{
"NDC": [
{
"NDCCode": "54458-885-10",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (54458-885-10)",
"NDC11Code": "54458-0885-10",
"ProductNDC": "54458-885",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131208",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021073",
"LabelerName": "International Laboratories, LLC",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (1.1, 14). Important Limitation of Use. Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.2).",
"Description": "Pioglitazone tablets are an oral antidiabetic medication. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets are available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF."
},
{
"NDCCode": "14593-885-02",
"PackageDescription": "10 kg in 1 BOTTLE (14593-885-02) ",
"NDC11Code": "14593-0885-02",
"ProductNDC": "14593-885",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Propofol",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20220214",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Emcure Pharmaceuticals Limited",
"SubstanceName": "PROPOFOL",
"StrengthNumber": "2",
"StrengthUnit": "kg/2kg",
"Status": "Unfinished",
"LastUpdate": "2025-11-28",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "14-FEB-22"
},
{
"NDCCode": "16571-885-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (16571-885-10) ",
"NDC11Code": "16571-0885-10",
"ProductNDC": "16571-885",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230921",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA016084",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230921",
"SamplePackage": "N",
"IndicationAndUsage": "Allopurinol tablet is indicated for: 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy), 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels , 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables).",
"Description": "Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored white hexagon-shaped tablet contains 100 mg allopurinol and the inactive ingredients lactose monohydrate, magnesium stearate, potato starch, and povidone. Each scored white round tablet contains 200 mg allopurinol and the inactive ingredients lactose monohydrate, magnesium stearate, corn starch, and povidone. Each scored peach tablet contains 300 mg allopurinol and the inactive ingredients corn starch, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and povidone."
},
{
"NDCCode": "21695-885-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (21695-885-10)",
"NDC11Code": "21695-0885-10",
"ProductNDC": "21695-885",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040596",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate."
},
{
"NDCCode": "31722-885-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (31722-885-10) ",
"NDC11Code": "31722-0885-10",
"ProductNDC": "31722-885",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161029",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207616",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210104",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). 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 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending."
},
{
"NDCCode": "43598-885-10",
"PackageDescription": "1 TUBE in 1 CARTON (43598-885-10) / 100 g in 1 TUBE",
"NDC11Code": "43598-0885-10",
"ProductNDC": "43598-885",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium Topical Gel, 1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210986",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201214",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) . this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use."
},
{
"NDCCode": "51326-885-01",
"PackageDescription": "10.5 g in 1 TUBE (51326-885-01) ",
"NDC11Code": "51326-0885-01",
"ProductNDC": "51326-885",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Perfect 10 Soothing Recovery",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Topiderm, Inc.",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "84",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190701",
"SamplePackage": "N",
"IndicationAndUsage": "Helps provide a moist environment that temporarily protects minor cuts, scrapes, burns and helps prevent chapped or cracked skin."
},
{
"NDCCode": "55910-885-10",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (55910-885-10) / 100 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "55910-0885-10",
"ProductNDC": "55910-885",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Senna Laxative",
"NonProprietaryName": "Sennosides",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210910",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)",
"SubstanceName": "SENNOSIDES",
"StrengthNumber": "8.6",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-03-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210910",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces bowel movement in 6-12 hours."
