{
"NDC": [
{
"NDCCode": "72205-336-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (72205-336-60) ",
"NDC11Code": "72205-0336-60",
"ProductNDC": "72205-336",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivabradine",
"NonProprietaryName": "Ivabradine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213483",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "IVABRADINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "Ivabradine tablets are a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: 1 To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. (1.1).",
"Description": "Ivabradine tablets contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one, hydrochloride. The molecular formula is C27H36N2O5.HCl, and the molecular weight (free base+ HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1.Figure 1. Chemical Structure of IvabradineTablets. Ivabradine tablets are supplied in 5 mg and 7.5 mg tablets for oral administration. The tablets contain 5 mg and 7.5 mg of ivabradine, as the active ingredient, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride, respectively. The tablets contain the following inactive ingredients: colloidal silicon dioxide, glycerin, hypromellose, lactose monohydrate, magnesium stearate, maize starch, maltodextrin, polyethylene glycol, FD&C yellow#6, iron oxide red, iron oxide yellow, and titanium dioxide."
},
{
"NDCCode": "72205-336-18",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (72205-336-18) ",
"NDC11Code": "72205-0336-18",
"ProductNDC": "72205-336",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivabradine",
"NonProprietaryName": "Ivabradine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213483",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "IVABRADINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "Ivabradine tablets are a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: 1 To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. (1.1).",
"Description": "Ivabradine tablets contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one, hydrochloride. The molecular formula is C27H36N2O5.HCl, and the molecular weight (free base+ HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1.Figure 1. Chemical Structure of IvabradineTablets. Ivabradine tablets are supplied in 5 mg and 7.5 mg tablets for oral administration. The tablets contain 5 mg and 7.5 mg of ivabradine, as the active ingredient, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride, respectively. The tablets contain the following inactive ingredients: colloidal silicon dioxide, glycerin, hypromellose, lactose monohydrate, magnesium stearate, maize starch, maltodextrin, polyethylene glycol, FD&C yellow#6, iron oxide red, iron oxide yellow, and titanium dioxide."
},
{
"NDCCode": "16714-336-01",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-336-01)",
"NDC11Code": "16714-0336-01",
"ProductNDC": "16714-336",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077455",
"LabelerName": "NorthStar RX LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-05-29"
},
{
"NDCCode": "43063-336-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-336-60) ",
"NDC11Code": "43063-0336-60",
"ProductNDC": "43063-336",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19970911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040218",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100413",
"SamplePackage": "N"
},
{
"NDCCode": "43353-336-60",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (43353-336-60)",
"NDC11Code": "43353-0336-60",
"ProductNDC": "43353-336",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Synthroid",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020724",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021402",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "137",
"StrengthUnit": "ug/1",
"Pharm_Classes": "l-Thyroxine [EPC],Thyroxine [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Hypothyroidism. SYNTHROID is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. SYNTHROID is indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. : 1 Limitations of Use:.",
"Description": "SYNTHROID (levothyroxine sodium tablets, USP) contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown. SYNTHROID tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each SYNTHROID tablet contains the inactive ingredients acacia, confectioner's sugar (contains corn starch), lactose monohydrate, magnesium stearate, povidone, and talc. Each tablet strength meets USP Dissolution Test 3. Table 6 provides a listing of the color additives by tablet strength."
},
{
"NDCCode": "52686-336-60",
"PackageDescription": "1 TUBE in 1 CARTON (52686-336-60) > 56.45 g in 1 TUBE",
"NDC11Code": "52686-0336-60",
"ProductNDC": "52686-336",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Extra Smooth Sun Protection N",
"NonProprietaryName": "Octinoxate, Octocrylene, And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICA INC.",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE; ZINC OXIDE",
"StrengthNumber": "2766; 1694; 7056",
"StrengthUnit": "mg/56.45g; mg/56.45g; mg/56.45g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130201",
"SamplePackage": "N"
},
{
"NDCCode": "54860-336-01",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (54860-336-01) ",
"NDC11Code": "54860-0336-01",
"ProductNDC": "54860-336",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Keep Clean Advanced Hand Sanitizingspray 60ml",
"ProprietaryNameSuffix": "01",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201014",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Shenzhen Lantern Scicence Co.,Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201014",
"SamplePackage": "Y",
"IndicationAndUsage": "place enough product on hands to cover all surfaces,Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing."
},
{
"NDCCode": "68180-336-07",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-336-07) ",
"NDC11Code": "68180-0336-07",
"ProductNDC": "68180-336",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090692",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110930",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride extended-release tablets, USP contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is:. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ammonio methacrylate copolymer type A, ammonio methacrylate copolymer type B, colloidal silicone dioxide, crospovidone, dibutyl sebacate, hypromellose, magnesium stearate, microcrystalline cellulose and povidone. Metformin hydrochloride extended-release tablets USP meets USP Dissolution Test 12."
},
{
"NDCCode": "68382-336-14",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-336-14) ",
"NDC11Code": "68382-0336-14",
"ProductNDC": "68382-336",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203499",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180725",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide extended-release tablets is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis.",
"Description": "Glipizide extended-release tablets are an oral sulfonylurea. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido) ethyl] phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide, USP is a white to off-white powder, with a pKa of 5.9. It is freely soluble in dimethylformamide, soluble in 0.1N sodium hydroxide and slightly soluble in methylene chloride. Glipizide extended-release tablets are formulated as a once-a-day extended-release tablet for oral use and are designed to deliver 2.5 mg, 5 mg, or 10 mg of glipizide. Each glipizide extended-release tablet contains the following inactive ingredients: acetyltributyl citrate, colloidal silicon dioxide, hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer and polyethylene glycol. Additionally each 2.5 mg tablet contains: FD&C yellow #5 aluminum lake and titanium dioxide. Each 5 mg tablet contains: FD&C yellow #6 aluminum lake and titanium dioxide. The tablet is imprinted with opacode black S-1-17823 which contains following ingredients: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac. System Components and Performance. Glipizide extended-release tablets are formulated as once-a-day extended-release tablets and are designed to deliver glipizide at a controlled rate over approximately 20 hours. The dosage form is comprised of a hydrophilic cellulose polymer matrix tablet containing the drug which is surrounded by a seal coat followed by an enteric coating system. The enteric coat is insoluble in the low pH environment of the stomach. As the tablet passes through the stomach and enters in the higher pH environment of the small intestine, the enteric coating dissolves and/or erodes to expose the polymer matrix tablet which swells and releases the drug at a controlled rate via diffusion and/or erosion."
