11Code>
<ProductNDC>43598-863</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride (sr)</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206122</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets, USP (SR) are indicated as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets, USP (SR) are a non-nicotine aid to smoking cessation. Bupropion is chemically unrelated to nicotine or other agents currently used in the treatment of nicotine addiction. Initially developed and marketed as an antidepressant (WELLBUTRIN [bupropion hydrochloride] tablets and WELLBUTRIN SR [bupropion hydrochloride] sustained-release tablets), Bupropion hydrochloride extended-release tablets, USP (SR) is also chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride USP is white powder, and soluble in 0.1N Hydrochloric acid, in alcohol (96.0%) and in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (SR) are supplied for oral administration as 150-mg (purple), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, FD&C Blue No.2 Lake and FD&C Red No. 40 Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide. Bupropion hydrochloride extended-release tablets, USP (SR) meets USP dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>16571-863-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-863-10) </PackageDescription>
<NDC11Code>16571-0863-10</NDC11Code>
<ProductNDC>16571-863</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211020</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>21130-863-10</NDCCode>
<PackageDescription>2 BOTTLE, SPRAY in 1 CARTON (21130-863-10) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>21130-0863-10</NDC11Code>
<ProductNDC>21130-863</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20250106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207957</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 itchy nose, 3 runny nose, 4 itchy, watery eyes, 5 sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50458-863-02</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-863-02) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50458-0863-02</NDC11Code>
<ProductNDC>50458-863</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nucynta</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110825</StartMarketingDate>
<EndMarketingDate>20200331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200533</ApplicationNumber>
<LabelerName>Janssen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110825</StartMarketingDatePackage>
<EndMarketingDatePackage>20200331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50594-863-10</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (50594-863-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50594-0863-10</NDC11Code>
<ProductNDC>50594-863</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Reliever Pm</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210820</StartMarketingDate>
<EndMarketingDate>20260820</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Big Lots</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210820</StartMarketingDatePackage>
<EndMarketingDatePackage>20260820</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54458-863-10</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BLISTER PACK (54458-863-10) </PackageDescription>
<NDC11Code>54458-0863-10</NDC11Code>
<ProductNDC>54458-863</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076118</ApplicationNumber>
<LabelerName>International Laboratories, LLC</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benazepril hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per 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. It may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
<Description>Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril hydrochloride is supplied as film-coated tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide, and triacetin. The 10 mg tablet also contains FD&C Red No. 40 aluminum lake. The 20 mg tablet also contains black iron oxide and yellow iron oxide. The 40 mg tablet also contains FD&C Blue No. 2 aluminum lake. Benazepril hydrochloride tablets USP, 5 mg, 10 mg, 20 mg and 40 mg meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55319-863-10</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (55319-863-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>55319-0863-10</NDC11Code>
<ProductNDC>55319-863</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Relief Pm</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200228</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Family Dollar (FAMILY WELLNESS)</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200228</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60429-863-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (60429-863-10) </PackageDescription>
<NDC11Code>60429-0863-10</NDC11Code>
<ProductNDC>60429-863</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076958</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60687-863-56</NDCCode>
<PackageDescription>10 TRAY in 1 CASE (60687-863-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-863-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-863-42) </PackageDescription>
<NDC11Code>60687-0863-56</NDC11Code>
<ProductNDC>60687-863</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guaifenesin</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241020</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62037-863-20</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (62037-863-20) > 1 SYRINGE in 1 BLISTER PACK > 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>62037-0863-20</NDC11Code>