},
{
"NDCCode": "58160-885-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-885-52) > .5 mL in 1 SYRINGE (58160-885-41) ",
"NDC11Code": "58160-0885-52",
"ProductNDC": "58160-885",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluarix Quadrivalent",
"ProprietaryNameSuffix": "2020/2021",
"NonProprietaryName": "Influenza Virus Vaccine",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20200702",
"EndMarketingDate": "20210630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125127",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 NIB-121 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "15; 15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200702",
"EndMarketingDatePackage": "20210630",
"SamplePackage": "N"
},
{
"NDCCode": "62135-885-23",
"PackageDescription": "2 TRAY in 1 BOX (62135-885-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-885-10) ",
"NDC11Code": "62135-0885-23",
"ProductNDC": "62135-885",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide Oral Solution",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215154",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250210",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide Oral Solution is indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2) .",
"Description": "The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3 methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "62135-885-24",
"PackageDescription": "2 TRAY in 1 BOX (62135-885-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-885-05) ",
"NDC11Code": "62135-0885-24",
"ProductNDC": "62135-885",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide Oral Solution",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215154",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250210",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide Oral Solution is indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2) .",
"Description": "The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3 methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "63323-885-10",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-885-10) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "63323-0885-10",
"ProductNDC": "63323-885",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180529",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210632",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180529",
"SamplePackage": "N",
"IndicationAndUsage": "Levothyroxine Sodium Injection is indicated for the treatment of myxedema coma.",
"Description": "Levothyroxine Sodium Injection contains synthetic crystalline levothyroxine (T4) in sodium salt form. Levothyroxine sodium has an empirical formula of C15H10I4NNaO4, a molecular weight of 798.85 g/mol (anhydrous), and the following structural formula:. Levothyroxine Sodium Injection is a sterile, preservative free, clear, colorless, sterile solution for intravenous administration available as: 100 mcg per 5 mL (20 mcg per mL), 200 mcg per 5 mL (40 mcg per mL), and 500 mcg per 5 mL (100 mcg per mL). Each mL of Levothyroxine Sodium Injection also contains 10 mg Tromethamine, USP; 0.14 mg Sodium Iodide, USP; 6.48 mg Sodium Chloride, USP; and Water for Injection, USP Sodium hydroxide, NF and/or Hydrochloric acid, USP may have been added for pH adjustment (9.5 – 10.8). Levothyroxine Sodium Injection is in single dose clear glass vials."
},
{
"NDCCode": "68999-885-23",
"PackageDescription": "2 TRAY in 1 BOX (68999-885-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (68999-885-10) ",
"NDC11Code": "68999-0885-23",
"ProductNDC": "68999-885",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide Oral Solution",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215154",
"LabelerName": "Chartwell Governmental & Specialty RX, LLC.",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260114",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide Oral Solution is indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2) .",
"Description": "The chemical name of Lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3 methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "68999-885-24",
"PackageDescription": "2 TRAY in 1 BOX (68999-885-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-885-05) ",
"NDC11Code": "68999-0885-24",
"ProductNDC": "68999-885",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide Oral Solution",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215154",
"LabelerName": "Chartwell Governmental & Specialty RX, LLC.",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260114",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide Oral Solution is indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2) .",
"Description": "The chemical name of Lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3 methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "69584-885-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69584-885-10) ",
"NDC11Code": "69584-0885-10",
"ProductNDC": "69584-885",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trazodone Hydrochloride",
"NonProprietaryName": "Trazodone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072193",
"LabelerName": "Oxford Pharmaceuticals, LLC",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230301",
"SamplePackage": "N",
"IndicationAndUsage": "Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Trazodone hydrochloride tablets for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride tablets are a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows. Each tablet, for oral administration, contains 50 mg or 100 mg of trazodone hydrochloride, USP. In addition, each tablet contains hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, pregelatinized corn starch, silicon dioxide, and titanium dioxide."
},
{
"NDCCode": "71205-885-10",
"PackageDescription": "10 CAPSULE in 1 BOTTLE (71205-885-10) ",
"NDC11Code": "71205-0885-10",
"ProductNDC": "71205-885",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210802",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091310",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210917",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate capsules USP are indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan- 28-yl p-(butylamino) benzoate; with a molecular weight of 603.0. Each benzonatate capsule USP, 100 mg contains: Benzonatate, USP 100 mg. Each benzonatate capsule USP, 200 mg contains: Benzonatate, USP 200 mg. Benzonatate capsules USP also contain: gelatin 175 bloom bone NF, glycerin 99% USP, methyl/propyl paraben blend (4:1 ), yellow #10-DC and white ink (shellac glaze in SD-45, titanium dioxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide and simethicone)."