},
{
"NDCCode": "71205-336-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-336-60) ",
"NDC11Code": "71205-0336-60",
"ProductNDC": "71205-336",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204106",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2020-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate, is a beta1-selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets, USP are indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. (1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: sugar spheres, povidone, ethyl cellulose, polyethylene glycol, hydroxypropyl cellulose, triethyl citrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, polydextrose, hypromellose, and triacetin."
},
{
"NDCCode": "71610-336-53",
"PackageDescription": "60 TABLET in 1 BOTTLE (71610-336-53) ",
"NDC11Code": "71610-0336-53",
"ProductNDC": "71610-336",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074649",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190815",
"SamplePackage": "N",
"IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General). .",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as tablets of 200 mg. Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. C 15H 12N 2O. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Inactive Ingredients: Carbamazepine Tablets USP, 200 mg – ammonio methacrylate copolymer, corn starch, croscarmellose sodium, diethyl phthalate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "71610-336-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (71610-336-60) ",
"NDC11Code": "71610-0336-60",
"ProductNDC": "71610-336",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074649",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190815",
"SamplePackage": "N",
"IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General). .",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as tablets of 200 mg. Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. C 15H 12N 2O. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Inactive Ingredients: Carbamazepine Tablets USP, 200 mg – ammonio methacrylate copolymer, corn starch, croscarmellose sodium, diethyl phthalate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "75786-336-04",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (75786-336-04) ",
"NDC11Code": "75786-0336-04",
"ProductNDC": "75786-336",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "All Good Rose Geranium Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Elemental Herbs, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "76150-336-04",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (76150-336-04) ",
"NDC11Code": "76150-0336-04",
"ProductNDC": "76150-336",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "All Good Rose Geranium Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Bell International Laboratories, Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "76282-336-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (76282-336-60) ",
"NDC11Code": "76282-0336-60",
"ProductNDC": "76282-336",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trospium Chloride",
"NonProprietaryName": "Trospium Chloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091688",
"LabelerName": "Exelan Pharmaceuticals Inc.",
"SubstanceName": "TROSPIUM CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2020-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170711",
"SamplePackage": "N",
"IndicationAndUsage": "Trospium chloride tablet is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Trospium chloride, USP is a quaternary ammonium compound with the chemical name of Spiro[8azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride, USP is C25H30ClNO3 and its molecular weight is 427.97. The structural formula of trospium chloride is represented below. Trospium chloride, USP is a fine, colorless to slightly yellow, crystalline solid. The compound’s solubility in water is approximately 1 g per 2 mL. Each trospium chloride tablet contains 20 mg of trospium chloride, USP a muscarinic antagonist, for oral administration. Each tablet also contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hypromellose 2910, titanium dioxide, polyethylene glycol 400, polysorbate 80, xylitol, sucralose, red iron oxide and yellow iron oxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "72205-006-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (72205-006-60) ",
"NDC11Code": "72205-0006-60",
"ProductNDC": "72205-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Capecitabine",
"NonProprietaryName": "Capecitabine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209365",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "CAPECITABINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180721",
"SamplePackage": "N",
"IndicationAndUsage": "Capecitabine tablets are a nucleoside metabolic inhibitor indicated for:Colorectal Cancer: 1 adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1), 2 perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. (1.1), 3 treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1).",
"Description": "Capecitabine, USP is a nucleoside metabolic inhibitor. The chemical name is 5’-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular weight of 359.35. Capecitabine has the following structural formula. Capecitabine, USP is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20ºC. Capecitabine tablets, USP are supplied as oblong shaped, biconvex film coated tablets for oral administration. Each light peach to peach colored tablet contains 150 mg or 500 mg capecitabine, USP. The inactive ingredients in capecitabine tablets, USP include: anhydrous lactose, croscarmellose sodium, hypromellose, magnesium stearate and microcrystalline cellulose. The light peach or peach film coating contains hypromellose, talc, titanium dioxide, iron oxide red, ferrosoferric oxide and iron oxide yellow."
},
{
"NDCCode": "72205-039-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (72205-039-60) ",
"NDC11Code": "72205-0039-60",
"ProductNDC": "72205-039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dofetilide",
"NonProprietaryName": "Dofetilide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213220",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "DOFETILIDE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200612",
"SamplePackage": "N",
"IndicationAndUsage": "Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).Conversion of Atrial Fibrillation/Flutter Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.",
"Description": "Dofetilide capsules are an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is:N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]- methanesulfonamide. Dofetilide USP is a white to off-white powder. It is soluble in 1.0 N sodium hydroxide, acetone, 0.1N hydrochloric acid, very slightly soluble in isopropyl alcohol and insoluble in water. Dofetilide capsules contain the following inactive ingredients: magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose.The capsule shell contains titanium dioxide, FD&C yellow 6 and gelatin, additionally 125 mcg capsule shell contains D&C yellow 10 and FD&C red 40. The printing ink contains shellac, iron oxide black, propylene glycol and potassium hydroxide. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules."