<ProductNDC>62037-863</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enoxaparin Sodium</ProprietaryName>
<NonProprietaryName>Enoxaparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20120213</StartMarketingDate>
<EndMarketingDate>20180630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076684</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>ENOXAPARIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120213</StartMarketingDatePackage>
<EndMarketingDatePackage>20180630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-863-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68382-863-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-863-30) </PackageDescription>
<NDC11Code>68382-0863-77</NDC11Code>
<ProductNDC>68382-863</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207382</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate extended-release capsules are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate, is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules are available as 25 mg, 50 mg and 100 mg capsules for oral administration. Topiramate, USP is a white to off-white crystalline powder. Topiramate is freely soluble in dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate extended-release capsules contain 25 mg, 50 mg, 100 mg or 200 mg of. topiramate and contains following inactive ingredients: ethyl cellulose, hypromellose. microcrystalline cellulose, polyethylene glycol, talc and triethyl citrate. Additionally, each 25 mg, 50 mg and 100 mg capsule contain hydrogenated castor oil. and povidone and each 200 mg capsule contains hydroxypropyl cellulose. The capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide and water. The capsule is imprinted with black pharmaceutical ink and contains following. inactive ingredients: black iron oxide, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>68382-863-78</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68382-863-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-863-30) </PackageDescription>
<NDC11Code>68382-0863-78</NDC11Code>
<ProductNDC>68382-863</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207382</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate extended-release capsules are indicated for: 1 Epilepsy:initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg and 200 mg capsules for oral administration. Topiramate, USP is a white to off-white crystalline powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate extended-release capsules, USP contain 25 mg, 50 mg ,100 mg or 200 mg of topiramate. Additionally, each capsule contains the following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and triethyl citrate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and water. All capsule shells are imprinted with black pharmaceutical ink that contains black iron oxide, potassium hydroxide, propylene glycol and shellac. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>68462-863-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (68462-863-10) </PackageDescription>
<NDC11Code>68462-0863-10</NDC11Code>
<ProductNDC>68462-863</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212144</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.</IndicationAndUsage>
<Description>Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chemical Name: C17H19ClN2S.HCl. Molecular Weight: 355.33 g/mol. Chlorpromazine hydrochloride, USP occurs as white or slightly creamy white crystalline powder. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive Ingredients:. 10 mg contains: corn starch, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. The coating material opadry brown contains diethyl phthalate, D&C yellow no 10, ethylcellulose, FD&C blue no 2, FD&C yellow no 6, hypromellose, red iron oxide, talc, and titanium dioxide. 25 mg contains: corn starch, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. The coating material opadry orange contains diethyl phthalate, D&C yellow no 10, ethylcellulose, FD&C yellow no 6, hypromellose, red iron oxide, talc, and titanium dioxide. 50 mg, 100 mg and 200 mg contains: corn starch, colloidal silicon dioxide, lactose monohydrate, anhydrous lactose, microcrystalline cellulose, magnesium stearate, poloxamer 188 micro, pregelatinized starch, povidone, and sodium starch glycolate. The coating material opadry brown contains diethyl phthalate, D&C yellow no 10, ethylcellulose, FD&C blue no 2, FD&C yellow no 6, hypromellose, red iron oxide, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-863-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (71610-863-10) </PackageDescription>
<NDC11Code>71610-0863-10</NDC11Code>
<ProductNDC>71610-863</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077856</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Clonazepam Tablets USP, a benzodiazepine, is available as scored tablets containing 0.5 mg of clonazepam and unscored tablets containing 1 mg or 2 mg of clonazepam. Each tablet also contains colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose, with the following colorants: 0.5 mg – D&C Yellow #10 aluminum lake; 1 mg – FD&C Blue #1 aluminum lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2 H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>43598-001-10</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-001-10) </PackageDescription>
<NDC11Code>43598-0001-10</NDC11Code>