},
{
"NDCCode": "76420-885-11",
"PackageDescription": "10 TABLET in 1 BLISTER PACK (76420-885-11) ",
"NDC11Code": "76420-0885-11",
"ProductNDC": "76420-885",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208187",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241227",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine tablets are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1).",
"Description": "Tizanidine tablets, USP contains tizanidine hydrochloride as the active ingredient, which is a central alpha 2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C 9H 8ClN 5S-HCl and a molecular weight of 290.2. Its structural formula is:. Tizanidine Hydrochloride is a white to slightly yellow crystalline powder. Tizanidine is slightly soluble in water and methanol. Each tizanidine tablet, USP intended for oral administration contains 2.29 mg or 4.58 mg of tizanidine hydrochloride USP, which is equivalent to 2 mg or 4 mg of tizanidine base. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "76420-885-88",
"PackageDescription": "10 TABLET in 1 BOTTLE (76420-885-88) ",
"NDC11Code": "76420-0885-88",
"ProductNDC": "76420-885",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208187",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241227",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine tablets are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1).",
"Description": "Tizanidine tablets, USP contains tizanidine hydrochloride as the active ingredient, which is a central alpha 2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C 9H 8ClN 5S-HCl and a molecular weight of 290.2. Its structural formula is:. Tizanidine Hydrochloride is a white to slightly yellow crystalline powder. Tizanidine is slightly soluble in water and methanol. Each tizanidine tablet, USP intended for oral administration contains 2.29 mg or 4.58 mg of tizanidine hydrochloride USP, which is equivalent to 2 mg or 4 mg of tizanidine base. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "76420-885-99",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (76420-885-99) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "76420-0885-99",
"ProductNDC": "76420-885",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208187",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241227",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine tablets are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1).",
"Description": "Tizanidine tablets, USP contains tizanidine hydrochloride as the active ingredient, which is a central alpha 2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C 9H 8ClN 5S-HCl and a molecular weight of 290.2. Its structural formula is:. Tizanidine Hydrochloride is a white to slightly yellow crystalline powder. Tizanidine is slightly soluble in water and methanol. Each tizanidine tablet, USP intended for oral administration contains 2.29 mg or 4.58 mg of tizanidine hydrochloride USP, which is equivalent to 2 mg or 4 mg of tizanidine base. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "54458-862-10",
"PackageDescription": "30 TABLET, COATED in 1 BLISTER PACK (54458-862-10)",
"NDC11Code": "54458-0862-10",
"ProductNDC": "54458-862",
"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": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-12-21",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"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": "54458-864-10",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (54458-864-10)",
"NDC11Code": "54458-0864-10",
"ProductNDC": "54458-864",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077210",
"LabelerName": "International Laboratories, LLC",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Monotherapy and Combination Therapy. Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)]. Important Limitations of Use. Pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].",
"Description": "Pioglitazone hydrochloride tablets USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. C19H20N2O3SHCl M.W. 392.90. Pioglitazone hydrochloride, USP is an odorless white crystalline powder. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone tablets USP are available for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: carboxymethylcellulose calcium, hydroxypropyl cellulose, magnesium stearate, and mannitol."
},
{
"NDCCode": "54458-865-10",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (54458-865-10)",
"NDC11Code": "54458-0865-10",
"ProductNDC": "54458-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077210",
"LabelerName": "International Laboratories, LLC",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Monotherapy and Combination Therapy. Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)]. Important Limitations of Use. Pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].",
"Description": "Pioglitazone hydrochloride tablets USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. C19H20N2O3SHCl M.W. 392.90. Pioglitazone hydrochloride, USP is an odorless white crystalline powder. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone tablets USP are available for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: carboxymethylcellulose calcium, hydroxypropyl cellulose, magnesium stearate, and mannitol."
},
{
"NDCCode": "54458-866-10",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (54458-866-10)",
"NDC11Code": "54458-0866-10",
"ProductNDC": "54458-866",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077210",
"LabelerName": "International Laboratories, LLC",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Monotherapy and Combination Therapy. Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)]. Important Limitations of Use. Pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].",
"Description": "Pioglitazone hydrochloride tablets USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. C19H20N2O3SHCl M.W. 392.90. Pioglitazone hydrochloride, USP is an odorless white crystalline powder. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone tablets USP are available for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: carboxymethylcellulose calcium, hydroxypropyl cellulose, magnesium stearate, and mannitol."
},
{
"NDCCode": "54458-867-10",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (54458-867-10) ",
"NDC11Code": "54458-0867-10",
"ProductNDC": "54458-867",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076056",
"LabelerName": "International Laboratories, LLC",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.",
"Description": "Pravastatin sodium, USP is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium, USP is designated chemically as 1-naphthaleneheptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α (βS*,δS*),2α,6α,8β(R*),8aα]]-. It has the following structural formula. Pravastatin. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets USP are available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: calcium phosphate dibasic, crospovidone, lactose anhydrous, microcrystalline cellulose, and povidone. Additionally, the 10 mg, 20 mg, and 40 mg tablet contains croscarmellose sodium and sodium stearyl fumarate. Additionally, the 10 mg tablet contains ferric oxide red; the 20 mg tablet contains ferric oxide yellow; the 40 mg tablet contains FD&C Blue No. 1 Aluminum Lake and Yellow D&C No. 10; and the 80 mg tablet contains magnesium stearate."