},
{
"NDCCode": "72205-040-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (72205-040-60) ",
"NDC11Code": "72205-0040-60",
"ProductNDC": "72205-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dofetilide",
"NonProprietaryName": "Dofetilide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213220",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "DOFETILIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200612",
"SamplePackage": "N",
"IndicationAndUsage": "Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).Conversion of Atrial Fibrillation/Flutter Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.",
"Description": "Dofetilide capsules are an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is:N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]- methanesulfonamide. Dofetilide USP is a white to off-white powder. It is soluble in 1.0 N sodium hydroxide, acetone, 0.1N hydrochloric acid, very slightly soluble in isopropyl alcohol and insoluble in water. Dofetilide capsules contain the following inactive ingredients: magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose.The capsule shell contains titanium dioxide, FD&C yellow 6 and gelatin, additionally 125 mcg capsule shell contains D&C yellow 10 and FD&C red 40. The printing ink contains shellac, iron oxide black, propylene glycol and potassium hydroxide. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules."
},
{
"NDCCode": "72205-041-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (72205-041-60) ",
"NDC11Code": "72205-0041-60",
"ProductNDC": "72205-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dofetilide",
"NonProprietaryName": "Dofetilide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213220",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "DOFETILIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200612",
"SamplePackage": "N",
"IndicationAndUsage": "Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).Conversion of Atrial Fibrillation/Flutter Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.",
"Description": "Dofetilide capsules are an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is:N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]- methanesulfonamide. Dofetilide USP is a white to off-white powder. It is soluble in 1.0 N sodium hydroxide, acetone, 0.1N hydrochloric acid, very slightly soluble in isopropyl alcohol and insoluble in water. Dofetilide capsules contain the following inactive ingredients: magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose.The capsule shell contains titanium dioxide, FD&C yellow 6 and gelatin, additionally 125 mcg capsule shell contains D&C yellow 10 and FD&C red 40. The printing ink contains shellac, iron oxide black, propylene glycol and potassium hydroxide. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules."
},
{
"NDCCode": "72205-060-78",
"PackageDescription": "60 mL in 1 BOTTLE, GLASS (72205-060-78) ",
"NDC11Code": "72205-0060-78",
"ProductNDC": "72205-060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseltamivir Phosphate",
"NonProprietaryName": "Oseltamivir Phosphate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20220506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215313",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "OSELTAMIVIR PHOSPHATE",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220506",
"SamplePackage": "N",
"IndicationAndUsage": "Oseltamivir phosphate for oral suspension is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2) Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).",
"Description": "Oseltamivir phosphate, USP an influenza neuraminidase inhibitor (NAI), is available as: : 1 A powder for oral suspension, which when constituted with water as directed contains 6 mg per mL oseltamivir base. ."
},
{
"NDCCode": "72205-097-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72205-097-60) ",
"NDC11Code": "72205-0097-60",
"ProductNDC": "72205-097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20221007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214815",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221014",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam, USP is an antiepileptic drug available as 250 mg (white), 500 mg (yellow), 750 mg (orange), and 1,000 mg (white) tablets for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam, USP is a white to almost white powder. It is very soluble in water, freely soluble in methanol, soluble in acetonitrile, practically insoluble in n-heptane and n- hexane. Levetiracetam tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, colloidal silicon dioxide, croscarmellose sodium, povidone K30, talc, magnesium stearate, microcrystalline cellulose, titanium dioxide, polyethylene glycol, polyvinyl alcohol and additional agents listed below: 500 mg tablets: iron oxide yellow 750 mg tablets: FD&C yellow No. 6 aluminum lake. FDA approved dissolution method differs from the USP."
},
{
"NDCCode": "72205-099-78",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (72205-099-78) / 60 mL in 1 BOTTLE, GLASS",
"NDC11Code": "72205-0099-78",
"ProductNDC": "72205-099",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sirolimus",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20230119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216728",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230214",
"SamplePackage": "N",
"IndicationAndUsage": "Sirolimus oral solution is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation (1.1).Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1,1.2,14.3).",
"Description": "Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder Freely soluble in Chloroform, acetone, methanol, methylene dichloride and acetonitrile. Soluble in ethanol and ethyl acetate. Insoluble in water. Sirolimus is available for administration as an oral solution containing 1 mg/mL sirolimus. The inactive ingredients in sirolimus oral solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, sunflower seed oil glyceride, ethanol, soy fatty acids, ascorbyl palmitate and tocopherol) and polysorbate 80. Sirolimus oral solution contains 1.5% - 2.5% ethanol."
},
{
"NDCCode": "72205-139-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (72205-139-60) ",
"NDC11Code": "72205-0139-60",
"ProductNDC": "72205-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tofacitinib",
"NonProprietaryName": "Tofacitinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217299",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "TOFACITINIB CITRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260603",
"SamplePackage": "N",
"IndicationAndUsage": "Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib tablets are indicated for the treatment of adult patients with.",
"Description": "Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). Tofacitinib citrate is sparingly soluble in 20% aqueous acetic acid, slightly soluble in methanol, water and insoluble in dichloromethane. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a: 1 5 mg white to off white colored, round shaped, biconvex, immediate-release film-coated tablet. Each tablet of tofacitinib contains 5 mg tofacitinib (equivalent to 8.08 mg tofacitinib citrate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose,hypromellose, titanium dioxide, polyethylene glycol and triacetin. , 2 10 mg blue colored, round shaped, biconvex, immediate-release film-coated tablet. Each tablet of tofacitinib contains 10 mg tofacitinib (equivalent to 16.16 mg tofacitinib citrate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, triacetin, FD&C Blue No.2 and FD&C Blue No.1."