<ProductNDC>43598-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078421</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>43598-002-10</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-10) </PackageDescription>
<NDC11Code>43598-0002-10</NDC11Code>
<ProductNDC>43598-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078421</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>43598-008-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-008-10) </PackageDescription>
<NDC11Code>43598-0008-10</NDC11Code>
<ProductNDC>43598-008</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<StartMarketingDate>20220315</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-30</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-MAR-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>43598-009-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-009-10) </PackageDescription>
<NDC11Code>43598-0009-10</NDC11Code>
<ProductNDC>43598-009</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<StartMarketingDate>20220315</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-30</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-MAR-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>43598-027-48</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (43598-027-48) * 10 mL in 1 VIAL, SINGLE-DOSE (43598-029-50) * 10 mL in 1 VIAL, SINGLE-USE (43598-028-35) </PackageDescription>
<NDC11Code>43598-0027-48</NDC11Code>
<ProductNDC>43598-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Melphalan Hydrochloride</ProprietaryName>
<NonProprietaryName>Melphalan Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203655</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Inc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Melphalan hydrochloride for injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.</IndicationAndUsage>
<Description>Melphalan, also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent that is active against selected human neoplastic diseases. It is known chemically as 4-[bis(2-chloroethyl)amino]-L-phenylalanine monohydrochloride. The molecular formula is C13H18Cl2N2O2. HCl and the molecular weight is 341.67. The structural formula is:. Melphalan is the active L-isomer of the compound and was first synthesized in 1953 by Bergel and Stock; the D-isomer, known as medphalan, is less active against certain animal tumors, and the dose needed to produce effects on chromosomes is larger than that required with the L-isomer. The racemic (DL-) form is known as merphalan or sarcolysin. Melphalan is practically insoluble in water and has a pKa1 of∼2.5. Melphalan salt is practically insoluble in acetone and chlorinated organic solvents. Slightly soluble in methanol and ethanol. Soluble in water, 0.1 N HCl and 0.1 N NaOH. Melphalan hydrochloride for injection is supplied as a sterile,nonpyrogenic, freeze-dried powder. Each single-dose vial contains melphalan hydrochloride equivalent to 50 mg melphalan and 20 mg povidone. Melphalan hydrochloride for injection is reconstituted using the sterile diluent provided. Each vial of sterile diluent contains sodium citrate 0.2 g, propylene glycol 6 mL, ethanol (96%) 0.52 mL, and Water for Injection toa total of 10 mL. Melphalan hydrochloride for injection is administered intravenously.</Description>
</NDC>
<NDC>
<NDCCode>43598-032-37</NDCCode>
<PackageDescription>10 CARTON in 1 BOX (43598-032-37) / 1 SYRINGE, GLASS in 1 CARTON (43598-032-11) / .5 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>43598-0032-37</NDC11Code>
<ProductNDC>43598-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phytonadione</ProprietaryName>
<NonProprietaryName>Phytonadione</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20261005</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215820</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>PHYTONADIONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Phytonadione is a vitamin K replacement, which is an intense yellow viscous oily liquid. It is very soluble in ether, chloroform, and hexane; soluble in ethanol and very slightly soluble in water. It has a molecular weight of 450.7. Phytonadione is 2-Methyl-3’,7’,11’,15’-tetramethyl-hexadec-2’-enylnaphthalene-1,4-dione. Its molecular formula is C31H46O2 and its molecular structure is. Phytonadione Injectable Emulsion, USP injection is a clear yellow color, sterile solution of vitamin K1, with a pH of 3.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Phytonadione Injectable Emulsion, USP is available in 1 mg (1 mg/0.5 mL) single-dose prefilled syringes. Each 0.5 mL of Phytonadione Injectable Emulsion, USP contains the following inactive ingredients: 10 mg polysorbate 80, 10.4 mg propylene glycol, 0.17 mg sodium acetate anhydrous, and 0.00002 mL glacial acetic acid. Additional glacial acetic acid or sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 3.5 to 7.0.</Description>
</NDC>
<NDC>
<NDCCode>43598-053-11</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (43598-053-11) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>43598-0053-11</NDC11Code>
<ProductNDC>43598-053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desmopressin Acetate</ProprietaryName>
<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215961</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Desmopressin Acetate Injection, USP is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1068.4. Molecular Formula: C46H64N14O12S2 C2H4O2. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt). Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>43598-078-58</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (43598-078-58) / 1 mL in 1 VIAL (43598-078-11) </PackageDescription>