},
{
"NDCCode": "54458-869-10",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (54458-869-10) ",
"NDC11Code": "54458-0869-10",
"ProductNDC": "54458-869",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076056",
"LabelerName": "International Laboratories, LLC",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.",
"Description": "Pravastatin sodium, USP is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium, USP is designated chemically as 1-naphthaleneheptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α (βS*,δS*),2α,6α,8β(R*),8aα]]-. It has the following structural formula. Pravastatin. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets USP are available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: calcium phosphate dibasic, crospovidone, lactose anhydrous, microcrystalline cellulose, and povidone. Additionally, the 10 mg, 20 mg, and 40 mg tablet contains croscarmellose sodium and sodium stearyl fumarate. Additionally, the 10 mg tablet contains ferric oxide red; the 20 mg tablet contains ferric oxide yellow; the 40 mg tablet contains FD&C Blue No. 1 Aluminum Lake and Yellow D&C No. 10; and the 80 mg tablet contains magnesium stearate."
},
{
"NDCCode": "54458-870-10",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (54458-870-10) ",
"NDC11Code": "54458-0870-10",
"ProductNDC": "54458-870",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
"NonProprietaryName": "Lovastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075551",
"LabelerName": "International Laboratories, LLC",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150520",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with Lovastatin Tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin Tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.",
"Description": "Lovastatin, USP is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, USP, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin, USP is [1S-[1α(R*),3α,7β,8β(2S*,4S*),8aβ]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. Its structural formula is. C24H36O5 M.W. 404.55. C24H36O5 M.W. 404.55. Lovastatin, USP is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin Tablets USP are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, USP, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized corn starch. Butylated hydroxyanisole (BHA) is added as a preservative. Lovastatin Tablets USP, 10 mg also contain FD&C Yellow #6 Aluminum Lake. Lovastatin Tablets USP, 20 mg also contain FD&C Blue #1 Aluminum Lake. Lovastatin Tablets USP, 40 mg also contain D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, and FD&C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "54458-871-10",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (54458-871-10) ",
"NDC11Code": "54458-0871-10",
"ProductNDC": "54458-871",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
"NonProprietaryName": "Lovastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075551",
"LabelerName": "International Laboratories, LLC",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150520",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with Lovastatin Tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin Tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.",
"Description": "Lovastatin, USP is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, USP, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin, USP is [1S-[1α(R*),3α,7β,8β(2S*,4S*),8aβ]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. Its structural formula is. C24H36O5 M.W. 404.55. C24H36O5 M.W. 404.55. Lovastatin, USP is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin Tablets USP are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, USP, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized corn starch. Butylated hydroxyanisole (BHA) is added as a preservative. Lovastatin Tablets USP, 10 mg also contain FD&C Yellow #6 Aluminum Lake. Lovastatin Tablets USP, 20 mg also contain FD&C Blue #1 Aluminum Lake. Lovastatin Tablets USP, 40 mg also contain D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, and FD&C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "54458-872-10",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (54458-872-10) ",
"NDC11Code": "54458-0872-10",
"ProductNDC": "54458-872",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077321",
"LabelerName": "International Laboratories, LLC",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150512",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril tablet USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril Structure. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch and starch (corn). 5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, red ferric oxide, pre-gelatinized starch and starch (corn). 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, yellow ferric oxide, pre-gelatinized starch and starch (corn)."