},
{
"NDCCode": "72205-140-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (72205-140-60) ",
"NDC11Code": "72205-0140-60",
"ProductNDC": "72205-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tofacitinib",
"NonProprietaryName": "Tofacitinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217299",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "TOFACITINIB CITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260603",
"SamplePackage": "N",
"IndicationAndUsage": "Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib tablets are indicated for the treatment of adult patients with.",
"Description": "Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). Tofacitinib citrate is sparingly soluble in 20% aqueous acetic acid, slightly soluble in methanol, water and insoluble in dichloromethane. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a: 1 5 mg white to off white colored, round shaped, biconvex, immediate-release film-coated tablet. Each tablet of tofacitinib contains 5 mg tofacitinib (equivalent to 8.08 mg tofacitinib citrate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose,hypromellose, titanium dioxide, polyethylene glycol and triacetin. , 2 10 mg blue colored, round shaped, biconvex, immediate-release film-coated tablet. Each tablet of tofacitinib contains 10 mg tofacitinib (equivalent to 16.16 mg tofacitinib citrate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, triacetin, FD&C Blue No.2 and FD&C Blue No.1."
},
{
"NDCCode": "72205-168-60",
"PackageDescription": "60 TABLET, COATED in 1 BOTTLE (72205-168-60) ",
"NDC11Code": "72205-0168-60",
"ProductNDC": "72205-168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Posaconazole",
"NonProprietaryName": "Posaconazole",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218434",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "POSACONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250401",
"SamplePackage": "N",
"IndicationAndUsage": "Posaconazole is an azole antifungal indicated as follows: 1 Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) o Posaconazole delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg.",
"Description": "Posaconazole is an azole antifungal agent. Posaconazole is available as delayed-release tablet intended for oral administration. Posaconazole is designated chemically as 4-[4-[4-[4-[[(3R,5R)-5-(2,4-difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with a molecular formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white to off-white color powder with a low aqueous solubility. Posaconazole delayed-release tablet is a yellow colored, capsule shaped, textured, biconvex film-coated tablets debossed with 'MP 1' on one side and plain on other side containing 100 mg of posaconazole. Each delayed-release tablet contains the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, iron oxide yellow, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide."
},
{
"NDCCode": "72205-184-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72205-184-60) ",
"NDC11Code": "72205-0184-60",
"ProductNDC": "72205-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Darunavir",
"NonProprietaryName": "Darunavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215389",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "DARUNAVIR",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231129",
"SamplePackage": "N",
"IndicationAndUsage": "Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].",
"Description": "Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir tablets contain the active ingredient darunavir, present as darunavir (amorphous) which has the following chemical name: [(1S,2R)-3-[[(4aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-carbamic acid(3R,3aS,6aR)hexahydrofuro[2,3-b]furan-3-yl ester. Its molecular formula is C27H37N3O7S and its molecular weight is 547.66. Darunavir (amorphous) has the following structural formula. Darunavir (Amorphous) is a white to off-white powder which is soluble in dichloromethane, sparingly soluble in methanol and insoluble in water. Darunavir 600 mg tablets: Beige colored, oval-shaped, biconvex, film-coated tablets, debossed with “M” on one side and “600” on other side. Darunavir 800 mg tablets: Brown colored, oval-shaped, biconvex, film-coated tablets, debossed with “M” on one side and “800” on other side. Each tablet also contains the inactive ingredients colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, magnesium stearate, polacrilin potassium, silicified microcrystalline cellulose and sodium chloride. The 600 mg tablet film coating contains iron oxide yellow, iron oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablet film coating, contains iron oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide."
},
{
"NDCCode": "72205-202-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (72205-202-60) ",
"NDC11Code": "72205-0202-60",
"ProductNDC": "72205-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213879",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240524",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine,N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C35H45N7O8S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, soluble in ethanol, and practically insoluble in ethyl acetate. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, magnesium stearate, talc, tartaric acid pellets. The capsule shell is composed of hypromellose, titanium dioxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac."
},
{
"NDCCode": "72205-203-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (72205-203-60) ",
"NDC11Code": "72205-0203-60",
"ProductNDC": "72205-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213879",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "110",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240814",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine,N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C35H45N7O8S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, soluble in ethanol, and practically insoluble in ethyl acetate. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, magnesium stearate, talc, tartaric acid pellets. The capsule shell is composed of hypromellose, titanium dioxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac."
},
{
"NDCCode": "72205-204-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (72205-204-60) ",
"NDC11Code": "72205-0204-60",
"ProductNDC": "72205-204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213879",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240524",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine,N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C35H45N7O8S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, soluble in ethanol, and practically insoluble in ethyl acetate. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, magnesium stearate, talc, tartaric acid pellets. The capsule shell is composed of hypromellose, titanium dioxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac."
},
{
"NDCCode": "72205-267-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (72205-267-60) ",
"NDC11Code": "72205-0267-60",
"ProductNDC": "72205-267",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brivaracetam",
"NonProprietaryName": "Brivaracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214921",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "BRIVARACETAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Epoxide Hydrolase Inhibitors [MoA]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260201",
"SamplePackage": "N",
"IndicationAndUsage": "Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older.",
"Description": "The chemical name of brivaracetam is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1H-pyrrol-1-yl] butanamide. Its molecular formula is C11H20N2O2 and its molecular weight is 212.29. The chemical structure is. Brivaracetam is a white to off-white crystalline powder. It is very soluble in water, in buffer (pH 1.2, 4.5, and 7.4), in ethanol, in methanol, and in glacial acetic acid. It is freely soluble in acetonitrile and in acetone and soluble in toluene. It is very slightly soluble in n-hexane.Tablets Brivaracetam tablets are for oral administration and contain the following inactive ingredients: anhydrous lactose, croscarmellose sodium, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose and film-coating agents specified below: 10 mg tablets: titanium dioxide, polyethylene glycol, talc. 25 mg tablets: titanium dioxide, polyethylene glycol, talc, iron oxide red. 50 mg tablets: titanium dioxide, polyethylene glycol, talc, iron oxide yellow. 75 mg tablets: titanium dioxide, polyethylene glycol, talc, iron oxide red, black iron oxide. 100 mg tablets: titanium dioxide, polyethylene glycol, talc, FD&C yellow No. 6."