<NDC11Code>43598-0078-58</NDC11Code>
<ProductNDC>43598-078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalaprilat</ProprietaryName>
<NonProprietaryName>Enalaprilat</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075578</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Inc</LabelerName>
<SubstanceName>ENALAPRILAT</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enalaprilat injection is indicated for the treatment of hypertension when oral therapy is not practical. Enalaprilat injection has been studied with only one other antihypertensive agent, furosemide, which showed approximately additive effects on blood pressure. Enalapril, the pro-drug of enalaprilat, has been used extensively with a variety of other antihypertensive agents, without apparent difficulty except for occasional hypotension. In using enalaprilat injection, 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, and that available data are insufficient to show that enalaprilat injection does not have a similar risk (see WARNINGS). In considering use of enalaprilat, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Angioedema).</IndicationAndUsage>
<Description>Enalaprilat injection, USP is a sterile aqueous solution for intravenous administration. Enalaprilat is an angiotensin-converting enzyme inhibitor. It is chemically described as (S)-1-[N-(1-carboxy-3-phenylpropyl)-L-alanyl]-L-proline dihydrate. Its molecular formula is C18H24N2O52H2O and its structural formula is. Enalaprilat, USP is a white or almost white crystalline powder with a molecular weight of 384.43. It is sparingly soluble in methanol and slightly soluble in water. Each milliliter of enalaprilat injection, USP contains 1.25 mg enalaprilat, USP (anhydrous equivalent); sodium chloride to adjust tonicity; sodium hydroxide to adjust pH; water for injection, q.s.; with benzyl alcohol, 9 mg, added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>43598-086-58</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (43598-086-58) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>43598-0086-58</NDC11Code>
<ProductNDC>43598-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<ProprietaryNameSuffix>Doxycycline</ProprietaryNameSuffix>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218753</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline for injection and other antibacterial drugs, doxycycline for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated in infections caused by the following microorganisms: 1 Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, , 2 Q fever, rickettsial pox and tick fevers)., 3 Mycoplasma pneumoniae (PPLO, Eaton Agent). , 4 Agents of psittacosis and ornithosis., 5 Agents of lymphogranuloma venereum and granuloma inguinale., 6 The spirochetal agent of relapsing fever (Borrelia recurrentis).</IndicationAndUsage>
<Description>Doxycycline for Injection, USP is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate, USP, ascorbic acid and mannitol in Water for Injection. Doxycycline hyclate, USP is a broad spectrum antibiotic derived from oxytetracycline. It is meant for INTRAVENOUS use only after reconstitution. Doxycycline hyclate, USP is a yellow to light yellow powder which is chemically designated 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11- dioxo-2-naphthacenecarboxamide, monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. It has the following structural formula. (C22H24N2O8·HCl)2·C2H6O·H2O M.W.1025.89. Doxycycline hyclate, USP is soluble in water and chars at 201°C without melting. The base doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Each 100 mg vial contains: Doxycycline hyclate, USP equivalent to 100 mg doxycycline; ascorbic acid 480 mg; mannitol 300 mg. pH of the reconstituted solution (10 mg/mL) is between 1.8 and 3.3.</Description>
</NDC>
<NDC>
<NDCCode>43598-087-58</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (43598-087-58) / 20 mL in 1 VIAL, SINGLE-DOSE (43598-087-11) </PackageDescription>
<NDC11Code>43598-0087-58</NDC11Code>
<ProductNDC>43598-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217718</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>43598-098-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (43598-098-78) / 10 TABLET in 1 BLISTER PACK (43598-098-10) </PackageDescription>
<NDC11Code>43598-0098-78</NDC11Code>
<ProductNDC>43598-098</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214659</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>43598-099-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (43598-099-78) / 10 TABLET in 1 BLISTER PACK (43598-099-10) </PackageDescription>
<NDC11Code>43598-0099-78</NDC11Code>
<ProductNDC>43598-099</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214659</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>43598-101-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (43598-101-78) / 10 TABLET in 1 BLISTER PACK (43598-101-10) </PackageDescription>
<NDC11Code>43598-0101-78</NDC11Code>
<ProductNDC>43598-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214659</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>43598-103-81</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (43598-103-81) / 10 TABLET in 1 BLISTER PACK (43598-103-10) </PackageDescription>
<NDC11Code>43598-0103-81</NDC11Code>
<ProductNDC>43598-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214659</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5.</Description>
</NDC>
</NDCList>