},
{
"NDCCode": "54458-873-10",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (54458-873-10) ",
"NDC11Code": "54458-0873-10",
"ProductNDC": "54458-873",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077321",
"LabelerName": "International Laboratories, LLC",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150512",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril tablet USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril Structure. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch and starch (corn). 5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, red ferric oxide, pre-gelatinized starch and starch (corn). 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, yellow ferric oxide, pre-gelatinized starch and starch (corn)."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>54458-885-10</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (54458-885-10)</PackageDescription>
<NDC11Code>54458-0885-10</NDC11Code>
<ProductNDC>54458-885</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131208</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021073</ApplicationNumber>
<LabelerName>International Laboratories, LLC</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (1.1, 14). Important Limitation of Use. Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.2).</IndicationAndUsage>
<Description>Pioglitazone tablets are an oral antidiabetic medication. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets are available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF.</Description>
</NDC>
<NDC>
<NDCCode>14593-885-02</NDCCode>
<PackageDescription>10 kg in 1 BOTTLE (14593-885-02) </PackageDescription>
<NDC11Code>14593-0885-02</NDC11Code>
<ProductNDC>14593-885</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Propofol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20220214</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Emcure Pharmaceuticals Limited</LabelerName>
<SubstanceName>PROPOFOL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>kg/2kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-28</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>14-FEB-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>16571-885-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (16571-885-10) </PackageDescription>
<NDC11Code>16571-0885-10</NDC11Code>
<ProductNDC>16571-885</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230921</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA016084</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allopurinol tablet is indicated for: 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy), 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels , 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables).</IndicationAndUsage>
<Description>Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored white hexagon-shaped tablet contains 100 mg allopurinol and the inactive ingredients lactose monohydrate, magnesium stearate, potato starch, and povidone. Each scored white round tablet contains 200 mg allopurinol and the inactive ingredients lactose monohydrate, magnesium stearate, corn starch, and povidone. Each scored peach tablet contains 300 mg allopurinol and the inactive ingredients corn starch, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>21695-885-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (21695-885-10)</PackageDescription>
<NDC11Code>21695-0885-10</NDC11Code>
<ProductNDC>21695-885</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040596</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>31722-885-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (31722-885-10) </PackageDescription>
<NDC11Code>31722-0885-10</NDC11Code>
<ProductNDC>31722-885</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161029</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207616</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</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>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). 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 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>43598-885-10</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (43598-885-10) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>43598-0885-10</NDC11Code>
<ProductNDC>43598-885</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium Topical Gel, 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210986</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) . this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51326-885-01</NDCCode>
<PackageDescription>10.5 g in 1 TUBE (51326-885-01) </PackageDescription>
<NDC11Code>51326-0885-01</NDC11Code>
<ProductNDC>51326-885</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Perfect 10 Soothing Recovery</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Topiderm, Inc.</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>84</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps provide a moist environment that temporarily protects minor cuts, scrapes, burns and helps prevent chapped or cracked skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55910-885-10</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (55910-885-10) / 100 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>55910-0885-10</NDC11Code>
<ProductNDC>55910-885</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Senna Laxative</ProprietaryName>
<NonProprietaryName>Sennosides</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210910</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)</LabelerName>
<SubstanceName>SENNOSIDES</SubstanceName>
<StrengthNumber>8.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces bowel movement in 6-12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58160-885-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-885-52) > .5 mL in 1 SYRINGE (58160-885-41) </PackageDescription>
<NDC11Code>58160-0885-52</NDC11Code>
<ProductNDC>58160-885</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluarix Quadrivalent</ProprietaryName>
<ProprietaryNameSuffix>2020/2021</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20200702</StartMarketingDate>
<EndMarketingDate>20210630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125127</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 NIB-121 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200702</StartMarketingDatePackage>