}
]
}
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<NDCList>
<NDC>
<NDCCode>72205-336-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (72205-336-60) </PackageDescription>
<NDC11Code>72205-0336-60</NDC11Code>
<ProductNDC>72205-336</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ivabradine</ProprietaryName>
<NonProprietaryName>Ivabradine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213483</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>IVABRADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ivabradine tablets are a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: 1 To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. (1.1).</IndicationAndUsage>
<Description>Ivabradine tablets contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one, hydrochloride. The molecular formula is C27H36N2O5.HCl, and the molecular weight (free base+ HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1.Figure 1. Chemical Structure of IvabradineTablets. Ivabradine tablets are supplied in 5 mg and 7.5 mg tablets for oral administration. The tablets contain 5 mg and 7.5 mg of ivabradine, as the active ingredient, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride, respectively. The tablets contain the following inactive ingredients: colloidal silicon dioxide, glycerin, hypromellose, lactose monohydrate, magnesium stearate, maize starch, maltodextrin, polyethylene glycol, FD&C yellow#6, iron oxide red, iron oxide yellow, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72205-336-18</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (72205-336-18) </PackageDescription>
<NDC11Code>72205-0336-18</NDC11Code>
<ProductNDC>72205-336</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ivabradine</ProprietaryName>
<NonProprietaryName>Ivabradine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213483</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>IVABRADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ivabradine tablets are a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: 1 To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. (1.1).</IndicationAndUsage>
<Description>Ivabradine tablets contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one, hydrochloride. The molecular formula is C27H36N2O5.HCl, and the molecular weight (free base+ HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1.Figure 1. Chemical Structure of IvabradineTablets. Ivabradine tablets are supplied in 5 mg and 7.5 mg tablets for oral administration. The tablets contain 5 mg and 7.5 mg of ivabradine, as the active ingredient, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride, respectively. The tablets contain the following inactive ingredients: colloidal silicon dioxide, glycerin, hypromellose, lactose monohydrate, magnesium stearate, maize starch, maltodextrin, polyethylene glycol, FD&C yellow#6, iron oxide red, iron oxide yellow, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16714-336-01</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-336-01)</PackageDescription>
<NDC11Code>16714-0336-01</NDC11Code>
<ProductNDC>16714-336</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077455</ApplicationNumber>
<LabelerName>NorthStar RX LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>43063-336-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-336-60) </PackageDescription>
<NDC11Code>43063-0336-60</NDC11Code>
<ProductNDC>43063-336</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040218</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43353-336-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (43353-336-60)</PackageDescription>
<NDC11Code>43353-0336-60</NDC11Code>
<ProductNDC>43353-336</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Synthroid</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020724</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021402</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>137</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>l-Thyroxine [EPC],Thyroxine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hypothyroidism. SYNTHROID is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. SYNTHROID is indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. : 1 Limitations of Use:.</IndicationAndUsage>
<Description>SYNTHROID (levothyroxine sodium tablets, USP) contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown. SYNTHROID tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each SYNTHROID tablet contains the inactive ingredients acacia, confectioner's sugar (contains corn starch), lactose monohydrate, magnesium stearate, povidone, and talc. Each tablet strength meets USP Dissolution Test 3. Table 6 provides a listing of the color additives by tablet strength.</Description>
</NDC>
<NDC>
<NDCCode>52686-336-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52686-336-60) > 56.45 g in 1 TUBE</PackageDescription>
<NDC11Code>52686-0336-60</NDC11Code>
<ProductNDC>52686-336</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Extra Smooth Sun Protection N</ProprietaryName>
<NonProprietaryName>Octinoxate, Octocrylene, And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO AMERICA INC.</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE; ZINC OXIDE</SubstanceName>
<StrengthNumber>2766; 1694; 7056</StrengthNumber>
<StrengthUnit>mg/56.45g; mg/56.45g; mg/56.45g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54860-336-01</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (54860-336-01) </PackageDescription>
<NDC11Code>54860-0336-01</NDC11Code>
<ProductNDC>54860-336</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Keep Clean Advanced Hand Sanitizingspray 60ml</ProprietaryName>
<ProprietaryNameSuffix>01</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201014</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Shenzhen Lantern Scicence Co.,Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201014</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>place enough product on hands to cover all surfaces,Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68180-336-07</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-336-07) </PackageDescription>
<NDC11Code>68180-0336-07</NDC11Code>
<ProductNDC>68180-336</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090692</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets, USP contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is:. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ammonio methacrylate copolymer type A, ammonio methacrylate copolymer type B, colloidal silicone dioxide, crospovidone, dibutyl sebacate, hypromellose, magnesium stearate, microcrystalline cellulose and povidone. Metformin hydrochloride extended-release tablets USP meets USP Dissolution Test 12.</Description>
</NDC>
<NDC>
<NDCCode>68382-336-14</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-336-14) </PackageDescription>
<NDC11Code>68382-0336-14</NDC11Code>
<ProductNDC>68382-336</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203499</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide extended-release tablets is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis.</IndicationAndUsage>