<EndMarketingDatePackage>20210630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62135-885-23</NDCCode>
<PackageDescription>2 TRAY in 1 BOX (62135-885-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-885-10) </PackageDescription>
<NDC11Code>62135-0885-23</NDC11Code>
<ProductNDC>62135-885</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide Oral Solution</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215154</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</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>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide Oral Solution is indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2) .</IndicationAndUsage>
<Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3 methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>62135-885-24</NDCCode>
<PackageDescription>2 TRAY in 1 BOX (62135-885-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-885-05) </PackageDescription>
<NDC11Code>62135-0885-24</NDC11Code>
<ProductNDC>62135-885</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide Oral Solution</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215154</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</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>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide Oral Solution is indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2) .</IndicationAndUsage>
<Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3 methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>63323-885-10</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (63323-885-10) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>63323-0885-10</NDC11Code>
<ProductNDC>63323-885</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180529</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210632</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levothyroxine Sodium Injection is indicated for the treatment of myxedema coma.</IndicationAndUsage>
<Description>Levothyroxine Sodium Injection contains synthetic crystalline levothyroxine (T4) in sodium salt form. Levothyroxine sodium has an empirical formula of C15H10I4NNaO4, a molecular weight of 798.85 g/mol (anhydrous), and the following structural formula:. Levothyroxine Sodium Injection is a sterile, preservative free, clear, colorless, sterile solution for intravenous administration available as: 100 mcg per 5 mL (20 mcg per mL), 200 mcg per 5 mL (40 mcg per mL), and 500 mcg per 5 mL (100 mcg per mL). Each mL of Levothyroxine Sodium Injection also contains 10 mg Tromethamine, USP; 0.14 mg Sodium Iodide, USP; 6.48 mg Sodium Chloride, USP; and Water for Injection, USP Sodium hydroxide, NF and/or Hydrochloric acid, USP may have been added for pH adjustment (9.5 – 10.8). Levothyroxine Sodium Injection is in single dose clear glass vials.</Description>
</NDC>
<NDC>
<NDCCode>68999-885-23</NDCCode>
<PackageDescription>2 TRAY in 1 BOX (68999-885-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (68999-885-10) </PackageDescription>
<NDC11Code>68999-0885-23</NDC11Code>
<ProductNDC>68999-885</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide Oral Solution</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215154</ApplicationNumber>
<LabelerName>Chartwell Governmental & Specialty RX, LLC.</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>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide Oral Solution is indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2) .</IndicationAndUsage>
<Description>The chemical name of Lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3 methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>68999-885-24</NDCCode>
<PackageDescription>2 TRAY in 1 BOX (68999-885-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-885-05) </PackageDescription>
<NDC11Code>68999-0885-24</NDC11Code>
<ProductNDC>68999-885</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide Oral Solution</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215154</ApplicationNumber>
<LabelerName>Chartwell Governmental & Specialty RX, LLC.</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>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide Oral Solution is indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2) .</IndicationAndUsage>
<Description>The chemical name of Lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3 methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13H 18N 2O 3and its molecular weight is 250.30. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>69584-885-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69584-885-10) </PackageDescription>
<NDC11Code>69584-0885-10</NDC11Code>
<ProductNDC>69584-885</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072193</ApplicationNumber>
<LabelerName>Oxford Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Trazodone hydrochloride tablets for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride tablets are a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows. Each tablet, for oral administration, contains 50 mg or 100 mg of trazodone hydrochloride, USP. In addition, each tablet contains hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, pregelatinized corn starch, silicon dioxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71205-885-10</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE (71205-885-10) </PackageDescription>
<NDC11Code>71205-0885-10</NDC11Code>
<ProductNDC>71205-885</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210802</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091310</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210917</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules USP are indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan- 28-yl p-(butylamino) benzoate; with a molecular weight of 603.0. Each benzonatate capsule USP, 100 mg contains: Benzonatate, USP 100 mg. Each benzonatate capsule USP, 200 mg contains: Benzonatate, USP 200 mg. Benzonatate capsules USP also contain: gelatin 175 bloom bone NF, glycerin 99% USP, methyl/propyl paraben blend (4:1 ), yellow #10-DC and white ink (shellac glaze in SD-45, titanium dioxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide and simethicone).</Description>
</NDC>
<NDC>
<NDCCode>76420-885-11</NDCCode>
<PackageDescription>10 TABLET in 1 BLISTER PACK (76420-885-11) </PackageDescription>
<NDC11Code>76420-0885-11</NDC11Code>
<ProductNDC>76420-885</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208187</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine tablets are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1).</IndicationAndUsage>
<Description>Tizanidine tablets, USP contains tizanidine hydrochloride as the active ingredient, which is a central alpha 2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C 9H 8ClN 5S-HCl and a molecular weight of 290.2. Its structural formula is:. Tizanidine Hydrochloride is a white to slightly yellow crystalline powder. Tizanidine is slightly soluble in water and methanol. Each tizanidine tablet, USP intended for oral administration contains 2.29 mg or 4.58 mg of tizanidine hydrochloride USP, which is equivalent to 2 mg or 4 mg of tizanidine base. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>76420-885-88</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (76420-885-88) </PackageDescription>
<NDC11Code>76420-0885-88</NDC11Code>
<ProductNDC>76420-885</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208187</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine tablets are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1).</IndicationAndUsage>
<Description>Tizanidine tablets, USP contains tizanidine hydrochloride as the active ingredient, which is a central alpha 2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C 9H 8ClN 5S-HCl and a molecular weight of 290.2. Its structural formula is:. Tizanidine Hydrochloride is a white to slightly yellow crystalline powder. Tizanidine is slightly soluble in water and methanol. Each tizanidine tablet, USP intended for oral administration contains 2.29 mg or 4.58 mg of tizanidine hydrochloride USP, which is equivalent to 2 mg or 4 mg of tizanidine base. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>76420-885-99</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (76420-885-99) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>76420-0885-99</NDC11Code>
<ProductNDC>76420-885</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208187</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine tablets are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1).</IndicationAndUsage>
<Description>Tizanidine tablets, USP contains tizanidine hydrochloride as the active ingredient, which is a central alpha 2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C 9H 8ClN 5S-HCl and a molecular weight of 290.2. Its structural formula is:. Tizanidine Hydrochloride is a white to slightly yellow crystalline powder. Tizanidine is slightly soluble in water and methanol. Each tizanidine tablet, USP intended for oral administration contains 2.29 mg or 4.58 mg of tizanidine hydrochloride USP, which is equivalent to 2 mg or 4 mg of tizanidine base. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>54458-862-10</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BLISTER PACK (54458-862-10)</PackageDescription>
<NDC11Code>54458-0862-10</NDC11Code>
<ProductNDC>54458-862</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>40</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>2019-12-21</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</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>54458-864-10</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (54458-864-10)</PackageDescription>
<NDC11Code>54458-0864-10</NDC11Code>
<ProductNDC>54458-864</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077210</ApplicationNumber>
<LabelerName>International Laboratories, LLC</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Monotherapy and Combination Therapy. Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)]. Important Limitations of Use. Pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].</IndicationAndUsage>
<Description>Pioglitazone hydrochloride tablets USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. C19H20N2O3SHCl M.W. 392.90. Pioglitazone hydrochloride, USP is an odorless white crystalline powder. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone tablets USP are available for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: carboxymethylcellulose calcium, hydroxypropyl cellulose, magnesium stearate, and mannitol.</Description>
</NDC>
<NDC>
<NDCCode>54458-865-10</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (54458-865-10)</PackageDescription>
<NDC11Code>54458-0865-10</NDC11Code>
<ProductNDC>54458-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077210</ApplicationNumber>
<LabelerName>International Laboratories, LLC</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Monotherapy and Combination Therapy. Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)]. Important Limitations of Use. Pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].</IndicationAndUsage>
<Description>Pioglitazone hydrochloride tablets USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. C19H20N2O3SHCl M.W. 392.90. Pioglitazone hydrochloride, USP is an odorless white crystalline powder. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone tablets USP are available for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: carboxymethylcellulose calcium, hydroxypropyl cellulose, magnesium stearate, and mannitol.</Description>
</NDC>
<NDC>
<NDCCode>54458-866-10</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (54458-866-10)</PackageDescription>
<NDC11Code>54458-0866-10</NDC11Code>
<ProductNDC>54458-866</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077210</ApplicationNumber>
<LabelerName>International Laboratories, LLC</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Monotherapy and Combination Therapy. Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)]. Important Limitations of Use. Pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].</IndicationAndUsage>
<Description>Pioglitazone hydrochloride tablets USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. C19H20N2O3SHCl M.W. 392.90. Pioglitazone hydrochloride, USP is an odorless white crystalline powder. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone tablets USP are available for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: carboxymethylcellulose calcium, hydroxypropyl cellulose, magnesium stearate, and mannitol.</Description>
</NDC>
<NDC>
<NDCCode>54458-867-10</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (54458-867-10) </PackageDescription>
<NDC11Code>54458-0867-10</NDC11Code>
<ProductNDC>54458-867</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076056</ApplicationNumber>