<Description>Glipizide extended-release tablets are an oral sulfonylurea. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido) ethyl] phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide, USP is a white to off-white powder, with a pKa of 5.9. It is freely soluble in dimethylformamide, soluble in 0.1N sodium hydroxide and slightly soluble in methylene chloride. Glipizide extended-release tablets are formulated as a once-a-day extended-release tablet for oral use and are designed to deliver 2.5 mg, 5 mg, or 10 mg of glipizide. Each glipizide extended-release tablet contains the following inactive ingredients: acetyltributyl citrate, colloidal silicon dioxide, hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer and polyethylene glycol. Additionally each 2.5 mg tablet contains: FD&C yellow #5 aluminum lake and titanium dioxide. Each 5 mg tablet contains: FD&C yellow #6 aluminum lake and titanium dioxide. The tablet is imprinted with opacode black S-1-17823 which contains following ingredients: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac. System Components and Performance. Glipizide extended-release tablets are formulated as once-a-day extended-release tablets and are designed to deliver glipizide at a controlled rate over approximately 20 hours. The dosage form is comprised of a hydrophilic cellulose polymer matrix tablet containing the drug which is surrounded by a seal coat followed by an enteric coating system. The enteric coat is insoluble in the low pH environment of the stomach. As the tablet passes through the stomach and enters in the higher pH environment of the small intestine, the enteric coating dissolves and/or erodes to expose the polymer matrix tablet which swells and releases the drug at a controlled rate via diffusion and/or erosion.</Description>
</NDC>
<NDC>
<NDCCode>71205-336-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-336-60) </PackageDescription>
<NDC11Code>71205-0336-60</NDC11Code>
<ProductNDC>71205-336</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204106</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate, is a beta1-selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets, USP are indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. (1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: sugar spheres, povidone, ethyl cellulose, polyethylene glycol, hydroxypropyl cellulose, triethyl citrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, polydextrose, hypromellose, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>71610-336-53</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71610-336-53) </PackageDescription>
<NDC11Code>71610-0336-53</NDC11Code>
<ProductNDC>71610-336</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074649</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General). .</IndicationAndUsage>
<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as tablets of 200 mg. Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. C 15H 12N 2O. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Inactive Ingredients: Carbamazepine Tablets USP, 200 mg – ammonio methacrylate copolymer, corn starch, croscarmellose sodium, diethyl phthalate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>71610-336-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71610-336-60) </PackageDescription>
<NDC11Code>71610-0336-60</NDC11Code>
<ProductNDC>71610-336</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074649</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General). .</IndicationAndUsage>
<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as tablets of 200 mg. Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. C 15H 12N 2O. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Inactive Ingredients: Carbamazepine Tablets USP, 200 mg – ammonio methacrylate copolymer, corn starch, croscarmellose sodium, diethyl phthalate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>75786-336-04</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (75786-336-04) </PackageDescription>
<NDC11Code>75786-0336-04</NDC11Code>
<ProductNDC>75786-336</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>All Good Rose Geranium Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Elemental Herbs, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand washing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76150-336-04</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (76150-336-04) </PackageDescription>
<NDC11Code>76150-0336-04</NDC11Code>
<ProductNDC>76150-336</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>All Good Rose Geranium Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Bell International Laboratories, Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand washing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76282-336-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (76282-336-60) </PackageDescription>
<NDC11Code>76282-0336-60</NDC11Code>
<ProductNDC>76282-336</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trospium Chloride</ProprietaryName>
<NonProprietaryName>Trospium Chloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091688</ApplicationNumber>
<LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TROSPIUM CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trospium chloride tablet is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Trospium chloride, USP is a quaternary ammonium compound with the chemical name of Spiro[8azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride, USP is C25H30ClNO3 and its molecular weight is 427.97. The structural formula of trospium chloride is represented below. Trospium chloride, USP is a fine, colorless to slightly yellow, crystalline solid. The compound’s solubility in water is approximately 1 g per 2 mL. Each trospium chloride tablet contains 20 mg of trospium chloride, USP a muscarinic antagonist, for oral administration. Each tablet also contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hypromellose 2910, titanium dioxide, polyethylene glycol 400, polysorbate 80, xylitol, sucralose, red iron oxide and yellow iron oxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>72205-006-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (72205-006-60) </PackageDescription>
<NDC11Code>72205-0006-60</NDC11Code>
<ProductNDC>72205-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Capecitabine</ProprietaryName>
<NonProprietaryName>Capecitabine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209365</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>CAPECITABINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Capecitabine tablets are a nucleoside metabolic inhibitor indicated for:Colorectal Cancer: 1 adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1), 2 perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. (1.1), 3 treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1).</IndicationAndUsage>
<Description>Capecitabine, USP is a nucleoside metabolic inhibitor. The chemical name is 5’-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular weight of 359.35. Capecitabine has the following structural formula. Capecitabine, USP is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20ºC. Capecitabine tablets, USP are supplied as oblong shaped, biconvex film coated tablets for oral administration. Each light peach to peach colored tablet contains 150 mg or 500 mg capecitabine, USP. The inactive ingredients in capecitabine tablets, USP include: anhydrous lactose, croscarmellose sodium, hypromellose, magnesium stearate and microcrystalline cellulose. The light peach or peach film coating contains hypromellose, talc, titanium dioxide, iron oxide red, ferrosoferric oxide and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>72205-039-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (72205-039-60) </PackageDescription>
<NDC11Code>72205-0039-60</NDC11Code>
<ProductNDC>72205-039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dofetilide</ProprietaryName>
<NonProprietaryName>Dofetilide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213220</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>DOFETILIDE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).Conversion of Atrial Fibrillation/Flutter Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.</IndicationAndUsage>
<Description>Dofetilide capsules are an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is:N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]- methanesulfonamide. Dofetilide USP is a white to off-white powder. It is soluble in 1.0 N sodium hydroxide, acetone, 0.1N hydrochloric acid, very slightly soluble in isopropyl alcohol and insoluble in water. Dofetilide capsules contain the following inactive ingredients: magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose.The capsule shell contains titanium dioxide, FD&C yellow 6 and gelatin, additionally 125 mcg capsule shell contains D&C yellow 10 and FD&C red 40. The printing ink contains shellac, iron oxide black, propylene glycol and potassium hydroxide. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules.</Description>