<LabelerName>International Laboratories, LLC</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>Pravastatin sodium, USP is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium, USP is designated chemically as 1-naphthaleneheptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α (βS*,δS*),2α,6α,8β(R*),8aα]]-. It has the following structural formula. Pravastatin. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets USP are available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: calcium phosphate dibasic, crospovidone, lactose anhydrous, microcrystalline cellulose, and povidone. Additionally, the 10 mg, 20 mg, and 40 mg tablet contains croscarmellose sodium and sodium stearyl fumarate. Additionally, the 10 mg tablet contains ferric oxide red; the 20 mg tablet contains ferric oxide yellow; the 40 mg tablet contains FD&C Blue No. 1 Aluminum Lake and Yellow D&C No. 10; and the 80 mg tablet contains magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>54458-869-10</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (54458-869-10) </PackageDescription>
<NDC11Code>54458-0869-10</NDC11Code>
<ProductNDC>54458-869</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076056</ApplicationNumber>
<LabelerName>International Laboratories, LLC</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>Pravastatin sodium, USP is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium, USP is designated chemically as 1-naphthaleneheptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α (βS*,δS*),2α,6α,8β(R*),8aα]]-. It has the following structural formula. Pravastatin. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets USP are available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: calcium phosphate dibasic, crospovidone, lactose anhydrous, microcrystalline cellulose, and povidone. Additionally, the 10 mg, 20 mg, and 40 mg tablet contains croscarmellose sodium and sodium stearyl fumarate. Additionally, the 10 mg tablet contains ferric oxide red; the 20 mg tablet contains ferric oxide yellow; the 40 mg tablet contains FD&C Blue No. 1 Aluminum Lake and Yellow D&C No. 10; and the 80 mg tablet contains magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>54458-870-10</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (54458-870-10) </PackageDescription>
<NDC11Code>54458-0870-10</NDC11Code>
<ProductNDC>54458-870</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075551</ApplicationNumber>
<LabelerName>International Laboratories, LLC</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with Lovastatin Tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin Tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.</IndicationAndUsage>
<Description>Lovastatin, USP is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, USP, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin, USP is [1S-[1α(R*),3α,7β,8β(2S*,4S*),8aβ]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. Its structural formula is. C24H36O5 M.W. 404.55. C24H36O5 M.W. 404.55. Lovastatin, USP is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin Tablets USP are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, USP, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized corn starch. Butylated hydroxyanisole (BHA) is added as a preservative. Lovastatin Tablets USP, 10 mg also contain FD&C Yellow #6 Aluminum Lake. Lovastatin Tablets USP, 20 mg also contain FD&C Blue #1 Aluminum Lake. Lovastatin Tablets USP, 40 mg also contain D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, and FD&C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>54458-871-10</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (54458-871-10) </PackageDescription>
<NDC11Code>54458-0871-10</NDC11Code>
<ProductNDC>54458-871</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075551</ApplicationNumber>
<LabelerName>International Laboratories, LLC</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with Lovastatin Tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin Tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.</IndicationAndUsage>
<Description>Lovastatin, USP is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, USP, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin, USP is [1S-[1α(R*),3α,7β,8β(2S*,4S*),8aβ]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. Its structural formula is. C24H36O5 M.W. 404.55. C24H36O5 M.W. 404.55. Lovastatin, USP is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin Tablets USP are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, USP, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized corn starch. Butylated hydroxyanisole (BHA) is added as a preservative. Lovastatin Tablets USP, 10 mg also contain FD&C Yellow #6 Aluminum Lake. Lovastatin Tablets USP, 20 mg also contain FD&C Blue #1 Aluminum Lake. Lovastatin Tablets USP, 40 mg also contain D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, and FD&C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>54458-872-10</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (54458-872-10) </PackageDescription>
<NDC11Code>54458-0872-10</NDC11Code>
<ProductNDC>54458-872</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077321</ApplicationNumber>
<LabelerName>International Laboratories, LLC</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril tablet USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril Structure. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch and starch (corn). 5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, red ferric oxide, pre-gelatinized starch and starch (corn). 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, yellow ferric oxide, pre-gelatinized starch and starch (corn).</Description>
</NDC>
<NDC>
<NDCCode>54458-873-10</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (54458-873-10) </PackageDescription>
<NDC11Code>54458-0873-10</NDC11Code>
<ProductNDC>54458-873</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077321</ApplicationNumber>
<LabelerName>International Laboratories, LLC</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril tablet USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril Structure. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch and starch (corn). 5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, red ferric oxide, pre-gelatinized starch and starch (corn). 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, yellow ferric oxide, pre-gelatinized starch and starch (corn).</Description>
</NDC>
</NDCList>