</NDC>
<NDC>
<NDCCode>72205-040-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (72205-040-60) </PackageDescription>
<NDC11Code>72205-0040-60</NDC11Code>
<ProductNDC>72205-040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dofetilide</ProprietaryName>
<NonProprietaryName>Dofetilide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213220</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>DOFETILIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).Conversion of Atrial Fibrillation/Flutter Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.</IndicationAndUsage>
<Description>Dofetilide capsules are an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is:N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]- methanesulfonamide. Dofetilide USP is a white to off-white powder. It is soluble in 1.0 N sodium hydroxide, acetone, 0.1N hydrochloric acid, very slightly soluble in isopropyl alcohol and insoluble in water. Dofetilide capsules contain the following inactive ingredients: magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose.The capsule shell contains titanium dioxide, FD&C yellow 6 and gelatin, additionally 125 mcg capsule shell contains D&C yellow 10 and FD&C red 40. The printing ink contains shellac, iron oxide black, propylene glycol and potassium hydroxide. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules.</Description>
</NDC>
<NDC>
<NDCCode>72205-041-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (72205-041-60) </PackageDescription>
<NDC11Code>72205-0041-60</NDC11Code>
<ProductNDC>72205-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dofetilide</ProprietaryName>
<NonProprietaryName>Dofetilide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213220</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>DOFETILIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).Conversion of Atrial Fibrillation/Flutter Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.</IndicationAndUsage>
<Description>Dofetilide capsules are an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is:N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]- methanesulfonamide. Dofetilide USP is a white to off-white powder. It is soluble in 1.0 N sodium hydroxide, acetone, 0.1N hydrochloric acid, very slightly soluble in isopropyl alcohol and insoluble in water. Dofetilide capsules contain the following inactive ingredients: magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose.The capsule shell contains titanium dioxide, FD&C yellow 6 and gelatin, additionally 125 mcg capsule shell contains D&C yellow 10 and FD&C red 40. The printing ink contains shellac, iron oxide black, propylene glycol and potassium hydroxide. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules.</Description>
</NDC>
<NDC>
<NDCCode>72205-060-78</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, GLASS (72205-060-78) </PackageDescription>
<NDC11Code>72205-0060-78</NDC11Code>
<ProductNDC>72205-060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseltamivir Phosphate</ProprietaryName>
<NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215313</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oseltamivir phosphate for oral suspension is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2) Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).</IndicationAndUsage>
<Description>Oseltamivir phosphate, USP an influenza neuraminidase inhibitor (NAI), is available as: : 1 A powder for oral suspension, which when constituted with water as directed contains 6 mg per mL oseltamivir base. .</Description>
</NDC>
<NDC>
<NDCCode>72205-097-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72205-097-60) </PackageDescription>
<NDC11Code>72205-0097-60</NDC11Code>
<ProductNDC>72205-097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214815</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam, USP is an antiepileptic drug available as 250 mg (white), 500 mg (yellow), 750 mg (orange), and 1,000 mg (white) tablets for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam, USP is a white to almost white powder. It is very soluble in water, freely soluble in methanol, soluble in acetonitrile, practically insoluble in n-heptane and n- hexane. Levetiracetam tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, colloidal silicon dioxide, croscarmellose sodium, povidone K30, talc, magnesium stearate, microcrystalline cellulose, titanium dioxide, polyethylene glycol, polyvinyl alcohol and additional agents listed below: 500 mg tablets: iron oxide yellow 750 mg tablets: FD&C yellow No. 6 aluminum lake. FDA approved dissolution method differs from the USP.</Description>
</NDC>
<NDC>
<NDCCode>72205-099-78</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (72205-099-78) / 60 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>72205-0099-78</NDC11Code>
<ProductNDC>72205-099</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sirolimus</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216728</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sirolimus oral solution is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation (1.1).Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1,1.2,14.3).</IndicationAndUsage>
<Description>Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder Freely soluble in Chloroform, acetone, methanol, methylene dichloride and acetonitrile. Soluble in ethanol and ethyl acetate. Insoluble in water. Sirolimus is available for administration as an oral solution containing 1 mg/mL sirolimus. The inactive ingredients in sirolimus oral solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, sunflower seed oil glyceride, ethanol, soy fatty acids, ascorbyl palmitate and tocopherol) and polysorbate 80. Sirolimus oral solution contains 1.5% - 2.5% ethanol.</Description>
</NDC>
<NDC>
<NDCCode>72205-139-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (72205-139-60) </PackageDescription>
<NDC11Code>72205-0139-60</NDC11Code>
<ProductNDC>72205-139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tofacitinib</ProprietaryName>
<NonProprietaryName>Tofacitinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217299</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>TOFACITINIB CITRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib tablets are indicated for the treatment of adult patients with.</IndicationAndUsage>
<Description>Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). Tofacitinib citrate is sparingly soluble in 20% aqueous acetic acid, slightly soluble in methanol, water and insoluble in dichloromethane. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a: 1 5 mg white to off white colored, round shaped, biconvex, immediate-release film-coated tablet. Each tablet of tofacitinib contains 5 mg tofacitinib (equivalent to 8.08 mg tofacitinib citrate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose,hypromellose, titanium dioxide, polyethylene glycol and triacetin. , 2 10 mg blue colored, round shaped, biconvex, immediate-release film-coated tablet. Each tablet of tofacitinib contains 10 mg tofacitinib (equivalent to 16.16 mg tofacitinib citrate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, triacetin, FD&C Blue No.2 and FD&C Blue No.1.</Description>
</NDC>
<NDC>
<NDCCode>72205-140-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (72205-140-60) </PackageDescription>
<NDC11Code>72205-0140-60</NDC11Code>
<ProductNDC>72205-140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tofacitinib</ProprietaryName>
<NonProprietaryName>Tofacitinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217299</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>TOFACITINIB CITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib tablets are indicated for the treatment of adult patients with.</IndicationAndUsage>
<Description>Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). Tofacitinib citrate is sparingly soluble in 20% aqueous acetic acid, slightly soluble in methanol, water and insoluble in dichloromethane. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a: 1 5 mg white to off white colored, round shaped, biconvex, immediate-release film-coated tablet. Each tablet of tofacitinib contains 5 mg tofacitinib (equivalent to 8.08 mg tofacitinib citrate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose,hypromellose, titanium dioxide, polyethylene glycol and triacetin. , 2 10 mg blue colored, round shaped, biconvex, immediate-release film-coated tablet. Each tablet of tofacitinib contains 10 mg tofacitinib (equivalent to 16.16 mg tofacitinib citrate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, triacetin, FD&C Blue No.2 and FD&C Blue No.1.</Description>
</NDC>
<NDC>
<NDCCode>72205-168-60</NDCCode>
<PackageDescription>60 TABLET, COATED in 1 BOTTLE (72205-168-60) </PackageDescription>
<NDC11Code>72205-0168-60</NDC11Code>
<ProductNDC>72205-168</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Posaconazole</ProprietaryName>
<NonProprietaryName>Posaconazole</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218434</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>POSACONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Posaconazole is an azole antifungal indicated as follows: 1 Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) o Posaconazole delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg.</IndicationAndUsage>
<Description>Posaconazole is an azole antifungal agent. Posaconazole is available as delayed-release tablet intended for oral administration. Posaconazole is designated chemically as 4-[4-[4-[4-[[(3R,5R)-5-(2,4-difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with a molecular formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white to off-white color powder with a low aqueous solubility. Posaconazole delayed-release tablet is a yellow colored, capsule shaped, textured, biconvex film-coated tablets debossed with 'MP 1' on one side and plain on other side containing 100 mg of posaconazole. Each delayed-release tablet contains the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, iron oxide yellow, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72205-184-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72205-184-60) </PackageDescription>
<NDC11Code>72205-0184-60</NDC11Code>
<ProductNDC>72205-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Darunavir</ProprietaryName>
<NonProprietaryName>Darunavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215389</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>DARUNAVIR</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].</IndicationAndUsage>
<Description>Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir tablets contain the active ingredient darunavir, present as darunavir (amorphous) which has the following chemical name: [(1S,2R)-3-[[(4aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-carbamic acid(3R,3aS,6aR)hexahydrofuro[2,3-b]furan-3-yl ester. Its molecular formula is C27H37N3O7S and its molecular weight is 547.66. Darunavir (amorphous) has the following structural formula. Darunavir (Amorphous) is a white to off-white powder which is soluble in dichloromethane, sparingly soluble in methanol and insoluble in water. Darunavir 600 mg tablets: Beige colored, oval-shaped, biconvex, film-coated tablets, debossed with “M” on one side and “600” on other side. Darunavir 800 mg tablets: Brown colored, oval-shaped, biconvex, film-coated tablets, debossed with “M” on one side and “800” on other side. Each tablet also contains the inactive ingredients colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, magnesium stearate, polacrilin potassium, silicified microcrystalline cellulose and sodium chloride. The 600 mg tablet film coating contains iron oxide yellow, iron oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablet film coating, contains iron oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72205-202-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (72205-202-60) </PackageDescription>
<NDC11Code>72205-0202-60</NDC11Code>
<ProductNDC>72205-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dabigatran</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213879</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine,N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C35H45N7O8S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, soluble in ethanol, and practically insoluble in ethyl acetate. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, magnesium stearate, talc, tartaric acid pellets. The capsule shell is composed of hypromellose, titanium dioxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>72205-203-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (72205-203-60) </PackageDescription>
<NDC11Code>72205-0203-60</NDC11Code>
<ProductNDC>72205-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dabigatran</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240812</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213879</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>110</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine,N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C35H45N7O8S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, soluble in ethanol, and practically insoluble in ethyl acetate. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, magnesium stearate, talc, tartaric acid pellets. The capsule shell is composed of hypromellose, titanium dioxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>72205-204-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (72205-204-60) </PackageDescription>
<NDC11Code>72205-0204-60</NDC11Code>
<ProductNDC>72205-204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dabigatran</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213879</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine,N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C35H45N7O8S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, soluble in ethanol, and practically insoluble in ethyl acetate. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, magnesium stearate, talc, tartaric acid pellets. The capsule shell is composed of hypromellose, titanium dioxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>72205-267-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (72205-267-60) </PackageDescription>
<NDC11Code>72205-0267-60</NDC11Code>
<ProductNDC>72205-267</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brivaracetam</ProprietaryName>
<NonProprietaryName>Brivaracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214921</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>BRIVARACETAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Epoxide Hydrolase Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older.</IndicationAndUsage>
<Description>The chemical name of brivaracetam is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1H-pyrrol-1-yl] butanamide. Its molecular formula is C11H20N2O2 and its molecular weight is 212.29. The chemical structure is. Brivaracetam is a white to off-white crystalline powder. It is very soluble in water, in buffer (pH 1.2, 4.5, and 7.4), in ethanol, in methanol, and in glacial acetic acid. It is freely soluble in acetonitrile and in acetone and soluble in toluene. It is very slightly soluble in n-hexane.Tablets Brivaracetam tablets are for oral administration and contain the following inactive ingredients: anhydrous lactose, croscarmellose sodium, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose and film-coating agents specified below: 10 mg tablets: titanium dioxide, polyethylene glycol, talc. 25 mg tablets: titanium dioxide, polyethylene glycol, talc, iron oxide red. 50 mg tablets: titanium dioxide, polyethylene glycol, talc, iron oxide yellow. 75 mg tablets: titanium dioxide, polyethylene glycol, talc, iron oxide red, black iron oxide. 100 mg tablets: titanium dioxide, polyethylene glycol, talc, FD&C yellow No. 6.</Description>
</NDC>
</NDCList>